FDA Product Code
FDA Product Code JDI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3350
510(k) Clearances — 565 records · page 1 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253515 | Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments | Biomet Orthopedics, Inc. | 2026-08-24 | Traditional | PDF ↗ |
| K253434 | OSSTM Orthopedic Salvage System | Biomet, Inc. | 2026-07-01 | Traditional | PDF ↗ |
| K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | Signature Orthopaedics Pty, Ltd. | 2026-03-12 | Traditional | PDF ↗ |
| K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners | Zimmer Biomet | 2025-07-31 | Traditional | PDF ↗ |
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems | Smith & Nephew, Inc. | 2024-10-21 | Traditional | PDF ↗ |
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-08-02 | Traditional | PDF ↗ |
| K240418 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-04-12 | Traditional | PDF ↗ |
| K233261 | Global Modular Replacement System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2023-12-08 | Traditional | PDF ↗ |
| K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-01-26 | Traditional | PDF ↗ |
| K220216 | C-Stem AMT LE Prosthesis | Depuy Ireland UC | 2022-07-22 | Traditional | PDF ↗ |
| K213701 | Exeter® X3® RimFit® Cup | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022-02-01 | Traditional | PDF ↗ |
| K213816 | MPO Hip Instruments | Microport Orthopedics, Inc. | 2022-01-05 | Special | PDF ↗ |
| K210842 | VerSys Cemented Revision/Calcar | Zimmer, Inc. | 2021-12-10 | Traditional | PDF ↗ |
| K203815 | ELEOS Limb Salvage System with BioGrip | Onkos Surgical | 2021-06-09 | Traditional | PDF ↗ |
| K203588 | ELEOS Limb Salvage System | Onkos Surgical | 2021-02-05 | Traditional | PDF ↗ |
| K203090 | ELEOS Limb Salvage System featuring BIOGRIP | Onkos Surgical | 2020-12-11 | Traditional | PDF ↗ |
| K201519 | PROFEMUR® GLADIATOR® Cemented Classic Stem | Microport Orthopedics, Inc. | 2020-12-10 | Traditional | PDF ↗ |
| K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | Howmedica Osteonics Corp. | 2020-08-13 | Traditional | PDF ↗ |
| K191449 | ZCA All-Poly Acetabular Cups | Zimmer, Inc. | 2020-07-16 | Traditional | PDF ↗ |
| K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | Zimmer, Inc. | 2020-07-09 | Traditional | PDF ↗ |
| K191735 | CPT Hip System | Zimmer, Inc. | 2020-03-20 | Traditional | PDF ↗ |
| K191056 | Conformity stem, cemented | United Orthopedic Corporation | 2020-01-03 | Traditional | PDF ↗ |
| K191414 | EXETER Centralizer, EXETER 2.5mm Plug | Stryker Orthopaedics | 2019-08-28 | Traditional | PDF ↗ |
| K181340 | Cemented TSI Hip Stem | Signature Orthopaedics Pty, Ltd. | 2019-02-11 | Traditional | PDF ↗ |
| K180973 | Libertas Hip Replacement System | Maxx Orthopedics, Inc. | 2018-09-28 | Traditional | PDF ↗ |
| K162125 | MALUC Total Hip Arthroplasty System | Surgtech, Inc. | 2017-05-10 | Traditional | PDF ↗ |
| K160923 | REDAPT Anteverted Cemented Liner | Smith & Nephew, Inc. | 2016-11-17 | Traditional | PDF ↗ |
| K153057 | FitRite Total Hip Arthroplasty System | Excera Orthopedics, Inc. | 2016-06-23 | Traditional | PDF ↗ |
| K153725 | Corin TaperFit Hip Stem | Corin U.S.A. Limited | 2016-03-25 | Traditional | PDF ↗ |
| K153216 | Alpine Cemented Hip System | Ortho Development Corporation | 2016-02-18 | Traditional | PDF ↗ |
| K152621 | OSS/Arcos IM Total Femur Rod | Biomet, Inc. | 2015-10-14 | Special | PDF ↗ |
| K142814 | Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial | Biomet Manufacturing, LLC | 2015-06-25 | Traditional | PDF ↗ |
| K142761 | Corin TaperFit Hip Stem | Corin USA | 2015-04-03 | Traditional | PDF ↗ |
