# K071059: Depuy Spa Porous Coated Proximal Sleeve

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Nov 9, 2007 after 207 days
- Product code: KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K860207: S-Rom 135 Porous Coated Femoral Stem Collar, Joint Medical Products Corp. (1986). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K934412: Coated ZT Proximal Sleeve, Joint Medical Products Corp. (1994). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The SPA Porous Coated Proximal Sleeve components of the S-ROM Total Hip System are indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion. The SPA Porous Coated Proximal Sleeves are intended for cementless use.

Source page: https://510kreport.com/device/K071059
Methodology: https://510kreport.com/methodology