510(k) K892800 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
MG II POROUS TOTAL KNEE SYSTEM
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Aug 3, 1989 |
| Received | Apr 17, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K892800
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 26 consists of all product under product code: JWH and same usage:
Item no:
234703104 DISTAL MEDIAL FEMORAL CON
234703206 DISTAL MEDIAL FEMORAL CON
234703208 DISTAL MEDIAL FEMORAL CON
234800 Terminated |
JWH | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 34 consists of all product under product code: JWH and same usage:
Item no:
522001700 I/B II KNEE DOMED PATELLA
522001800 I/B II KNEE DOMED PATELLA
522001900 I/B II KNEE DOMED PATELLA
for us Terminated |
JWH | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 45 consists of all product under product code: JWH and same usage:
Item no:
511007020 MGII KNEE SLF-TAP BONE ST
511007025 MGII KNEE SLF-TAP BONE ST
511007030 MGII KNEE SLF-TAP BONE ST
511007 Terminated |
JWH | None listed |
| Feb 20, 2014 | Zimmer, Inc. I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST Terminated |
JWH | None listed |
| Feb 20, 2014 | Zimmer, Inc. FEM HD ION (various sizes) Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00595202010, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 10mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN
The NexGen Articu Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00595202012, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 12mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN
The NexGen Articu Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00595202014, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 14mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN
The NexGen Articu Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00595202017, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 17 mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN
The NexGen Artic Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00595202020, NexGen CompleteKnee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface Size Purple/A E Micro 20 mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN
The NexGen Artic Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5970-02023, NexGen CompleteKnee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert, Size Purple/A E Micro 23mm Height; Sterile, Rx ,Zimmer, Inc Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 90595202012, NexGen CompleteKnee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert, Size Purple/A E Micro 12 mm Height; Sterile, Rx ,Zimmer, Inc. Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5976-020-23 NexGen Complete Knee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert, Size Purple/A E Micro 23 mm Height; Sterile, Rx ,Zimmer, I Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 90595202017, NexGen Complete Knee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert, Size Purple/A E Micro 17 mm Height; Sterile, Rx ,Zimmer, Inc Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 90-5952-020-20, NexGen Complete Knee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert, Size Purple/A E Micro 20mm Height; Sterile, Rx ,Zimmer, I Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5970-020-09, NexGen CR Complete Knee Solution, Articular Surface regular constraint, Size Purple, Height; 9 mm CR Sterile, Rx ,Zimmer, Inc. Warsaw, IN
The NexGen Articular Surface serves as a sp Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5970-020-10, NexGen CR Complete Knee Solution, Articular Surface regular constraint, Size Purple, Height; 10 mm CR Sterile, Rx ,Zimmer, Inc. Warsaw, IN
The NexGen Articular Surface serves as a s Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5970-020-12, NexGen CR Complete Knee Solution, Articular Surface regular constraint, Size Purple, Height; 12 mm CR Sterile, Rx ,Zimmer, Inc. Warsaw, IN
The NexGen Articular Surface serves as a s Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5970-020-14, NexGen CR Complete Knee Solution, Articular Surface regular constraint, Size Purple, Height; 14 mm CR Sterile, Rx ,Zimmer, Inc. Warsaw, IN
The NexGen Articular Surface serves as a s Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5970-020-17, NexGen CR Complete Knee Solution, Articular Surface regular constraint, Size Purple, Height; 17 mm CR Sterile, Rx ,Zimmer, Inc. Warsaw, IN
The NexGen Complete Knee System ,integrated Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5970-020-20 NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 20 mm Height , Use With Plate 1,2 (5.5 MM under the Condyles) St Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 90-5970-020-09, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 9 mm Height , Use With Plate 1,2 (5.5 MM under the Condyles) St Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 90-5970-020-10, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) 10 MM Height , Use With Plate 1,2 Sterile R, Rx ,Zimmer, Inc. Warsaw, IN
The NexGen Complete Knee System ,integrated, with a Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 90-5970-020-12, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 12mm Height , Use With Plate 1,2 Sterile R, Rx ,Zimmer, Inc. Wa Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 90-5970-020-14, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 14mm Height , Use With Plate 1,2 Sterile R, Rx ,Zimmer, Inc. Wa Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 90-5970-020-17, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 17mm Height , Use With Plate 1,2 Sterile R, Rx ,Zimmer, Inc. Wa Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 90-5970-020-20, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 20mm Height , Use With Plate 1,2 Sterile R, Rx ,Zimmer, Inc. Wa Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5972-020-09, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 9mm Height , ( 5.5MM under the Condyles) Sterile R, Rx ,Zimmer, Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5972-020-10, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 10mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN
The NexGen Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5972-020-12, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 12mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN
The NexGen Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5972-020-14, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 14 mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN
The NexGe Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5972-020-17, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 17mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN
