# K051569: Ringloc BI-Polar Acetabular Component

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Sep 29, 2005 after 107 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K833175 (1983). 2 ancestors in all.
25 later devices descend from it; 4 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K833175: Biomet Bipolar Prosthesis, Biomet, Inc. (1983) Summary page 1.
- K991990: Tri-Polar System, Biomet, Inc. (1999) Summary page 1.

## Most influential descendants
- K060707: Aesculap Bipolar Acetabular Cup (2006), 11 descendants of its own
- K112019: Bencox ID Stem, Bencox Metal Head, Bencox Bipolar Cup (2011), 10 descendants of its own
- K121665: Bencox Foret & Bencox Delta (2012), 8 descendants of its own
- K150007: Modified Bencox Hip System (2015), 7 descendants of its own
- K162127: Bencox M Stem Lateralized & Bencox Mirabo Cup System (2016), 6 descendants of its own

## Recalls of this device
- May 17, 2024 · Class II · Z-2179-2024: 41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention
- Nov 25, 2020 · Class II · Z-0628-2021: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
- Sep 3, 2020 · Class II · Z-0097-2021: Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to s
- Feb 17, 2017 · Class II · Z-1860-2017: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

## Indications for use
1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

Source page: https://510kreport.com/device/K051569
Methodology: https://510kreport.com/methodology