Anesthesiology
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- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- NDHNail, Fixation, Bone, Metallic2Product Code
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- HRZProsthesis, Knee, Hinged (Metal-Metal)3Product Code
- HSAProsthesis, Knee, Hemi-, Femoral3Product Code
- HSBRod, Fixation, Intramedullary And Accessories2Product Code
- NDIStaple, Fixation, Bone, Metallic2Product Code
- HRSPlate, Fixation, Bone2Product Code
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented2Product Code
- HSHProsthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)2Product Code
- HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer2Product Code
- HTGProsthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented2Product Code
- HTNWasher, Bolt Nut2Product Code
- HTYPin, Fixation, Smooth2Product Code
- HWCScrew, Fixation, Bone2Product Code
- HXAProsthesis, Tendon, Passive2Product Code
- JDBProsthesis, Elbow, Semi-Constrained, Cemented2Product Code
- JDCProsthesis, Elbow, Constrained, Cemented2Product Code
- JDDProsthesis, Upper Femoral2Product Code
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal2Product Code
- JDHProsthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal3Product Code
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2Product Code
- JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)3Product Code
- JDNImplant, Fixation Device, Spinal2Product Code
- JDODevice, Fixation, Proximal Femoral, Implant2Product Code
- JDPCondylar Plate Fixation Implant2Product Code
- JDQCerclage, Fixation2Product Code
- JDRStaple, Fixation, Bone2Product Code
- JDSNail, Fixation, Bone2Product Code
- JDTCap, Bone1Product Code
- JDWPin, Fixation, Threaded2Product Code
- JECComponent, Traction, Invasive2Product Code
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- K253314Freedom Infinia™ Total Knee System2Cleared 510(K)
- K253144Freedom® Total Knee System – Titan PCK Components2Cleared 510(K)
- K252725Stem Extension Line (U2 Total Knee System—PSA Type)2Cleared 510(K)
- K251554Materialise TKA Guide System2Cleared 510(K)
- K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)2Cleared 510(K)
- K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)2Cleared 510(K)
- K251717Freedom® Total Knee System – Titanium Tibial Base Plate2Cleared 510(K)
- K242410NextStep Arthropedix Total Knee System2Cleared 510(K)
- K250889EXULT Knee Replacement System2Cleared 510(K)
- K250677LEGION Total Knee System2Cleared 510(K)
- K243991Klassic Knee System - Revision Tibial Baseplate2Cleared 510(K)
- K250382Freedom Total Knee System (All-poly Tibial Plate)2Cleared 510(K)
- K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)2Cleared 510(K)
- K244039MedalOne Total Knee System2Cleared 510(K)
- K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique2Cleared 510(K)
- K243817Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert2Cleared 510(K)
- K241180Consensus Knee System with TiNbN2Cleared 510(K)
- K243295Initia Knee System2Cleared 510(K)
- K243024Cellbrick Knee Spacer2Cleared 510(K)
- K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System2Cleared 510(K)
- K243277Freedom® Medial Congruent Liner2Cleared 510(K)
- K242984BKS Revision System2Cleared 510(K)
- K242377REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component2Cleared 510(K)
- K241570Unity Total Knee System2Cleared 510(K)
- K242401EXULT Knee Replacement System2Cleared 510(K)
- K240683Rx Knee System2Cleared 510(K)
- K234044ACS® LD FB Knee System2Cleared 510(K)
- K242046EXULT Knee Replacement System2Cleared 510(K)
- K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM™ NOILES™ Rotating Hinge Knee System; DePuy P.F.C. ™ SIGMA™ Total Knee System; DePuy SIGMA™ Total Knee System;2Cleared 510(K)
- K240863Freedom® Total Knee System2Cleared 510(K)
- K240327UNIKO PointCloud™ Knee Instruments2Cleared 510(K)
- K240875Unity Knee PS-C Tibial Insert2Cleared 510(K)
- K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System2Cleared 510(K)
- K240324EMPOWR Revision Symmetric Knee Cones2Cleared 510(K)
- K230120KeYi Total Knee System2Cleared 510(K)
- K232175XN Knee Prosthesis System2Cleared 510(K)
- K234011AMF TT Cones2Cleared 510(K)
- K231975PNK Total Knee System2Cleared 510(K)
- K230078TRAX® CR Total Knee System2Cleared 510(K)
- K231947EVOLUTION® Cement Keel2Cleared 510(K)
- K233093Balanced Knee® System TriMax PS Plus Tibial Insert2Cleared 510(K)
- K232414Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post2Cleared 510(K)
- K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System2Cleared 510(K)
- K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas2Cleared 510(K)
- K231037MyKnee UNI-ST2Cleared 510(K)
- K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component2Cleared 510(K)
- K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS2Cleared 510(K)
- K230537Klassic Knee Revision System2Cleared 510(K)
- K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates2Cleared 510(K)
- K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert2Cleared 510(K)
- K230169EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert2Cleared 510(K)
- K230555Cemented Tibia Baseplate no Taper with JRNY Lock2Cleared 510(K)
- K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface2Cleared 510(K)
- K230441EMPOWR Stem Extender, 50mm2Cleared 510(K)
- K230321Persona™ Personalized Knee System2Cleared 510(K)
- K222570COPAL knee moulds2Cleared 510(K)
- K223650REMEDY Stemmed Knee Spacer2Cleared 510(K)
- K222816Opulent TiNbN Coated Knee2Cleared 510(K)
- K221479Persona Personalized Knee System2Cleared 510(K)
- K223062World Total Knee System2Cleared 510(K)
- K222700Tibial baseplate, Tibial insert2Cleared 510(K)
- K222431b-ONER MOBIO Total Knee System2Cleared 510(K)
- K222380TriVerse Total Knee Replacement System2Cleared 510(K)
- K222278LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation2Cleared 510(K)
- K221939Cemented Round Patella with JRNY Pegs2Cleared 510(K)
- K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)2Cleared 510(K)
- K221337Materialise TKA Guide System2Cleared 510(K)
- K211877Klassic Knee System2Cleared 510(K)
- K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)2Cleared 510(K)
- K220705MyKnee R Pin Positioners2Cleared 510(K)
- K220896Legion Inserts with JRNY Lock2Cleared 510(K)
- K220737World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC)2Cleared 510(K)
- K213793EMPOWR Revision Knee2Cleared 510(K)
- K213673b-ONE MOBIO Total Knee System2Cleared 510(K)
- K213381Physica system2Cleared 510(K)
- K212034LOSPA TKR System2Cleared 510(K)
- K212839Opulent TiNbN Coated Knee2Cleared 510(K)
