510(k) · Cleared
ClearedTyber Medical Wedge System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyber Medical, LLC · PLF Bone Wedge
Cleared on Jul 28, 2015 as substantially equivalent to K140531 (Wrightmedicaltechnologyinc, 2014) after a 160-day review. Its family tree reaches back 2 generations to 2010. 6 later devices descend from it.
- Decided
- Jul 28, 2015
- Review
- 160 days
- Class
- Class II
- Product code
- PLF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K093950 (2010). 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK093950 Biofoam Bone Wedge Model AssortedWrightmedicaltechnologyinc · 2010
- 1 generation backK140531 Biofoam Bone WedgeWrightmedicaltechnologyinc · 2014
- This deviceK150394 Tyber Medical Wedge SystemTyber Medical, LLC · 2015
- Descendant · cites it directly · 5 of its ownK171327 Tyber Medical Wedge SystemTyber Medical, LLC · 2017
- Descendant · 2 generations on · 4 of its ownK220197 Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK243231 Trigon PEEK HA WedgesNvision Biomedical Technologies · 2024
- Descendant · 4 generations on · 0 of its ownK252254 Osteotomy Wedge SystemSinaptic Surgical · 2025
- Descendant · 3 generations on · 0 of its ownK234116 Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K171327Tyber Medical Wedge SystemTyber Medical, LLC · 2017 · cites it directly5descendants
- K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2022 · 2 generations on4descendants
- K243231Trigon PEEK HA WedgesNvision Biomedical Technologies · 2024 · 3 generations on1descendant
- K252254Osteotomy Wedge SystemSinaptic Surgical · 2025 · 4 generations on0descendants
- K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K093950 | Biofoam Bone Wedge Model Assorted | Wrightmedicaltechnologyinc | 2010 | — |
| −1 | K140531 | Biofoam Bone Wedge | Wrightmedicaltechnologyinc | 2014 | — |
| 0 (this device) | K150394 | Tyber Medical Wedge System | Tyber Medical, LLC | 2015 | — |
| +1 | K171327 | Tyber Medical Wedge System | Tyber Medical, LLC | 2017 | — |
| +2 | K220197 | Trigon HA Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2022 | — |
| +3 | K243231 | Trigon PEEK HA Wedges | Nvision Biomedical Technologies | 2024 | — |
| +4 | K252254 | Osteotomy Wedge System | Sinaptic Surgical | 2025 | — |
| +3 | K234116 | Trigon Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PLF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PLF device
- #1 K193414 Trigon HA Stand-Alone Wedge Fixation Systemscore 17.8 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K140531 | Biofoam Bone WedgeSummary page 4…Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040) Product Code PLF, HRS and HWC Primary Predicates 1. WRIGHT MEDICAL; Biofoam – K140531 Devices Reference Devices 1. IBALANCE MEDICAL; AKR FX Medical Opening Wedge Tibial System –… | 2014 |
| † | K092381 | Ibalance Akrfx Medial Opening Wedge Tibial System, Ifx Medial Peek Implant and Anchor… | 2009 |
| † | K130573 | Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif | 2013 |
| † | K141905 | Pro-Link Wedge System | 2014 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171327 | Tyber Medical Wedge System | 2017 | 5 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K171327 (Tyber Medical, LLC, 2017) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K140531.
How does its category compare?
All PLF devicesPLF Bone Wedge: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PLF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PLF
30in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PLF
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PLF
2in 2025
MAUDE reports naming product code PLF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 2 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 3 | 30 | 0 | 3 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
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…
Read the full statement (241 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150394 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150394: Tyber Medical Wedge System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150394
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026