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
- 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
- K251718ArTT Augments and Buttresses and Bone Screws2Cleared 510(K)
- K250989Stryker and Serf hip devices2Cleared 510(K)
- K243456ONVOY™ Acetabular System2Cleared 510(K)
- K242744Trinity EVO Acetabular Shell2Cleared 510(K)
- K242232Mpact 3D Metal Augments II2Cleared 510(K)
- K242045Initia T3 Acetabular Hemispherical Shell System2Cleared 510(K)
- K243784Stryker Orthopaedics Hip Devices Labeling Update2Cleared 510(K)
- K243977EMPHASYS Acetabular System2Cleared 510(K)
- K241059Pantheon Proximal Femur Reconstruction (PFR) System2Cleared 510(K)
- K241636MobileLink Acetabular Cup System - Line Extension (Multiple)2Cleared 510(K)
- K242833Legend® Acetabular Shell2Cleared 510(K)
- K242375OR3O Dual Mobility System2Cleared 510(K)
- K242084EMPHASYS Acetabular Shell with RapiTite HA2Cleared 510(K)
- K240046Ethylene Oxide Sterilization Supplier Change for MPO Hips2Cleared 510(K)
- K231522EMPHASYS™ Dual Mobility System2Cleared 510(K)
- K233498Stryker Orthopaedics Hip Systems Labeling Update2Cleared 510(K)
- K232667OR3O Dual Mobility Liners2Cleared 510(K)
- K232556DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System2Cleared 510(K)
- K230011Mpact Extension2Cleared 510(K)
- K222436Latitud™ Hip Replacement System2Cleared 510(K)
- K222066LINK MobileLink Acetabular Cup System2Cleared 510(K)
- K223223BENCOX Mirabo Z Cup Cortinium2Cleared 510(K)
- K223779EMPOWR™ blade stem2Cleared 510(K)
- K223348My3D® Personalized Pelvic Reconstruction2Cleared 510(K)
- K211047CoCr Head2Cleared 510(K)
- K221675United U2 femoral head, 22mm delta ceramic head2Cleared 510(K)
- K213842ONVOY Acetabular System2Cleared 510(K)
- K220336Mg-PSZ Ceramic Femoral Head2Cleared 510(K)
- K221636EMPHASYS Acetabular System2Cleared 510(K)
- K220959OR3O Dual Mobility System2Cleared 510(K)
- K212815My3D® Personalized Pelvic Reconstruction2Cleared 510(K)
- K211176Smith & Nephew Hip Systems2Cleared 510(K)
- K201348DePuy 3D Additive TriFlange Acetabular Cup2Cleared 510(K)
- K210614BENCOX Mirabo Z Cup Cortinium2Cleared 510(K)
- K220468BENCOX Mirabo Cup System2Cleared 510(K)
- K212761Biocore9 Acetabular Cup System2Cleared 510(K)
- K220376Acetabular Dome Hole Plug2Cleared 510(K)
- K212187Restoration® Modular Hip System2Cleared 510(K)
- K211330R3 Large Head Liners2Cleared 510(K)
- K202568Mpact® 3D Metal Implants - DMLS Technology2Cleared 510(K)
- K200011E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS2Cleared 510(K)
- K211866Bencox THR System2Cleared 510(K)
- K201733Provident II Hip Stems2Cleared 510(K)
- K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters2Cleared 510(K)
- K200391MPACT Extension2Cleared 510(K)
- K210893Restoration Anatomic Shell2Cleared 510(K)
- K203557EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing2Cleared 510(K)
- K202472ACTIS Duofix Hip Prosthesis2Cleared 510(K)
- K202484Cordera Hip System2Cleared 510(K)
- K200854DePuy PINNACLE Dual Mobility Liner2Cleared 510(K)
- K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head2Cleared 510(K)
- K200656Delta Multihole TT Pro Acetabular System2Cleared 510(K)
- K193233Restoration® Modular Hip System2Cleared 510(K)
- K191826KeYi Total Hip System2Cleared 510(K)
- K192450Precision Casting Solutions Total Hip System2Cleared 510(K)
- K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings2Cleared 510(K)
- K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene2Cleared 510(K)
- K192919Pinnacle Duofix HA Acetabular Cup Prosthesis2Cleared 510(K)
- K192198Conformis Hip System2Cleared 510(K)
- K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head2Cleared 510(K)
- K191622Delta Multihole TT Pro Acetabular System2Cleared 510(K)
- K191002OR3O Dual Mobility System2Cleared 510(K)
- K190847REDAPT Blade Augments2Cleared 510(K)
- K191358Trident II Acetabular System2Cleared 510(K)
- K192071iNSitu Total Hip System2Cleared 510(K)
- K190904Conformis BeneFIT Hip System2Cleared 510(K)
- K191936iNSitu Total Hip System2Cleared 510(K)
- K183129Medtronic Total Hip Arthroplasty System2Cleared 510(K)
- K190123MicroPort CoCr Femoral Heads2Cleared 510(K)
- K190057DJO Acetabular System2Cleared 510(K)
- K182678Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling2Cleared 510(K)
- K182221Bencox Mirabo Cup Multi Hole2Cleared 510(K)
- K183582MPACT Extension2Cleared 510(K)
- K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System2Cleared 510(K)
- K182502Alteon Acetabular Cup System2Cleared 510(K)