- K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System2Cleared 510(K)
- K212129Persona® Personalized Knee System2Cleared 510(K)
- K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)2Cleared 510(K)
- K212742GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating2Cleared 510(K)
- K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert2Cleared 510(K)
- K211671Journey II Mid-Level Tibial Inserts2Cleared 510(K)
- K210695CPM Medical Consultants Tibial Revision Knee System2Cleared 510(K)
- K211664GMK Sphere Revision2Cleared 510(K)
- K211602Klassic Knee System2Cleared 510(K)
- K211938Physica LMC Knee System2Cleared 510(K)
- K210829Persona Revision Knee System Femoral Metaphyseal Cones2Cleared 510(K)
- K211004GMK Spherika Femurs and Fixed Tibial Trays Plus2Cleared 510(K)
- K202924LinkSymphoKnee System2Cleared 510(K)
- K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)2Cleared 510(K)
- K210191Identity Imprint Knee Replacement System2Cleared 510(K)
- K200765Genius / Genuin Total Knee System2Cleared 510(K)
- K210961U2 Total Knee System, XPE Tibial Insert, PS PLUS2Cleared 510(K)
- K210483MOBIO Total Knee System2Cleared 510(K)
- K201611Apex Knee System2Cleared 510(K)
- K210551Persona Revision Knee System2Cleared 510(K)
- K210252iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System2Cleared 510(K)
- K202248Attune Revision Sleeve LPS Femoral Adaptors2Cleared 510(K)
- K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement2Cleared 510(K)
- K202684GMK Total Knee System - TiNbN Coating2Cleared 510(K)
- K200912Freedom(R) - TiNbN Coated Knee2Cleared 510(K)
- K202429Mobio Total Knee System2Cleared 510(K)
- K202740Klassic Knee System Tibial Inserts, PS-Max2Cleared 510(K)
- K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE)2Cleared 510(K)
- K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - Right2Cleared 510(K)
- K201343Triathlon Total KneeSystem2Cleared 510(K)
- K201023iTotal® Identity Posterior Stabilized Knee Replacement System2Cleared 510(K)
- K193540TRUMATCH Personalized Solutions2Cleared 510(K)
- K200227Journey II XR Knee Instrument2Cleared 510(K)
- K200653AMF Revision TT Cones2Cleared 510(K)
- K200395LOSPA II Knee System (EXULT Knee Replacement System)2Cleared 510(K)
- K200826Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks2Cleared 510(K)
- K200209Persona Personalized Knee System2Cleared 510(K)
- K200407LEGION Inserts with JRNY Lock2Cleared 510(K)
- K2000753DMetal Diaphyseal Femoral Cones2Cleared 510(K)
- K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System2Cleared 510(K)
- K193284Physica LMC Knee System2Cleared 510(K)
- K193057ATTUNE All-Polyethylene Tibia2Cleared 510(K)
- K193223Persona Personalized Knee System2Cleared 510(K)
- K192507LOSPA II Knee System2Cleared 510(K)
- K190577World Knee Total Knee Systems2Cleared 510(K)
- K190911Physica KR Liner and SMR Reverse Humeral Liner2Cleared 510(K)
- K182301PFC SIGMA Knee System2Cleared 510(K)
- K192084Madison Total Knee System2Cleared 510(K)
- K191765OMNI TiN Coated Apex Knee™ System2Cleared 510(K)
- K192148Freedom Primary PCK2Cleared 510(K)
- K191625Persona Revision Knee System2Cleared 510(K)
- K190402Triathlon Total Knee System-Additional Components2Cleared 510(K)
- K190562iTotal Identity Cruciate Retaining Knee Replacement System2Cleared 510(K)
- K191192SurgTech GENOLL Total Knee System2Cleared 510(K)
- K183017Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer2Cleared 510(K)
- K191755SPAR-K Instruments (for use with Gemini SL Total Knee System)2Cleared 510(K)
- K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee System2Cleared 510(K)
- K190068Vanguard XP Knee System2Cleared 510(K)
- K183533Unity Total Knee System2Cleared 510(K)
- K190355Precision Casting Solutions Total Knee System2Cleared 510(K)
- K182251EVOLUTION NitrX Medial-Pivot Knee2Cleared 510(K)
- K183583Vanguard Complete Knee System2Cleared 510(K)
- K181732InterSpace Knee Extra-Large Size, InterSpace Knee ATS2Cleared 510(K)
- K182872LINK GEMINI SL Total Knee System2Cleared 510(K)
- K183596Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly2Cleared 510(K)
- K183344The Progressive Orthopaedic Company Total Knee System II2Cleared 510(K)
- K190280Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly2Cleared 510(K)
- K183225Stabil Orthopaedic Solutions Total Knee System2Cleared 510(K)
- K183025MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component2Cleared 510(K)
- K182574Freedom Ultra-Congruent CR Tibial Liner2Cleared 510(K)
- K181338Imboki Knee Instrument System2Cleared 510(K)
- K182125EVOLUTION Stemmed CS Femur2Cleared 510(K)
- K183010Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks2Cleared 510(K)
- K182085Balanced Knee Revision System Trabecular Tibial Cone Augments2Cleared 510(K)
- K181947Persona Revision Knee System2Cleared 510(K)
- K181530World Total Knee System2Cleared 510(K)
- K181569BKS Revision Sleeves System2Cleared 510(K)
- K180446b-ONE Total Knee System2Cleared 510(K)
- K182370Acculoc Total Knee System2Cleared 510(K)
- K181635GMK Sphere CR Tibial Inserts2Cleared 510(K)
- K173890GMK Sphere - Kinematic Alignment2Cleared 510(K)
- K181146ASK System2Cleared 510(K)
- K180930EMPOWR VVC TIBIAL INSERT2Cleared 510(K)
- K180493A3 Total Knee System2Cleared 510(K)
- K180743Balanced Knee Revision System - Offset Junction Box2Cleared 510(K)
- K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement System2Cleared 510(K)
- K180750World Knee System2Cleared 510(K)
- K173057Zimmer Knee Joint Replacement Prostheses MR Labeling2Cleared 510(K)
- K170753Acculoc Total Knee System2Cleared 510(K)
- K180159Klassic® Knee System2Cleared 510(K)
- K180334LEGION Knee System2Cleared 510(K)
- K173723EMPOWR Universal Tibial Baseplate2Cleared 510(K)
- K173445Materialise TKA Guide System2Cleared 510(K)
- K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert2Cleared 510(K)
- K173884Unity Total Knee System2Cleared 510(K)
- K172336Smith & Nephew Patient Matched Cutting Blocks2Cleared 510(K)
- K171269X-PSI Knee System2Cleared 510(K)
- K172936Destiknee™ Total Knee System2Cleared 510(K)
- K173331JOURNEY II XR Knee Instruments2Cleared 510(K)
- K170534PROLIXUS TOTAL KNEE SYSTEM2Cleared 510(K)
- K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System2Cleared 510(K)
- K170106MyKnee PPS-Pin Positioners2Cleared 510(K)
- K1701493DMetal Tibial Cones2Cleared 510(K)
- K163167CKS Plus Knee System2Cleared 510(K)
- K171389EVOLUTION Revision CCK System2Cleared 510(K)
- K171054Biomet Knee Joint Replacement Prostheses2Cleared 510(K)
- K170613Genius Total Knee System2Cleared 510(K)
- K170808Unity Total Knee System2Cleared 510(K)
