# K993082: Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular Component

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Nov 19, 1999 after 65 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K921114 (1993). 4 ancestors in all.
161 later devices descend from it; 9 cite it directly.
0 of 166 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921114: Exactech MCS Porous Coated Total Hip Acetabular, Exactech, Inc. (1993) Summary page 1.
- K990197: Modulus Compatible Stability (MCS)-HA Total Hip System, Exactech, Inc. (1999) Summary page 1.
- K932755: Reflection Acetabular Component, Smith & Nephew Richards, Inc. (1994) Summary page 1.
- K934765: Trilogy Acetabular System, Zimmer, Inc. (1994) Summary page 1.
- (no number) Omnifit: named in the summary without a submission number
- (no number) Inter-Op: named in the summary without a submission number

## 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
- K040613: Exactech Acumatch a-Series and MCS Acetabular Shells and Liners (2004), 61 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

## Recalls of this device
- Aug 11, 2022 · Class II · Z-1734-2022: Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
- Nov 7, 2016 · Class II · Z-1031-2017: Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.

## Indications for use
All Exactech Hip Systems 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 Exactech Hip Systems are also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present and to restore mobility resulting from previous fusion. The AcuMatch A-Series Porous Coated Acetabular Components are intended to be used in press fit and cemented applications.

Source page: https://510kreport.com/device/K993082
Methodology: https://510kreport.com/methodology