Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
FDA product code LWJ · Class II (moderate risk) · 21 CFR 888.3360 · Orthopedic
81510(k) clearances
0PMA approvals
21recalls
Implantimplanted device
Manufacturers
- Plus Orthopedics 7
- Osteonics Corp. 6
- Stelkast Company 5
- Encore Orthopedics, Inc. 4
- Hayes Medical, Inc. 3
- Turnkey Intergration USA, Inc. 3
- Intermedics Orthopedics 3
- Depuy, Inc. 3
- Howmedica Corp. 3
- Orthopedic Systems, Inc. 3
- Protek, Inc. 2
- Med-Tek Corp. 2
- 3M Company 2
- Smith & Nephew Richards, Inc. 2
- Exactech, Inc. 2
- Implex Corp. 2
- Howmedica Osteonics Corp. 2
- Artos Medical Products GmbH 2
- Wrightmedicaltechnologyinc 2
- Joint Medical Products Corp. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K120595 | Unisyn Plus Hip StemLWJ · Traditional | Consensus Orthopedics, Inc. | 10/12/2012SE |
| K103518 | Trinity Acetabular SystemLWJ · Traditional | Corin USA | 03/09/2011SE |
| K090764 | Novation CFS Press-Fit and Cemented StemsLWJ · Special | Exactech, Inc. | 04/21/2009SE |
| K082146 | Metha Short Stem Hip System XL Femoral HeadLWJ · Special | Aesculap Implant Systems, Inc. | 09/09/2008SE |
| K070061 | 36MM Cocr Femoral Head and 36MM Acetabular InsertLWJ · Special | Hayes Medical, Inc. | 01/31/2007SE |
| K062978 | U2 Hip Stem, Ti Plasma SprayLWJ · Traditional | United Orthopedic Corp. | 01/16/2007SE |
| K062383 | Unisyn Ha Plasma Modular HipLWJ · Special | Hayes Medical, Inc. | 12/21/2006SE |
| K061699 | ExciaLWJ · Special | Aesculap, Inc. | 08/18/2006SE |
| K051826 | Betacone Hip Prosthesis SystemLWJ · Traditional | Waldemar Link GmbH & Co. KG | 11/18/2005SE |
| K050262 | U2 Acetabular ComponentLWJ · Traditional | United Orthopedic Corp. | 08/15/2005SE |
| K042344 | Excia Total Hip SystemLWJ · Abbreviated | Aesculap, Inc. | 03/16/2005SE |
| K040685 | Z - Series Modular Total Hip System Plasma CoatedLWJ · Traditional | Osteoimplant Technology, Inc. | 01/25/2005SE |
| K033313 | Quatro M Femoral ComponentLWJ · Traditional | Whiteside Biomechanics, Inc. | 07/28/2004SE |
| K032709 | Modular Plus Hip StemLWJ · Special | Plus Orthopedics | 09/23/2003SE |
| K032110 | Proclass Press Fit Hip StemLWJ · Traditional | Stelkast Company | 09/22/2003SE |
| K030971 | Modification to Modular Plus Revision StemLWJ · Special | Plus Orthopedics | 04/24/2003SE |
| K023692 | Global Modular Replacement System AdapterLWJ · Traditional | Howmedica Osteonics Corp. | 03/20/2003SE |
| K030122 | Depuy Summit Basic Press-Fit Hip StemLWJ · Special | DePuy Orthopaedics, Inc. | 02/05/2003SE |
| K024134 | Uni Hip StemLWJ · Special | Plus Orthopedics | 01/15/2003SE |
| K022966 | Proxilock Hip Prosthesis; Size 12/36LWJ · Special | Implex Corp. | 10/02/2002SE |
| K003649 | Triton Hip SystemLWJ · Traditional | Hayes Medical, Inc. | 02/23/2001SE |
| K010243 | Tri-Fit Femoral StemLWJ · Special | Corin USA | 02/15/2001SE |
| K003016 | Pro-Femur RLWJ · Abbreviated | Wrightmedicaltechnologyinc | 12/13/2000SE |
| K994146 | Epf-Plus Cementless Press-Fit Acetabular CupLWJ · Traditional | Plus Orthopedics | 12/11/2000SE |
| K002941 | Acetabular PlatesLWJ · Traditional | Encore Orthopedics, Inc. | 12/04/2000SE |
| K002575 | Inter-Op Durasul Acetabular Inserts (4MM)LWJ · Traditional | Sulzer Orthopedics, Inc. | 11/15/2000SE |
