# K051858: Acumatch M-Series LPB 12/14 Femoral Stem

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Dec 1, 2005 after 146 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K993736 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993736: Exactech Acumatch Integrated Hip System M-Series Femoral Stem Component, Exactech, Inc. (2000) Summary page 2.
- K011081: Acumatch M-Series Extra-Small Metaphyseal Segments, Exactech, Inc. (2001) Summary page 3.
- K032964: Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck Segments, Exactech, Inc. (2003) Summary page 2.

## Indications for use
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, 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 ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. AcuMatch M-Series LPB 12/14 Femoral Stems are intended to be used in press-fit and cemented applications.

Source page: https://510kreport.com/device/K051858
Methodology: https://510kreport.com/methodology