# K973453: Tornier Cement Restrictor

- Pathway: 510(k) (Traditional)
- Applicant: Tornier
- Decided: Dec 9, 1997 after 89 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K061824: Tornier Cement Restrictor (2006), 0 descendants of its own

## Indications for use
Total Shoulder Arthroplasty Total Hip Arthroplasty Intramedullary Occlusion Cement Pressurization

Source page: https://510kreport.com/device/K973453
Methodology: https://510kreport.com/methodology