Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- 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
- 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
- K241292MyShoulder Planner (5.3SSWPL)2Cleared 510(K)
- K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)2Cleared 510(K)
- K241609Tornier Humeral Reconstruction System (Tornier HRS)2Cleared 510(K)
- K230513Arthrex Univers Apex OptiFit Humeral Stem2Cleared 510(K)
- K222592AltiVate® Anatomic Shoulder AG e+™ with Markers2Cleared 510(K)
- K230572AETOS Shoulder System2Cleared 510(K)
- K220847AETOS Shoulder System2Cleared 510(K)
- K222317Catalyst EA Convertible Stemmed Shoulder2Cleared 510(K)
- K213387AltiVate® Anatomic Shoulder AG e+™ with Markers2Cleared 510(K)
- K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid2Cleared 510(K)
- K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst)2Cleared 510(K)
- K212356Exactech® Equinoxe® Laser Cage Glenoid2Cleared 510(K)
- K212435Comprehensive Humeral Fracture Positioning Sleeves2Cleared 510(K)
- K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)2Cleared 510(K)
- K210050Augmented VaultLock Glenoid2Cleared 510(K)
- K203315BLUEPRINT™ Patient Specific Instrumentation2Cleared 510(K)
- K203230Global Shoulder and Delta CTA systems2Cleared 510(K)
- K203026AltiVate® Anatomic Pegged Glenoid with Markers2Cleared 510(K)
- K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)2Cleared 510(K)
- K193180Alliance Augmented Glenoid2Cleared 510(K)
- K191247SmartSPACE Shoulder System2Cleared 510(K)
- K191814Alliance Glenoid2Cleared 510(K)
- K190286Materialise Glenoid Positioning System2Cleared 510(K)
- K191318AEQUALIS FLEX REVIVE Shoulder System2Cleared 510(K)
- K190521Aequalis Ascend Flex Shoulder System2Cleared 510(K)
- K190290AltiVate Reverse Humeral Stem, 48mm2Cleared 510(K)
- K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads2Cleared 510(K)
- K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)2Cleared 510(K)
- K183042SMR Lateralized Connectors with screws2Cleared 510(K)
- K181555Arthrex Fracture Adapter Hemi Shoulder Prosthesis2Cleared 510(K)
- K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)2Cleared 510(K)
- K181420Aequalis Flex Revive Shoulder System2Cleared 510(K)
- K171841Arthrex Shoulder System2Cleared 510(K)
- K172054Materialise Glenoid Positioning System2Cleared 510(K)
- K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert2Cleared 510(K)
- K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)2Cleared 510(K)
- K170910Medacta Anatomic Shoulder Prosthesis2Cleared 510(K)
- K170893Materialise Glenoid Positioning System2Cleared 510(K)
- K162800BLUEPRINT Patient Specific Instrumentation2Cleared 510(K)
- K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal2Cleared 510(K)
- K161789BLUEPRINT Patient Specific Instrumentation2Cleared 510(K)
- K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)2Cleared 510(K)
- K162024AltiVate Anatomic Shoulder System2Cleared 510(K)
- K161108Arthrex VaultLock Glenoid2Cleared 510(K)
- K160975Aequalis PerFORM+ Shoulder System2Cleared 510(K)
- K160555BLUEPRINT Patient Specific Instrumentation2Cleared 510(K)
- K153602Materialise Glenoid Positioning System2Cleared 510(K)
- K153722SMR 3-Pegs Glenoids2Cleared 510(K)
- K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System2Cleared 510(K)
- K153215SmartBase for Arthrex Glenoid IRIS2Cleared 510(K)
- K152047INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid2Cleared 510(K)
- K152267Remedy® Shoulder Spacer2Cleared 510(K)
- K153115Arthrex Univers Apex, Size 5 Stem2Cleared 510(K)
- K151500Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)2Cleared 510(K)
- K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis2Cleared 510(K)
- K143256SMR Modular Glenoid2Cleared 510(K)
- K150583Aequalis PerFORM+ Shoulder System2Cleared 510(K)
- K143374BLUEPRINT Patient Specific Instrumentation2Cleared 510(K)
- K142403Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System2Cleared 510(K)
- K142072GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)2Cleared 510(K)
- K142413TITAN Modular Total Shoulder System2Cleared 510(K)
- K133349SMR TT METAL BACK GLENOID2Cleared 510(K)
