# K051616: Vanguard Reprocessed External Fixation Devices

- Pathway: 510(k) (Traditional)
- Applicant: Vanguard Medical Concepts, Inc.
- Decided: Sep 6, 2005 after 81 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) EBI® Medical Systems, Inc. DFS® Standard Fixator: named in the summary without a submission number
- (no number) EBI® Medical Systems, Inc. DFS® Small Fixator: named in the summary without a submission number
- (no number) EBI® Medical Systems, Inc. DFS® Distal Radius Fixator: named in the summary without a submission number
- (no number) EBI® Medical Systems, Inc. DFS® Hybrid 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/K051616
Methodology: https://510kreport.com/methodology