# K962002: Aura Hip System Calcar Replacement Femoral Stem

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Aug 8, 1996 after 78 days
- Product code: JDG (Prosthesis, Hip, Femoral Component, Cemented, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3360
- 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) Howmedica hnr Head/Neck Replacement System: named in the summary without a submission number

## Indications for use
The Exactech AuRA Calcar Replacement Femoral Stem is indicated for use in skeletally mature patients in whom the calcar region is missing due to a failed previous total hip replacement as a result of osteoarthritis, osteonecrosis, rheumatoid arthritis or congenital hip dysplasia. It is also potentially indicated for use in post-traumatic degenerative problems. FOR CEMENTED USE ONLY

Source page: https://510kreport.com/device/K962002
Methodology: https://510kreport.com/methodology