510(k) K953337 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
BETA HIP PROSTHESIS
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jan 22, 1996 |
| Received | Jul 17, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953337
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 1, 2017 | Zimmer Biomet, Inc. Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows:
a. VERSYS 6 INCH BEADED FC 19X160MM STD BODY STD NECK (Item No. 00894301906);
b. VERSYS 6 INCH BEADED FC 21X160MM STD BODY Terminated |
LPH | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Por fullct fem st 15x200mm, Sterile,
prosthesis, hip, semi-constrained, metal/polymer, porous uncemented- Specific Knee, Hip and Nail Implants Terminated |
LPH | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Por fullct fem st 16x200mm, Sterile, Terminated |
LPH | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Por fullct fem st 17x200mm, Sterile, Terminated |
LPH | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Por fullct fem st 18x200mm, Sterile, Terminated |
LPH | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Por fullct fem st 20x200mm, Sterile,
Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants Terminated |
LPH | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 29 consists of all product under product code: LPHand same usage:
Item no:
32902603800 FEMORAL HEAD +0.5 X 22 MM
32902604810 FEMORAL HEAD +3.5 X 22 MM
32902604845 FEMORAL HEAD +7.0 X 22 MM
Terminated |
LPH | None listed |
| Feb 22, 2016 | Zimmer Biomet, Inc. VERSYS 6 INCH BEADED FC 1
VERSYS 6 INCH BEADED FC S
VERSYS 8 INCH BEADED FC 1
VERSYS 8 INCH BEADED FC 2
prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
"" Total hip replacement fo Terminated |
LPH | None listed |
| Feb 20, 2014 | Zimmer, Inc. 12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M) Terminated |
LPH | None listed |
| Feb 20, 2014 | Zimmer, Inc. 6 DEGREE COCR FEM HEAD 36 Terminated |
LPH | None listed |
| Oct 25, 2013 | Zimmer, Inc. Versys Beaded Fullcoat Femoral Stem (POR FULL-CT FEM ST 11X160MM; VERSYS BEADED FC 11X200MM 8ST; POR FULLCT FEM ST 11 LOW EXT; POR FULLCT FEM ST 11 EXT; POR FLCT FEM STEM LM 11X160MM; POR FULLCT LM FE Terminated |
LPH | None listed |
| Aug 26, 2010 | Zimmer Inc. VERSYS HIP SYSTEM
FEMORAL HEAD 12/14 TAPER 32 MM DIA. -3.5 MM NECK LENGTH
ZIMALOY CO-CR-MO ALLOY STERILE QTY-1
MANUFACTURED BY ZIMMER MANUFACTURING B.V.,
A SUBSIDIARY OF ZIMMER, INC. (WARSAW, IN)
The Terminated |
LPH | None listed |
| Aug 26, 2010 | Zimmer Inc. VERSYS HIP SYSTEM
FEMORAL HEAD 12/14 TAPER 28 MM DIA. -3.5 MM NECK LENGTH
ZIMALOY CO-CR-MO ALLOY STERILE QTY-1
MANUFACTURED BY ZIMMER MANUFACTURING B.V.,
A SUBSIDIARY OF ZIMMER, INC. (WARSAW, IN)
The Terminated |
LPH | None listed |
| Nov 13, 2009 | Zimmer Inc. Zimmer VerSys Hip System Femoral Head, 12/14 taper, 28 mm dia., neck length +0 mm, sterile, Zimmer, Warsaw, IN; REF 8018-28-02.
Intended for mating femoral stems equipped with tapered necks. Terminated |
LPH | None listed |
| Aug 3, 2005 | Zimmer Inc. Zimmer brand Versys Hip System Femoral Head 12/14 taper, 32 mm dia., neck length +0mm; Product 00-8018-032-02. Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.