- K170806ATTUNE Cemented Tibial Base, Fixed Bearing2Cleared 510(K)
- K170573Empowr CR Knee Tibial Insert2Cleared 510(K)
- K170282Smith & Nephew VISIONAIRE Adaptive Guides2Cleared 510(K)
- K170648ANTHEM CR Total Knee System2Cleared 510(K)
- K171045Exactech® Truliant™ Line Extensions2Cleared 510(K)
- K163332Apex Revision Knee System2Cleared 510(K)
- K161705U2 Total Knee System E-XPE products2Cleared 510(K)
- K162035GMK Sphere2Cleared 510(K)
- K162026EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions2Cleared 510(K)
- K170240Truliant Femoral Components2Cleared 510(K)
- K161360U2 Total Knee System, PSA Tibial Insert2Cleared 510(K)
- K161414Anatomic Total Knee System2Cleared 510(K)
- K162775Legion Cone System2Cleared 510(K)
- K160771Destiknee Total Knee System2Cleared 510(K)
- K160515PS2 Knee System2Cleared 510(K)
- K160157LOSPA Modular Knee System2Cleared 510(K)
- K162273Materialise TKA Guide System2Cleared 510(K)
- K162422Klassic Knee System2Cleared 510(K)
- K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)2Cleared 510(K)
- K162222GENflex2 Total Knee System2Cleared 510(K)
- K160159Active-X Total Knee System2Cleared 510(K)
- K161668ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)2Cleared 510(K)
- K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)2Cleared 510(K)
- K160700ATTUNE Revision Knee System2Cleared 510(K)
- K160342EMPOWR PS Knee System2Cleared 510(K)
- K152430All Poly Tibial Component2Cleared 510(K)
- K153721iTotal Cruciate Retaining (CR) Knee Replacement System2Cleared 510(K)
- K153595Optetrak Logic Metaphyseal Cones2Cleared 510(K)
- K160484Optetrak Advanced Patella2Cleared 510(K)
- K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System2Cleared 510(K)
- K153217ConforMIS iTotal Posterior Stabilized Knee Replacement System2Cleared 510(K)
- K153437Apex Revision Knee System2Cleared 510(K)
- K153310Klassic Knee System2Cleared 510(K)
- K152494Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments2Cleared 510(K)
- K153075Klassic Knee System2Cleared 510(K)
- K152382Arthrex iBalance TKA System2Cleared 510(K)
- K152008Physica PS Knee System2Cleared 510(K)
- K152169Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts2Cleared 510(K)
- K150241Genesis II XLPE Resurfacing Patellar Components2Cleared 510(K)
- K152726JOURNEY II XR Knee System2Cleared 510(K)
- K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System2Cleared 510(K)
- K151266Physica CR Knee System2Cleared 510(K)
- K150829U2 Total Knee System- Additional Sizes2Cleared 510(K)
- K152170Exactech Optetrak Logic Enhanced Assembly2Cleared 510(K)
- K150928Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides2Cleared 510(K)
- K150783Progressive Orthopaedic Total Knee System2Cleared 510(K)
- K150496Total Knee Arthroplasty System2Cleared 510(K)
- K150890Exactech Optetrak Logic CC2Cleared 510(K)
- K150544Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System2Cleared 510(K)
- K143242Rebel 3DKNEE System2Cleared 510(K)
- K141934PHYSICA KR KNEE SYSTEM2Cleared 510(K)
- K143443VEGA Knee System, Columbus Total Knee System2Cleared 510(K)
- K142649Progressive Orthopedic Total Knee System2Cleared 510(K)
- K143725Consensus Knee System Modular Tibial Baseplate2Cleared 510(K)
- K143635KINETIS Total Knee System2Cleared 510(K)
- K150105Klassic Knee System-Sombrero Patella2Cleared 510(K)
- K143226Visionaire Disposable Instruments2Cleared 510(K)
- K143192Vanguard 360 Revision Knee System2Cleared 510(K)
- K142933Biomet Tibial trays2Cleared 510(K)
- K142807ANTHEM PS Total Knee System2Cleared 510(K)
- K142787Zimmer Persona Personalized Knee System2Cleared 510(K)
- K142404iTotal Posterior Stabilized (PS) Knee Replacement System2Cleared 510(K)
- K142388Neo Total Knee System2Cleared 510(K)
- K142069GMK EXTENSION2Cleared 510(K)
- K143106VEGA Knee System2Cleared 510(K)
- K143047Arthrex iBalance Patella Implant, Dome2Cleared 510(K)
- K140222SAIPH KNEE SYSTEM2Cleared 510(K)
- K142161ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM2Cleared 510(K)
- K141471JOURNEY II XR KNEE SYSTEM2Cleared 510(K)
- K142550EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments2Cleared 510(K)
- K141585SMITH & NEPHEW DISPOSABLE FIN PUNCH2Cleared 510(K)
- K140826GMK SPHERE EXTENSION2Cleared 510(K)
- K133919CONSENSUS VITALITE TIBIAL INSERT2Cleared 510(K)
- K140830EXPRT REVISION KNEE2Cleared 510(K)
- K140902E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1 SERIES PATELLAE, ASYMMETRICAL, 3-PEG2Cleared 510(K)
- K140833ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM2Cleared 510(K)
- K140073U2 FEMORAL COMPONENT, CR, CEMENTED2Cleared 510(K)
- K140555JOURNEY II BCS CONSTRAINED INSERTS2Cleared 510(K)
- K140423ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM2Cleared 510(K)
- K140027ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER2Cleared 510(K)
- K140942KLASSIC KNEE TIBIAL STEM EXTENSION2Cleared 510(K)
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- K012776DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT2Cleared 510(K)
- K012172DURACON PS LIPPED TIBIAL INSERT2Cleared 510(K)
- K012866THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-02Cleared 510(K)
- K012348MAXIM RPG PS FEMORAL COMPONENT2Cleared 510(K)
- K012251OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES2Cleared 510(K)
- K012095THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND 05-119-XXYY1-0 (IMPLEX)2Cleared 510(K)
- K011904NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO)2Cleared 510(K)
- K011976OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION)2Cleared 510(K)
- K011643SCORPIO CR SUPERFLEX TIBIAL INSERT2Cleared 510(K)
- K003182ORTHOGENESIS LPS SYSTEM2Cleared 510(K)
- K003026PFC SIGMA LUGGED TIBIAL TRAY2Cleared 510(K)
- K011288TC-PLUS POROUS TIBIAL COMPONENTS2Cleared 510(K)
- K011258TC-PLUS POROUS FEMORAL COMPONENTS2Cleared 510(K)
- K011219ASCENT KNEE SYSTEM2Cleared 510(K)
- K010101GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM2Cleared 510(K)
- K003910NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS2Cleared 510(K)
- K010434OPTETRAK B-SERIES TOTAL KNEE SYSTEM2Cleared 510(K)
- K001147ENHANCED POLYETHYLENE KNEE PROSTHESES2Cleared 510(K)
- K004013IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY2Cleared 510(K)
- K010027MAXIM KNEE SYSTEM2Cleared 510(K)
- K002740TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS2Cleared 510(K)
- K003296BIOMET SCK KNEE SYSTEM2Cleared 510(K)
- K002335NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA2Cleared 510(K)
- K000666TC-PLUS SOLUTION KNEE2Cleared 510(K)
- K002772ASCENT XXL CLOSED BOX FEMORAL COMPONENT2Cleared 510(K)
- K002735ASCENT XXL OPEN BOX FEMORAL COMPONENT2Cleared 510(K)
