ClearanceBrief
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)
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Top companies in JDI

DateFirm and productCodeLinked 510(k)
Jun 11, 2015Biomet, 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
JDIK911684
Mar 3, 2015Stryker 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
JDIK010757
Dec 17, 2014Biomet, 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
JDIK130610
Dec 17, 2014Biomet, 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
JDIK130610
Oct 20, 2014Zimmer, Inc.
Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Metal/Polymer
Terminated
JDIK091508
Aug 26, 2014Zimmer, 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
JDIK960278
Aug 26, 2014Zimmer, 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
JDIK955473
Feb 20, 2014Zimmer, Inc.
CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)
Terminated
JDIK840643
K960658
Feb 20, 2014Zimmer, Inc.
6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE
Terminated
JDIK840643
K960278
Feb 20, 2014Zimmer, Inc.
CPT 12/14 COCR (various sizes)
Terminated
JDIK030265
K960658
Feb 20, 2014Zimmer, Inc.
ZIMTRON 6 DEG 22 HEADS
Terminated
JDINone listed
Feb 20, 2014Zimmer, 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
JDIK913649
K950312 +2
Feb 20, 2014Zimmer, Inc.
HGP II ACETABULAR CUP BON
Terminated
JDIK840643
Dec 30, 2013Zimmer, 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
JDIK913649
K960658
Dec 30, 2013Zimmer, 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
JDIK913649
K960658
Dec 7, 2013Stryker 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
JDIK120578
Nov 14, 2013Zimmer, Inc.
VerSys Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems. Indicated for total hip arthroplasty.
Terminated
JDIK913649
K963109
Oct 25, 2013Zimmer, 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
JDIK960658
Nov 13, 2012Stryker 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
JDINone listed
Nov 8, 2012Medacta 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
JDINone listed
Nov 6, 2012Zimmer, Inc.
Original M.E. Mueller" Low Profile Cup Sterile, Rx
Terminated
JDIK960025
Nov 6, 2012Zimmer, Inc.
CoCr Head, sterile, Rx
Terminated
JDIK993259
Oct 15, 2012Zimmer, 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
JDIK960658
Jul 10, 2012Stryker 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
JDIK936127
Jun 29, 2012DePuy 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
JDIK983136
Jun 29, 2012DePuy 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
JDINone listed
Jun 29, 2012DePuy 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
JDIK983136
Jun 29, 2012DePuy 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
JDIK983136
Jun 29, 2012DePuy 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
JDIK983136
Jun 29, 2012DePuy 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
JDIK983136
Jun 29, 2012DePuy 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
JDIK983136
Jun 29, 2012DePuy 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
JDIK983136
Jun 29, 2012DePuy 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
JDIK983136
Jun 29, 2012DePuy 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
JDIK983136
Jun 29, 2012DePuy 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
JDIK972435
Jun 29, 2012DePuy 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
JDIK972435
Jun 29, 2012DePuy 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
JDIK972435
Jun 29, 2012DePuy 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
JDIK972435
Jun 29, 2012DePuy 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
JDIK972435
Jun 29, 2012DePuy 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
JDIK972435
Jun 29, 2012DePuy 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
JDIK972435
Jun 29, 2012DePuy 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
JDIK972435
Jun 29, 2012DePuy 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
JDIK972435
Jan 25, 2012Zimmer 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
JDIK002324
Jan 11, 2012Encore 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
JDIK961890
Nov 4, 2011Biopro, Inc.
BioPro Femoral Head 28 mm +18, Item 19010. Orthopedic femoral head for implantation
Terminated
JDIK090208
Nov 4, 2011Biopro, Inc.
BioPro Femoral Head 28 mm -6 mm, Item 19003. Orthopedic femoral head for implantation.
Terminated
JDIK090208
Sep 27, 2011Zimmer 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
JDIK021891
May 13, 2010Stryker 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
JDIK974054
May 12, 2010Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, Accolade Distal Centralizer 13 mm Medium; Catalog No.: 1059-4513. For use with Accolade hip prosthesis.
Terminated
JDIK974054

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