# K994041: Tornier Bipolar Radial Head Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Aug 31, 2000 after 276 days
- Product code: KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 2 cite it directly.
0 of 20 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 Radial Head implant, Wright Medical Technologies, Inc.: named in the summary without a submission number
- (no number) Swanson Titanium Radial Head Implant, Wright Medical Technologies, Inc.: named in the summary without a submission number

## Most influential descendants
- K060438: RHS (2006), 18 descendants of its own
- K130533: Salto Talaris Total Ankle Prosthesis, RHS (2013), 16 descendants of its own
- K153452: Salto XT, Salto Talaris (2016), 15 descendants of its own
- K192994: Paragon 28 APEX 3D Total Ankle Replacement System (2020), 8 descendants of its own
- K210390: Apex 3D Total Ankle Replacement System (2021), 2 descendants of its own

## Indications for use
Acute traumatic fracture of the proximal radius not suitable for internal fixation. Unstable elbow following radial head resection, including wrist pain following radial head resection after radio-cubital dislocation or impingement of the carpus.

Source page: https://510kreport.com/device/K994041
Methodology: https://510kreport.com/methodology