510(k) K113369 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
ZIMMER PERSONA KNEE SYSTEM
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 27, 2012 |
| Received | Nov 15, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113369
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2017 | Zimmer Biomet, Inc. Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301
For use during orthopaedic surgery for implantation of a prosthesis. Terminated |
JWH | None listed |
| Aug 7, 2017 | Zimmer Biomet, Inc. Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302
For use during orthopaedic surgery for implantation of a prosthesis. Terminated |
JWH | None listed |
| Aug 7, 2017 | Zimmer Biomet, Inc. Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301
For use during orthopaedic surgery for implantation of a prosthesis. Terminated |
JWH | None listed |
| Aug 7, 2017 | Zimmer Biomet, Inc. Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302
For use during orthopaedic surgery for implantation of a prosthesis. Terminated |
JWH | None listed |
| Apr 6, 2016 | Zimmer Manufacturing B.V. Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For use in total knee arthroplasty. REF 42-5114-005-14 Terminated |
JWH | None listed |
| Apr 6, 2016 | Zimmer Manufacturing B.V. Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthroplasty. REF 42-5114-008-18 Terminated |
JWH | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 59 consists of all product under product code: JWH and same usage:
Item no:
42540000026 PSN ALL POLY PAT PLY 26MM
42540000029 PSN ALL POLY PAT PLY 29MM
42540000032 PSN ALL POLY PAT PLY 32MM
4 Terminated |
JWH | None listed |
| Apr 1, 2015 | Zimmer, Inc. Brand Name: Persona Anterior Referencing Sizer with Locking Boom
The Persona Anterior Referencing Sizer is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Th Terminated |
JWH | None listed |
| Feb 3, 2015 | Zimmer, Inc. Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee arthroplasty (orthopedic). Terminated |
JWH | None listed |
| Dec 23, 2014 | Zimmer, Inc. Persona Cemented Tibial Broach Inserter/Extractor.
The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable instrument intended for use In multiple TKA procedures. The Perso Terminated |
JWH | None listed |
| Nov 8, 2014 | Zimmer, Inc. Persona Stemmed 5 Degree Cemented Tibia
Product Usage:
This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, Terminated |
JWH | None listed |
| Oct 23, 2014 | Zimmer, Inc. The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for
use in multiple total knee arthroplasty procedures. Per the Persona Surgical
technique, the Persona Tibial Artic Terminated |
JWH | None listed |
| Sep 4, 2014 | Zimmer, Inc. PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM with the following: L CD +0MM; L CD +6MM; L EF +0MM;L EF +6MM; L GH +0MM; L GH +6MM; L J +0MM; L J +6MM; Terminated |
JWH | None listed |
| Sep 4, 2014 | Zimmer, Inc. PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional TOP with the following: L 3-5 CD; L 6-9 CD; L 3-5 EF; L 6-9 EF; L 10-11 EF; L 6-9 GH; L 10-12 Terminated |
JWH | None listed |
| Sep 4, 2014 | Zimmer, Inc. PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional with the following: Left Size 3-9 CD Top; Left Size 3-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Left Size 3-9 Terminated |
JWH | None listed |
| Sep 4, 2014 | Zimmer, Inc. PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left with the following: Size CD +0 mm Thickness Bottom(TB); Size CD +6 mm Thickness Bottom; Size EF +0 mm Thickness Bottom; Terminated |
JWH | None listed |
| Sep 4, 2014 | Zimmer, Inc. PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Size 3-5 CD Top; Size 6-9 CD Top; Size 3-5 EF Top; Size 6-9 EF Top; Size 10-11 EF Top; Size 6-9 GH Top; Size 10-1 Terminated |
JWH | None listed |
| Sep 4, 2014 | Zimmer, Inc. PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Left Size 3-7 CD Top; Left Size 4-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Right Size 3-7 CD Top; Right Siz Terminated |
JWH | None listed |
| Aug 21, 2014 | Zimmer, Inc. Persona (TM) The Personalized Knee System
PS Tibial Articular Surface Provisional Top
Nonsterile
TASP PS L 3-5 CD TOP
TASP PS L 3-5 CD TOP
TASP PS L 3-5 CD TOP
TASP PS L 3-5 CD TOP
TASP PS L 3-5 CD Terminated |
JWH | None listed |
| Aug 21, 2014 | Zimmer, Inc. Persona (TM) The Personalized Knee System
Tibial Articular Surface Provisional Bottom
Nonsterile
