# K030319: Orthosphere Ceramic Spherical Implant

- Pathway: 510(k) (Abbreviated)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Nov 26, 2003 after 300 days
- Product code: KWD (Prosthesis, Toe, Hemi-, Phalangeal)
- Device class: 2
- Regulation: 21 CFR 888.3730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 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) Ceramic Spherical CMC Implant: named in the summary without a submission number
- (no number) Swanson Titanium Great Toe 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
- K060560: Ascension Pyrosphere CMC/TMT (2006), 0 descendants of its own

## Indications for use
The Orthosphere® Ceramic Spherical Implant is indicated for use in cases of isolated carpometacarpal (CMC) or 4th/5th tarsometatarsal (TMT) joint involvement from either degenerative or post-traumatic arthritis presenting: Decreased motion X-ray evidence of arthritic changes and/or subluxation of the carpometacarpal or tarsometatarsal joints Localized pain and palpable crepitation during circumduction movement with axial compression of the involved thumb (“grind test”) Associated unstable, stiff or painful distal joints Decreased pinch and grip strength Degenerative joint disease of the midfoot associated with gout or pseudogout Only sizes 9mm-12mm are indicated for use in the 4th/5th tarsometatarsal joints. Sizes 9mm-14mm are indicated for use in the carpometacarpal (CMC) joints. The Orthosphere® Ceramic Spherical Implant is for single use only.

Source page: https://510kreport.com/device/K030319
Methodology: https://510kreport.com/methodology