# K053051: Vanguard Reprocessed External Fixation Devices

- Pathway: 510(k) (Traditional)
- Applicant: Vanguard Medical Concepts, Inc.
- Decided: Dec 22, 2005 after 55 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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
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) Orthofix Radiolucent Wrist Fixator: named in the summary without a submission number

## Indications for use
Reprocessed External Fixation Devices are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.

Source page: https://510kreport.com/device/K053051
Methodology: https://510kreport.com/methodology