# K070292: Durom Hip Resurfacing System, Femoral Components

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer GmbH
- Decided: Apr 26, 2007 after 85 days
- Product code: KXA (Prosthesis, Hip, Femoral, Resurfacing)
- Device class: 2
- Regulation: 21 CFR 888.3400
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K983452 (1998). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021799: Cemented Femoral Head Resurfing Device, Biomet Orthopedics, Inc. (2002) Summary page 1.
- K032659: Depuy Asr Resurfacing Femoral Heads, DePuy Orthopaedics, Inc. (2003) Summary page 1.
- K043542: Biopro Tara Femoral Resurfacing Component, Biopro, Inc. (2005) Summary page 1.
- K994153: Cormet 2000 Hemi Hip Metallic Resurfacing Prosthesis, Corin USA (2000) Summary page 1.

## Recalls of this device
- Sep 4, 2012 · Class II · Z-0216-2013: Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints 
- Sep 26, 2007 · Not classified · Z-0276-2008: Mislabeled as to size; 54mm package contains 46 mm device and vice versa.
- Sep 26, 2007 · Not classified · Z-0275-2008: Mislabeled as to size; 54mm package contains 46 mm device and vice versa.

## Indications for use
FOR HEMI-HIP RESURFACING ARTHROPLASTY: The Durom Hip Resurfacing system femoral component, when used for hemi-hip arthroplasty, has been designed for cemented use in patients who are likely to outlive a conventional hip prosthesis. Femoral hip resurfacing hemi arthroplasty is most appropriate for patients with good bone quality in the femoral head and acetabulum, where the bearing surface and supportive bone structure of the acetabulum is normal, and where acetabular replacement is neither required nor desirable. Such patients will generally be under the age of 65. * Non inflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis if remaining bone stock is adequate, and osteoarthritis * Inflammatory joint disease (IJD), e.g. rheumatoid arthritis * Joint 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 Additional indications include other abnormalities where major pathology affects the femoral head; where the bearing surface and supportive bone structure of the acetabulum is normal; and where acetabular replacement is neither required nor desirable * WARNING: The Durom Femoral component is not approved for use with the Durom Acetabular cup for total hip surface replacement arthroplasty in the USA.

Source page: https://510kreport.com/device/K070292
Methodology: https://510kreport.com/methodology