# K061955: Rayhack Low Profile Locking Plate and Instruments

- Pathway: 510(k) (Special)
- Applicant: Creative Medical Designs, Inc.
- Decided: Aug 4, 2006 after 24 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K952766 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952766: Rayhack Osteotomy System (Modification), Creative Medical Designs, Inc. (1995) Summary page 1.

## Indications for use
The Rayhack® Low Profile Locking Plate is a metallic surgical implant intended for long bone fixation utilized to assist healing but not intended to replace normal body structures. The plate and screws which attach to the bone are temporary internal fixation devices which align the bone surfaces in order to permit bone healing.

Source page: https://510kreport.com/device/K061955
Methodology: https://510kreport.com/methodology