# K964444: Quicklock Orthopaedic Targeting System

- Pathway: 510(k) (Traditional)
- Applicant: Rdh Medical
- Decided: Aug 11, 1997 after 278 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- 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) Richards radiolucent drills: named in the summary without a submission number
- (no number) Synthes radiolucent drills: named in the summary without a submission number

## Indications for use
The QuickLock Orthopaedic Targeting System is indicated for use whenever distal interlocking screws are placed in intramedullary nails to which the QuickLock System has been adapted by making available accessory adapter components that enable mechanical attachment of the QuickLock Probe to the nail system proximal instrumentation and alignment of the QuickLock Guide during calibration.

Source page: https://510kreport.com/device/K964444
Methodology: https://510kreport.com/methodology