# K013935: Allofit Acetabular System 32MM Alpha Durasul Inserts

- Pathway: 510(k) (Special)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Dec 13, 2001 after 15 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003758 (2001). 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)
- K003758: Allofit Acetabular System, Sulzer Orthopedics, Inc. (2001). Our OCR of the scanned summary read K003578, which is not a number in FDA’s lists. Corrected to the only number with two digits swapped that is an earlier device of this one’s maker, Sulzer Orthopedics, Inc., in this field.

## Indications for use
Components of the Allofit Acetabular System are intended for use in total hip arthroplasty for treatment of the following: patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., theumatoid arthritis. those patients with failed previous surgery where pain, deformity, or dysfunction persists. revision of a previously failed hip arthroplasty.

Source page: https://510kreport.com/device/K013935
Methodology: https://510kreport.com/methodology