# K991622: 26 MM Cast Cocr Head and Polyethylene Acetabular Shell Liner

- Pathway: 510(k) (Traditional)
- Applicant: Stelkast Company
- Decided: Jul 14, 1999 after 64 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
29 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K073068: Accin Hip System (2008), 28 descendants of its own
- K100445: Klassic HD Hip System (2010), 25 descendants of its own
- K143407: Klassic HD Hip System (2014), 16 descendants of its own
- K141972: Klassic HD Acetabular Insert with E-Link Poly (2014), 14 descendants of its own
- K163577: Ecofit® Hip System (2017), 9 descendants of its own

## Indications for use
1. Joint impairment from arthritis (rtheumatoid, osteo and post traumatic). 2. Revision of failed femoral head replacements. 3. When alternative reconstructive techniques are not viable. 4. When arthrodesis is contraindicated. 5. Avascular necrosis or fracture of the femoral head. 6. Congenital defects that will allow adequate function of the system.

Source page: https://510kreport.com/device/K991622
Methodology: https://510kreport.com/methodology