# K993736: Exactech Acumatch Integrated Hip System M-Series Femoral Stem Component

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Jan 20, 2000 after 77 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
No predicates in its family tree.
27 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) S-ROM: named in the summary without a submission number
- (no number) Impact: named in the summary without a submission number
- (no number) Mallory-Head: named in the summary without a submission number
- (no number) Link MP: named in the summary without a submission number

## Most influential descendants
- K010120: Modification to Exactech Acumatch Integrated Hip System, M-Series High Off-Set Neck Segment, M-Series Low Off-Set Neck S (2001), 26 descendants of its own
- K032964: Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck Segments (2003), 25 descendants of its own
- 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

## Recalls of this device
- Jul 21, 2006 · Not classified · Z-0916-2007: The packaging was mislabeled: Exterior and interior packaging on the device was labeled with catalog number 150-07-19 15mm x 200mm, however, the actual part inside the packaging was a 21mm x 200mm (ca

## Indications for use
AcuMatch Integrated Hip System — M-Series Femoral Components are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, osteonecrosis, congenital hip dysplasia, rheumatoid arthritis, ankylosing spondylitis, and/or post-traumatic degenerative problems. M-Series components are also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present. AcuMatch M-Series components are intended to be used in press-fit and cemented applications.

Source page: https://510kreport.com/device/K993736
Methodology: https://510kreport.com/methodology