| K002796 | Modification to Provident Hip SystemLWJ · Special | Stelkast Company | 09/28/2000SE |
| K002141 | Acumatch P-Series Press-Fit Plasma, Acumatch P-Series Press-Fit, Acumatch L-Series…LWJ · Special | Exactech, Inc. | 08/16/2000SE |
| K001471 | The Implex Hedrocel Acetabular Augment, Xx-Yyy-ZzzzLWJ · Traditional | Implex Corp. | 08/07/2000SE |
| K001745 | Modification to Provident Hip SystemLWJ · Special | Stelkast Company | 07/27/2000SE |
| K001942 | Sl-Plus and Slr-Plus StemsLWJ · Special | Plus Orthopedics | 07/25/2000SE |
| K994126 | Modular-Plus Revision StemLWJ · Traditional | Plus Orthopedics | 05/04/2000SE |
| K993601 | Howmedica Osteonics Femoral HeadsLWJ · Special | Howmedica Osteonics Corp. | 11/16/1999SE |
| K982936 | Osteonics Extended Femoral Bearing HeadLWJ · Traditional | Osteonics Corp. | 10/21/1998SE |
| K971900 | Lateral Flare Internal Collar (Lfic)LWJ · Traditional | Pro-Lfic, LLC | 12/18/1997SE |
| K973077 | Plus-Fit Acetabular CupLWJ · Traditional | Plus Orthopedics | 11/13/1997SE |
| K972931 | Plus Epf Acetabular CupLWJ · Traditional | Hhl Consulting | 11/13/1997SE |
| K964178 | Press-Fit Hip StemLWJ · Traditional | Encore Orthopedics, Inc. | 05/05/1997SE |
| K955553 | Perfecta Revision Hip SystemLWJ · Traditional | Wrightmedicaltechnologyinc | 10/24/1996SE |
| K962268 | Chrome Cobalt Ball HeadLWJ · Traditional | Artos Medical Products GmbH | 10/23/1996SE |
| K962034 | SC, Cementless Hip SystemLWJ · Traditional | Artos Medical Products GmbH | 10/23/1996SE |
| K961378 | Delta Hip ProsthesisLWJ · Traditional | Zimmer, Inc. | 10/08/1996SE |
| K963155 | Intermoore Fracture Hip Stem (Modify)LWJ · Traditional | Intermedics Orthopedics | 10/01/1996SE |
| K960633 | Press-Fit Flared ShellLWJ · Traditional | Encore Orthopedics, Inc. | 10/01/1996SE |
| K960908 | SRRS Pressed Fit Femoral Revision ComponentLWJ · Traditional | Stelkast Company | 08/08/1996SE |
| K954854 | Intermoore Fracture Hip StemLWJ · Traditional | Intermedics Orthopedics | 02/15/1996SE |
| K952776 | Lfic or Fetto HipLWJ · Traditional | Zimmer, Inc. | 02/14/1996SE |
| K953268 | Dual Taper Wedge Pressed Fit Femoral ComponentLWJ · Traditional | Stelkast Company | 01/17/1996SE |
| K952297 | Foundation Textured StemLWJ · Traditional | Encore Orthopedics, Inc. | 07/17/1995SE |
| K950541 | Howmedica V40 22MM Femoral HeadLWJ · Traditional | Howmedica Corp. | 03/21/1995SE |
| K931423 | Paradigm Femoral Stem, Perfecta Total Hip SystemLWJ · Traditional | Orthomed | 10/13/1994SN |
| K934909 | Cobalt Chrome GeminiLWJ · Traditional | Depuy, Inc. | 04/28/1994SE |
| K933359 | Osteonics 22MM, +10 Neck Bearing HeadsLWJ · Traditional | Osteonics Corp. | 03/07/1994SE |
| K921382 | Futura Texture-Trakked Total Hip StemLWJ · Traditional | Arthronics, Inc. | 01/07/1994SE |
| K923911 | Intrinsic StemLWJ · Traditional | Turnkey Intergration USA, Inc. | 04/14/1993SE |
| K910664 | Mod. Trochanter Screw & Washer W/ Anodized Titan.LWJ · Traditional | Medimix Products, Inc. | 04/01/1992SE |
| K913708 | Venus HipLWJ · Traditional | Turnkey Intergration USA, Inc. | 01/27/1992SE |
| K914343 | Ti-Fit Femoral ComponentLWJ · Traditional | Smith & Nephew Richards, Inc. | 01/13/1992SE |
| K903563 | Howmedica HNR SystemLWJ · Traditional | Howmedica Corp. | 03/14/1991SE |
| K910010 | Q System 28 Hip StemLWJ · Traditional | Turnkey Intergration USA, Inc. | 03/12/1991SE |
