510(k) · Cleared
ClearedBIOFOAM Bone Wedge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · HRS Plate, Fixation, Bone
Cleared on May 17, 2016 as substantially equivalent to K070525 (Wrightmedicaltechnologyinc, 2007) and 1 other predicate after a 298-day review. Its family tree reaches back 3 generations to 2010. 11 later devices descend from it.
- Decided
- May 17, 2016
- Review
- 298 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K093950 (2010). 6 ancestors in all, the oldest K070525 (2007). 11 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK093950 Biofoam Bone Wedge Model AssortedWrightmedicaltechnologyinc · 2010
- 2 generations backK140531 Biofoam Bone WedgeWrightmedicaltechnologyinc · 2014
- 1 generation backK142724 BIOFOAM Bone WedgeWrightmedicaltechnologyinc · 2015
- This deviceK152062 BIOFOAM Bone WedgeWrightmedicaltechnologyinc · 2016
- Descendant · cites it directly · 10 of its ownK172294 Osteotomy Truss System (OTS)4Web, Inc. · 2018
- Descendant · 2 generations on · 7 of its ownK201314 Restor3d Utility WedgeRestor3D, Inc. · 2021
- Descendant · 3 generations on · 4 of its ownK220197 Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2022
- Descendant · 4 generations on · 1 of its ownK243231 Trigon PEEK HA WedgesNvision Biomedical Technologies · 2024
- Descendant · 2 generations on · 1 of its ownK220463 Osteotomy Truss System (OTS)4Web Medical, Inc. · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K172294Osteotomy Truss System (OTS)4Web, Inc. · 2018 · cites it directly10descendants
- K201314Restor3d Utility WedgeRestor3D, Inc. · 2021 · 2 generations on7descendants
- K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2022 · 3 generations on4descendants
- K243231Trigon PEEK HA WedgesNvision Biomedical Technologies · 2024 · 4 generations on1descendant
- K220463Osteotomy Truss System (OTS)4Web Medical, Inc. · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K093950 | Biofoam Bone Wedge Model Assorted | Wrightmedicaltechnologyinc | 2010 | — |
| −2 | K140531 | Biofoam Bone Wedge | Wrightmedicaltechnologyinc | 2014 | — |
| −1 | K142724 | BIOFOAM Bone Wedge | Wrightmedicaltechnologyinc | 2015 | — |
| 0 (this device) | K152062 | BIOFOAM Bone Wedge | Wrightmedicaltechnologyinc | 2016 | — |
| +1 | K172294 | Osteotomy Truss System (OTS) | 4Web, Inc. | 2018 | — |
| +2 | K201314 | Restor3d Utility Wedge | Restor3D, Inc. | 2021 | — |
| +3 | K220197 | Trigon HA Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2022 | — |
| +4 | K243231 | Trigon PEEK HA Wedges | Nvision Biomedical Technologies | 2024 | — |
| +2 | K220463 | Osteotomy Truss System (OTS) | 4Web Medical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2024 | 3 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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 |
|---|---|---|---|
| * | K070525 | Charlotte 7.0 Multi-Use Compression Screw and WasherSummary page 4…d Reference: 21 CFR 888.3030 – Class II Device Product Code, Device Panel: HRS, HWC (a)(3). Predicate Device: K070525: CHARLOTTE® 7.0 MUC Screw and Washer… | 2007 |
| * | K142724 | BIOFOAM Bone WedgeSummary page 4…K070525: CHARLOTTE® 7.0 MUC Screw and Washer K142724: BIOFOAM® Bone Wedge (a)(4). Device Description The BIOFOAM® Bone Wedge is a titanium metal foam implant used for angular… | 2015 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172294 | Osteotomy Truss System (OTS) | 2018 | 10 |
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 6 years and passes through 1 company; a new generation was cleared every 12 months on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K172294 (4Web, Inc., 2018) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K070525.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The BIOFOAM® Bone Wedge 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: • 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 arthrodesis • Midfoot…
Read the full statement (127 words)
The BIOFOAM® Bone Wedge 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:
• 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 arthrodesis
• Midfoot Wedges:
• Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
• Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus)
• Subtalar Implant:
• Hindfoot Arthrodesis
This device is intended for use with ancillary fixation.
The BIOFOAM® Bone Wedge is not intended for use in the spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152062 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152062: BIOFOAM Bone Wedge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152062
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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