- K002678ASCENT KNEE SYSTEM2Cleared 510(K)
- K002281STELKAST PROVEN KNEE SYSTEM2Cleared 510(K)
- K001456CONSENSUS KNEE SYSTEM2Cleared 510(K)
- K994214GEM KNEE SYSTEM2Cleared 510(K)
- K000978ANATOMIC TOTAL KNEE PROSTHESIS2Cleared 510(K)
- K001307CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL XX-YYY-ZZZZZ2Cleared 510(K)
- K000590LATERAL PIVOT INSERT2Cleared 510(K)
- K001010ASCENT KNEE REVISION FEMORAL STEM2Cleared 510(K)
- K000113PROVEN KNEE SYSTEM2Cleared 510(K)
- K994370ORTHO DEVELOPMENT BALANCED KNEE SYSTEM2Cleared 510(K)
- K000091DURACON SYMMETRIC METAL-BACKED PATELLAR COMPONENT2Cleared 510(K)
- K994128SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEM2Cleared 510(K)
- K000232ROTAGLIDE + MODULAR KNEE SYSTEM WITH FIXED MENISCUS2Cleared 510(K)
- K994076IMPLEX HEDROCEL PS TIBIAL COMPONENT, MODEL HEDROCEL POSTERIOR STABILIZED TIBIAL COMPONENT 05-XXX-YYYYY2Cleared 510(K)
- K993371SADDLE SHAPED PATELLA2Cleared 510(K)
- K991882NEXFLEX TOTAL KNEE SYSTEM2Cleared 510(K)
- K993692DURACON INSET PATELLA, 25MM2Cleared 510(K)
- K991052FS 1000 KNEE SYSTEM2Cleared 510(K)
- K993159MAXIM KNEE SYSTEM2Cleared 510(K)
- K993111ASCENT KNEE SYSTEM2Cleared 510(K)
- K991753MAXIM REMOVABLE MOLDED POLY TIBIA2Cleared 510(K)
- K991581NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE CO2Cleared 510(K)
- K984054AGC V2 REVISION KNEE SYSTEM2Cleared 510(K)
- K992167PERFORMANCE KNEE SYSTEM2Cleared 510(K)
- K991143MAGNA-ROM 21 KNEE SYSTEEM2Cleared 510(K)
- K991106P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAY2Cleared 510(K)
- K991428ASCENT KNEE SYSTEM2Cleared 510(K)
- K991461OSTEONICS SCORPIO TOTAL KNEE RELAXED BACK P/S TIBIAL BEARING INSERT2Cleared 510(K)
- K972774GAS PLASMA STERILIZATION2Cleared 510(K)
- K983835IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA2Cleared 510(K)
- K981996TITANIUM FEMORAL COMPONENT2Cleared 510(K)
- K984623MAXIM REMOVABLE MOLDED POLY TIBIA2Cleared 510(K)
- K990030ADVANCED REVISION PRODUCT LINE EXTENSION2Cleared 510(K)
- K984291CONTINUUM KNEE SYSTEM COBALT CHROMIUM ALLOY TIBIAL COMPONENT2Cleared 510(K)
- K984158P.F.C. MODULAR PLUS OFFSET TIBIAL TRAY2Cleared 510(K)
- K983733SULZER ORTHOPEDICS APOLLO REVISION/CONSTRAINED KNEE TIBIAL BASEPLATE STEM PLUGS2Cleared 510(K)
- K980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION2Cleared 510(K)
- K980637IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT2Cleared 510(K)
- K980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION2Cleared 510(K)
- K983153NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS2Cleared 510(K)
- K983004CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI2Cleared 510(K)
- K980999ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT2Cleared 510(K)
- K982903SULZER ORTHOPEDICS FLUTED STEMS2Cleared 510(K)
- K982585DEPUY AMK TOTAL KNEE SYSTEM DEPUY COORDINATE ULTRA KNEE REVISION SYSTEM2Cleared 510(K)
- K982869ASCENT SYSTEM2Cleared 510(K)
- K982302IMPLEX CONTINUUM KNEE - HEDROCEL TIBIAL SPACERS2Cleared 510(K)
- K974843DURACON(R) SMALL STABILIZER TIBIAL INSERT2Cleared 510(K)
- K981560IMPLEX CONTINUUM KNEE SYSTEM: POROUS TIBIAL COMPONENT MODEL NUMBER 05-230 SYSTEM2Cleared 510(K)
- K980781IMPLEX CONTINUUM KNEE- HEDROCEL REVISION FEMORAL SPACERS2Cleared 510(K)
- K980713FEMORAL AND TIBIAL PLUGS OF INTERAX TOTAL KNEE SYSTEM2Cleared 510(K)
- K980545THE NUFFIELD TOTAL KNEE SYSTEM2Cleared 510(K)
- K980276STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM2Cleared 510(K)
- K974556OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM2Cleared 510(K)
- K974328ADVANCE TOTAL KNEE SYSTEM2Cleared 510(K)
- K972643DEPUY AMK 3 PEG PATELLA2Cleared 510(K)
- K972967OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT;OSTEONICS SCORPIO TOTAL KNEE RECESSED PATELLAR COMPONENT2Cleared 510(K)
- K973595THE POSTERIOR STABILISED NUFFIELD TOTAL KNEE SYSTEM2Cleared 510(K)
- K973672FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA2Cleared 510(K)
- K973524ADVANCE MODULAR TIBIAL COMPONENT2Cleared 510(K)
- K973406OSTEONICS SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT2Cleared 510(K)
- K973412NATURAL-KNEE II CONSTRAINED KNEE SYSTEM2Cleared 510(K)
- K972270NEXGEN COMPLETE KNEE SOLUTION CONVEX INSET PATELLA COMPONENT2Cleared 510(K)
- K973164HOWMEDICA TOTAL STABILIZER KNEE COMPONENTS2Cleared 510(K)
- K973121INTERAX TOTAL KNEE SYSTEM2Cleared 510(K)
- K972863DURATION STABILIZED UHMWPE KNEE COMPONENTS2Cleared 510(K)
- K972864DURATION STABILIZED UHMWPE KNEE COMP., WEAR CLAIMS2Cleared 510(K)
- K972770ADVANCE ULTRA-CONGRUENT TIBIAL INSERT2Cleared 510(K)
- K972752DURACON CONVERSION METAL BACKED PATELLA2Cleared 510(K)
- K972501APOLLO REVISION/CONSTRAINED KNEE SYSTEM2Cleared 510(K)
- K972626ADVANCE KNEE SYSTEM2Cleared 510(K)
- K971770APOLLO KNEE FEMORAL SPACERS2Cleared 510(K)
- K971789IMPLEX CONTINUUM POROUS PATELLAR2Cleared 510(K)
- K971189P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5)2Cleared 510(K)
- K971652P.F.C. SIGMA INSET PATELLA2Cleared 510(K)
- K971550KINEMATIC ALL-POLYETHYLENE PATELLA WITH THREE PEGS2Cleared 510(K)
- K965173DURATION STABILIZED UHMWPE KNEE COMPONENTS2Cleared 510(K)
- K970758DURACON EXTRA-SMALL STABILIZER TIBIAL INSERT & BASEPLATE2Cleared 510(K)
- K970498NATURAL-KNEE II REVISION FEMORAL SPACER LUGS2Cleared 510(K)
- K970031FOUNDATION KNEE SYSTEM TIBIAL COMPONENT2Cleared 510(K)
- K961021KIRSCHNER KNEE MODIFIED2Cleared 510(K)
- K964951KINEMAX PLUS TIBIAL SPACERS2Cleared 510(K)
- K963148NEXGEN COMPLETE KNEE SOLUTION2Cleared 510(K)
- K963255PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL INSERT2Cleared 510(K)
- K964008FOUNDATION KNEE SYSTEM2Cleared 510(K)
- K963796KINEMAX PLUS MODULAR STABILIZER FEMORAL COMPONENT AND FEMORAL SPACERS2Cleared 510(K)
- K962557GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT2Cleared 510(K)
- K963709CEMENT-ON FEMORAL STEM2Cleared 510(K)
- K960856KONSTRUCT PATELLAR COMPONENT2Cleared 510(K)
- K963242DURACON POSTERIOR FEMORAL SPACER2Cleared 510(K)
- K963117P.F.C. CRUCIATE RETAING KNEE SYSTEM2Cleared 510(K)
- K963028TIBIAL INSERT2Cleared 510(K)
- K962196NEXGEN KNEE PROSTHESIS & LEGACY KNEE PROSTHESIS W/CO-NIDIUM SURFACE HARDENING PROCESS2Cleared 510(K)
- K962152OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM2Cleared 510(K)
- K960976KINEMATIC II REPLACEMENT TIBIAL INSERTS2Cleared 510(K)
- K962137GENESIS II CONSTRAINED SYSTEM2Cleared 510(K)
- K961685P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)2Cleared 510(K)
- K961483DURACON ALL POLYETHYLENE PATELLA II2Cleared 510(K)
- K961482DURACON INSET PATELLA WITH CENTRAL PEG2Cleared 510(K)
- K961379DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501)2Cleared 510(K)
