# K012493: Acumatch C-Series Cemented Femoral Component, Model Size 0

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Aug 29, 2001 after 26 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: 2 generations back to K961304 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001335: Acumatch L-Series Cemented Femoral Stem, Model L-Series Cemented, Exactech, Inc. (2000) Summary page 2.
- K011218: Acumatch L-Series Cemented Femoral Stem, Model Size 1, Exactech, Inc. (2001) Summary page 2.
- K961304: Aura Hip System Cemented Femoral Stem/Cemented Long Femoral Stem, Exactech, Inc. (1996) Summary page 2.
- (no number) Conquest FX: named in the summary without a submission number
- (no number) Spectron: named in the summary without a submission number
- (no number) PFC: named in the summary without a submission number

## Indications for use
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present and to restore mobility resulting from previous fusion. The AcuMatch C-Series Femoral component is intended to be used with bone cement.

Source page: https://510kreport.com/device/K012493
Methodology: https://510kreport.com/methodology