510(k) · Cleared
ClearedOsteotomy Wedge System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sinaptic Surgical · PLF Bone Wedge
Cleared on Oct 17, 2025 as substantially equivalent to K243231 (Nvision Biomedical Technologies, 2024) and 2 other predicates after an 88-day review. Its family tree reaches back 18 generations to 1996.
- Decided
- Oct 17, 2025
- Review
- 88 days
- Class
- Class II
- Product code
- PLF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 18 generations to K954385 (1996). 147 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.
- Root · 18 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 14 generations between
- 3 generations backK203445 Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2020
- 2 generations backK220197 Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2022
- 1 generation backK243231 Trigon PEEK HA WedgesNvision Biomedical Technologies · 2024
- This deviceK252254 Osteotomy Wedge SystemSinaptic Surgical · 2025
Show all 18 generations
- Root · 18 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 17 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 16 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 15 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 14 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 13 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 12 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 11 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 10 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 9 generations backK113048 Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2012
- 8 generations backK141905 Pro-Link Wedge SystemLife Spine · 2014
- 7 generations backK150368 Tarsa-Link Wedge Fixation SystemLife Spine · 2015
- 6 generations backK161037 Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc. · 2016
- 5 generations backK192645 Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2019
- 4 generations backK193414 Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2020
- 3 generations backK203445 Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2020
- 2 generations backK220197 Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2022
- 1 generation backK243231 Trigon PEEK HA WedgesNvision Biomedical Technologies · 2024
- This deviceK252254 Osteotomy Wedge SystemSinaptic Surgical · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −17 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −16 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −15 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −14 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −13 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −12 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −11 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −10 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −9 | K113048 | Maxlock Extreme System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −8 | K141905 | Pro-Link Wedge System | Life Spine | 2014 | — |
| −7 | K150368 | Tarsa-Link Wedge Fixation System | Life Spine | 2015 | — |
| −6 | K161037 | Tarsa-Link Stand-Alone Wedge Fixation System | Life Spine, Inc. | 2016 | — |
| −5 | K192645 | Trigon™ Ti Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2019 | — |
| −4 | K193414 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2020 | — |
| −3 | K203445 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2020 | — |
| −2 | K220197 | Trigon HA Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2022 | — |
| −1 | K243231 | Trigon PEEK HA Wedges | Nvision Biomedical Technologies | 2024 | — |
| 0 (this device) | K252254 | Osteotomy Wedge System | Sinaptic Surgical | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 1 | 0 |
| 1994 | 9 | 0 |
| 1995 | 9 | 0 |
| 1996 | 6 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 6 | 0 |
| 2002 | 6 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 9 | 0 |
| 2006 | 7 | 0 |
| 2007 | 8 | 0 |
| 2008 | 8 | 0 |
| 2009 | 3 | 0 |
| 2010 | 8 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K243231 | Trigon PEEK HA WedgesSummary page 5…Panel: Orthopedic, Product Code: PLF Predicate Device Identification 510(k) Number Device Name Predicate K243231 Nvision Biomedical’s Trigon HA Stand-Alone Wedge Primary Fixation System K240461… | 2024 |
| * | K240461 | OsteoSinter® EVANS and COTTON wedges and related accessoriesSummary page 5…Predicate K243231 Nvision Biomedical’s Trigon HA Stand-Alone Wedge Primary Fixation System K240461 AMES’s Medical OsteoSinter Evans and Cotton Wedges Additional K201314 Restor3d Utility Wedge… | 2024 |
| * | K201314 | Restor3d Utility WedgeSummary page 5…tand-Alone Wedge Primary Fixation System K240461 AMES’s Medical OsteoSinter Evans and Cotton Wedges Additional K201314 Restor3d Utility Wedge Additional K220513 CTL Medical Nitro Interbody… | 2021 |
| † | K220513 | NITRO Interbody Fusion Cage System Family | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 9 companies; a new generation was cleared every 1.3 years on median.
- 48 of the 147 ancestors have a recall of any class.
How does its category compare?
All PLF devicesPLF Bone Wedge: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 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…
Read the full statement (138 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252254 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252254: Osteotomy Wedge System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252254
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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