510(k) K171858 ยท PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Sidus Stem-Free Shoulder
| Applicant | Zimmer GmbH, Winterthur, CH |
| Decision | Substantially Equivalent, Dec 18, 2017 |
| Received | Jun 21, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171858
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2019 | Zimmer Biomet, Inc. Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380
0104555400
0104555420
0104555440
0104555460
0104555480
0104555485
0104555500
0104555505
0104555520
0104555525 Terminated |
PKC | None listed |
| Oct 10, 2019 | Zimmer Biomet, Inc. Various Hip Joint Replacement Systems, Item Nos. 00151504232
00151504432
00151504636
00151504836
00151505040
00151505240
00151505444
00151505644
00151505848
00151506048
00151506248
00151506448
0015150 Terminated |
LPH | None listed |
| Aug 21, 2019 | Zimmer GmbH Sidus Stem-Free Shoulder Humeral Head 50-18
Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for long-term implantation into the human shoulder jo Terminated |
PKC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.