510(k) · Cleared
ClearedBiofoam Bone Wedge Model Assorted
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · HRS Plate, Fixation, Bone
Cleared on Jan 22, 2010 after a 30-day review. The FDA summary names no predicate by number. 32 later devices descend from it.
- Decided
- Jan 22, 2010
- Review
- 30 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
32 later devices descend from it, 6 citing it directly.
- This deviceK093950 Biofoam Bone Wedge Model AssortedWrightmedicaltechnologyinc · 2010
- Descendant · cites it directly · 24 of its ownK140531 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 · cites it directly · 11 of its ownK141905 Pro-Link Wedge SystemLife Spine · 2014
- Descendant · 3 generations on · 10 of its ownK172294 Osteotomy Truss System (OTS)4Web, Inc. · 2018
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K140531Biofoam Bone WedgeWrightmedicaltechnologyinc · 2014 · cites it directly24descendants
- K142724BIOFOAM Bone WedgeWrightmedicaltechnologyinc · 2015 · cites it directly20descendants
- K152062BIOFOAM Bone WedgeWrightmedicaltechnologyinc · 2016 · 2 generations on11descendants
- K141905Pro-Link Wedge SystemLife Spine · 2014 · cites it directly11descendants
- K172294Osteotomy Truss System (OTS)4Web, Inc. · 2018 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093950 | Biofoam Bone Wedge Model Assorted | Wrightmedicaltechnologyinc | 2010 | — |
| +1 | K140531 | Biofoam Bone Wedge | Wrightmedicaltechnologyinc | 2014 | — |
| +1 | K142724 | BIOFOAM Bone Wedge | Wrightmedicaltechnologyinc | 2015 | — |
| +2 | K152062 | BIOFOAM Bone Wedge | Wrightmedicaltechnologyinc | 2016 | — |
| +1 | K141905 | Pro-Link Wedge System | Life Spine | 2014 | — |
| +3 | K172294 | Osteotomy Truss System (OTS) | 4Web, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 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?
The FDA summary names no predicate by number.
What descends from it? (32)
See all 326 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?
- Of its descendants, K140531 (Wrightmedicaltechnologyinc, 2014) has gone furthest, with 24 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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:
• Opening wedge osteotomies of Hallux Valgus
* Evans lengthening osteotomies
* Metatarsal/cuneiform 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/K093950 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093950: Biofoam Bone Wedge Model Assorted.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093950
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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