- K190276Provident II Hip Stem2Cleared 510(K)
- K182099Delta TT Pro2Cleared 510(K)
- K182109REDAPT Modular Acetabular Shell2Cleared 510(K)
- K181366REDAPT Porous Acetabular Shell2Cleared 510(K)
- K172857Latitud Hip Replacement System2Cleared 510(K)
- K180798Prime Acetabular Cup System2Cleared 510(K)
- K172551Trinity PLUS Acetabular Shell2Cleared 510(K)
- K173951Legend Acetabular Liners2Cleared 510(K)
- K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™2Cleared 510(K)
- K172456Bone Screws 6.5mm2Cleared 510(K)
- K171934Birmingham Hip (BH) Dual Mobility Insert2Cleared 510(K)
- K171073Smith & Nephew, Inc. REDAPT Augments2Cleared 510(K)
- K172251UTS Stem2Cleared 510(K)
- K172806Bencox Mirabo Cup System2Cleared 510(K)
- K172684Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem2Cleared 510(K)
- K171768Trident® II Acetabular System2Cleared 510(K)
- K172501iNSitu Total Hip System2Cleared 510(K)
- K171962Klassic HD® Hip System2Cleared 510(K)
- K162957U2 Femoral Head2Cleared 510(K)
- K170444PROCOTYL® PRIME Acetabular Cup System2Cleared 510(K)
- K162719iTotal® Hip Replacement System2Cleared 510(K)
- K163193UTF Stem, reduced, #0, #002Cleared 510(K)
- K162127Bencox M Stem Lateralized & Bencox Mirabo Cup System2Cleared 510(K)
- K161073Klassic HD Hip System2Cleared 510(K)
- K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws2Cleared 510(K)
- K161184iNSitu Total Hip System2Cleared 510(K)
- K151424The Progressive Orthopaedic Total Hip System2Cleared 510(K)
- K161190G7 Dual Mobility System, Active Articulation System2Cleared 510(K)
- K153345Stryker Orthopaedics Hip Systems Labeling Update2Cleared 510(K)
- K161080Escalade Legend Acetabular Shell2Cleared 510(K)
- K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug2Cleared 510(K)
- K160266ICONACY(TM) I-Hip(TM)2Cleared 510(K)
- K150790REDAPT Porous Acetabular Shell and Cemented Liner2Cleared 510(K)
- K151603Arcos One-piece Femoral Revision System2Cleared 510(K)
- K151440Klassic HD Hip System2Cleared 510(K)
- K141960Exactech® Novation® Crown Cup®2Cleared 510(K)
- K151448Continuum and Trilogy Integrated Taper (IT) Acetabular Systems2Cleared 510(K)
- K151316U2 Hip Stem, Ti Porous Coated, Matrix2Cleared 510(K)
- K151264Restoration Anatomic Shell2Cleared 510(K)
- K150007Modified Bencox Hip System2Cleared 510(K)
- K150522G7 Dual Mobility System2Cleared 510(K)
- K150503Echo Bi-Metric Microplasty Line Extension2Cleared 510(K)
- K143453Mpact Double Mobility System2Cleared 510(K)
- K143314Progressive Orthopaedic Total Hip System2Cleared 510(K)
- K142119PROCOTYL L-O ACETABULAR SYSTEM2Cleared 510(K)
- K142882G7 Freedom and Offset Liners, Freedom Head, Size 322Cleared 510(K)
- K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach2Cleared 510(K)
- K142606Trident® Tritanium® PST® Acetabular Shells2Cleared 510(K)
- K142201OMNI Interface Acetabular System2Cleared 510(K)
- K140547EXCERA FITRITE TOTAL HIP ARTHROPLASTY SYSTEM2Cleared 510(K)
- K142746G7 Finned Acetabular Shell2Cleared 510(K)
- K143009Echo Bi-Metric Microplasty Hip System2Cleared 510(K)
- K140669G7 OSSEOTI ACETUBLAR SHELLS2Cleared 510(K)
- K142462Restoration Anatomic Shell2Cleared 510(K)
- K141676RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM2Cleared 510(K)
- K141001ALPINE HIP STEM; ALPINE HA HIP STEM2Cleared 510(K)
- K141797ALTEON 6.5MM BONE SCREWS2Cleared 510(K)
- K133370REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE2Cleared 510(K)
- K141395DELTA TT ACETABULAR SYSTEM2Cleared 510(K)
- K132697ENCOMPASS 10/12 HIP STEM2Cleared 510(K)
- K141043CS2 MULTI-HOLE ACETABULAR SHELL2Cleared 510(K)
- K132312RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM2Cleared 510(K)
- K132572I-HIP TOTAL HIP SYSTEM2Cleared 510(K)
- K133832KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUS2Cleared 510(K)
- K133386OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM2Cleared 510(K)
- K132959DEPUY PINNACLE ALTRX ACETABULAR LINERS2Cleared 510(K)
- K132158NOVOHIP TOTAL HIP SYSTEM2Cleared 510(K)
- K131454KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEAD2Cleared 510(K)
- K132879MPACT EXTENSION2Cleared 510(K)
- K133228ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEM2Cleared 510(K)
- K131022OVATION 10/12 HIP STEM2Cleared 510(K)
- K132626PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)2Cleared 510(K)
- K132207UTF STEM-REDUCED, ADDITIONAL SIZES2Cleared 510(K)
- K131279ICONACY I-HIP SYSTEM2Cleared 510(K)
- K130353PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)2Cleared 510(K)
