# K081025: Isoelasticu

- Pathway: 510(k) (Traditional)
- Applicant: Remi Sciences, Inc.
- Decided: Nov 21, 2008 after 225 days
- Product code: KXE (Prosthesis, Wrist, Hemi-, Ulnar)
- Device class: 2
- Regulation: 21 CFR 888.3810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) SBI Small Bone Innovations U head implant: named in the summary without a submission number
- (no number) Silastic Swanson Ulnar Head Implant: named in the summary without a submission number

## Indications for use
The IsoelasticU' m is indicated for joint replacement arthroplasty of the ulnar head at the distal radioulnar joint (DRUJ) for the following indications - Rheumatoid arthritis with or without tendon ruptures - Degenerative arthritis or post traumatic arthritis o 1. Arthrofibrosis of the DRUJ o 2. Reconstruction of the distal ulna post tumor resection o 3. Failed Ulnar Head Resection o 4. Distal ulna instability with xray or bone scan evidence of arthritic or inflammatory changes o 5. Revision following failed ulnar head arthroplasty - Ulna stems are intended for uncemented use

Source page: https://510kreport.com/device/K081025
Methodology: https://510kreport.com/methodology