510(k) K913649 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
MODULAR CALCAR REPLACEMENT
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Nov 13, 1991 |
| Received | Aug 16, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913649
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 68 consists of all product under product code: JDI and same usage:
Item no:
787101360 VERSYS CEM/REV/CALCAR 13X
787101361 VERSYS CEM/REV/CALCAR 13X
787101362 VERSYS CEM/REV/CALCAR 13X
7871013 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.