# K013211: Modification to: Acumatch L-Series Bipolar Endoprosthesis

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Dec 5, 2001 after 70 days
- Product code: KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3390
- 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: 1 generation back to K905370 (1991). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905370: Exactech Bipolar Hip Prosthesis, Exactech, Inc. (1991) Summary page 1.
- (no number) Giliberty: named in the summary without a submission number
- (no number) Bi-articular: named in the summary without a submission number
- (no number) Centrax: named in the summary without a submission number
- (no number) Conversion: named in the summary without a submission number
- (no number) Self-Centering: named in the summary without a submission number

## Most influential descendants
- K152439: U2 Bipolar Implant and 22mm Femoral Head (2016), 3 descendants of its own
- K162957: U2 Femoral Head (2017), 1 descendant of its own
- K221675: United U2 femoral head, 22mm delta ceramic head (2022), 0 descendants of its own
- K173455: SurgTech Bipolar Head System (2018), 0 descendants of its own

## Recalls of this device
- Apr 26, 2024 · Class II · Z-2236-2024: The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packaging process utilized t

## 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.

Source page: https://510kreport.com/device/K013211
Methodology: https://510kreport.com/methodology