TASP L CD BOTTOM, +0MM
TASP L CD BOTTOM, +6MM
TASP L EF BOTTOM, +0MM
TASP L EF BOTTOM, +6MM
TASP L GH Terminated |
JWH | None listed |
| Aug 21, 2014 | Zimmer, Inc. Persona (TM) The Personalized Knee System
UC Tibial Articular Surface Provisional Top
Nonsterile
TASP UC L 3-7 CD TOP
TASP UC L 4-11 EF TOP
TASP UC L 7-12 GH TOP
TASP UC L 9-12 J TOP Terminated |
JWH | None listed |
| Dec 18, 2012 | Zimmer, Inc. Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile
SIZE C, LEFT; SIZE C RIGHT
This device is indicated for patients with severe knee pain and disabi Terminated |
JWH | None listed |
| Dec 18, 2012 | Zimmer, Inc. Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile
This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid art Terminated |
JWH | None listed |
| Dec 18, 2012 | Zimmer, Inc. Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile
TIBIA SIZE E, LEFT
TIBIA SIZE E RIGHT
This device is indicated for patients with severe knee pain an Terminated |
JWH | None listed |
| Dec 18, 2012 | Zimmer, Inc. Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile
TIBIA SIZE F, LEFT
TIBIA SIZE F RIGHT
This device is indicated for patients with severe knee pain an Terminated |
JWH | None listed |
| Dec 18, 2012 | Zimmer, Inc. Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile
TIBIA SIZE G, LEFT
TIBIA SIZE G RIGHT
This device is indicated for patients with severe knee pain an Terminated |
JWH | None listed |
| Dec 18, 2012 | Zimmer, Inc. Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile
TIBIA SIZE H, LEFT
TIBIA SIZE H RIGHT
This device is indicated for patients with severe knee pain an Terminated |
JWH | None listed |
| Dec 18, 2012 | Zimmer, Inc. Persona, The Personalized Knee System,Tibial Drill, Cemented, 15.7 mm Diameter, Nonsterile
This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, Terminated |
JWH | None listed |
| Dec 18, 2012 | Zimmer, Inc. Persona, The Personalized Knee System, Tibial Drill Guide, Cemented, 15.7 mm Diameter, Nonsterile, Nonsterile
This drill guide is used with the Persona Knee System for patients with severe knee pai Terminated |
JWH | None listed |
| Dec 18, 2012 | Zimmer, Inc. Persona, The Personalized Knee System, Tibial Broach,, Cemented, Size C-D, Nonsterile,
This device is used with the Persona Knee System for patients with severe knee pain and disability due to: R Terminated |
JWH | None listed |
| Dec 18, 2012 | Zimmer, Inc. Persona, The Personalized Knee System, Tibial Broach, Cemented, Size E-F, Nonsterile,
This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rh Terminated |
JWH | None listed |
| Dec 18, 2012 | Zimmer, Inc. Persona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, Nonsterile,
This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rh Terminated |
JWH | None listed |
| Dec 18, 2012 | Zimmer, Inc. Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size C Left; Size C Right
This device is used with the Persona Knee System for patients with severe knee pain and d Terminated |
JWH | None listed |
| Dec 18, 2012 | Zimmer, Inc. Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size D Left; Size D Right
This device is used with the Persona Knee System for patients with severe knee pain and d Terminated |
JWH | None listed |
| Dec 18, 2012 | Zimmer, Inc. Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size E Left; Size E Right
This device is used with the Persona Knee System for patients with severe knee pain and d Terminated |
JWH | None listed |
| Dec 18, 2012 | Zimmer, Inc. Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size F Left; Size F Right
This device is used with the Persona Knee System for patients with severe knee pain and d Terminated |
JWH | None listed |
| Dec 18, 2012 | Zimmer, Inc. Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size G Left; Size G Right
This device is used with the Persona Knee System for patients with severe knee pain and d Terminated |
JWH | None listed |
| Dec 18, 2012 | Zimmer, Inc. Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size H Left; Size H Right
This device is used with the Persona Knee System for patients with severe knee pain and d Terminated |
JWH | None listed |
| Sep 28, 2012 | Zimmer, Inc. Cemented Tibial Drill
Product Usage:
The cemented tibial drill is used to prepare the tibial bone prior to the impaction of the applicable stemmed tibial broach. The cemented tibial drill has engrave Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.