# K212761: Biocore9 Acetabular Cup System

- Pathway: 510(k) (Traditional)
- Applicant: Biocore9, LLC
- Decided: May 17, 2022 after 259 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- 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 K842202 (1984). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K842202: New Jersey Acetabular Component &, Endomedics, Inc. (1984) Summary page 4.
- K884888: Modified New Jersey Acetabular Comp. & Bone Screws, Protek, Inc. (1988) Summary page 4.

## Indications for use
1. Painful hip arthritis refractory to medical management resulting from post-traumatic arthritis, osteoarthritis, or rheumatoid arthritis. 2. Painful femoral head. cup arthroplasty, or bi-polar or universal type femoral head replacement. 3. Cases where more conventional arthroplasty techniques or arthrodesis are contraindicated because of a difficult clinical management problem, age, sex, occupation, or height of the patient The Biocore9 Acetabular Cup System components are intended for use in total hip arthroplasty in primary or revision surgery of skeletally mature patients. The Biocore9 Acetabular Cup System shells and liners are single use implants intended for cemented or cementless arthroplasty.

Source page: https://510kreport.com/device/K212761
Methodology: https://510kreport.com/methodology