- K133834DEPUY GLOBAL UNITE SHOULDER SYSTEM2Cleared 510(K)
- K140063EQUINOXE EXTRA SHORT HUMERAL HEAD2Cleared 510(K)
- K133462DUOCENTRIC REVERSED SHOULDER PROSTHESIS2Cleared 510(K)
- K130048REVERSE SHOULDER PROSTHESIS MONOBLOCK2Cleared 510(K)
- K131633ARTHREX UNIVERS APEX2Cleared 510(K)
- K131559MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES2Cleared 510(K)
- K131277SEVIIN FRACTURE SHOULDER2Cleared 510(K)
- K131129CAS PSI SHOULDER2Cleared 510(K)
- K130050TITAN REVERSE SHOULDER SYSTEM2Cleared 510(K)
- K130642SMR 3-PEGS GLENOIDS2Cleared 510(K)
- K131112LIMACORPORATE SMR CTA HUMERAL HEADS2Cleared 510(K)
- K130129UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM2Cleared 510(K)
- K123122GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)2Cleared 510(K)
- K123982TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+2Cleared 510(K)
- K122698AEQUALIS ASCEND FLEX SHOULDER SYSTEM2Cleared 510(K)
- K121220EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT2Cleared 510(K)
- K121493ASCEND SHOULDER SYSTEM2Cleared 510(K)
- K120794ASCEND SHOULDER SYSTEM2Cleared 510(K)
- K112438TITAN MODULAR TOTAL SHOULDER SYSTEM2Cleared 510(K)
- K113413ASCEND SHOULDER SYSTEM2Cleared 510(K)
- K120044ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED2Cleared 510(K)
- K113012PROMOS MODULAR SHOULDER SYSTEM2Cleared 510(K)
- K113309EXACTECH EQUINOXE CAGE GLENOIDS2Cleared 510(K)
- K111902AEQUALIS SHOULDER SYSTEM2Cleared 510(K)
- K111212SMR SHOULDER SYSTEM- REVISION STEMS2Cleared 510(K)
- K110847SMR SHOULDER SYSTEM - CTA HUMERAL HEADS2Cleared 510(K)
- K111596TOTAL SHOULDER SYSTEM2Cleared 510(K)
- K111379EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT2Cleared 510(K)
- K110905TOTAL SHOULDER SYSTEM2Cleared 510(K)
- K103835REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N2Cleared 510(K)
- K110865AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM2Cleared 510(K)
- K102924AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM2Cleared 510(K)
- K102670TOTAL SHOULDER SYSTEM2Cleared 510(K)
- K103466ARTHREX UNIVERS II SHOULDER PROSTHESIS2Cleared 510(K)
- K103419EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM2Cleared 510(K)
- K093599ARROW ANATOMICAL SHOULDER SYSTEM2Cleared 510(K)
- K103104SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT2Cleared 510(K)
- K103007AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM2Cleared 510(K)
- K093430EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD.2Cleared 510(K)
- K100448ASCENSION MODULAR TOTAL SHOULDER SYSTEM2Cleared 510(K)
- K091196GRS GLENOID RESURFACING SYSTEM2Cleared 510(K)
- K092122GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID2Cleared 510(K)
- K091751DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP2Cleared 510(K)
- K083435ARTHREX UNIVERS II SHOULDER PEGGED GLENOID2Cleared 510(K)
- K082120AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS2Cleared 510(K)
- K081707AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS2Cleared 510(K)
- K081620MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM2Cleared 510(K)
- K080402ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-382Cleared 510(K)
- K071032ARTHREX UNIVERS II SHOULDER PROSTHESIS2Cleared 510(K)
- K071090TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION2Cleared 510(K)
- K060694MODULAR HYBRID GLENOID2Cleared 510(K)
- K060988TOTAL AND HEMI SHOULDER SYSTEM2Cleared 510(K)
- K062029ANATOMICAL SHOULDER FRACTURE SYSTEM2Cleared 510(K)
- K062113SOLAR REUNION FRACTURE STEM2Cleared 510(K)
- K060874DEPUY GLOBAL AP SHOULDER SYSTEM2Cleared 510(K)
- K060209AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM2Cleared 510(K)
- K052472DEPUY GLOBAL SHOULDER CROSSLINK GLENOID2Cleared 510(K)
- K051623ANATOMICAL SHOULDER KEELED GLENOID2Cleared 510(K)
- K043346GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-002Cleared 510(K)
- K043077MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOULDER SYSTEM2Cleared 510(K)
- K043061THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX2Cleared 510(K)
- K042021EXACTECH EQUINOXE SHOULDER SYSTEM2Cleared 510(K)
- K041339AEQUALIS SHOULDER SYSTEM2Cleared 510(K)
- K040610VERSA-DIAL HUMERAL HEAD2Cleared 510(K)