- K954818CONSENSUS POSTERIOR STABILIZED KNEE2Cleared 510(K)
- K934695NATURAL-KNEE TIBIAL BASEPLATE/ALL POLY PATELLA2Cleared 510(K)
- K960279NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES2Cleared 510(K)
- K953443CONSENSUS PCL SUBSITUTING TIBIAL INSERT2Cleared 510(K)
- K960535APOLLO TOTAL KNEE SYSTEM SINGLE LUG PATELLA2Cleared 510(K)
- K952943CONSENSUS ALL POLY TIBIA2Cleared 510(K)
- K951185NEXGEN COMPLETE KNEE SOLUTION 9MM ARTICULAR SURFACE2Cleared 510(K)
- K955884COORDINATE REVISION KNEE SYSTEM2Cleared 510(K)
- K943025FREEMAN/SAMUELSON TOTAL KNEE SYSTEM2Cleared 510(K)
- K954208OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY2Cleared 510(K)
- K955421OSTEONICS N2/VAC PACKAGING PROCESS2Cleared 510(K)
- K953274GENESIS POROUS TIBIAL TRAYS & REVISION KNEE SYSTEM2Cleared 510(K)
- K954909PROFIX POSTERIOR-STABILIZED KNEE SYSTEM2Cleared 510(K)
- K953439ULTRACK TOTAL KNEE SYSTEM2Cleared 510(K)
- K954684DEPUY ANATOMIC MODULAR KNEE (AMK) CONGRUENCY POSTERIOR STABILIZED TIBIAL INSERT2Cleared 510(K)
- K952830DARWIN KNEE SYSTEM (TC3)2Cleared 510(K)
- K954138DURACON MONOLITHIC STABILIZER FEMORAL COMPONENT2Cleared 510(K)
- K940861PCA(R) MODULAR TOTAL KNEE TIB INSERT DUROCON BASEPLATE2Cleared 510(K)
- K952271GENESIS CONSTRAINED SYSTEM (GCS)2Cleared 510(K)
- K951987GENESIS II TOTAL KNEE SYSTEM2Cleared 510(K)
- K944321S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II2Cleared 510(K)
- K951956OSTEONICS SERIES 7000 TOTAL KNEE FULL TIBIAL BONE AUGEMENTATION BLOCKS & WEDGES2Cleared 510(K)
- K936008DURACON BASEPLATES2Cleared 510(K)
- K946088GENESIS POSTERIOR STABILIZED (P/S) KNEE SYSTEM2Cleared 510(K)
- K951027DEPUY AMK CO-CR FINNED TIBIAL TRAY2Cleared 510(K)
- K951655DURACON RECESSED PATELLA2Cleared 510(K)
- K946150CRUCIATE RETAINING (AUGMENTABLE) AND CONSTRAINED CONDYLAR KNEE (CCK)2Cleared 510(K)
- K935523NATURAL-KNEE(R)/APOLLO(TM) KNEE2Cleared 510(K)
- K945589CONSENSUS(TM) KNEE COBALT CHROME NONPOROUS STEMMED TIBIAL BASEPLATE2Cleared 510(K)
- K936159NATURAL-KNEE II SYSTEM2Cleared 510(K)
- K935080INSALL-BURSTEIN II2Cleared 510(K)
- K950010DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED2Cleared 510(K)
- K932070DURACON STABILIZER FEMORAL COMPONENT AND INSERT2Cleared 510(K)
- K945087ORTHOLOC ADVANTIM POROUS COATED TIBIAL BASE2Cleared 510(K)
- K933494EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM2Cleared 510(K)
- K932690EXACTECH CRUCIATE RETAINING CEMENTED TOTAL KNEE SY2Cleared 510(K)
- K941306FOUNDATION KNEE AUGMENTATION BLOCKS2Cleared 510(K)
- K934381APOLLO KNEE TIBIAL BASEPLATE/KNEE TIBIAL INSERT2Cleared 510(K)
- K935789POSTERIOR STABILIZED APOLLO KNEE SYSTEM2Cleared 510(K)
- K941769KNEE PROTHESIS2Cleared 510(K)
- K940813OSTEONICS(R) SERIES 7000 TOTAL KNEE2Cleared 510(K)
- K933785NEXT GENERATION KNEE SYSTEM2Cleared 510(K)
- K943299DEPUY AMK ALL POLYETHYLENE POSTERIOR STABLILIZED TIBIAL TRAY2Cleared 510(K)
- K933229APOLLO KNEE FEMORAL COMPONENT2Cleared 510(K)
- K936274KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEM2Cleared 510(K)
- K941755ORTHOLOC ADVANTIM LSI POSTERIOR STABLIZED ALL POLYTHYLENE TIBIAL COMPONENT2Cleared 510(K)
- K933610EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS2Cleared 510(K)
- K933958RICHARDS TOTAL KNEE SYSTEM2Cleared 510(K)
- K943462DARWIN KNEE SYSTEM2Cleared 510(K)
- K944285OSTEONICS SERIES 7000 TOTAL KNEE FEMORAL COMPONENTS2Cleared 510(K)
- K944845ORTHOLOC ADVANTIM MODULAR FEMORAL AUGMENT COMPONENT2Cleared 510(K)
- K935773EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENT2Cleared 510(K)
- K931466PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI2Cleared 510(K)
- K940713PCA MODULAR PRIMARY/REVISION PATELLA2Cleared 510(K)
- K933539FOUNDATION POSTERIOR STABILIZED KNEE2Cleared 510(K)
- K935726EXACTECH POROUS COATED CRUCIATE RETAINED FEMORAL COMPONENT2Cleared 510(K)
- K932776CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTS2Cleared 510(K)
- K926334AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER2Cleared 510(K)
- K932677AXIOM TOTAL KNEE SYSTEM2Cleared 510(K)
- K931960NUFFIELD TOTAL KNEE2Cleared 510(K)
- K940235ORTHOLOC ADVANTIM PS LSI TIBIAL INSERT2Cleared 510(K)
- K936037S-ROM NOILES CRUCIATE RETAINING KNEE2Cleared 510(K)
- K932837CONSENSUS KNEE SYSTEM - PRIMARY KNEE2Cleared 510(K)
- K936079ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT2Cleared 510(K)
- K934166NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION2Cleared 510(K)
- K932210ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENT2Cleared 510(K)
- K934620ORTHOLOC ADVANTIM FIXED STEM NON-POROUS TIBIAL BASE2Cleared 510(K)
- K933290ORTHOLOC ADVANTIM2Cleared 510(K)
- K933289THICK TIBIAL INSERT2Cleared 510(K)
- K933843LINE EXTENSION FOR KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS COATED2Cleared 510(K)
- K932425FOUNDATION MODULAR TIBIAL BASEPLATE2Cleared 510(K)
- K932246FOUNDATION METAL-BACKED PATELLA2Cleared 510(K)
- K931651NATURAL-KNEE CONGRUENT TIBIAL INSERT WITH SCREW2Cleared 510(K)
- K934589KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM POROUS COATED2Cleared 510(K)
- K932911ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT2Cleared 510(K)
- K933867UNIVERSAL INSET PATELLA2Cleared 510(K)
- K935262P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA2Cleared 510(K)
- K934354LACEY ALL POLYETHYLENE TIBIAL COMPONENT2Cleared 510(K)
- K926228DURACON CRUCIFORM TIBIAL BASEPLATE2Cleared 510(K)
- K924482HOWMEDICAL TOTAL KNEE STEM EXTENDER2Cleared 510(K)
- K932858ORTHOLOC ADVANTIM TIBIAL BASE COMPONENT2Cleared 510(K)
- K931054TRICK MODULAR KNEE TIBIAL TRAY-POROUS2Cleared 510(K)
- K924340P.F.C. MOD TOTAL KNEE/CONDYL 3 FEM COMP TIB INSERT2Cleared 510(K)
- K925072AMK LANDMARK REVISION KNEE SYSTEM2Cleared 510(K)
- K925837AMK LANDMARK REVISION KNEE FULL WEDGE TIBIAL TRAY2Cleared 510(K)
- K930228ORTHOLOC ADVANTIM TIBIAL STEM 5 DEGREE2Cleared 510(K)
- K930831MG II POROUS KNEE SYSTEM FEMORAL COMPONENTS2Cleared 510(K)
- K924698AXIOM TOTAL KNEE SYSTEM, MODULAR TIBIAL TRAY2Cleared 510(K)
- K930595AXIOM TOTAL KNEE SYST, DUAL DOME ALL POLY TIB TRAY2Cleared 510(K)
- K922859ANATOMICAL TYPE KNEE SYSTEM2Cleared 510(K)
- K930554THE NATURAL-KNEE REVISION2Cleared 510(K)
- K922841BIOPRO MODULAR TIBIAL TRAY2Cleared 510(K)
- K933304ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED2Cleared 510(K)
- K925900LACEY REVISION FEMORAL COMPONENT2Cleared 510(K)
- K930189ORTHOLOC(R) ADVANTIM(TM) POSTERIOR STAB FEMOR COMP2Cleared 510(K)
- K930188ORTHOLOC(R) ADVANTIM(TM) FEMORAL COMPONENT2Cleared 510(K)
- K930190ORTHOLOC(R) ADVANTIM(TM) NON-POR COAT FEMOR COMP2Cleared 510(K)
- K921182ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT2Cleared 510(K)
