# K033529: Tie-in Trapezium

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Dec 3, 2003 after 23 days
- Product code: KYI (Prosthesis, Wrist, Carpal Trapezium)
- Device class: 2
- Regulation: 21 CFR 888.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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) Swanson Trapezium Implant: named in the summary without a submission number

## Most influential descendants
- K092548: Extremity Medical Trapezium Prosthesis (2009), 1 descendant of its own
- K201072: Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 (2020), 0 descendants of its own

## Indications for use
Use of the TIE-INTm Trapezium may be considered in degenerative or post-traumatic disabilities of the thumb basil joint with: * Localized pain and palpable crepitation during circumduction movement with axial compression of involved thumb ("grind test") * Decreased motion, decreased pinch and decreased grip strength * X-ray evidence of arthritic changes of the trapeziometacarpal, trapezioscaphoid, trapeziotrapezoid, and trapezium second metacarpal joints, singly or in combination * Associated unstable, stiff, or painful distal joints of thumb or swan-neck deformity The TIE-INTM Trapezium is for single use.

Source page: https://510kreport.com/device/K033529
Methodology: https://510kreport.com/methodology