# K060438: RHS

- Pathway: 510(k) (Traditional)
- Applicant: Tornier
- Decided: Apr 18, 2006 after 56 days
- Product code: JDB (Prosthesis, Elbow, Semi-Constrained, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K984290 (1999). 10 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994041: Tornier Bipolar Radial Head Prosthesis, Tornier, Inc. (2000) Summary page 1.
- K023604: Modification to Radial Head Implant, Avanta Orthopaedics, Inc. (2002) Summary page 1.
- K051385: Explor Modular Radial Head Replacement Device, Biomet, Inc. (2005) Summary page 1.

## Most influential descendants
- 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
- K171004: Hintermann Series H2 Total Ankle System (2017), 2 descendants of its own

## Indications for use
The RHS is intended for: 1) Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: a. Joint destruction and/or subluxation visible on x-ray b. Resistance to conservative treatment 2) Primary replacement after fracture of the radial head 3) Symptomatic sequelae after radial head resection 4) Revision following failed radial head arthroplasty The long stem is for single cemented use only. The short stem coated with titanium plasma-spray is for single use with or without cement.

Source page: https://510kreport.com/device/K060438
Methodology: https://510kreport.com/methodology