# K053536: Durom Acetabular Component and Metasul LDH Large Diameter Heads

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer GmbH
- Decided: Mar 16, 2006 after 87 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K881288 (1988). 24 ancestors in all.
74 later devices descend from it; 1 cites it directly.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042037: M2A Magnum System, Biomet, Inc. (2004) Summary page 1.
- K021349: Metal Transcend Articulation System (Larger Sizes), Wrightmedicaltechnologyinc (2002) Summary page 1.
- K033634: Epsilon Metasul 32MM Acetabular Inserts, Standard and Hooded, Centerpulse Orthopedics, Inc. (2004) Summary page 1.

## Most influential descendants
- K071723: Zimmer Porolock Mis Stem (2008), 73 descendants of its own
- K123392: Avenir Muller Stem (2013), 41 descendants of its own
- K110400: Taperloc Complete Microplasty Stem (2011), 34 descendants of its own
- K130899: Biolox Delta Ceramic Femoral Heads (2013), 19 descendants of its own
- K120030: Taperloc Complete Size 4MM and XR 123 (2012), 14 descendants of its own

## Recalls of this device
- Sep 4, 2012 · Class II · Z-0248-2013: Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints 
- Jul 22, 2008 · Not classified · Z-2426-2008: Instructions for use/surgical technique instructions are inadequate.
- Jul 22, 2008 · Not classified · Z-2417-2008: Instructions for use/surgical technique instructions are inadequate.
- Jul 22, 2008 · Not classified · Z-2419-2008: Instructions for use/surgical technique instructions are inadequate.
- Jul 22, 2008 · Not classified · Z-2421-2008: Instructions for use/surgical technique instructions are inadequate.
- Jul 22, 2008 · Not classified · Z-2422-2008: Instructions for use/surgical technique instructions are inadequate.
- Jul 22, 2008 · Not classified · Z-2415-2008: Instructions for use/surgical technique instructions are inadequate.
- Jul 22, 2008 · Not classified · Z-2424-2008: Instructions for use/surgical technique instructions are inadequate.
- Jul 22, 2008 · Not classified · Z-2420-2008: Instructions for use/surgical technique instructions are inadequate.
- Jul 22, 2008 · Not classified · Z-2423-2008: Instructions for use/surgical technique instructions are inadequate.
- Jul 22, 2008 · Not classified · Z-2416-2008: Instructions for use/surgical technique instructions are inadequate.
- Jul 22, 2008 · Not classified · Z-2418-2008: Instructions for use/surgical technique instructions are inadequate.
- Jul 22, 2008 · Not classified · Z-2425-2008: Instructions for use/surgical technique instructions are inadequate.

## Indications for use
* Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. * Those patients with 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 crippled 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.

Source page: https://510kreport.com/device/K053536
Methodology: https://510kreport.com/methodology