Panels › Orthopedic › Product code JDI · Class 2
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Regulation 888.3350
3510(k)s in 12 months (565 all time)
0recalls in 12 months (255 all time)
161recalls that name a 510(k)
Top companies in JDI
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer Biomet | 1 | 92 |
| Biomet, Inc. | 51 | 18 |
| Zimmer, Inc. | 27 | 23 |
| Depuy, Inc. | 45 | 0 |
| Howmedica Corp. | 43 | 0 |
| Stryker Howmedica Osteonics | 0 | 37 |
| DePuy Orthopaedics, Inc. | 12 | 20 |
| Osteonics Corp. | 29 | 0 |
| Howmedica Osteonics | 17 | 11 |
| Intermedics Orthopedics | 21 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2015 | Biomet, Inc. Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD COCR -3 MM NECK; 32MM MOD HEAD COCR STD NECK ; 32MM MOD HEAD COCR +3MM NECK; 32MM COCR MOD HD +6MM NO SKIRT
Hip j Terminated |
JDI | K911684 |
| Mar 3, 2015 | Stryker Howmedica Osteonics Corp. LFT v40 Femoral Head; Catalog Number 6260-9-032;
V40 CoCr LFit Head 32mm/-4.
Designed to be assembled onto a femoral hip stem trunnion during surgery for a total hip arthroplasty. Terminated |
JDI | K010757 |
| Dec 17, 2014 | Biomet, Inc. Sirius Polish Cemented Stem 38C
Catalog Number: 51-199335
Lot Number Identification: 141680, 180920
The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem, design Terminated |
JDI | K130610 |
| Dec 17, 2014 | Biomet, Inc. Device Brand Name: Sirius Polish Cemented Stem 34B
Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemented
Device Common Name: Sirius Femoral Stem
The Biomet's Sirius F Terminated |
JDI | K130610 |
| Oct 20, 2014 | Zimmer, Inc. Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Metal/Polymer Terminated |
JDI | K091508 |
| Aug 26, 2014 | Zimmer, Inc. Endo & Unipolar Femoral Heads:
ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 54MM DIA, E Terminated |
JDI | K960278 |
| Aug 26, 2014 | Zimmer, Inc. Endo & Unipolar Femoral Heads:
ENDO FEMORAL HEAD 41MM DIA
ENDO FEMORAL HEAD 42MM DIA
ENDO FEMORAL HEAD 43MM DIA
ENDO FEMORAL HEAD 44MM DIA
ENDO FEMORAL HEAD 45MM DIA
ENDO FEMORAL HEAD 46MM DIA
ENDO FE Terminated |
JDI | K955473 |
| Feb 20, 2014 | Zimmer, Inc. CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes) Terminated |
JDI | K840643 K960658 |
| Feb 20, 2014 | Zimmer, Inc. 6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE Terminated |
JDI | K840643 K960278 |
| Feb 20, 2014 | Zimmer, Inc. CPT 12/14 COCR (various sizes) Terminated |
JDI | K030265 K960658 |
| Feb 20, 2014 | Zimmer, Inc. ZIMTRON 6 DEG 22 HEADS Terminated |
JDI | None listed |
| Feb 20, 2014 | Zimmer, Inc. 12/14 UNIPOLAR FEMORAL HE
VERSYS CEM LD/FX SZ 11X12
VERSYS CEM LD/FX SZ 12X12
VERSYS CEM LD/FX SZ 14X13
VERSYS CEM LD/FX SZ 16X14
VERSYS CEM LD/FX ST 18X15
VERSYS PRESS FIT LD/FX ST
VERSYS PRESS FIT L Terminated |
JDI | K913649 K950312 +2 |
| Feb 20, 2014 | Zimmer, Inc. HGP II ACETABULAR CUP BON Terminated |
JDI | K840643 |
| Dec 30, 2013 | Zimmer, Inc. Versys Build-Up Block
The VerSys CRC Hip System is indicated for total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated Terminated |
JDI | K913649 K960658 |
| Dec 30, 2013 | Zimmer, Inc. CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00
Hip joint metal/polymer semi-constrained cemented prosthesis.
The CPT Hip System is indicated for cemented use in: Patients suffering from seve Terminated |
JDI | K913649 K960658 |
| Dec 7, 2013 | Stryker Howmedica Osteonics Corp. 1) Accolade II 127 Neck Angle Hip Stem, Size # 3
2) Accolade II 127 Neck Angle Hip Stem, Size #5
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 USA
Telephone # +1 201-831-5000
Stryk Terminated |
JDI | K120578 |
| Nov 14, 2013 | Zimmer, Inc. VerSys Cemented Revision Calcar (CRC) Hip System Femoral Stems
VerSys Heritage Hip System Revision Femoral Stems.
