# K150394: Tyber Medical Wedge System

- Pathway: 510(k) (Traditional)
- Applicant: Tyber Medical, LLC
- Decided: Jul 28, 2015 after 160 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: 2 generations back to K093950 (2010). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 9 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.

## Most influential descendants
- K171327: Tyber Medical Wedge System (2017), 5 descendants of its own
- K220197: Trigon HA Wedge Fixation System (2022), 4 descendants of its own
- K243231: Trigon PEEK HA Wedges (2024), 1 descendant of its own
- K252254: Osteotomy Wedge System (2025), 0 descendants of its own
- K234116: Trigon Trigon HA Stand-Alone Wedge Fixation System (2024), 0 descendants of its own

## Indications for use
The Tyber Medical PEEK Wedge System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot such as: • Cotton and Evans Wedges o Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus o Opening wedge of Medial Cuneiform of Cotton osteotomies o Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy) • Midfoot Wedges o Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus o Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus) The device is intended for use with ancillary fixation The Tyber Medical Wedge System is not intended for use in the spine The Tyber Medical TyPEEK Wedge System 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 o Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus o Opening wedge of Medial Cuneiform of Cotton osteotomies o Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy) • Midfoot Wedges o Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus o Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus) The device is intended for use with ancillary fixation The Tyber Medical Wedge System is not intended for use in the spine

Source page: https://510kreport.com/device/K150394
Methodology: https://510kreport.com/methodology