# K010243: Tri-Fit Femoral Stem

- Pathway: 510(k) (Special)
- Applicant: Corin USA
- Decided: Feb 15, 2001 after 21 days
- Product code: LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
74 later devices descend from it; 2 cite it directly.
0 of 75 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 its predicate without a number.
- (no number) CTi II femoral stem: named in the summary without a submission number

## Most influential descendants
- K111911: Corin Optimom Modular Head (2011), 62 descendants of its own
- K120362: Metafix Femoral Stem for Hemi-Arthroplasty (2012), 61 descendants of its own
- K123991: Depuy Corail Amt Hip Prosthesis (2013), 48 descendants of its own
- K150862: DePuy Actis Duofox Hip Prosthesis (2015), 38 descendants of its own
- K170339: Summit Hip System (2018), 27 descendants of its own

## Indications for use
Tri-Fit Total Hip System is indicated for the relief of pain and restoration of hip function following the effects of osteo, rheumatoid and inflammatory arthritis, post-traumatic disease effects, hip fractures, avascular necrosis and total hip revision. Tri-Fit Hip System Components are intended to be used in press-fit applications or with bone cement,

Source page: https://510kreport.com/device/K010243
Methodology: https://510kreport.com/methodology