# K161334: RASL Repair Kit

- Pathway: 510(k) (Traditional)
- Applicant: Radicle Orthopaedics, Inc.
- Decided: Feb 9, 2017 after 273 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K110506: Acumed S.H. Screw Repair System. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K131475: Barricade Embolization Coil System, Blockade Medical (2013). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The RASL Repair Kit is intended to provide fixation and anatomically reduce two bones or bone portions. Specifically, these indications include acute or chronic, static or dynamic scapholunate instability in the absence of significant capitolunate osteoarthritis, scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability.

Source page: https://510kreport.com/device/K161334
Methodology: https://510kreport.com/methodology