# K091973: Metasul Taper Liners, Metasul Femoral Heads

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer GmbH
- Decided: Nov 17, 2009 after 139 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K004043 (2001). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974728: Inter-OP Metasul Acetabular System, Sulzer Orthopedics, Inc. (1999) Summary page 1.
- K033634: Epsilon Metasul 32MM Acetabular Inserts, Standard and Hooded, Centerpulse Orthopedics, Inc. (2004) Summary page 1.
- K062426: Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners, DePuy Orthopaedics, Inc. (2006) Summary page 1.

## Recalls of this device
- Oct 10, 2019 · Class II · Z-0334-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Oct 10, 2019 · Class II · Z-0335-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Jan 11, 2016 · Class II · Z-0850-2016: LDPE bag containing the implant adheres to the highly polished implant surface.
- Aug 30, 2013 · Class II · Z-0071-2014: The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.

## Indications for use
Noninflammatory degenerative joint disease (NIDJD) including avascular necrosis, osteoarthritis, post-traumatic arthritis and congenital hip dysplasia and inflammatory joint disease (IJD), e.g. rheumatoid arthritis if bone quality is adequate. Failed previous surgery where pain, deformity, or dysfunction persists. Revision of previously failed hip arthroplasty. Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely handicapped patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives. The system is intended for use either with or without bone cement in total hip arthroplasty.

Source page: https://510kreport.com/device/K091973
Methodology: https://510kreport.com/methodology