# K122773: Cross-Over Acetabular Shell & Liner

- Pathway: 510(k) (Special)
- Applicant: Stelkast Company
- Decided: Oct 9, 2012 after 29 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K810258 (1981). 10 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001745: Modification to Provident Hip System, Stelkast Company (2000)
- K094035: Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM, Stelkast Company (2011) Summary page 2.

## Most influential descendants
- K190276: Provident II Hip Stem (2019), 2 descendants of its own
- K213842: ONVOY Acetabular System (2022), 1 descendant of its own
- K254043: TRIVANCE™ Hip Stem (2026), 0 descendants of its own
- K243456: ONVOY™ Acetabular System (2025), 0 descendants of its own
- K201733: Provident II Hip Stems (2021), 0 descendants of its own

## Recalls of this device
- Jan 24, 2013 · Class II · Z-1066-2013: Firm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over 36mm liner into the Cross-Over shell.

## Indications for use
The Cross-Over Acetabular Shell and Liner are intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from: 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. The Cross-Over Acetabular Shell and Liner are used as part of the Provident Hip Systems. The components of this hip system are intended for cementless fixation.

Source page: https://510kreport.com/device/K122773
Methodology: https://510kreport.com/methodology