510(k) K141056 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS
| Applicant | Stryker Orthopaedics, Mahwah NJ, US |
| Decision | Substantially Equivalent, Aug 5, 2014 |
| Received | Apr 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141056
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2024 | Howmedica Osteonics Corp. Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee S Open, Classified |
JWH | None listed |
| Jul 1, 2021 | Howmedica Osteonics Corp. Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700 Terminated |
JWH | None listed |
| Feb 10, 2021 | Howmedica Osteonics Corp. Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer. Terminated |
MBH | None listed |
| 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 |
| Jan 30, 2018 | Howmedica Osteonics Corp. Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601
The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and r Terminated |
MBH | None listed |
| Jan 12, 2018 | Howmedica Osteonics Corp. Knee Prosthesis, Sterile, Single-Use devices
Product Usage:
The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function Terminated |
MBH | None listed |
| Aug 14, 2015 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR
REF 5530-G-209 (component of the Triathlon Total Knee System) for fixation to the tibial baseplates via a locking wire mechanism. Terminated |
MBH | None listed |
| Aug 10, 2015 | Stryker Howmedica Osteonics Corp. Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm
Product Usage:
The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.