# K032964: Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck Segments

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Nov 13, 2003 after 51 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: 2 generations back to K993736 (2000). 4 ancestors in all.
25 later devices descend from it; 5 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914574: Exactech Ceramic Femoral Head Component, Exactech, Inc. (1992) Summary page 2.
- K931617: Exactech Ziramic Femoral Head Component, Exactech, Inc. (1994) Summary page 2.
- K993736: Exactech Acumatch Integrated Hip System M-Series Femoral Stem Component, Exactech, Inc. (2000) Summary page 4.
- K010120: Modification to Exactech Acumatch Integrated Hip System, M-Series High Off-Set Neck Segment, M-Series Low Off-Set Neck S, Exactech, Inc. (2001)

## Most influential descendants
- K073337: Mectacer Biolox Forte-Femoral Heads (2008), 16 descendants of its own
- K112115: Mectacer Biolox (R) Delta Femoral Heads (2011), 14 descendants of its own
- K121665: Bencox Foret & Bencox Delta (2012), 8 descendants of its own
- K150007: Modified Bencox Hip System (2015), 7 descendants of its own
- K162127: Bencox M Stem Lateralized & Bencox Mirabo Cup System (2016), 6 descendants of its own

## Recalls of this device
- Nov 1, 2007 · Not classified · Z-0572-2008: Mislabeled: A ten piece lot of 140-32-03, 12/14 BIOLOXforte Alumina Femoral Heads 32mm (1069020 - 1069029), from Ceramtec were incorrectly labeled as 140-28-03 12/14 BIOLOXforte Alumina Femoral Heads,

## 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 detemiined 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 12/14 Neck Segments and Exactech 12/14 Alumina Femoral Heads are intended to be used in press-fit and cemented applications.

Source page: https://510kreport.com/device/K032964
Methodology: https://510kreport.com/methodology