# K081071: Synthes 6.5MM Midfoot Fusion Bolt

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: May 1, 2008 after 16 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
80 later devices descend from it; 5 cite it directly.
0 of 81 devices 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) Synthes 6.5mm Cannulated Screw: named in the summary without a submission number

## Most influential descendants
- K082934: Extremity Medical Midfoot Screw System (2009), 63 descendants of its own
- K101700: IO Fix Hand, IO Fix Foot, Extremity Medical Screw System (2010), 56 descendants of its own
- K140741: Salvation Beams and Bolts System (2014), 34 descendants of its own
- K171018: Axis Charcot Fixation System, 4.5 to 8.5mm Screw System (2017), 24 descendants of its own
- K142581: APTUS Foot System (2015), 22 descendants of its own

## Recalls of this device
- Mar 8, 2013 · Class II · Z-0014-2014: A post market safety review following several customer complaints indicated additional clarification was necessary in the Midfoot Fusion Bolt Technique Guide to reduce potential for bolt back-out or m

## Indications for use
Synthes 6.5mm Midfoot Fusion Bolt is indicated for fracture fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.

Source page: https://510kreport.com/device/K081071
Methodology: https://510kreport.com/methodology