| K141331 | BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS) | Biomet, Inc. | 2014-10-27 | Traditional | PDF ↗ |
| K142295 | Sirius Femoral Stem, Size 30A | Biomet, Inc. | 2014-09-15 | Special | PDF ↗ |
| K141370 | RENOVIS CEMENTED HIP SYSTEM | Renovis Surgical Technologies, Inc. | 2014-09-02 | Traditional | PDF ↗ |
| K130610 | SIRIUS FEMORAL STEM | Biomet, Inc. | 2013-08-30 | Traditional | PDF ↗ |
| K123598 | SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION | Smith & Nephew, Inc. | 2013-06-28 | Traditional | PDF ↗ |
| K123501 | OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS | Biomet, Inc. | 2013-02-27 | Special | PDF ↗ |
| K121056 | METS MODULAR PROXIMAL FEMUR | Stanmore Implants Worldwide , Ltd. | 2012-09-20 | Traditional | PDF ↗ |
| K121055 | METS MODULAR TOTAL FEMUR | Stanmore Implants Worldwide , Ltd. | 2012-09-19 | Traditional | PDF ↗ |
| K111863 | SIGNATURE PLANNER,SIGNATURE GUIDES | Materialise NV | 2012-06-15 | Traditional | PDF ↗ |
| K120578 | ACCOLADE II HIP STEM | Howmedica Osteonics | 2012-03-29 | Special | PDF ↗ |
| K111848 | EXETER X3 RIMFIT ACETABULAR CUP | Stryker Corp. | 2011-10-05 | Traditional | PDF ↗ |
| K110290 | EXETER HIP STEM | Howmedica Osteonics Corp. | 2011-09-27 | Traditional | PDF ↗ |
| K093646 | DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS | DePuy Orthopaedics, Inc. | 2009-12-17 | Special | PDF ↗ |
| K090998 | DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS | DePuy Orthopaedics, Inc. | 2009-06-12 | Special | PDF ↗ |
| K090208 | BIOPRO FEMORAL HEADS | Biopro, Inc. | 2009-05-22 | Traditional | PDF ↗ |
| K082792 | MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS | Medacta International S.A. | 2008-12-29 | Special | PDF ↗ |
| K082239 | DEPUY C-STEM AMT | DePuy Orthopaedics, Inc. | 2008-08-29 | Special | PDF ↗ |
| K080539 | ACCIN UNIPOLAR HEAD SYSTEM | Accelerated Innovation, LLC | 2008-06-02 | Traditional | PDF ↗ |
| K080885 | MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION | Medacta International S.A. | 2008-04-28 | Special | PDF ↗ |
| K072857 | TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT | Medacta International S.A. | 2008-02-04 | Traditional | PDF ↗ |
| K070399 | 100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES | Biomet Manufacturing, Inc. | 2007-05-04 | Special | PDF ↗ |
| K070364 | 100KGY E-POLY MAXROM ACETABULAR LINERS | Biomet, Inc. | 2007-05-03 | Special | PDF ↗ |
| K063278 | PORTLAND COBALT CHROME FEMORAL HEAD | Portland Orthopaedics Limited | 2007-01-12 | Traditional | PDF ↗ |
| K061344 | EXCIA TOTAL HIP SYSTEM LATERAL OFFSET | Aesculap, Inc. | 2006-08-02 | Special | PDF ↗ |
| K052639 | GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER | Biomet Manufacturing, Inc. | 2006-05-03 | Traditional | PDF ↗ |
| K052748 | SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTS | Howmedica Osteonics Corp. | 2005-12-02 | Traditional | PDF ↗ |
| K052792 | ANTHOLOGY HIP STEM | Smith & Nephew, Inc. | 2005-10-07 | Special | PDF ↗ |
| K051569 | RINGLOC BI-POLAR ACETABULAR COMPONENT | Biomet, Inc. | 2005-09-29 | Traditional | PDF ↗ |
| K050637 | ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS | Ortho Development Corp. | 2005-09-23 | Traditional | PDF ↗ |
| K051407 | LEGEND ALL-POLY CUP | Ortho Development Corp. | 2005-09-08 | Traditional | PDF ↗ |
| K051516 | TRABECULAR METAL REVISION SHELL LINERS | Zimmer, Inc. | 2005-07-27 | Special | PDF ↗ |
| K050441 | TAPER 2 POROUS FEMORAL STEM | Biomet, Inc. | 2005-06-29 | Traditional | PDF ↗ |
| K051363 | RESTORATION MODULAR SYSTEM | Howmedica Osteonics Corp. | 2005-06-23 | Special | PDF ↗ |
| K051335 | ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS | Exactech, Inc. | 2005-06-21 | Special | PDF ↗ |