| K905254 | Thackray Orthogenesis Identifit Femoral Hip ProsthLWJ · Traditional | Depuy, Inc. | 02/26/1991SN |
| K905186 | Geri Total Hip SystemLWJ · Traditional | Smith & Nephew Richards, Inc. | 02/15/1991SE |
| K900435 | Acsys Shearer Acetabular Cup ProsthesisLWJ · Traditional | 3M Company | 09/14/1990SE |
| K900262 | Acsys Selftap Acetabular Cup ProsthesisLWJ · Traditional | 3M Company | 09/14/1990SE |
| K901687 | F-24 Femoral Hip ProsthesisLWJ · Traditional | Med-Tek Corp. | 09/07/1990SE |
| K901594 | H.N. Total Hip ProsthesisLWJ · Traditional | Med-Tek Corp. | 08/03/1990SE |
| K895702 | KDR Acetabular ComponentLWJ · Traditional | Osteonics Corp. | 11/03/1989SE |
| K890331 | Freeman Total Hip System Ridged StemLWJ · Traditional | Orthopedic Systems, Inc. | 10/13/1989SE |
| K894051 | Premier-Total HipLWJ · Traditional | Intermedics Orthopedics | 08/28/1989SE |
| K893785 | ARC-2F Acetabular CupLWJ · Traditional | Protek, Inc. | 08/09/1989SN |
| K893584 | Gripper II Acetabular CupLWJ · Traditional | Joint Medical Products Corp. | 07/28/1989SN |
| K891539 | Cti II Straight StemLWJ · Traditional | Orthopedic Systems, Inc. | 06/08/1989SE |
| K891262 | KDG Acetabular ComponentLWJ · Traditional | Osteonics Corp. | 06/06/1989SE |
| K883794 | Resubmitted CLW Acetabular Cup W/SulmeshLWJ · Traditional | Protek, Inc. | 05/26/1989SE |
| K883661 | Modified Universal Acetabular Cup System (Uacs)LWJ · Traditional | Depuy, Inc. | 02/08/1989SN |
| K883921 | Omnifit Threaded Acetabular Comp. W/Micro CoatingLWJ · Traditional | Osteonics Corp. | 10/13/1988SE |
| K881983 | Howmedica Precision Osteolock Femoral ComponentLWJ · Traditional | Howmedica Corp. | 10/06/1988SE |
| K881288 | Corin Modular Moore StemLWJ · Traditional | Orthopedic Systems, Inc. | 06/29/1988SE |
| K870088 | S-Rom Supercup Acetabular CupLWJ · Traditional | Joint Medical Products Corp. | 04/22/1988SN |
| K873797 | Ti-Fit Total Hip SystemLWJ · Traditional | Richards Medical Co., Inc. | 11/02/1987SE |
| K833970 | Micro-Structured HS2P Hip StemsLWJ · Traditional | Osteonics Corp. | 01/27/1984SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0905-2024 Class II | P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-307Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of… | Howmedica Osteonics Corp. | 12/01/2023Open, Classified |
| Z-0904-2024 Class II | P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of… | Howmedica Osteonics Corp. | 12/01/2023Open, Classified |
| Z-2948-2020 Class II | PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item…MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR Titanium and Cobalt… | MicroPort Orthopedics Inc. | 07/31/2020Open, Classified |
| Z-2942-2020 Class I | PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip…MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long… | MicroPort Orthopedics Inc. | 07/31/2020Terminated |
| Z-2941-2020 Class I | PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234…MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long… | MicroPort Orthopedics Inc. | 07/31/2020Terminated |
| Z-2588-2016 Class II | PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use…Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212 (Short AR… | MicroPort Orthopedics Inc. | 06/30/2016Terminated |