Indicated for total hip arthroplasty. Terminated |
JDI | K913649 K963109 |
| Oct 25, 2013 | Zimmer, Inc. CPT Femoral Stem (CPT 12/14 STEM SIZE 0 COCR; CPT 12/14 SIZE 0 COCR EXT; CPT 12/14 STEM SIZE 1 COCR; CPT 12/14 SIZE 1 COCR EXT
CPT 12/14 STEM SIZE 2 COCR; CPT 12/14 SIZE 2 COCR EXT; CPT 12/14 SIZE 2 C Terminated |
JDI | K960658 |
| Nov 13, 2012 | Stryker Howmedica Osteonics Corp. Special Orthopaedic Solution
Peri-Acetabular Prosthesis
V40 Femoral Extension Component
Product Usage:
The PAR extension piece is a component of the PAR assembly. The Peri-Acetabular Reconstruction Terminated |
JDI | None listed |
| Nov 8, 2012 | Medacta Usa Inc Quadra S Offset Broach Handle
The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the fem Terminated |
JDI | None listed |
| Nov 6, 2012 | Zimmer, Inc. Original M.E. Mueller" Low Profile Cup
Sterile, Rx Terminated |
JDI | K960025 |
| Nov 6, 2012 | Zimmer, Inc. CoCr Head, sterile, Rx Terminated |
JDI | K993259 |
| Oct 15, 2012 | Zimmer, Inc. CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10.
CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty. Terminated |
JDI | K960658 |
| Jul 10, 2012 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp. Str Terminated |
JDI | K936127 |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. LUSTER HIP SZ 10
Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protector Terminated |
JDI | K983136 |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. LUSTER HIP SZ 9
Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors Terminated |
JDI | None listed |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. LUSTER HIP SZ 8
Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors Terminated |
JDI | K983136 |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. LUSTER HIP SZ 7
Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors Terminated |
JDI | K983136 |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. LUSTER HIP SZ 6
Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors Terminated |
JDI | K983136 |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. LUSTER HIP SZ 5
Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors Terminated |
JDI | K983136 |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. LUSTER HIP SZ 4
Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors Terminated |
JDI | K983136 |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. LUSTER HIP SZ 3
Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Terminated |
JDI | K983136 |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. LUSTER HIP SZ 2
Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors Terminated |
JDI | K983136 |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. LUSTER HIP SZ 1
Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors Terminated |
JDI | K983136 |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. ULTIMA*LX STM,POL 10/12TAP/4M
Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to Terminated |
JDI | K972435 |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. ULTIMA*LX STM,POL 10/12TAP/3M
Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to Terminated |
JDI | K972435 |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. ULTIMA*LX STM,POL 10/12TAP/2M
Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to Terminated |
JDI | K972435 |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. ULTIMA*LX STM,POL 10/12TAP/1M
Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to Terminated |
JDI | K972435 |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. ULTIMA*LX STM,POL 10/12TAP/SZ5
Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to Terminated |
JDI | K972435 |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. ULTIMA*LX STM,POL 10/12TAP/SZ4
Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to Terminated |
JDI | K972435 |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. ULTIMA*LX STM,POL 10/12TAP/SZ3
Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to Terminated |
JDI | K972435 |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. ULTIMA*LX STM,POL 10/12TAP/SZ2
Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to Terminated |
JDI | K972435 |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. ULTIMA*LX STM,POL 10/12TAP/SZ1
Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to Terminated |
JDI | K972435 |
| Jan 25, 2012 | Zimmer Inc. 5100-03-707 -- MOST Option STEM DISTRACTOR
MATL: SS NONSTERILE QTY-1
Designed to facilitate intraoperative decisions with a variety of options for femoral and tibial components, implant connections a Terminated |
JDI | K002324 |
| Jan 11, 2012 | Encore Medical, Lp FOUNDATION HIP SYSTEM Series 460 Hip Stem STERILE R CEMENTED Sz 16.5mm
DJO Surgical 9800 Metric Blvd., Austin, TX 78758
The Foundation Non-Porous Stem is intended for treatment of patients who are c Terminated |
JDI | K961890 |
| Nov 4, 2011 | Biopro, Inc. BioPro Femoral Head 28 mm +18, Item 19010.
Orthopedic femoral head for implantation Terminated |
JDI | K090208 |
| Nov 4, 2011 | Biopro, Inc. BioPro Femoral Head 28 mm -6 mm, Item 19003.
Orthopedic femoral head for implantation. Terminated |
JDI | K090208 |
| Sep 27, 2011 | Zimmer Inc. The Trabecular Metal Modular Acetabular System is a modular acetabular cup system consisting of a shell with a preassembled locking ring, a liner, and optional screws. The Shells are available in a v Terminated |
JDI | K021891 |
| May 13, 2010 | Stryker Howmedica Osteonics Corp. Distal Centralizer, Exeter II Hip System. Catalog number - 0920-2-920.
Intended to be used to centralize the femoral stem within the intramedullary canal. intended to be used with bone cement. Terminated |
JDI | K974054 |
| May 12, 2010 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics, Accolade Distal Centralizer 13 mm Medium; Catalog No.: 1059-4513. For use with Accolade hip prosthesis. Terminated |
JDI | K974054 |
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