# K960025: Protek Low Profile Acetabular Cup

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics Orthopedics
- Decided: Jun 7, 1996 after 157 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- 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 K933203 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933203: Apollo (TM) Hip Syst-Straight Stem/All-Poly Acet Comp, Intermedics Orthopedics (1994) Summary page 1.
- (no number) Richards Cemented Acetabular Component: named in the summary without a submission number
- (no number) Osteonics All Poly Acetabular Cup: named in the summary without a submission number
- (no number) Ultima Polyethylene Acetabular Cup: named in the summary without a submission number

## Recalls of this device
- Sep 4, 2012 · Class II · Z-0235-2013: 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 

## Indications for use
Advanced Joint destruction resulting from degenerative, posttraumatic or rheumatoid arthritis. Fracture or avascular necrosis of the femoral head. Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty and total hip replacement.

Source page: https://510kreport.com/device/K960025
Methodology: https://510kreport.com/methodology