| K050105 | NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS | Zimmer, Inc. | 2005-05-17 | Traditional | PDF ↗ |
| K050138 | MODIFICATION TO: RESTORATION MODULAR SYSTEM | Howmedica Osteonics Corp. | 2005-03-21 | Special | PDF ↗ |
| K042959 | DEPUY C-STEM AMT HIP PROSTHESIS | DePuy Orthopaedics, Inc. | 2004-12-22 | Special | PDF ↗ |
| K033871 | IM TOTAL FEMUR | Biomet, Inc. | 2004-04-16 | Traditional | PDF ↗ |
| K032730 | FIXION HIP SYSTEM | Disc-O-Tech Medical Technologies, Ltd. | 2004-03-26 | Traditional | PDF ↗ |
| K034028 | ATH FEMORAL STEM | Wrightmedicaltechnologyinc | 2004-03-11 | Special | PDF ↗ |
| K031474 | SC TOTAL HIP SYSTEM | Orthopedic Alliance, LLC | 2003-10-15 | Traditional | PDF ↗ |
| K030867 | ESKA MODULAR HIP SYSTEM CEMENTED | Eska Implants GmbH | 2003-09-22 | Traditional | PDF ↗ |
| K031730 | 36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS | Howmedica Osteonics Corp. | 2003-08-29 | Special | PDF ↗ |
| K032396 | RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS | Biomet, Inc. | 2003-08-21 | Special | PDF ↗ |
| K031744 | OMNIFIT HFX HIP STEM SERIES | Howmedica Osteonics Corp. | 2003-08-08 | Traditional | PDF ↗ |
| K030766 | OXINIUM FEMORAL HEADS | Smith & Nephew, Inc. | 2003-07-25 | Special | PDF ↗ |
| K031734 | GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS | Biomet, Inc. | 2003-07-01 | Special | PDF ↗ |
| K031165 | PLUS ORTHOPEDICS CEMENTED HIP STEM | Plus Orthopedics | 2003-06-06 | Traditional | PDF ↗ |
| K030153 | ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32 | Zimmer, Inc. | 2003-04-01 | Traditional | PDF ↗ |
| K030265 | CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00 | Zimmer, Inc. | 2003-03-04 | Special | PDF ↗ |
| K024340 | SMITH & NEPHEW FEMORAL HEADS | Smith & Nephew, Inc. | 2003-02-26 | Special | PDF ↗ |
| K022799 | TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE | Howmedica Osteonics Corp. | 2002-11-21 | Traditional | PDF ↗ |
| K023453 | DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS | DePuy Orthopaedics, Inc. | 2002-11-13 | Special | PDF ↗ |
| K023646 | EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM | Exactech, Inc. | 2002-11-13 | Special | PDF ↗ |
| K023085 | RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM | Biomet Orthopedics, Inc. | 2002-10-17 | Special | PDF ↗ |
| K022958 | TOTAL HIP FEMORAL HEADS AND LINERS | Smith & Nephew, Inc. | 2002-10-02 | Special | PDF ↗ |
| K022077 | 36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) | Howmedica Osteonics Corp. | 2002-07-25 | Special | PDF ↗ |
| K022094 | PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING | Biomet, Inc. | 2002-07-25 | Special | PDF ↗ |
| K021822 | R120 MODULAR TOTAL HIP SYSTEM | Osteoimplant Technology, Inc. | 2002-07-23 | Traditional | PDF ↗ |
| K021380 | OSS LES PROXIMAL FEMORAL COMPONENT | Biomet, Inc. | 2002-05-28 | Special | PDF ↗ |
| K021310 | 36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) | Howmedica Osteonics Corp. | 2002-05-21 | Special | PDF ↗ |
| K021178 | SL-PLUS LATERALIZED STEM | Plus Orthopedics | 2002-05-14 | Special | PDF ↗ |
| K020989 | SUPER EON PLUS FEMORAL STEMS | Howmedica Osteonics Corp. | 2002-04-26 | Special | PDF ↗ |
| K020970 | MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS) | Biomet, Inc. | 2002-04-04 | Special | PDF ↗ |
| K020291 | EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER | Exactech, Inc. | 2002-02-27 | Special | PDF ↗ |
| K020076 | PATRIOT PROTRUSIO CAGE | Biomet Orthopedics, Inc. | 2002-01-30 | Special | PDF ↗ |
| K011887 | AVALON CUP SYSTEM | Orthopedic Source, Inc. | 2001-12-27 | Traditional | PDF ↗ |
Product code JDI · Class II · Orthopedic. Data: openFDA.