# K961304: Aura Hip System Cemented Femoral Stem/Cemented Long Femoral Stem

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Oct 1, 1996 after 180 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices 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) Smith & Nephew Orthopaedics Spectron® Total Hip System: named in the summary without a submission number

## Most influential descendants
- K001335: Acumatch L-Series Cemented Femoral Stem, Model L-Series Cemented (2000), 4 descendants of its own
- K052787: Acumatch 12/14 C-Series Cemented Femoral Stems (Size 1-6), Acumatch 12/14 L-Series Cemented Femoral Stems (Size 1-5) (2005), 2 descendants of its own
- K083392: Novation 12/14 Cemented Femoral Stems (2008), 1 descendant of its own
- K090764: Novation CFS Press-Fit and Cemented Stems (2009), 0 descendants of its own
- K012493: Acumatch C-Series Cemented Femoral Component, Model Size 0 (2001), 0 descendants of its own

## Indications for use
The AuRA™ Cemented Femoral Stem and Cemented Long Femoral Stem are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, osteonecrosis, congenital hip dysplasia, rheumatoid arthritis and/or post-traumatic degenerative problems. It is also potentially indicated for revision of failed previous reconstruction where sufficient bone stock is present. FOR CEMENTED USE ONLY

Source page: https://510kreport.com/device/K961304
Methodology: https://510kreport.com/methodology