# K980286: Ultima Acetabular Roof Reinforcement Ring

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: Apr 3, 1998 after 67 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953578 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953578: Protek Acetabular Roof Reinforcement Ring, Intermedics Orthopedics (1995) Summary page 2.

## Indications for use
The ULTIMA® Acetabular Roof Reinforcement Ring is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques. The Ultma® Acetabular Roof Reinforcement Ring is secured in the prepared acetabulumn using a combination of Polymethylmethacrylate (PMMA) bone cement, bone allograft, and cancellous screws to provide stabilization.

Source page: https://510kreport.com/device/K980286
Methodology: https://510kreport.com/methodology