# K252254: Osteotomy Wedge System

- Pathway: 510(k) (Traditional)
- Applicant: Sinaptic Surgical
- Decided: Oct 17, 2025 after 88 days
- Product code: PLF (Bone Wedge)
- 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
Longest line of descent: 18 generations back to K954385 (1996). 147 ancestors in all.
No later device cites it as a predicate yet.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243231: Trigon PEEK HA Wedges, Nvision Biomedical Technologies (2024) Summary page 5.
- K240461: OsteoSinter® EVANS and COTTON wedges and related accessories, Ames Medical Prosthetic Solutions, S.A.U. (2024) Summary page 5.
- K201314: Restor3d Utility Wedge, Restor3D, Inc. (2021) Summary page 5.

## Indications for use
The SiNAPTIC Osteotomy Wedge System is intended to be used for internal bone fixation for fractures or osteotomies in the ankle and foot, such as: 1. Opening wedge osteotomies of the bones of the foot, including osteotomies for Hallux Valgus 2. Opening wedge of the medial cuneiform or Cotton osteotomies. 3. Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z-Osteotomy) 4. Metatarsal Cuneiform osteotomies 5. Nonunion of arthrodesis of the Midfoot including Metatarsal Cuneiform osteotomies (TMT or Lapidus) 6. Hindfoot osteotomies such as Ankle fusion and Subtalar fusion The Osteotomy Wedge System MTP Wedges are intended to be used for internal fixation of metatarsal bones that have been surgically prepared (osteotomy) for correction of deformity. The Osteotomy Wedge System is indicated for use with supplemental fixation. The Osteotomy Wedge System is not indicated for use in the spine.

Source page: https://510kreport.com/device/K252254
Methodology: https://510kreport.com/methodology