# K094035: Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM

- Pathway: 510(k) (Traditional)
- Applicant: Stelkast Company
- Decided: Mar 24, 2011 after 449 days
- Product code: OQG (Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K810258 (1981). 8 ancestors in all.
79 later devices descend from it; 10 cite it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935484: Provident Hip System, Stelkast Company (1994) Summary page 2.
- K950827: Proform Porous Acetabular Assembly, Stelkast Company (1995) Summary page 2.
- K032396: Ringloc 36MM Line and Modular Femoral Heads, Biomet, Inc. (2003) Summary page 2.
- K970501: Pegged Acetabular Component, Biomet, Inc. (1997) Summary page 2.

## Most influential descendants
- K112802: Pipeline Total Hip System (2012), 53 descendants of its own
- K122158: PBP Total Hip System (2012), 21 descendants of its own
- K131237: Pipeline Total Hip System (2013), 20 descendants of its own
- K161184: iNSitu Total Hip System (2016), 19 descendants of its own
- K162719: iTotal® Hip Replacement System (2017), 17 descendants of its own

## Indications for use
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip Arthroplasty. Cemented and Uncemented Applications

Source page: https://510kreport.com/device/K094035
Methodology: https://510kreport.com/methodology