# K151256: Arthrex BioSync® Bone Wedge

- Pathway: 510(k) (Traditional)
- Applicant: Arthex, Inc.
- Decided: Aug 12, 2015 after 92 days
- Product code: PLF (Bone Wedge)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K810258 (1981). 82 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140531: Biofoam Bone Wedge, Wrightmedicaltechnologyinc (2014) Summary page 4.
- K141635: Arthrex Ibalance Tka System, Arthrex, Inc. (2014) Summary page 4.

## Most influential descendants
- K192645: Trigon™ Ti Stand-Alone Wedge Fixation System (2019), 7 descendants of its own
- K193414: Trigon HA Stand-Alone Wedge Fixation System (2020), 6 descendants of its own
- K203445: Trigon HA Stand-Alone Wedge Fixation System (2020), 5 descendants of its own
- K220197: Trigon HA Wedge Fixation System (2022), 4 descendants of its own
- K240461: OsteoSinter® EVANS and COTTON wedges and related accessories (2024), 2 descendants of its own

## Recalls of this device
- Apr 22, 2016 · Class II · Z-1960-2016: Potential for polystyrene particulate presence.
- Apr 22, 2016 · Class II · Z-1962-2016: Potential for polystyrene particulate presence.
- Apr 22, 2016 · Class II · Z-1958-2016: Potential for polystyrene particulate presence.
- Apr 22, 2016 · Class II · Z-1963-2016: Potential for polystyrene particulate presence.
- Apr 22, 2016 · Class II · Z-1961-2016: Potential for polystyrene particulate presence.
- Apr 22, 2016 · Class II · Z-1959-2016: Potential for polystyrene particulate presence.

## Indications for use
The Anthrex BioSync Bone Wedge is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies, in the ankle and foot, such as: Cotton and Evans Wedges: + Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus * Opening wedge of Medial Cunciform or Cotton osteotomies + Lateral Column Lengthening (Evans Lengthening Osteotomy of Calcaneal Z Osteotomy) * Metatarsal/Cuneifrom arthrodesis Midfoot Wedges: * Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus * Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus) This device is intended for use with ancillary fixation. The Arthrex BioSync Bone Wedge is not intended for use in the spine.

Source page: https://510kreport.com/device/K151256
Methodology: https://510kreport.com/methodology