# K992058: BI-Metric Ccocr Head/Neck Replacement System

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Jul 1, 1999 after 13 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 K955350 (1996). 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)
- K955350: Bimetric Cocr Head/Neck Replacement Hip Stem, Biomet, Inc. (1996) Summary page 2.

## Indications for use
The Bi-Metric CoCr Head/Neck Replacement Hip Stem is intended for use in cases with diagnoses of: a) Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis b) Rheumatoid arthritis c) Correction of functional deformities d) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques e) Revisions of hip replacement components The Bi-Metric CoCr Head/Neck Replacement Hip Stem is intended for cemented application and is a single use device.

Source page: https://510kreport.com/device/K992058
Methodology: https://510kreport.com/methodology