510(k) K051569 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
RINGLOC BI-POLAR ACETABULAR COMPONENT
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Sep 29, 2005 |
| Received | Jun 14, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051569
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 25, 2024 | Biomet, Inc. RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty
Item Number: 11-165206 Open, Classified |
JDI | None listed |
| Dec 17, 2020 | Biomet, Inc. RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, Prosthesis, Hip, Terminated |
MEH | None listed |
| Oct 9, 2020 | Biomet, Inc. (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom:
Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM:
Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) Terminated |
JDI | None listed |
| 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.