510(k) · Cleared
ClearedRestor3d Utility Wedge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Restor3D, Inc. · PLF Bone Wedge
Cleared on Jun 17, 2021 as substantially equivalent to K191047 (Additive Device, Inc. (Adi) D/B/A Restor3D, 2019) and 1 other predicate after a 395-day review. Its family tree reaches back 5 generations to 2010. 7 later devices descend from it.
- Decided
- Jun 17, 2021
- Review
- 395 days
- Class
- Class II
- Product code
- PLF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K093950 (2010). 11 ancestors in all, the oldest K070525 (2007). 7 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK093950 Biofoam Bone Wedge Model AssortedWrightmedicaltechnologyinc · 2010
- 4 generations backK140531 Biofoam Bone WedgeWrightmedicaltechnologyinc · 2014
- 3 generations backK142724 BIOFOAM Bone WedgeWrightmedicaltechnologyinc · 2015
- 2 generations backK152062 BIOFOAM Bone WedgeWrightmedicaltechnologyinc · 2016
- 1 generation backK172294 Osteotomy Truss System (OTS)4Web, Inc. · 2018
- This deviceK201314 Restor3d Utility WedgeRestor3D, Inc. · 2021
- Descendant · cites it directly · 4 of its ownK220197 Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK243231 Trigon PEEK HA WedgesNvision Biomedical Technologies · 2024
- Descendant · cites it directly · 0 of its ownK252733 ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLC · 2026
- Descendant · cites it directly · 0 of its ownK252254 Osteotomy Wedge SystemSinaptic Surgical · 2025
- Descendant · cites it directly · 0 of its ownK251791 Auxano® Wedge Fixation SystemAuxano Medical, LLC · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2022 · cites it directly4descendants
- K243231Trigon PEEK HA WedgesNvision Biomedical Technologies · 2024 · 2 generations on1descendant
- K252733ATLAS™ Expandable Osteotomy Wedge SystemMiRus, LLC · 2026 · cites it directly0descendants
- K252254Osteotomy Wedge SystemSinaptic Surgical · 2025 · cites it directly0descendants
- K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K093950 | Biofoam Bone Wedge Model Assorted | Wrightmedicaltechnologyinc | 2010 | — |
| −4 | K140531 | Biofoam Bone Wedge | Wrightmedicaltechnologyinc | 2014 | — |
| −3 | K142724 | BIOFOAM Bone Wedge | Wrightmedicaltechnologyinc | 2015 | — |
| −2 | K152062 | BIOFOAM Bone Wedge | Wrightmedicaltechnologyinc | 2016 | — |
| −1 | K172294 | Osteotomy Truss System (OTS) | 4Web, Inc. | 2018 | — |
| 0 (this device) | K201314 | Restor3d Utility Wedge | Restor3D, Inc. | 2021 | — |
| +1 | K220197 | Trigon HA Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2022 | — |
| +2 | K243231 | Trigon PEEK HA Wedges | Nvision Biomedical Technologies | 2024 | — |
| +1 | K252733 | ATLAS™ Expandable Osteotomy Wedge System | MiRus, LLC | 2026 | — |
| +1 | K252254 | Osteotomy Wedge System | Sinaptic Surgical | 2025 | — |
| +1 | K251791 | Auxano® Wedge Fixation System | Auxano Medical, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2013 | 2 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K191047 | ADI TiDAL Osteotomy WedgeSummary page 4…e 21 CFR 888.3030 Product Code: PLF Predicate Device(s): ADI TiDAL Osteotomy Wedge, K191047, Primary Predicate Product Code: PLF 4Web Osteotomy Truss System, K172294, Additiona… | 2019 |
| * | K172294 | Osteotomy Truss System (OTS)Summary page 4…te Device(s): ADI TiDAL Osteotomy Wedge, K191047, Primary Predicate Product Code: PLF 4Web Osteotomy Truss System, K172294, Additional Predicate Product Code: HRS E. Physical Description: The proposed… | 2018 |
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K220197 (Nvision Biomedical Technologies, Inc., 2022) has gone furthest, with 4 descendants of its own.
How does its category compare?
All PLF devicesPLF Bone Wedge: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 restor3d Utility Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus • Opening wedge of Medial Cuneiform or Cotton osteotomies • Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy) • Metatarsal Cuneiform osteotomies • Nonunion of arthrodesis of the Midfoot…
Read the full statement (111 words)
The restor3d Utility Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
• Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
• Opening wedge of Medial Cuneiform or Cotton osteotomies
• Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
• Metatarsal Cuneiform osteotomies
• Nonunion of arthrodesis of the Midfoot including Metatarsal Cuneiform osteotomies (TMT or Lapidus)
• Hindfoot osteotomies such as Ankle fusion and Subtalar fusion
The restor3d Utility Wedges are intended for use with supplemental fixation.
The restor3d Utility Wedges are not intended for use in the spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201314 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201314: Restor3d Utility Wedge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201314
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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