510(k) K162719 · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
iTotal® Hip Replacement System
| Applicant | Conformis, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Jun 14, 2017 |
| Received | Sep 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162719
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2019 | Conformis, Inc. iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right Terminated |
LPH | None listed |
| Aug 22, 2019 | Conformis, Inc. iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right Terminated |
LPH | None listed |
| Mar 29, 2019 | Conformis, Inc. Conformis iTotal Hip Replacement System:
HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT) Terminated |
LPH | None listed |
| Oct 16, 2018 | Conformis, Inc. iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101 Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.