510(k) K100866 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
PROFEMUR HIP SYSTEM MODULAR NECKS
| Applicant | Wrightmedicaltechnologyinc, Arlington TN, US |
| Decision | Substantially Equivalent, Apr 28, 2010 |
| Received | Mar 29, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100866
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 9, 2020 | MicroPort Orthopedics Inc. PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions:
Item Number Description Description 2
PHAC1202 PROFEMUR NECK NEUTRAL SHORT COBALT CHROME
PHAC1204 PROFEMUR NECK NEUTRA Open, Classified |
LWJ | None listed |
| Dec 1, 2016 | MicroPort Orthopedics Inc. Lineage Liners:
REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF 70303258, REF 70402864, REF 70403264, REF 70403664
For use with the conserve metal head Terminated |
LZO | None listed |
| Dec 1, 2016 | MicroPort Orthopedics Inc. Dynasty Liners:
REF DLCOGA28, REF DLCOGB32, REF DLCOGC36, REF DLCOGD38, REF DLCOGE40, REF DLCOGF42, REF DLCOGG44, REF DLCOGH48, REF DLCOGJ52, REF DLCOGK56,
For use with the conserve metal head Terminated |
LZO | None listed |
| Dec 1, 2016 | MicroPort Orthopedics Inc. Procotyl (Rim- Lock) Liners:
REF PHA04702, REF PHA04704, REF PHA04706, REF PHA04708, REF PHA04710, REF PHA04712, REF PHA04714
For use with the conserve metal head Terminated |
LZO | None listed |
| Dec 1, 2016 | MicroPort Orthopedics Inc. Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 36694858, REF 36695060, REF 36695262, REF 36695464
For use with the conserve metal head Terminated |
LZO | None listed |
| Dec 1, 2016 | MicroPort Orthopedics Inc. Conserve Shells: REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF 38021154, REF 38021156, REF 38021158, REF 38021160, REF 38021162, REF 38021164, REF 38023642, REF 38023646, REF 38023844, Terminated |
LZO | None listed |
| Dec 1, 2016 | MicroPort Orthopedics Inc. Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, REF 38BF4046SP, REF 38BF4248, REF 38BF4248SP, REF 38BF4450, REF 38BF4450SP,
REF 38BF4652, REF 38BF4652SP, REF Terminated |
LZO | None listed |
| Dec 1, 2016 | MicroPort Orthopedics Inc. Cobalt Chromium Heads
Transcend: 26000017, 26000018, 26000019, 26000020, 26000021, 26000022, 26000023, 26000024, 26000025, 26000026, 26000027, 26000028
Conserve:
38013800, 38013804, 38013835, 38 Terminated |
LZO | None listed |
| Sep 28, 2015 | MicroPort Orthopedics, Inc. PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper.
Orthopedic hip prosthesis component. Terminated |
MBL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.