# K092548: Extremity Medical Trapezium Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Extremity Medical, LLC
- Decided: Dec 15, 2009 after 118 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
Longest line of descent: 5 generations back to K864488 (1987). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960534: Metallic Spherical CMC Implant, Wrightmedicaltechnologyinc (1997) Summary page 1.
- K030319: Orthosphere Ceramic Spherical Implant, Wrightmedicaltechnologyinc (2003) Summary page 1.
- K864490: Swanson Titanium Carpal Scaphoid Implant, Dow Corning Wright (1987) Summary page 1.
- K864491: Swanson Titanium Carpal Lunate Implant, Dow Corning Wright (1987) Summary page 1.
- K033529: Tie-in Trapezium, Wrightmedicaltechnologyinc (2003) Summary page 1.
- K781756: Silastic H.P. Trapexial Implant, Dow Corning Corp. Healthcare Industries Materials (1978) Summary page 1.
- K042690: Ascension Pyrosphere (PCS), Ascension Orthopedics, Inc. (2004) Summary page 1.
- K080997: Ascension Pyrocarbon Lunate, Ascension Orthopedics, Inc. (2008) Summary page 1.

## Most influential descendants
- K201072: Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 (2020), 0 descendants of its own

## Indications for use
The Extremity Medical Trapezium Prosthesis is indicated for use in degenierative or post-traumnatic (e.gu. following an old Bennett fracture) disabilities of the thumb basal joint with: - Localized pain and palpable crepitation at the base of the thumb onl the "grind test" (circumduction with axial compression of the thumb) - Decreased motion, pinch; and 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

Source page: https://510kreport.com/device/K092548
Methodology: https://510kreport.com/methodology