- K922869TOTAL CONDYLAT TYPE KNEE SYSTEM2Cleared 510(K)
- K925242APOLLO(TM) KNEE SYSTEM2Cleared 510(K)
- K926257ORTHOLOC ADVANTIM THICK TIBIAL BASE COMPONENT2Cleared 510(K)
- K915525WHITESIDE ORTHOLOC(R) MODULAR REVISION FEMOR COMP2Cleared 510(K)
- K923443NATURAL-KNEE ALL-POLY TIBIA2Cleared 510(K)
- K925901KINEMAX(R) CONDYLAR TOTAL KNEE SYST FEMORAL SPACER2Cleared 510(K)
- K923573DURACON METAL BACKED PATELLA2Cleared 510(K)
- K924940FEMORAL & TIBIAL AUGMENT BLOCK2Cleared 510(K)
- K915798PSK POSTERIOR STABILIZED TOATAL KNEE2Cleared 510(K)
- K925372OSTEONICS(R) 700 SERIES TOTAL KNEE MOD FEMOR COMP2Cleared 510(K)
- K915584CRK CONDYLAR RESURFACING TOTAL KNEE2Cleared 510(K)
- K923277FOUNDATION KNEE SYSTEM2Cleared 510(K)
- K923807P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS2Cleared 510(K)
- K923451AMK MODULAR POROUS COATED TITANIUM TIBIAL TRAY2Cleared 510(K)
- K922734AXIOM TOTAL KNEE SYSTEM AND PLUS TOTAL KNEE SYSTEM2Cleared 510(K)
- K922048DURACON ALL PLASTIC TIBIAL COMPONENT2Cleared 510(K)
- K921640KINEMAX PLUS ALL PLASTIC TIBIAL COMPONENT2Cleared 510(K)
- K922620AMK FIXED STEM CEMENTED TIBIAL TRAY2Cleared 510(K)
- K920080CONTINUUM KNEE SYSTEM2Cleared 510(K)
- K915512DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS2Cleared 510(K)
- K922285AGC AND MAXIM KNEE COMPONENTS WITH NTS2Cleared 510(K)
- K9221047000 SERIES TOTAL KNEE MODULAR COMPONENT CEMENT CA2Cleared 510(K)
- K910992AMK TOTAL KNEE SYSTEM W/DU PONT ENHANCED UHMWPE2Cleared 510(K)
- K920396KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM2Cleared 510(K)
- K920426PSK FEMORAL AND TIBIAL INSERT COMPONENT2Cleared 510(K)
- K920698FEMORAL AND ALL POLY TIBIAL TRAY COMPONENTS2Cleared 510(K)
- K920524OSTEONICS 7000 SERIES TOTAL KNEE BONE AUGMENTATION2Cleared 510(K)
- K914565OSTEONICS 7000 POSTERIOR STAB. TOTAL KNEE FEM. COM2Cleared 510(K)
- K920034DURACON MODULAR FEMORAL COMPONENT AND FEMORAL SPAC2Cleared 510(K)
- K914072CONTINUUM KNEE SYSTEM (CKS)2Cleared 510(K)
- K9151927000 SERIES MODULAR TIBIAL COMPONENTS2Cleared 510(K)
- K9151867000 SERIES TOTAL KNEE PATELLAR COMPONENTS2Cleared 510(K)
- K915132MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM2Cleared 510(K)
- K914169WHITESIDE ORTHOLOC MOD.TIBIAL AUGMENTATION COMP2Cleared 510(K)
- K913492KIRSCHNER(R) HYBRIDFIT TOTAL KNEE SYSTEM2Cleared 510(K)
- K914230AXIOM TOTAL KNEE SYSTEM, ALL POLY TIBIAL TRAY2Cleared 510(K)
- K911972FREEMAN-SAMUELSON MODULAR TOTAL KNEE REPLACEMENT2Cleared 510(K)
- K912894AXIOM TOTAL KNEE SYSTEM, A/P CURVED TIBIAL INSERT2Cleared 510(K)
- K913188KINEMAX PLUS TIBIAL INSERT2Cleared 510(K)
- K912663NATURAL-KNEE ULTRA CONGRUENT TIBIAL INSERT2Cleared 510(K)
- K910940ANATOMIC MODULAR KNEE POLYETHYLENE TIBIAL TRAY2Cleared 510(K)
- K912266MODIFICATION AXIOM TOTAL KNEE SYST, PATELLAR COMP2Cleared 510(K)
- K912245AGC REVISION KNEE PROTHESIS2Cleared 510(K)
- K912147OSTEONICS 7000 SERIES STAND TOTAL KNEE FEMOR COMP2Cleared 510(K)
- K904448TOWNLEY TOTAL KNEE (TTK)2Cleared 510(K)
- K911572MG II POROUS COBAL T-CHROME FEMORAL COMPONENT2Cleared 510(K)
- K905613MTS KNEE SYSTEM2Cleared 510(K)
- K910235PCA MTK II TOTAL KNEE SYSTEM2Cleared 510(K)
- K910990OSTEONICS 7000 SERIES TOTAL KNEE TIBIAL COMPONENTS2Cleared 510(K)
- K905810NOILES(TM) TOTAL KNEE PROSTHESIS, MODIFICATION2Cleared 510(K)
- K910989OSTEONICS ION IMPLANTED TOTAL KNEE FEMORAL COMP2Cleared 510(K)
- K911197PLUS TOTAL KNEE SYST/AXIOM TOTAL KNEE SYSTEM2Cleared 510(K)
- K911198TIBIAL TRAY PMMA PLUG FOR PLUS/AXIOM TOTAL KNEE SY2Cleared 510(K)
- K910563P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL2Cleared 510(K)
- K910500HOWMEDICA KINEMAX PLUS TOTAL KNEE SYSTEM2Cleared 510(K)
- K904208KINEMAX SUPERSTABILIZER TOTAL KNEE SYSTEM2Cleared 510(K)
- K905076WHITESIDE ORTHOLOC MODULAR TIBIAL CONSTRAIN.INSERT2Cleared 510(K)
- K904205AMK MODULAR TIBIAL WEDGE SYSTEM2Cleared 510(K)
- K904300INSET PATELLAR COMPONENT2Cleared 510(K)
- K904170PCA (R) TIBIAL BONE WEDGES2Cleared 510(K)
- K901085DORR KNEE SYSTEM2Cleared 510(K)
- K902335NATURAL-KNEE SYSTEM SYSTEM W/COCR/CSTI(TM)2Cleared 510(K)
- K902246AMK UNIVERSAL FEMORAL COMPONENT2Cleared 510(K)
- K901406ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED2Cleared 510(K)
- K895145SECOND GENERATION KNEE SYSTEM, FEMORAL, PATELLAR2Cleared 510(K)
- K901936PLUS TOTAL KNEE SYST/PERI POST DESIGN TIBIAL COMP2Cleared 510(K)
- K901992WHITESIDE ORTHOLOC MODULAR POST. STAB. KNEE SYSTEM2Cleared 510(K)
- K901457CONTINUUM KNEE SYSTEM (CKS)2Cleared 510(K)
- K901338KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM2Cleared 510(K)
- K892503NUFFIELD TOTAL KNEE2Cleared 510(K)
- K896081WHITESIDE ORTHOLOC MODULAR METAL-BACKED PATELLA2Cleared 510(K)
- K896397S-ROM(TM)/NOILES(TM) MARK 5 KNEE2Cleared 510(K)
- K896542ADDITION TO THE CONTINUUM KNEE SYSTEM (CKS(TM))2Cleared 510(K)
- K895639MG II POROUS TOTAL KNEE SYSTEM/METAL-BACK PATELLAR2Cleared 510(K)
- K894403PCA MODULAR KNEE CONSTRAINED TIBIAL INSERT2Cleared 510(K)
- K894937SHAW KNEE MODULAR TIBIAL TRAY-POROUS2Cleared 510(K)
- K895962KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS2Cleared 510(K)
- K896045WHITESIDE ORTHOLOC MODULAR-C TOTAL KNEE SYSTEM2Cleared 510(K)
- K896452KINEMAX TIBIAL STEM EXTENSION2Cleared 510(K)
- K893040ORTHOMET PLUS TOTAL KNEE SYST, TITANIUM TIBIAL PEG2Cleared 510(K)
- K894658KINEMAX TOTAL KNEE SYSTEM FEMORAL SPACERS2Cleared 510(K)
- K894504WHITESIDE ORTHOLOC M.A. TIBIAL BASE2Cleared 510(K)
- K894334SECOND GENERATION KNEE SYSTEM2Cleared 510(K)
- K893762PLUS TOTAL KNEE SYSTEM, (PPD) TIBIAL COMPONENT2Cleared 510(K)
- K892800MG II POROUS TOTAL KNEE SYSTEM2Cleared 510(K)
- K893252WHITESIDE ORTHOLOC M.A. TOTAL KNEE SYSTEM2Cleared 510(K)
- K892394P.F.C. MODULAR KNEE SYSTEM, TIBIAL TRAY-POROUS2Cleared 510(K)
- K892366POROUS GENESIS STEMMED TIBIAL COMPONENT2Cleared 510(K)
- K890132POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP.2Cleared 510(K)
- K885036POROUS COATED GENESIS FEMORAL COMPONENT2Cleared 510(K)
- K884796P.F.C.(TM) MODULAR KNEE SYSTEM2Cleared 510(K)
- K882322CONTINUUM KNEE SYSTEM (CKS)2Cleared 510(K)
- K884338LACEY POSTERIOR STABILIZED KNEE SYSTEM2Cleared 510(K)
- K884410OMNIFIT TOTAL KNEE SERIES III,IV & POST. STAB. FEM2Cleared 510(K)
- K884398OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS2Cleared 510(K)
- K883122AMK TOTAL KNEE SYSTEM WITHOUT POROCOAT2Cleared 510(K)
- K883215KIRSCHNER TC-IV/NON POR COAT/TOTAL CONDYLAR KNEE S2Cleared 510(K)
- K882234JOHNSON & JOHNSON MODULAR TOTAL KNEE PROSTHESIS2Cleared 510(K)
- K874923PCA MODULAR TOTAL KNEE-UNIVERSAL TIBIAL BASEPLATE2Cleared 510(K)
- K881982PCA MODULAR TOTAL KNEE SYS-ALL PLAS PATELLAR COMP2Cleared 510(K)
