# K983710: 150MM Cocr Bimetric Head/Neck Replacement Hip Stem- Color Buff Finish

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Dec 2, 1998 after 42 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) HNR (Howmedica): named in the summary without a submission number
- (no number) Solution (DePuy): named in the summary without a submission number
- (no number) Modular Calcar (Zimmer): named in the summary without a submission number
- (no number) Bi-Metric CoCr Head Neck Replacement — Grit Blast Finish (Biomet): named in the summary without a submission number

## Indications for use
Biomet’s 150mm CoCr BiMetric Head/Neck Replacement Hip Stem — Color Buff Finish Prosthesis is indicated for use in noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; theumatoid arthritis; correction of functional deformity; treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. This device is a single use implant intended for cemented application only.

Source page: https://510kreport.com/device/K983710
Methodology: https://510kreport.com/methodology