- K130099TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_0192Cleared 510(K)
- K131237PIPELINE TOTAL HIP SYSTEM2Cleared 510(K)
- K130149U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE2Cleared 510(K)
- K123550UTF STEM, REDUCED2Cleared 510(K)
- K120599DEPUY M-SPEC 36MM FEMORAL HEADS2Cleared 510(K)
- K130063ARCOS TROCHANTER BUTTON2Cleared 510(K)
- K121297ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR2Cleared 510(K)
- K112898DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS2Cleared 510(K)
- K122512CS2 HIP SYSTEM2Cleared 510(K)
- K122636REVELATION POROUS COATED HIP STEM, SIZE 82Cleared 510(K)
- K123012SMITH & NEPHEW SMF HIP STEM2Cleared 510(K)
- K121636ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT2Cleared 510(K)
- K123019LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERS2Cleared 510(K)
- K122798INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL2Cleared 510(K)
- K122504FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH2Cleared 510(K)
- K122099BENCOX II STEM, BENCOX METAL HEAD2Cleared 510(K)
- K121684NOVATION LPI PRIME FEMORAL STEM2Cleared 510(K)
- K113296ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER2Cleared 510(K)
- K121935TAPERSET HIP SMALL STEMS2Cleared 510(K)
- K120924BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG2Cleared 510(K)
- K121034IOI TOTAL HIP2Cleared 510(K)
- K122244POLARCUP DUAL MOBILITY SYSTEM2Cleared 510(K)
- K120030TAPERLOC COMPLETE SIZE 4MM AND XR 1232Cleared 510(K)
- K121308HIP SYSTEMS2Cleared 510(K)
- K121777U2 ACETABULAR CUP, PLASMA SPRAY2Cleared 510(K)
- K121024LINEAR POROUS COATED HIP STEM, SIZE 5; REVELATION HIP STEM, SIZE 8; FOUNDATION POROUS PRESS FIT STEM, SIZE 8;2Cleared 510(K)
- K121263TAPER SET HIP SYSTEM RDP STEM2Cleared 510(K)
- K112158MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS2Cleared 510(K)
- K120241LINEAR HIP STEM, SIZE 52Cleared 510(K)
- K113242APEX ARC HIP STEM2Cleared 510(K)
- K113609NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 52Cleared 510(K)
- K112779APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)2Cleared 510(K)
- K110135POLARCUP DUAL MOBILITY SYSTEM2Cleared 510(K)
- K111472HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICON2Cleared 510(K)
- K110245UNITED UTF STEM2Cleared 510(K)
- K103431COREN TOTAL HIP SYSTEM2Cleared 510(K)
- K111546U2 HIP SYSTEM2Cleared 510(K)
- K110947APEX K1 HIP STEM2Cleared 510(K)
- K103662CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS; LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LI2Cleared 510(K)
- K101072TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE2Cleared 510(K)
- K110542CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD2Cleared 510(K)
- K110555ARCOMXL ACTIVE ARTICULATION2Cleared 510(K)
- K103721MPACT ACETABULAR SYSTEM2Cleared 510(K)
- K103384ESCALADE ACETABULAR CUP SYSTEM2Cleared 510(K)
- K102019RESTORATION ACETABULAR WEDGE AUGMENTS2Cleared 510(K)
- K103256SMITH & NEPHEW SMF HIP STEM2Cleared 510(K)
- K101336E1 AVANTAGE HEAD2Cleared 510(K)
- K101229LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER2Cleared 510(K)
- K100445KLASSIC HD HIP SYSTEM2Cleared 510(K)
- K102399CONSENSUS TAPERSET HIP SYSTEM2Cleared 510(K)
- K103124SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS2Cleared 510(K)
- K102975NOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLE2Cleared 510(K)
- K102423DEPUY PINNACLE ALTRX ACETABULAR LINERS2Cleared 510(K)
- K100933CONSENSUS CS2 PLUS ACETABULAR INSERT2Cleared 510(K)
- K101761EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/132Cleared 510(K)
- K101976INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET2Cleared 510(K)
- K101575APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,3040102Cleared 510(K)
- K100269NOVATION CROWN CUP GXL LINERS2Cleared 510(K)
- K093561ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM2Cleared 510(K)
- K094045MODIFICAITON TO: CARDO MEDICAL HIP SYSTEM2Cleared 510(K)
- K100555APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK2Cleared 510(K)
- K092098PATIENT SPECIFIC ACETABULAR RECONSTRUCTION PROSTHESIS2Cleared 510(K)
- K092443INTERFACE ACETABULAR CUP LINERS2Cleared 510(K)
- K090897TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT2Cleared 510(K)
- K091508ZIMMER CONTINUUM ACETABULAR SYSTEM, ZIMMER TRILOGY IT ACETABULAR SYSTEM2Cleared 510(K)
- K081566SMITH & NEPHEW OXINIUM DH FEMORAL HEADS2Cleared 510(K)
- K081679REVELATION HIP STEM, MODELS, 427-01, 427-02; LINEAR HIP STEM, MODELS 425-00, 425-052Cleared 510(K)
- K081171TRITANIUM ACETABULAR SHELL SYSTEM2Cleared 510(K)
