# K032396: Ringloc 36MM Line and Modular Femoral Heads

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Aug 21, 2003 after 17 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K810258 (1981). 5 ancestors in all.
505 later devices descend from it; 10 cite it directly.
0 of 511 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970501: Pegged Acetabular Component, Biomet, Inc. (1997) Summary page 1.
- K974558: Salvage/Onocology Hip and Total Femur System, Biomet, Inc. (1998) Summary page 1.

## Most influential descendants
- K042051: Arcomxl Polyethylene Liners (2005), 355 descendants of its own
- K051411: Arcomxl Polyethylene Liners and Biolox Delta Heads (2005), 344 descendants of its own
- K061312: 36MM Biolox Delta Ceramic Heads (2006), 343 descendants of its own
- K050327: E-Poly (Vitamin E) Acetabular Liners (2005), 289 descendants of its own
- K070364: 100KGY E-Poly Maxrom Acetabular Liners (2007), 286 descendants of its own

## Recalls of this device
- Apr 2, 2018 · Class II · Z-1538-2018: Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head.
- Sep 15, 2017 · Class II · Z-1008-2018: One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functional use of
- 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
The indications for use of the Biomet hip replacement prosthesis include: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. These devices are intended for either

Source page: https://510kreport.com/device/K032396
Methodology: https://510kreport.com/methodology