# K963612: Duration Stabilized Uhmwpe

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Jun 11, 1997 after 274 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.
19 later devices descend from it; 1 cites it directly.
0 of 20 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
- K993352: Crossfire System 12 Acetabular Inserts (1999), 18 descendants of its own
- K111546: U2 Hip System (2011), 13 descendants of its own
- K122185: U-Motion II Acetabular System (2013), 7 descendants of its own
- K163441: Locking Cage, Full XPE Cup (2017), 3 descendants of its own
- K132455: U-Motion II PS+ Cup (2013), 3 descendants of its own

## Indications for use
The P.C.A.® System Inserts (previously cleared in K921384) are intended to be used with P.C.A® Acetabular Shells, and Howmedica femoral stems and heads in cementless primary or cemented primary/revision total hip arthroplasty. The Premise® Hip Acetabular Components (previously cleared in K912426) are intended to be used with Howmedica femoral stems and heads in cemented primary or revision total hip arthroplasty. The Osteolock™ Inserts (previously cleared in K903362), and the System 12® inserts (previously cleared in K851114 and K951115), when used with the Osteolock™ and Vitalock® Shells, are intended to be used with Howmedica femoral stems and heads in cemented primary or revision total hip arthroplasty.

Source page: https://510kreport.com/device/K963612
Methodology: https://510kreport.com/methodology