# K991869: Cobrex Hip Stem, Model 01-128-Xxxxx

- Pathway: 510(k) (Abbreviated)
- Applicant: Implex Corp.
- Decided: Jul 14, 1999 after 43 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 no predicate by number.

## Indications for use
The Implex Cobrex Hip Stem is intended for use where severe degeneration, trauma, or other pathology of the hip joint indicates cemented or hybrid total hip arthroplasty.

Source page: https://510kreport.com/device/K991869
Methodology: https://510kreport.com/methodology