- K072817ECHELON TITANIUM HIP SYSTEM2Cleared 510(K)
- K080625SMITH & NEPHEW MIS HIP STEM WITH STIKTITE2Cleared 510(K)
- K073150APEX-LNK POLY ACETABULAR CUP LINERS2Cleared 510(K)
- K073068ACCIN HIP SYSTEM2Cleared 510(K)
- K072888REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED)2Cleared 510(K)
- K072417SMITH & NEPHEW MIS HIP STEM2Cleared 510(K)
- K072963DEPUY PINNACLE ALTRX ACETABULAR LINERS2Cleared 510(K)
- K072154FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM2Cleared 510(K)
- K072101RIGI-FIX HIP STEM SYSTEM2Cleared 510(K)
- K071160REFLECTION, TANDEM UNIPOLAR2Cleared 510(K)
- K062489APEX HCLA ACETABULAR CUP LINERS2Cleared 510(K)
- K071784DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS2Cleared 510(K)
- K070050VITALITY HIP SYSTEM MODEL#4202Cleared 510(K)
- K070278POLARCUP DUAL MOBILITY SYSTEM2Cleared 510(K)
- K070369REGENERX RINGLOC + MODULAR ACETABULAR SHELLS2Cleared 510(K)
- K063822MODIFICATION TO HIPSTAR FEMORAL STEM2Cleared 510(K)
- K062775EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM2Cleared 510(K)
- K061461MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 00.65-8026-010-052Cleared 510(K)
- K063257FMP COATED SPIKED ACETABULAR CUP; HEMISPHERICAL ACETABULAR CUP; FLARED RIM ACETABULAR CUP; METAL/METAL ACETABULAR INSERT2Cleared 510(K)
- K062419TRIDENT LARGE DIAMETER ACETABULAR INSERTS2Cleared 510(K)
- K062148DEPUY PINNACLE ALTRX ACETABULAR CUP LINER2Cleared 510(K)
- K060072MONOBLOCK PRESS-FIT HIP STEM2Cleared 510(K)
- K061434TRIDENT LARGE DIAMETER HIP SYSTEM2Cleared 510(K)
- K061226TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE2Cleared 510(K)
- K061786VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS2Cleared 510(K)
- K053417M-COR HIP REPLACEMENT SYSTEM2Cleared 510(K)
- K061168PCA 36MM FEMORAL HEADS2Cleared 510(K)
- K061124ORTHOPEDIC SOURCE PRESS-FIT HIP2Cleared 510(K)
- K061833DEPUY AML HIP PROSTHESIS2Cleared 510(K)
- K061547DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER2Cleared 510(K)
- K060630REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING2Cleared 510(K)
- K061067TRABECULAR METAL ACETABULAR AUGMENTS2Cleared 510(K)
- K060581DEPUY SOLUTION SYSTEM HIP PROSTHESIS2Cleared 510(K)
- K060040ZIMMER M/L TAPER HIP PROSTHESIS2Cleared 510(K)
- K060635CONSENSUS ACETABULAR SHELL SYSTEM2Cleared 510(K)
- K052996POROUS TITANIUM ACETABULAR SHELLS2Cleared 510(K)
- K052089XR-SERIES BI-METRIC FEMORAL COMPONENTS2Cleared 510(K)
- K053293ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS2Cleared 510(K)
- K052321VERSYS EPOCH FULLCOAT HIP PROSTHESIS2Cleared 510(K)
- K060031DEPUY MODULAR M HEADS2Cleared 510(K)
- K053557ESKA-LIBUR HIP STEM2Cleared 510(K)
- K052026LINEAGE A-CLASS POLY LINER2Cleared 510(K)
- K052255ARCOMXL POLYETHYLENE RX90 ACETABULAR LINERS2Cleared 510(K)
- K050327E-POLY (VITAMIN E) ACETABULAR LINERS2Cleared 510(K)
- K051556ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE2Cleared 510(K)
- K051491TRABECULAR METAL PRIMARY HIP PROSTHESIS2Cleared 510(K)
- K050937TRABECULAR METAL ACETABULAR REVISION SHELLS2Cleared 510(K)
- K042989RX90 LOW PROFILE ACETABULAR SYSTEM2Cleared 510(K)
- K042565ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER2Cleared 510(K)
- K042051ARCOMXL POLYETHYLENE LINERS2Cleared 510(K)
- K043123APEX MODULAR HA HIP STEM2Cleared 510(K)
- K033716TRIDENT ACETABULAR SYSTEM2Cleared 510(K)
- K042774MALLORY-HEAD MODULAR CALCAR STEMS WITH INTERLOCKING SLOTS2Cleared 510(K)
- K043537TAPERLOC 12/14 TAPER FEMORAL COMPONENTS2Cleared 510(K)
- K042871TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX32Cleared 510(K)
- K041950APEX K2 HIP SYSTEM2Cleared 510(K)
- K041850MEDALLION MODULAR HIP SYSTEM2Cleared 510(K)
- K042252NEXFLEX TOTAL HIP SYSTEM2Cleared 510(K)
- K031402PERFECTA FEMORAL STEM2Cleared 510(K)
- K042029X-SERIES INTEGRAL RPP FEMORAL COMPONENTS2Cleared 510(K)
- K042776VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS, MODEL 00-7840-XXX-XX2Cleared 510(K)
- K042337ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING2Cleared 510(K)
- K041906EXACTECH 12/14 TOTAL HIP SYSTEM2Cleared 510(K)
- K040191BICONTACT HIP STEM AND FEMORAL HEAD2Cleared 510(K)
- K033580NEXFLEX TOTAL HIP SYSTEM2Cleared 510(K)
- K041109ZIMMER ANATOMIC II HIP PROSTHESIS2Cleared 510(K)
- K040544DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -0622Cleared 510(K)
- K040412TRIDENT T ACETABULAR SHELLS2Cleared 510(K)
- K040383TRIFLANGE II ACETABULAR CUP SYSTEM2Cleared 510(K)
- K033273DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE LINERS, AND DEPUY ULTIMA UNIPOLAR FEMORAL HEADS2Cleared 510(K)