The NexGen Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5972-020-20, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 20mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN
The NexGen Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5976-020-10, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Anterior Constrained AC, Size Purple, AE Micro 10mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN
The N Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5976-020-12, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Anterior Constrained AC, Size Purple, AE Micro 12mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN
The N Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5976-020-17, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Anterior Constrained AC, Size Purple, AE Micro 17mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN
The N Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5976-020-20, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Anterior Constrained AC, Size Purple, AE Micro 20mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN
The N Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5952-031-10, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Yellow A-E Micro 10mm Height , Sterile R, Rx ,Zimmer, Inc. Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5952-31-12, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Yellow A-E Micro 12mm Height , Sterile R, Rx ,Zimmer, Inc. W Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. REF 00-5952-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Yellow A-E Micro 14mm Height , Sterile R, Rx ,Zimmer, I Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. REF 00-5952-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Yellow A-E Micro 17mm Height , Sterile R, Rx ,Zimmer, I Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. REF 00-5952-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Yellow A-E Micro 20mm Height , Sterile R, Rx ,Zimmer, I Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. REF 00-5972-031-09, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 9mm Height , Sterile R, Rx ,Zimmer, Inc. Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. REF 00-5972-031-10, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 10mm Height , Sterile R, Rx ,Zimmer, Inc Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. REF 00-5972-031-12, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 12mm Height , Sterile R, Rx ,Zimmer, Inc Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. REF 00-5972-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 14mm Height , Sterile R, Rx ,Zimmer, Inc Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. REF 00-5972-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 17mm Height , Sterile R, Rx ,Zimmer, Inc Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. REF 90-5952-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Yellow/A-E 17 mm Height , Sterile R, Rx ,Zimmer, Inc. Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. REF 90-5972-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 20 mm Height , Sterile R, Rx ,Zimmer, In Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. REF 00-5970-031-09, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 9 mm Height , Sterile R, Rx ,Zimmer, Inc Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. REF 00-5970-031-10, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 10mm Height , Sterile R, Rx ,Zimmer, Inc Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. REF 00-5970-031-12, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 12mm Height , Sterile R, Rx ,Zimmer, Inc Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. REF 00-5970-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 14mm Height , Sterile R, Rx ,Zimmer, Inc Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. REF 00-5970-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 17 mm Height , Sterile R, Rx ,Zimmer, In Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. REF 00-5970-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 20 mm Height , Sterile R, Rx ,Zimmer, In Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. REF 90-5970-031-09, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 9mm Height , Sterile R, Rx ,Z Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. REF 90-5970-031-10, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 10mm Height , Sterile R, Rx , Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. REF 90-5970-031-12, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 12mm Height , Sterile R, Rx , Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. REF 90-5970-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 14 mm Height , Sterile R, Rx Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. REF 90-5970-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 17 mm Height , Sterile R, Rx Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 90-5970-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 20 mm Height , Sterile R, Rx ,Zim Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. REF 00-5972-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 20mm Height , Sterile R, Rx , Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5976-031-10, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 10mm Height , Sterile R, Rx ,Zimm Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5976-031-12, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface AC Size Striped Yellow 12 mm Height , Sterile R, Rx ,Zimmer, Inc Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5976-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface AC Size Striped Yellow 14 mm Height , Sterile R, Rx ,Zimmer, Inc Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5976-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface AC Size Striped Yellow 17 mm Height , Sterile R, Rx ,Zimmer, Inc Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5976-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface AC Size Striped Yellow 20 mm Height , Sterile R, Rx ,Zimmer, Inc Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5970-031-23, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Striped Yellow 23 mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5972-031-23, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 23 mm Height , Sterile R, Rx ,Zimmer, Inc. W Terminated |
JWH | None listed |
| May 14, 2012 | Zimmer Inc. 00-5976-031-23, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface AC Size Striped Yellow 23 mm Height , Sterile R, Rx ,Zimmer, Inc Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.