510(k) K994370 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
ORTHO DEVELOPMENT BALANCED KNEE SYSTEM
| Applicant | Ortho Development Corp., Draper UT, US |
| Decision | Substantially Equivalent, Mar 24, 2000 |
| Received | Dec 27, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994370
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 30, 2019 | Ortho Development Corporation Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V. Open, Classified |
JWH | None listed |
| May 30, 2019 | Ortho Development Corporation Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A
Material: Ti6Al4V. Open, Classified |
JWH | None listed |
| Aug 17, 2014 | Ortho Development Corporation Patella 38mm, REF164-0038
Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact with the femoral component Terminated |
JWH | None listed |
| Aug 17, 2014 | Ortho Development Corporation PS Tibial Insert, REF 163-1XXX
Product Usage:
UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component Terminated |
JWH | None listed |
| May 13, 2014 | Ortho Development Corporation PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures. Terminated |
JWH | None listed |
| Sep 9, 2009 | Ortho Development Corporation Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R, Size 3, REF 162-1300, Ortho Development, Draper, Utah 84020.
The Balanced Knee System is indicated in the salva Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.