- K033893SPECTRUM MODULAR SYSTEM2Cleared 510(K)
- K033338PINNACLE REVISION SYSTEM2Cleared 510(K)
- K032729Z-SERIES MODULAR TOTAL HIP SYSTEM2Cleared 510(K)
- K032964EXACTECH 12/14 ALUMINA FEMORAL HEAD; EXACTECH ACUMATCH M-SERIES 12/14 NECK SEGMENTS2Cleared 510(K)
- K033034VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS2Cleared 510(K)
- K032385GLOBAL PRESS-FIT STEM2Cleared 510(K)
- K032726ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES2Cleared 510(K)
- K032581GLOBAL MODULAR REPLACEMENT SYSTEM ANTEVERTED PROMIMAL FEMORAL COMPONENT2Cleared 510(K)
- K030055MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS2Cleared 510(K)
- K031693MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA2Cleared 510(K)
- K031572ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 99232Cleared 510(K)
- K030861HA PMI FLANGED ACETABULAR COMPONENT2Cleared 510(K)
- K031495PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS2Cleared 510(K)
- K031110APEX MODULAR ACETABULAR CUP2Cleared 510(K)
- K030733MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIES2Cleared 510(K)
- K030979MODIFICATION TO DEPUY SOLUTION SYSTEM HIP PROSTHESIS2Cleared 510(K)
- K030501X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS2Cleared 510(K)
- K021878ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS2Cleared 510(K)
- K022520U2 ACETABULAR CUP2Cleared 510(K)
- K030236ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT2Cleared 510(K)
- K030079VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS2Cleared 510(K)
- K030048HA PMI FEMORAL HIP STEM2Cleared 510(K)
- K023409HA X-SERIES BI-METRIC HIP FEMORAL COMPONENTS2Cleared 510(K)
- K023357ARCPM 1050 RESIN-HIPS2Cleared 510(K)
- K023375MODIFICATION TO ESOP CO-CR FEMORAL HEADS2Cleared 510(K)
- K022382RHS ACETABULAR COMPONENT2Cleared 510(K)
- K022902SMITH & NEPHEW HIP SYSTEM2Cleared 510(K)
- K021891ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM2Cleared 510(K)
- K022556REFLECTION MODIFIED ACETABULAR SHELLS2Cleared 510(K)
- K022711MODIFICATION TO AVALON CUP SYSTEM2Cleared 510(K)
- K022463HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED PROXIMAL POROUS FEMORAL STEMS2Cleared 510(K)
- K014070EPOCH HIP PROSTHESIS, MODEL 4075 SERIES2Cleared 510(K)
- K021466CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE2Cleared 510(K)
- K021970THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND 02-293-28XX1 (IMPLEX PART #)2Cleared 510(K)
- K021911TRIDENT CROSSFIRE POLYUETHYLENE LINERS2Cleared 510(K)
- K021346STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX2Cleared 510(K)
- K021109ESOP CO-CR FEMORAL HEADS2Cleared 510(K)
- K020145ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM2Cleared 510(K)
- K020153CONSENSUS ACETABLAR SHELL, TI COATED2Cleared 510(K)
- K020580X-SERIES BI-METRIC HIP FEMORAL COMPONENTS2Cleared 510(K)
- K012787VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE REFLECTION ACTABULAR SYSTEM (ACETABULAR LINE2Cleared 510(K)
- K020497TRIDENT ELEVATED RIM LINER2Cleared 510(K)
- K020170KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP2Cleared 510(K)
- K013490CEMENTED CALCAR HIP SYSTEM2Cleared 510(K)
- K013475TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING2Cleared 510(K)
- K013658MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS2Cleared 510(K)
- K012739CONVERGE ACETABULAR SYSTEM2Cleared 510(K)
- K012364AML HIP PROSTHESIS2Cleared 510(K)
- K012507THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODELS 4893-XX-YY (ZIMMER), 02-212-05XX1 ( IMPLEX)2Cleared 510(K)
- K011489SUMMIT DUOFIX HIP PROSTHESIS2Cleared 510(K)
- K011081ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS2Cleared 510(K)
- K010170TRIDENT POROUS TITANIUM ACETABULAR COMPONENT2Cleared 510(K)
- K010171DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER2Cleared 510(K)
- K010367MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM2Cleared 510(K)
- K003875TI-REPLICA HIP STEM2Cleared 510(K)
- K004032PERFECTA AND EXTEND2Cleared 510(K)
- K010282LATERAL OFFSET PROTRACT PRESS FIT HIP STEM2Cleared 510(K)
- K010120MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH OFF-SET NECK SEGMENT, M-SERIES LOW OFF-SET NECK S2Cleared 510(K)
- K003800AML HIP PROSTHESIS2Cleared 510(K)
- K010241PROTRACT PRESS FIT HIP STEM-HA COATED2Cleared 510(K)
- K003478TRIOLOGY ACETABULAR SYSTEM 46MM LARGE HEAD LINERS, MODEL 63102Cleared 510(K)
- K003237U2 HIP STEM, TI POROUS COATED2Cleared 510(K)
- K003199TRIAD II MODULAR TOTAL HIP SYSTEM2Cleared 510(K)
