# K002141: Acumatch P-Series Press-Fit Plasma, Acumatch P-Series Press-Fit, Acumatch L-Series Press-Fit

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Aug 16, 2000 after 30 days
- Product code: LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3360
- 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 K921113 (1993). 2 ancestors in all.
147 later devices descend from it; 2 cite it directly.
0 of 150 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921113: Exatech MCS Porous Coated Total Hip Femoral Stem, Exactech, Inc. (1993) Summary page 4.
- K990197: Modulus Compatible Stability (MCS)-HA Total Hip System, Exactech, Inc. (1999) Summary page 4.

## Most influential descendants
- K030236: Acumatch P-Series Porous Press-Fit Femoral Component (2003), 146 descendants of its own
- K041906: Exactech 12/14 Total Hip System (2004), 145 descendants of its own
- K042842: Novation 12/14 Press-Fit Femoral Stem (2004), 64 descendants of its own
- K051556: Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene (2005), 60 descendants of its own
- K070479: Exactech Novation Crown Cup and Liners (2007), 59 descendants of its own

## Indications for use
AcuMatch Press-Fit Femoral 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 the AcuMatch Integrated Hip System 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 Press-Fit Femoral Components are intended to be used in press-fit applications. Components without the optional hydroxyapatite (HA) coating may also be used in cemented applications.

Source page: https://510kreport.com/device/K002141
Methodology: https://510kreport.com/methodology