- K033506COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE2Cleared 510(K)
- K032679AEQUALIS SHOULDER FRACTURE SYSTEM2Cleared 510(K)
- K031449MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION2Cleared 510(K)
- K030259AMATOMICAL SHOULDER WITH REMOVABLE HEAD2Cleared 510(K)
- K030344MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS2Cleared 510(K)
- K020345ARTHREX UNIVERS FRACTURE PROSTHESIS2Cleared 510(K)
- K012788VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II2Cleared 510(K)
- K0123783D HUMERAL HEADS2Cleared 510(K)
- K003324PLASMA SPRAYED SHOULDER2Cleared 510(K)
- K012212MODIFICATION TO AEQUALIS SHOULDER SYSTEM2Cleared 510(K)
- K010124ARTHREX UNIVERS 30 SHOULDER PROSTHESIS2Cleared 510(K)
- K003801ANATOMICAL PRESS-FIT HUMERAL STEM2Cleared 510(K)
- K003566COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS2Cleared 510(K)
- K003832SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM2Cleared 510(K)
- K003728MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM2Cleared 510(K)
- K002683WMT ULTRA-FIT MODULAR SHOULDER SYSTEM2Cleared 510(K)
- K001706WMT MODULAR SHOULDER SYSTEM2Cleared 510(K)
- K994393AEQUALIS UNIVERSAL SHOULDER GLENOID2Cleared 510(K)
- K001046BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS2Cleared 510(K)
- K994350NEER III TOTAL SHOULDER SYSTEM2Cleared 510(K)
- K000575GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD2Cleared 510(K)
- K994392AEQUALIS SHOULDER FRACTURE SYSTEM2Cleared 510(K)
- K992899BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS2Cleared 510(K)
- K992119BIO-MODULAR SHOULDER SYSTEM2Cleared 510(K)
- K980244AEQUALIS SHOULDER PROSTHESIS2Cleared 510(K)
- K992065GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEAD2Cleared 510(K)
- K990598OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD2Cleared 510(K)
- K990136ANATOMICA GLENOID COMPONENT2Cleared 510(K)
- K990137ANATOMICA HUMERAL STEM/HEAD COMPONENTS2Cleared 510(K)
- K981487DEPUY GLOBAL SHOULDER GLENOID2Cleared 510(K)
- K974044GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD2Cleared 510(K)
- K971715SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS2Cleared 510(K)
- K962224SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS2Cleared 510(K)
- K962082OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT2Cleared 510(K)
- K960906FOUNDATION GLENOID COMPONENT2Cleared 510(K)
- K955944OSTEONICS N2/VAC PACKAGING PROCESS2Cleared 510(K)
- K955767COFIED MODULAR SHOULDER SYSTEM2Cleared 510(K)
- K955731OSTEONICS SHOULDER HUMERAL COMPONENTS2Cleared 510(K)
- K952928AEQUALIS SHOULDER SYSTEM FOR TOTAL & HEMISHOULDER APPLICATIONS2Cleared 510(K)
- K950521OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT2Cleared 510(K)
- K950651TOTAL SHOULDER PROSTHESIS2Cleared 510(K)
- K935802SELECT(R) SHOULDER ALL POLY GLENOID2Cleared 510(K)
- K943300DEPUY POROUS COATED GLOBAL SHOULDER2Cleared 510(K)
- K9203623M MODULAR SHOULDER SYSTEM2Cleared 510(K)
- K904880BUECHEL-PAPPAS HUMERAL STEM COMPONENT2Cleared 510(K)
- K904879BEUCHEL-PAPPAS GLENOID COMPONENT2Cleared 510(K)
- K903886OSTEONICS SR GLENOID COMPONENTS2Cleared 510(K)
- K902855NEW JERSEY TOTAL SHOULDER GLENOID COMPONENT2Cleared 510(K)
- K901434PAPILLOTOME2Cleared 510(K)
- K895226NEER II TOTAL SHOULDER SYSTEM & PROSTHESIS2Cleared 510(K)
- K884943INTERMEDICS SELECT SHOULDER METAL-BACKED GLENOID2Cleared 510(K)
- K883816SHOULDER MICROSTRUCTURED HUMERAL PROSTHESIS2Cleared 510(K)
- K881750NORMAL HUMERAL PROSTHESIS2Cleared 510(K)
- K881836INTERMEDICS SELECT SHOULDER ALL PLASTIC GLEN. COMP2Cleared 510(K)
- K870262FENLIN II SHOULDER PROSTHESIS2Cleared 510(K)
- K862535OSTEONICS SHOULDER PROSTHESIS2Cleared 510(K)
- K855183COFIELD SHOULDER SYSTEM2Cleared 510(K)
- K852365LINK SHOULDER PROSTHESIS ENDO-MODEL SYSTEM2Cleared 510(K)
- K843624COFIELD SHOULDER SYSTEM2Cleared 510(K)
- K833410MONOSPHERICAL GLENOID PROSTH. KEEL2Cleared 510(K)
- K801970UCLA SHOULDER2Cleared 510(K)
- 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
TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K213827
- 510(k) Type
- Traditional
- Applicant
- Smith & Nephew, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/11/2022
- Days to Decision
- 93 days
- Submission Type
- Summary