- K003447PROTRACT PRESS FIT HIP STEM2Cleared 510(K)
- K002747REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS2Cleared 510(K)
- K002960TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 63532Cleared 510(K)
- K994078U1 HIP SYSTEM2Cleared 510(K)
- K003429MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL2Cleared 510(K)
- K003181IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY-ZZZZ2Cleared 510(K)
- K002149LINEAGE ACETABULAR SYSTEM2Cleared 510(K)
- K001991TITAN POROCOAT HIP PROSTHESIS2Cleared 510(K)
- K000788APEX MODULAR HIP STEM2Cleared 510(K)
- K001982TRI-LOCK HIP STEM2Cleared 510(K)
- K001778POROCOAT PRODIGY HIP PROSTHESIS2Cleared 510(K)
- K001320SULZER ORTHOPEDICS INC. NATURAL-HIP SYSTEM LD STEM2Cleared 510(K)
- K001277TRIFLANGE ACETABULAR CUP SYSTEM2Cleared 510(K)
- K001039THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP2Cleared 510(K)
- K001660MALLORY HEAD MODULAR CALCAR2Cleared 510(K)
- K001534PINNACLE ACETABULAR SYSTEM2Cleared 510(K)
- K000760REACH FEMORAL COMPONENT2Cleared 510(K)
- K000521KEYSTONE HIP2Cleared 510(K)
- K990830MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS2Cleared 510(K)
- K000321HEMISPHERE MODULAR CUP SYSTEM2Cleared 510(K)
- K993027ESKA MODULAR HIP SYSTEM2Cleared 510(K)
- K992154BICON-PLUS ACETABULAR COMPONENTS2Cleared 510(K)
- K000306PINNACLE ACETABULAR SYSTEM2Cleared 510(K)
- K000538MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL2Cleared 510(K)
- K994286ZMR HIP SYSTEM-POROUS REVISION2Cleared 510(K)
- K993259INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS2Cleared 510(K)
- K000335MALLORY-HEAD MODULAR CALCAR TOTAL HIP SYSTEM2Cleared 510(K)
- K000334IMPACT MODULAR TOTAL HIP SYSTEM2Cleared 510(K)
- K000207POROCOAT PRODIGY HIP PROSTHESIS2Cleared 510(K)
- K994415MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS2Cleared 510(K)
- K994070REVELATION POROUS HIP STEM2Cleared 510(K)
- K993736EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENT2Cleared 510(K)
- K994038MODULAR REACH HIP2Cleared 510(K)
- K990849DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS)2Cleared 510(K)
- K993352CROSSFIRE SYSTEM 12 ACETABULAR INSERTS2Cleared 510(K)
- K993082EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENT2Cleared 510(K)
- K992667ZMR HIP SYSTEM-REVISION TAPER2Cleared 510(K)
- K991026REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS2Cleared 510(K)
- K992109ENCORE FULLY COATED HIP2Cleared 510(K)
- K991485SYNERGY POROUS SIZE 8 HIP STEM2Cleared 510(K)
- K990135TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE2Cleared 510(K)
- K991807TITANIUM LOW PROFILE SCREWS2Cleared 510(K)
- K983837HEDROCEL ACETABULAR CAGE SYSTEM2Cleared 510(K)
- K991325MODIFICATION OF ENCORE LINEAR POROUS COATED HIP2Cleared 510(K)
- K991123PERFECTA RS LATERALIZED HIP STEM, BRIDGE HIP SYSTEM2Cleared 510(K)
- K990523B2C, ESPACE REVISION CUP SYSTEM2Cleared 510(K)
- K984492TIGRAN HIP PROSTHESIS2Cleared 510(K)
- K990003J-SERIES OMEGA TOTAL HIP SYSTEM2Cleared 510(K)
- K983834ECHELON HIP STEM2Cleared 510(K)
- K984296LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENT2Cleared 510(K)
- K984408130 MODIFIED INTEGRAL FEMORAL COMPONENT2Cleared 510(K)
- K983509INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT2Cleared 510(K)
- K984459DEPUY PROFILE FEMORAL HIP WITH POROCOAT2Cleared 510(K)
- K983502OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM2Cleared 510(K)
- K983491DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER2Cleared 510(K)
- K983035CUSTOM FLANGED ACETABULAR COMPONENT2Cleared 510(K)
- K980711HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING2Cleared 510(K)
- K983014SUMMIT ACETABULAR SYSTEM2Cleared 510(K)
- K982248HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR SHELLS WITH MESH INGROWTH SURFACE WITH PERI-A2Cleared 510(K)
- K982367REACH HIP COMPONENT2Cleared 510(K)
- K981211APR -T REVISION HIP STEM2Cleared 510(K)
- K980981OMEGA HA COATED TOTAL HIP SYSTEM2Cleared 510(K)
- K980020ACTIVELOCK MODULAR FEMORAL HIP SYSTEM2Cleared 510(K)
- K974740DEPUY TRI-LOCK HIP STEM2Cleared 510(K)
- K974506LSF HA COATED TRIAD TOTAL HIP SYSTEM2Cleared 510(K)
- K971206MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATING2Cleared 510(K)
- K974331UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM2Cleared 510(K)
- K974093FOUNDATION POROUS COATED HEMISPHERICAL SHELL2Cleared 510(K)
- K974095FOUNDATION POROUS COATED FLARED RIM SHELL2Cleared 510(K)
- K973119FOUNDATION POROUS ACETABULAR SYSTEM2Cleared 510(K)
- K974294ENCORE LINEAR POROUS COATED HIP2Cleared 510(K)
