# K010081: Acumatch L-Series Unipolar Endoprosthesis

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Feb 5, 2001 after 26 days
- Product code: KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3390
- 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 K881288 (1988). 3 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K960538: Opteon Unipolar, Exactech, Inc. (1996) Summary page 2.

## Most influential descendants
- K021109: Esop CO-CR Femoral Heads (2002), 1 descendant of its own
- K050556: Alumina Head (2005), 0 descendants of its own

## Indications for use
The AcuMatch L-Series Unipolar Endoprosthesis is indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. It is also indicated for use in replacement of the femoral head following femoral neck fracture. The AcuMatch L-Series Unipolar Endoprosthesis is contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, in neuromuscular disorders that do not allow control of the hip joint, and in patients whose weight, age, or activity level would cause the surgeon to expect early failure of the system. The L-Series Unipolar is also contraindicated for use in patients with evidence of degenerative changes in the acetabulum and/or pelvic fractures.

Source page: https://510kreport.com/device/K010081
Methodology: https://510kreport.com/methodology