# K980626: Duration II Acetabular Components-Gas Plasma Sterilization

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Dec 11, 1998 after 296 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) System 12® acetabular liners: named in the summary without a submission number

## Indications for use
The intended use of this additional style of System 12® acetabular inserts is identical to that of previously released System 12® inserts: they are intended to be used with Osteolock/Vitalock acetabular shells in primary or revision total hip arthroplasty.

Source page: https://510kreport.com/device/K980626
Methodology: https://510kreport.com/methodology