- K973714VERSYS HIP SYSTEM BEADED HIP PROSTHESIS2Cleared 510(K)
- K973685REVELATION POROUS HIP STEM2Cleared 510(K)
- K973675NATURAL-HIP POROUS STEM WITH OFFSET2Cleared 510(K)
- K971824REACH FEMORAL HIP COMPONENT2Cleared 510(K)
- K973302FOUNDATION POROUS HIP STEM2Cleared 510(K)
- K973163ACETABULAR SHELLS WITH MESH INGROWTH SURFACE2Cleared 510(K)
- K972596DEPUY DURALOC ACETABULAR CUP SYSTEM2Cleared 510(K)
- K973124APR POROUS HA HIP SYSTEM2Cleared 510(K)
- K971018SMC ACETABULAR COMPONENT2Cleared 510(K)
- K973530INFINTY DISTAL FEMORAL COMPONENT2Cleared 510(K)
- K972393INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI)2Cleared 510(K)
- K970241DEPUY PROXIMAL FEMORAL REPLACEMENT PROSTHESIS2Cleared 510(K)
- K964616QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT2Cleared 510(K)
- K971854OSTEOLOCK ACETABULAR SHELL SYSTEM2Cleared 510(K)
- K971718MICRO-SEAL ACETABULAR SYSTEM2Cleared 510(K)
- K971429INTERSEAL ACETABULAR SCREW HOLE PLUG2Cleared 510(K)
- K970300NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI2Cleared 510(K)
- K964650TCP-COATED POROCOAT AML FEMORAL HIP PROSTHESIS2Cleared 510(K)
- K964509IMPLEX A-240 HEP ACETABULAR CUP SYSTEM2Cleared 510(K)
- K971020LSF TRIAD TOTAL HIP SYSTEM2Cleared 510(K)
- K970705INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES2Cleared 510(K)
- K970706INTER-OP POROUS PROTRUSIO SHELL WITH SEALABLE SCREWHOLES2Cleared 510(K)
- K970501PEGGED ACETABULAR COMPONENT2Cleared 510(K)
- K965164HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR2Cleared 510(K)
- K964882IMPLEX REPLACEMENT ACETABULAR CUP INSERT2Cleared 510(K)
- K964924OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTENSION)2Cleared 510(K)
- K964769VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS2Cleared 510(K)
- K963100TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP2Cleared 510(K)
- K963101B-P HEMISPHERICAL ACETABULAR COMPONENT2Cleared 510(K)
- K963998METAL BACKED ACETABULAR COMPONENT2Cleared 510(K)
- K963946OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION)2Cleared 510(K)
- K963509GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON2Cleared 510(K)
- K964227METAL ACETABULAR COMPONENT2Cleared 510(K)
- K943230MAYO HIP PROSTHESIS2Cleared 510(K)
- K963309APEX HOLE ELIMINATOR PS2Cleared 510(K)
- K963266NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED2Cleared 510(K)
- K962769HORIZON HIP SYSTEM2Cleared 510(K)
- K962923DEPUY GRADED POROSITY AML HIP (1371-03/06-500/1371-43/46-500)2Cleared 510(K)
- K961526PRESS-FIT POROUS SHELL2Cleared 510(K)
- K961186DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM2Cleared 510(K)
- K961625QUATROLOC FEMORAL COMPONENT & HEAD2Cleared 510(K)
- K961939S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115)2Cleared 510(K)
- K955563FOUNDATION FORGED, TEXTURED & POROUS STEMS W/BIOLOX CERAMIC HEADS2Cleared 510(K)
- K960303FENNING FEMORAL COMPONENT2Cleared 510(K)
- K960660HEMISPHERE ACETABULAR CUP2Cleared 510(K)
- K96018022 MM COCR HEAD & POLYETHLENE LINER2Cleared 510(K)
- K960172DEPUY POROCOAT HPS II HIP PROSTHESIS W/ARTICUL-EZE TAPER2Cleared 510(K)
- K955739MODULAR ACETABULAR SHELL II2Cleared 510(K)
- K955871HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENT2Cleared 510(K)
- K955511ARTHOPOR I & II ACETABULAR CUP/ARTHOPOR II OBLONG ACETABULAR CUP2Cleared 510(K)
- K955170NEXFLEX FEMORAL STEM, STANDARD DESIGN2Cleared 510(K)
- K953703DEPUY VISION SOLUTION HIP PROSTHESIS2Cleared 510(K)
- K953694DEPUY VISION AML HIP PROTHESIS2Cleared 510(K)
- K955033RIM FLARE ACETABULAR COMPONENT2Cleared 510(K)
- K955271MICRO-SEAL ACETABULAR SYSTEM2Cleared 510(K)
- K954935S-ROM FEMORAL HIP STEM - SIZE 14 X 82Cleared 510(K)
- K953337BETA HIP PROSTHESIS2Cleared 510(K)
- K954811DEPUY ADVANTAGE HIP FEMORAL PROSTHESIS WITH POROCOAT2Cleared 510(K)
- K954698TRILOGY ACETABULAR COMPONENT 7MM OFFSET2Cleared 510(K)
- K954417A-B ACETABULAR COMPONENT2Cleared 510(K)
- K954466PROFORM POROUS BEADED FEMORAL STEM2Cleared 510(K)
- K954288EXTEND HIP SYSTEM2Cleared 510(K)
- K954213ATH FULL PROFILE ACETABULAR CUP SYSTEM2Cleared 510(K)
- K953664VITALOCK SPIKED ACETABULAR SHELL2Cleared 510(K)
- K953490TRILOGY ACETABULAR SHELL & LINERS 36MM2Cleared 510(K)
- K952740DEPUY DURALOC 400 ACETABULAR CUP2Cleared 510(K)
- K936292PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTS2Cleared 510(K)
- K934060HOWMEDICA(R) ACETABULAR COMP PACK/MANUF METH CHANGE2Cleared 510(K)
- K933882OSTEONICS PS HEMI-HIP STEM SERIES2Cleared 510(K)
- K951741REPLICA TOTAL HIP SYSTEM2Cleared 510(K)
