510(k) K190991 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment
| Applicant | Howmedica Osteonics Corp. (Aka Stryker Orthopaedics), Mahwah NJ, US |
| Decision | Substantially Equivalent, Aug 15, 2019 |
| Received | Apr 15, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190991
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2019 | Howmedica Osteonics Corp. TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT
Catalog # 5541-A-201 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Art Terminated |
MBH | None listed |
| Aug 19, 2019 | Howmedica Osteonics Corp. TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT
Catalog # 5541-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Ar Terminated |
MBH | None listed |
| Aug 19, 2019 | Howmedica Osteonics Corp. TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Prim Terminated |
MBH | None listed |
| Aug 19, 2019 | Howmedica Osteonics Corp. TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT
Catalog # 5542-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Ar Terminated |
MBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.