510(k) K042051 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
ARCOMXL POLYETHYLENE LINERS
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 8, 2005 |
| Received | Jul 30, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042051
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2017 | Zimmer Biomet, Inc. various polyethylene implants
Hips
Active Articulation ArComXL Bearings
Active Articulation E1 Bearings
Arcos Taper Cap
BIOLOX delta Option Head
E1 RingLoc Bi-Polar
Freedom Constrained Liner +5mm
Hi Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.