# K030236: Acumatch P-Series Porous Press-Fit Femoral Component

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Feb 20, 2003 after 28 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- 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 K931641 (1994). 9 ancestors in all.
146 later devices descend from it; 1 cites it directly.
0 of 156 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002141: Acumatch P-Series Press-Fit Plasma, Acumatch P-Series Press-Fit, Acumatch L-Series Press-Fit, Exactech, Inc. (2000)
- K921113: Exatech MCS Porous Coated Total Hip Femoral Stem, Exactech, Inc. (1993) Summary page 2.
- K990197: Modulus Compatible Stability (MCS)-HA Total Hip System, Exactech, Inc. (1999) Summary page 2.
- K003800: Aml Hip Prosthesis, DePuy Orthopaedics, Inc. (2001)
- K012364: Aml Hip Prosthesis, DePuy Orthopaedics, Inc. (2001)
- K991485: Synergy Porous Size 8 Hip Stem, Smith & Nephew, Inc. (1999) Summary page 2.
- K002996: Synergy HA Coated Porous Femoral  Stems, Smith & Nephew, Inc. (2000)

## Most influential descendants
- 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
- K102487: Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma Coated, Press-Fit, Size 19/20 (2010), 54 descendants of its own

## 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 Press-Fit components are intended for use in press-fit applications. Components without the optional hydroxyapatite (HA) coating may also be used with bone cement.

Source page: https://510kreport.com/device/K030236
Methodology: https://510kreport.com/methodology