ClearanceBrief
510(k) K960658 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

COLLARLESS POLISHED TAPER HIP PROSTHESIS

ApplicantZimmer, Inc., Warsaw IN, US
DecisionSubstantially Equivalent, Jul 16, 1996
ReceivedFeb 16, 1996
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K960658

DateFirm and productCodeLinked 510(k)
Jul 30, 2024Zimmer, Inc.
CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00811400010 00811400100 00811400110 00811400200 00811400210 00811400218 00811400230
Open, Classified		 JDINone listed
Nov 29, 2017Zimmer Biomet, Inc.
CPT 12/14 COCR REVISION SIZE 2 180MM prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Terminated		 JDINone listed
Nov 29, 2017Zimmer Biomet, Inc.
CPT 12/14 COCR SIZE 0 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Terminated		 MBHNone listed
Nov 29, 2017Zimmer Biomet, Inc.
CPT 12/14 COCR SIZE 1 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Terminated		 JWHNone listed
Nov 29, 2017Zimmer Biomet, Inc.
CPT 12/14 COCR SIZE 2 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Terminated		 JDINone listed
Nov 29, 2017Zimmer Biomet, Inc.
CPT 12/14 COCR SIZE 2 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Terminated		 JDINone listed
Mar 12, 2016Zimmer Manufacturing B.V.
Product 21 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14 COCR REVISION S 811400420 CPT 12/14 COCR REVISION S 811400
Terminated		 JDINone listed
Feb 22, 2016Zimmer Biomet, Inc.
CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes "The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and dis
Terminated		 JDINone listed
Feb 20, 2014Zimmer, Inc.
CPT 12/14 COCR (various sizes)
Terminated		 JDINone listed
Feb 20, 2014Zimmer, Inc.
CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)
Terminated		 JDINone listed
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		 JDINone listed
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		 JDINone listed
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		 JDINone listed
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		 JDINone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.