- K874635OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES2Cleared 510(K)
- K875201PLUS TOTAL KNEE SYSTEM, POLY TIBIAL PEG2Cleared 510(K)
- K873602INTERMEDICS' NATURAL-KNEE(R) REVISION SYSTEM2Cleared 510(K)
- K874547KIRSCHNER PERFORM TOTAL KNEE SYSTEM POROUS COATED2Cleared 510(K)
- K872379INSALL/BURSTEIN* II MODULAR TOTAL KNEE2Cleared 510(K)
- K873197AMK TOTAL KNEE SYSTEM, PATELLA COMPONENT2Cleared 510(K)
- K872134PLUS TOTAL KNEE SYSTEM, POLY PATELLAR BUTTON2Cleared 510(K)
- K871349HOWMEDICA KINEMATIC II MODULAR TIBIAL COMPONENT2Cleared 510(K)
- K872266CLARIFIED APPLICA. FOR LACEY CONDYLAR TOTAL KNEE2Cleared 510(K)
- K871776WHITESIDE ORTHOLOC II REV POST STAB TOTAL KNEE SY2Cleared 510(K)
- K871146GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS)2Cleared 510(K)
- K871585MODIFIED ANATOMIC MODULAR KNEE (AMK) SYSTEM2Cleared 510(K)
- K870273LACEY METAL BACKED PATELLA PROSTHESIS2Cleared 510(K)
- K871772KINEMATIC III POST CRUCIATE TOTAL CONDYLAR KNEE SY2Cleared 510(K)
- K871769OMNIFIT(R) TOTAL KNEE SYSTEM (MODIFICATION)2Cleared 510(K)
- K870730NOILES TOTAL KNEE PROSTHESIS2Cleared 510(K)
- K870702ADG PATELLAR COMPONENT2Cleared 510(K)
- K864632P.C.A. MODULAR KNEE SYSTEM2Cleared 510(K)
- K864518LACEY PRESS-FIT CONDYLAR TOTAL KNEE2Cleared 510(K)
- K864671ANATOMIC MODULAR KNEE (AMK) SYSTEM2Cleared 510(K)
- K864627WHITESIDE ORTHOLOC II METAL BACKED PATELLA2Cleared 510(K)
- K863668OMNIFIT (TM) TOTAL KNEE PROSTHESIS SYSTEM2Cleared 510(K)
- K863667MODIFIED SYNATOMIC KNEE PATELLA PROSTHESIS2Cleared 510(K)
- K863805MILLER/GALANTE TOTAL KNEE POR COATED PATELLAR DOME2Cleared 510(K)
- K861266HOWMEDICA KINEMATIC PLUS KNEE SYSTEM2Cleared 510(K)
- K860654M.C.R. KNEE PROSTHESIS (SERIES 3000)2Cleared 510(K)
- K860594SYNATOMIC REVISION FEMORAL PROSTHESIS2Cleared 510(K)
- K855166THACKRAY TOTAL CONDYLAR KNEES2Cleared 510(K)
- K853991HOFMANN KNEE2Cleared 510(K)
- K854883OMKNEE SYSTEM2Cleared 510(K)
- K853661MILLAR/GALANTE PRECOATED TOTAL KNEE2Cleared 510(K)
- K852059THE P.C.A. DOME PATELLA COMPONENT2Cleared 510(K)
- K851231RMC POSTERIOR STABILIZED KNEE SYSTEM2Cleared 510(K)
- K843907POROUS COATED TITANIUM KNEE PROSTHES-2Cleared 510(K)
- K843242TRICON M TIBIAL COMPONENT2Cleared 510(K)
- K843241TRICON-P TIBIAL COMPONENT2Cleared 510(K)
- K834432ANTHRO-MODULAR TOTAL KNEE2Cleared 510(K)
- K833363CLOUTIER II FIBER METAL TOTAL KNEE2Cleared 510(K)
- K840100PATELLA PROSTHESIS2Cleared 510(K)
- K833921AGC TOTAL KNEE PROSTHESIS2Cleared 510(K)
- K833411KNEE PROSTHESIS-PATELLA COMPONENT2Cleared 510(K)
- K830927KNEE PROSTHESIS-TIBIAL COMPONENT2Cleared 510(K)
- K830121INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE2Cleared 510(K)
- K813598101 TOTAL CONDYLAR KNEE SYSTEM2Cleared 510(K)
- K810328BIO CONDYLAR TM KNEE2Cleared 510(K)
- K810326POROCOAT TM TOWNLEY ANATOMIC KNEE2Cleared 510(K)
- K802922POROUS COATED ANATOMICAL-TOTAL KNEE2Cleared 510(K)
- K792089THE HOWMEDICA KINEMATIC KNEE SYSTEM2Cleared 510(K)
- K790219PROTHESIS, RETAINED GEOMETRIC KNEE2Cleared 510(K)
- K781294PROSTHESIS, KNEE, TOTAL2Cleared 510(K)
- K772225PATELLAR PROSTHESIS2Cleared 510(K)
- K771598PATELLA PROSTHESIS/TRAIL COMPONENT2Cleared 510(K)
- K760200PROSTHESIS, PATELLAR ARTICULAR SURFACE2Cleared 510(K)
- JWIProsthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained2Product Code
- JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained2Product Code
- KIGProsthesis, Wrist, Constrained, Polymer2Product Code
- KMBProsthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented2Product Code
- KMCProsthesis, Hip, Semi-Constrained, Composite/Metal2Product Code
- KMDProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite2Product Code
- KRNMetal Cemented Constrained Femorotibial Knee Prosthesis3Product Code
- KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2Product Code
- KRPProsthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal3Product Code
- KRQProsthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- KRSProsthesis, Knee, Hemi-, Femoral (Uncemented)3Product Code
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component2Product Code
- KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component2Product Code
- KTXProsthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented2Product Code
- KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)3Product Code
- KWBProsthesis, Hip, Hemi-, Acetabular, Cemented, Metal3Product Code
- KWDProsthesis, Toe, Hemi-, Phalangeal2Product Code
- KWEProsthesis, Finger, Constrained, Metal, Uncemented3Product Code
- KWFProsthesis, Finger, Polymer2Product Code
- KWGProsthesis, Finger, Constrained, Metal/Polymer3Product Code
- KWHProsthesis, Toe, Constrained, Polymer2Product Code
- KWIProsthesis, Elbow, Hemi-, Radial, Polymer2Product Code
- KWJProsthesis, Elbow, Hemi-, Humeral, Metal3Product Code
- KWKAppliance, Nail/Blade/Plate Combination, Single Component2Product Code
- KWLProsthesis, Hip, Hemi-, Femoral, Metal2Product Code
- KWMProsthesis, Wrist, Semi-Constrained2Product Code
- KWNProsthesis, Wrist, Carpal Lunate2Product Code
- KWOProsthesis, Wrist, Carpal Scaphoid2Product Code
- KWPAppliance, Fixation, Spinal Interlaminal2Product Code
- KWQAppliance, Fixation, Spinal Intervertebral Body2Product Code
- KWRProsthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented3Product Code
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented2Product Code
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2Product Code
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented2Product Code
- KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer2Product Code
- KXAProsthesis, Hip, Femoral, Resurfacing2Product Code
- KXBProsthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer3Product Code
- KXCProsthesis, Ankle, Cemented, Non-Constrained3Product Code
- KXDProsthesis, Hip, Constrained, Metal3Product Code
- KXEProsthesis, Wrist, Hemi-, Ulnar2Product Code
- KYIProsthesis, Wrist, Carpal Trapezium2Product Code
- KYJProsthesis, Finger, Constrained, Polymer2Product Code
- KYKProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite2Product Code
- KYMMetallic Cemented Glenoid Hemi-Shoulder Prosthesis3Product Code
- KYNProsthesis, Wrist, Constrained, Metal3Product Code
- LBCProsthesis, Finger, Constrained, Metal, Cemented3Product Code
- LGEProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing2Product Code
- LODBone Cement2Product Code
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2Product Code
- LRNWire, Surgical2Product Code
- LTOSpacer, Cement3Product Code
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented2Product Code
- LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite2Product Code
