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 Jul 9, 2014 as substantially equivalent to K093950 (Wrightmedicaltechnologyinc, 2010) after a 127-day review. Its family tree reaches back 1 generation to 2010. 24 later devices descend from it.
- Decided
- Jul 9, 2014
- Review
- 127 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K093950 (2010). 24 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK093950 Biofoam Bone Wedge Model AssortedWrightmedicaltechnologyinc · 2010
- This deviceK140531 Biofoam Bone WedgeWrightmedicaltechnologyinc · 2014
- Descendant · cites it directly · 20 of its ownK142724 BIOFOAM Bone WedgeWrightmedicaltechnologyinc · 2015
- Descendant · 2 generations on · 11 of its ownK152062 BIOFOAM Bone WedgeWrightmedicaltechnologyinc · 2016
- Descendant · 3 generations on · 10 of its ownK172294 Osteotomy Truss System (OTS)4Web, Inc. · 2018
- Descendant · cites it directly · 10 of its ownK151256 Arthrex BioSync® Bone WedgeArthex, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 9 of its ownK161037 Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc. · 2016
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K142724BIOFOAM Bone WedgeWrightmedicaltechnologyinc · 2015 · cites it directly20descendants
- K152062BIOFOAM Bone WedgeWrightmedicaltechnologyinc · 2016 · 2 generations on11descendants
- K172294Osteotomy Truss System (OTS)4Web, Inc. · 2018 · 3 generations on10descendants
- K151256Arthrex BioSync® Bone WedgeArthex, Inc. · 2015 · cites it directly10descendants
- K161037Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc. · 2016 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K093950 | Biofoam Bone Wedge Model Assorted | Wrightmedicaltechnologyinc | 2010 | — |
| 0 (this device) | K140531 | Biofoam Bone Wedge | Wrightmedicaltechnologyinc | 2014 | — |
| +1 | K142724 | BIOFOAM Bone Wedge | Wrightmedicaltechnologyinc | 2015 | — |
| +2 | K152062 | BIOFOAM Bone Wedge | Wrightmedicaltechnologyinc | 2016 | — |
| +3 | K172294 | Osteotomy Truss System (OTS) | 4Web, Inc. | 2018 | — |
| +1 | K151256 | Arthrex BioSync® Bone Wedge | Arthex, Inc. | 2015 | 6 |
| +2 | K161037 | Tarsa-Link Stand-Alone Wedge Fixation System | Life Spine, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 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? (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 |
|---|---|---|---|
| * | K093950 | Biofoam Bone Wedge Model AssortedSummary page 1…eference: 21 CFR 888.3030 - Class II Device Product Code, Device Panel: HRS, HWC (a)(3). Predicate Device: K093950: BIOFOAMO Bone Wedge (a)(4). Device Description The BIOFOAMO Bone Wedge is atitanium metal foam wedge used for angular c… | 2010 |
What descends from it? (24)
See all 245 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?
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 (120 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)
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/K140531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140531: 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/K140531
Report an extraction error
Are you the manufacturer?
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