# K001335: Acumatch L-Series Cemented Femoral Stem, Model L-Series Cemented

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: May 18, 2000 after 21 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: 1 generation back to K961304 (1996). 1 ancestor in all.
4 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)
- K961304: Aura Hip System Cemented Femoral Stem/Cemented Long Femoral Stem, Exactech, Inc. (1996) Summary page 1.
- (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

## Most influential descendants
- 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
AcuMatch L-Series Cemented Femoral Stem Components 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. AcuMatch L-Series Cemented Femoral Stem Components are intended to be used with bone cement.

Source page: https://510kreport.com/device/K001335
Methodology: https://510kreport.com/methodology