| Z-1027-2014 Class II | PRESSFIT FEM ST FX 16 X 1Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | Zimmer, Inc. | 10/11/2013Terminated |
| Z-1822-2009 | V 40 Femoral Head, Sterile, 22 mm; Catalog number 6260-4-122, Catalog number 6260-5-226…Sterilization issue: During post-sterilization inspection of the outer blister packaging of the affected… | Stryker Howmedica Osteonics Corp. | 06/18/2009Terminated |
| Z-1615-2009 | Zimmer femoral stem, revision taper, 15 mm diameter, 185 mm stem length, w/compression…The threads on the screw are incomplete/non-functional. | Zimmer Inc. | 05/15/2009Terminated |
| Z-1073-2009 | Dual Taper Wedge Pressed Fit Femoral Component. The Dual Taper Wedge is a single use…A possible breach of the sterile barrier packaging (Tyvek pouch). | Stelkast Co | 10/31/2008Terminated |
| Z-0664-2009 | Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number…Sterility may be compromised due to breach in packaging. | Stelkast Co | 10/07/2008Terminated |
| Z-0445-2008 | Excia Cemented Hip Stems ,Size 18mm, Part Number NJ318K, Aesculap Implant Systems, Inc.…Sterility (package integrity) Compromised: Device package damaged during shipment | Aesculap Implant Systems | 10/10/2007Terminated |
| Z-0444-2008 | Excia Cemented Hip Stems, Size 17mm, Part Number : NJ317K, Aesculap Implant Systems…Sterility (package integrity) Compromised: Device package damaged during shipment | Aesculap Implant Systems | 10/10/2007Terminated |
| Z-0443-2008 | Excia Cemented Hip Stems, Size 16mm, Part Number NJ316K, Aesculap Implant Systems, Inc.…Sterility (package integrity) Compromised: Device package damaged during shipment | Aesculap Implant Systems | 10/10/2007Terminated |
| Z-0442-2008 | Excia Cemented Hip Stems, Size 15mm, Part Number: NJ315K Aesculap Implant Systems, Inc.…Sterility (package integrity) Compromised: Device package damaged during shipment | Aesculap Implant Systems | 10/10/2007Terminated |
| Z-0441-2008 | Excia Cemented Hip Stems, Size 14mm, Part Number : NJ314K, Aesculap Implant Systems…Sterility (package integrity) Compromised: Device package damaged during shipment | Aesculap Implant Systems | 10/10/2007Terminated |
| Z-0440-2008 | Excia Cemented Hip Stems, Size 13mm, Part Number : NJ313K, Aesculap Implant Systems…Sterility (package integrity) Compromised: Device package damaged during shipment | Aesculap Implant Systems | 10/10/2007Terminated |
| Z-0439-2008 | Excia Cemented Hip Stems, Size 12mm, Part Number: NJ312K, Aesculap Implant Systems…Sterility (package integrity) Compromised: Device package damaged during shipment | Aesculap Implant Systems | 10/10/2007Terminated |
| Z-0438-2008 | Excia Cemented Hip Stems, Size 11mm, Part Number : NJ311K, Aesculap Implant Systems…Sterility (package integrity) Compromised: Device package damaged during shipment | Aesculap Implant Systems | 10/10/2007Terminated |
| Z-0437-2008 | Excia Cemented Hip Stems, Size 10mm, Part Number: NJ310K, Aesculap Implant Systems…Sterility (package integrity) Compromised: Device package damaged during shipment | Aesculap Implant Systems | 10/10/2007Terminated |
| Z-0436-2008 | Excia Cemented Hip Stems, Size 9mm, Part Number: NJ309K, Aesculap Implant Systems, Inc.…Sterility (package integrity) Compromised: Device package damaged during shipment | Aesculap Implant Systems | 10/10/2007Terminated |