# K041906: Exactech 12/14 Total Hip System

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Sep 10, 2004 after 57 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K931641 (1994). 16 ancestors in all.
145 later devices descend from it; 7 cite it directly.
0 of 162 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030236: Acumatch P-Series Porous Press-Fit Femoral Component, Exactech, Inc. (2003) Summary page 2.
- K002141: Acumatch P-Series Press-Fit Plasma, Acumatch P-Series Press-Fit, Acumatch L-Series Press-Fit, Exactech, Inc. (2000) Summary page 2.
- K862234: Exactech Total Hip System, Exactech, Inc. (1986) Summary page 2.
- K964262: Exactech Total Hip Systme: 22MM Femoral Head, Exactech, Inc. (1996) Summary page 2.
- K993082: Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular Component, Exactech, Inc. (1999) Summary page 2.
- (no number) AcuMatch L-Series Press-Fit Femoral Stem: named in the summary without a submission number

## Most influential descendants
- 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
- K112802: Pipeline Total Hip System (2012), 53 descendants of its own

## Recalls of this device
- Aug 11, 2022 · Class II · Z-1727-2022: Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

## 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® P-Series and AcuMatch® L-Series press-fit femoral stems are intended for press-fit fixation. AcuMatch® A-Series press-fit acetabular cups are intended for press-fit fixation. Press-fit acetabular shells and press-fit femoral stems without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon. Cobalt chromium femoral heads are intended for use in cemented and press-fit applications.

Source page: https://510kreport.com/device/K041906
Methodology: https://510kreport.com/methodology