# K983918: Radiolucent Cassette Limb Positioner (R-Clip)

- Pathway: 510(k) (Traditional)
- Applicant: Mastek, Inc.
- Decided: Mar 12, 1999 after 128 days
- Product code: IXA (Cassette, Radiographic Film)
- Device class: 2
- Regulation: 21 CFR 892.1850
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
1. The R-CLIP positions and secures limbs for radiographic x-ray exposure. 2. The R-CLIP brovides vertical and horizontal limb positioning relative to plane of operating table in order to optimize desired angle of radiographic view. 3. The R-CLIP avoids x-ray exposure to surgical staff by eliminating the need to hold the limb during exposure. 4. The R-CLIP is reusable and autoclavable. The R-CLIP Retainer kit is sterile, single use only.

Source page: https://510kreport.com/device/K983918
Methodology: https://510kreport.com/methodology