- K952397VITALOCK SOLID BACKED ACETABULAR SHELL2Cleared 510(K)
- K941612F-230 POROUS FEMORAL HIP STEM (CEMENTLESS)2Cleared 510(K)
- K951356VARIOUS UHMWP HIP & KNEE JOINT PROSTHESIS MODIFIED2Cleared 510(K)
- K951115HOWMEDICA VITALOCK 22MM ACERTABULAR SHELL AND SYSTEM 12 INSERTS2Cleared 510(K)
- K951114SYSTEM 12 P1 26MM ACETABULAR INSERT2Cleared 510(K)
- K936310ORTHOMET HMC FEMORAL STEM COMPONENT2Cleared 510(K)
- K940715OSTEONICS OMNIFIT AD HIP STEM SERIES2Cleared 510(K)
- K944592PRECISION OSTEOLOCK FEMORAL COMPONENT2Cleared 510(K)
- K951674DEPUY DURALOC 100C ACETABULAR CUP2Cleared 510(K)
- K95109510.5MM REPLICA HIP STEM2Cleared 510(K)
- K951301DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM2Cleared 510(K)
- K950827PROFORM POROUS ACETABULAR ASSEMBLY2Cleared 510(K)
- K951000ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM2Cleared 510(K)
- K934515BIAS(TM) FIBER METAL TOTAL HIP STEM (TFB)2Cleared 510(K)
- K921525HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS2Cleared 510(K)
- K934334APOGEE HIP STEM WITH POROCOAT2Cleared 510(K)
- K931333ORTHOMET ACETABULAR CUP SYSTEM2Cleared 510(K)
- K943054OSTEONICS SECURE-FIT AD ACETABULAR COMPONENT SYSTEM2Cleared 510(K)
- K942115INFINITY REVISION HIP STEM2Cleared 510(K)
- K941141PRECISION OSTELOCK SP FEMORAL COMPONENT2Cleared 510(K)
- K935875OSTEONICS SCREWLESS ACETABULAR COMPONENTS2Cleared 510(K)
- K935484PROVIDENT HIP SYSTEM2Cleared 510(K)
- K934412COATED ZT PROXIMAL SLEEVE2Cleared 510(K)
- K933102HOWMEDICA ACETABULAR SHELL W/SCREW HOLES2Cleared 510(K)
- K932924IMPLEX A-230 POROUS ACETABULAR CUP SYST. CEMENTED2Cleared 510(K)
- K932755REFLECTION ACETABULAR COMPONENT2Cleared 510(K)
- K932923IMPLEX A-230 POROUS ACETABULAR CUP SYST.CEMENTLESS2Cleared 510(K)
- K934765TRILOGY ACETABULAR SYSTEM2Cleared 510(K)
- K931642RMHS MONOLITHIC FEMORAL COMPONENT2Cleared 510(K)
- K933787POROCOAT POROUS COATING/AML PROXIMALLY-COATED STEM2Cleared 510(K)
- K931641POROCOAT POROUS COATING2Cleared 510(K)
- K926156REPLICA(TM) TOTAL HIP SYSTEM2Cleared 510(K)
- K935731ACETABULAR SHELL2Cleared 510(K)
- K925172PCA(R) E SERIES HIP SYSTEM (CEMENTLESS USE)2Cleared 510(K)
- K922071ZIMMER ANATOMIC HIP SYSTEM2Cleared 510(K)
- K921557BIAS TOTAL HIP SYSTEM ACETABULAR COMPONENT2Cleared 510(K)
- K921308HG MULTILOCK HIP PROSTHESIS W/ TI-NIDIUM2Cleared 510(K)
- K923452PMI HIP FEMORAL2Cleared 510(K)
- K921301TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM2Cleared 510(K)
- K921277RANAWAT/BURSTEIN TOTAL HIP SYSTEM2Cleared 510(K)
- K921274METALLIC TOATAL HIP SYSTEM2Cleared 510(K)
- K920955APR(R) HIP SYST & NATURAL-HIP(R) FOR UNCEMENT USE2Cleared 510(K)
- K922500PSL TOTAL HIP REPLACEMENT SYSTEM2Cleared 510(K)
- K921113EXATECH MCS POROUS COATED TOTAL HIP FEMORAL STEM2Cleared 510(K)
- K921114EXACTECH MCS POROUS COATED TOTAL HIP ACETABULAR2Cleared 510(K)
- K922159INFINITY POROUS-COATED TROCHANTERIC MODULE2Cleared 510(K)
- K926107ARCOM POLYETHYLENE ACETABULAR LINERS & COMPONENTS2Cleared 510(K)
- K921400HIP JOINT PROTHESIS2Cleared 510(K)
- K924492POLY-DIAL INSERTS2Cleared 510(K)
- K921639BIAS TOTAL HIP SYSTEM 300-MM FEMORAL STEM2Cleared 510(K)
- K920831PCA TOTAL HIP SYSTEM (CEMENTLESS USE)2Cleared 510(K)
- P880025AML(R) POROCOAT(R) ACETABULAR CUP PROSTHESIS2PMA Approval
- P880076WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS2PMA Approval
- P850061BIAS(R) FIBER METAL TOTAL HIP SYSTEM2PMA Approval
- P880025DURALOC(TM) 300S ACETABULAR CUP WITH POROCOAT(TM)2PMA Approval
- P880025AML(R) POROCOAT(R) ACETABULAR CUP PROSTHESIS2PMA Approval
- K896637ACCESS(TM), SOFTWARE RELEASE 4.11P2Cleared 510(K)
- P850061BIAS(R) FIBER METAL TOTAL HIP SYSTEM2PMA Approval
- K862702TRI-LOCK II TITANIUM ACETABULUM PROSTHESIS2Cleared 510(K)
- K862326POROUS COATED HIP FEMORAL PROSTHESIS2Cleared 510(K)
- K860442PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #62592Cleared 510(K)
- K860635OPTI-FIX TOTAL HIP SYSTEM2Cleared 510(K)
- K852198AML PROXIMAL POROCOAT FEMORAL HIP2Cleared 510(K)
- K851421S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP2Cleared 510(K)
- K833681POROCOAT HPS II HIP PROSTHESIS2Cleared 510(K)
- K833439POROCOAT NEB TOTAL HIP SYSTEM2Cleared 510(K)
- K833464POROCOAT SCHATZKER ACETABULUM2Cleared 510(K)
- 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
ACTIS Duofix Hip Prosthesis
- Page Type
- Cleared 510(K)
- 510(k) Number
- K202472
- 510(k) Type
- Special
- Applicant
- DePuy Orthopaedics Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/21/2020
- Days to Decision
- 54 days
- Submission Type
- Summary