- LYPAccessories, Fixation, Spinal Interlaminal2Product Code
- LYTFixation Accessory2Product Code
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2Product Code
- LZYProsthesis, Hip, Hemi-, Femoral, Metal Ball2Product Code
- MAIFastener, Fixation, Biodegradable, Soft Tissue2Product Code
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar2Product Code
- MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish2Product Code
- MBBBone Cement, Antibiotic2Product Code
- MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented2Product Code
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer2Product Code
- MBIFastener, Fixation, Nondegradable, Soft Tissue2Product Code
- MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous2Product Code
- MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)2Product Code
- MBVProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer2Product Code
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate2Product Code
- MJWProsthesis, Subtalar, Plug, Polymer2Product Code
- MNHOrthosis, Spondylolisthesis Spinal Fixation2Product Code
- MNIOrthosis, Spinal Pedicle Fixation2Product Code
- MNUStaple, Absorbable2Product Code
- MQPSpinal Vertebral Body Replacement Device2Product Code
- MQVFiller, Bone Void, Calcium Compound2Product Code
- MRYAppliances And Accessories, Fixation, Bone, Absorbable Single/Multiple Component2Product Code
- NDDCerclage, Fixation, Metallic2Product Code
- NDERod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible2Product Code
- NDFPlate, Fixation, Bone, Non-Spinal, Metallic2Product Code
- NDGWasher, Bolt, Nut, Non-Spinal, Metallic2Product Code
- NDJScrew, Fixation, Bone, Non-Spinal, Metallic2Product Code
- NDKSystem, External Fixator (With Metallic Invasive Components)2Product Code
- NDLPin, Fixation, Smooth, Metallic2Product Code
- NDMPin, Fixation, Threaded, Metallic2Product Code
- NDNCement, Bone, Vertebroplasty2Product Code
- NJAAccessory, System, External Fixator, Containing Antimicrobial Agent2Product Code
- NJDProsthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer2Product Code
- NKBThoracolumbosacral Pedicle Screw System2Product Code
- NKGPosterior Cervical Screw System2Product Code
- NOVAnchor, Suture, Bone Fixation, Metallic2Product Code
- NPJProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- NQPPosterior Metal/Polymer Spinal System, Fusion2Product Code
- NQWOrthosis, Spine, Plate, Laminoplasty, Metal2Product Code
- NUDVertebroplasty Compound, Calcium Based2Product Code
- NVCBone, Heterograft3Product Code
- NWNLaparoscopic Bone Anchor Urethropexy Instrument Kit2Product Code
- OBLCement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty2Product Code
- OBMCement, Bone, Vertebroplasty, Pre-Formed, Modular2Product Code
- OBTPlate, Bone, Growth Control, Pediatric, Epiphysiodesis2Product Code
- OCGProsthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented3Product Code
- ODPIntervertebral Fusion Device With Bone Graft, Cervical2Product Code
- OISCalcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation2Product Code
- OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive2Product Code
- OJBResorbable Spinal Intervertebral Body Fixation Orthosis - Plate2Product Code
- OJMResorbable Spinal Intervertebral Body Fixation Orthosis - Mesh2Product Code
- OOGKnee Arthroplasty Implantation System2Product Code
- OOLElectronic Depth Gauge2Product Code
- OQBIntervertebral Body Graft Containment Device2Product Code
- OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented2Product Code
- OQHHip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented2Product Code
- OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented2Product Code
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis2Product Code
- OSNSoftware For Diagnosis/Treatment2Product Code
- OURSacroiliac Joint Fixation2Product Code
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar2Product Code
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical2Product Code
- OVZPin, Fixation, Resorbable, Hard Tissue2Product Code
- OWIBone Fixation Cerclage, Sublaminar2Product Code
- OYKAnkle Arthroplasty Implantation System2Product Code
- OZIInternal Hinged Elbow Fixator2Product Code
- PAOProsthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented2Product Code
- PBFOrthopaedic Surgical Planning And Instrument Guides2Product Code
- PBIProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive2Product Code
- PEKSpinous Process Plate2Product Code
- PHMIntervertebral Fusion Device With Bone Graft, Thoracic2Product Code
- PHQAnterior Staple As Supplemental Fixation For Fusion2Product Code
- PHXShoulder Prosthesis, Reverse Configuration2Product Code
- PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained2Product Code
- PLFBone Wedge2Product Code
- PLRSpinal Vertebral Body Replacement Device - Cervical2Product Code
- PLWAcetabular Cup Orientation System2Product Code
- PMLBone Cement, Posterior Screw Augmentation2Product Code
- PPQTranstibial Anterior Cruciate Ligament Kit2Product Code
- QHQTotal Shoulder Arthroplasty System2Product Code
- PQCPedicle Screw Placement Guide2Product Code
- QACScrew Sleeve Bone Fixation Device2Product Code
- QADRod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated2Product Code
- QFPIntraoperative Orthopedic Strain Sensor2Product Code
- QHEShoulder Arthroplasty Implantation System2Product Code
- QNIResorbable Implant For Anterior Cruciate Ligament (Acl) Repair2Product Code
- QPPImplantable Post-Surgical Kinematic Measurement Knee Device2Product Code
- QPQShoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed2Product Code
- JDJMesh, Surgical, Acetabular, Hip, Prosthesis2Product Code
- JDKProsthesis, Hip, Cement Restrictor2Product Code
- LZNCement Obturator2Product Code
- OLCScaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen2Product Code
- QSDPosterior Cervical Screw Placement Guide2Product Code
- QSRSacroiliac Screw Placement Guide2Product Code
- QVIScrew Sleeve Bone Fixation Device, Spine2Product Code
- QUWMesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament2Product Code
- QWJMesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament2Product Code
- SAIAnkle Fusion Cage2Product Code
- SCYSacroiliac Joint Guidewire Placement Device2Product Code
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
GMK Sphere Revision
- Page Type
- Cleared 510(K)
- 510(k) Number
- K211664
- 510(k) Type
- Traditional
- Applicant
- Medacta International S.A.
- Country
- Switzerland
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/29/2021
- Days to Decision
- 58 days
- Submission Type
- Summary