510(k) · Cleared
Recalled · Class II · 2016Arthrex BioSync® Bone Wedge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthex, Inc. · PLF Bone Wedge
Cleared on Aug 12, 2015 as substantially equivalent to K140531 (Wrightmedicaltechnologyinc, 2014) and 1 other predicate after a 92-day review. Its family tree reaches back 11 generations to 1981. 10 later devices descend from it. It has been recalled 6 times.
- Decided
- Aug 12, 2015
- Review
- 92 days
- Class
- Class II
- Product code
- PLF
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 11 generations to K810258 (1981). 82 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 7 generations between
- 3 generations backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- 2 generations backK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
- 1 generation backK141635 Arthrex Ibalance Tka SystemArthrex, Inc. · 2014
- This deviceK151256 Arthrex BioSync® Bone WedgeArthex, Inc. · 2015
- Descendant · cites it directly · 7 of its ownK192645 Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2019
- Descendant · cites it directly · 6 of its ownK193414 Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2020
- Descendant · 2 generations on · 5 of its ownK203445 Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2020
- Descendant · 2 generations on · 4 of its ownK220197 Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK240461 OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U. · 2024
Show all 11 generations
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 10 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 9 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 8 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 7 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 6 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 5 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 4 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- 3 generations backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- 2 generations backK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
- 1 generation backK141635 Arthrex Ibalance Tka SystemArthrex, Inc. · 2014
- This deviceK151256 Arthrex BioSync® Bone WedgeArthex, Inc. · 2015
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2019 · cites it directly7descendants
- K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2020 · cites it directly6descendants
- K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2020 · 2 generations on5descendants
- K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc. · 2022 · 2 generations on4descendants
- K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U. · 2024 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −10 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −9 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −8 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −7 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −6 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −5 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −4 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| −3 | K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners | Zimmer, Inc. | 2012 | — |
| −2 | K121771 | Zimmer Persona the Personalized Knee System | Zimmer, Inc. | 2012 | 2 |
| −1 | K141635 | Arthrex Ibalance Tka System | Arthrex, Inc. | 2014 | — |
| 0 (this device) | K151256 | Arthrex BioSync® Bone Wedge | Arthex, Inc. | 2015 | — |
| +1 | K192645 | Trigon™ Ti Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2019 | — |
| +1 | K193414 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2020 | — |
| +2 | 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 | K240461 | OsteoSinter® EVANS and COTTON wedges and related accessories | Ames Medical Prosthetic Solutions, S.A.U. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 8 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K140531 | Biofoam Bone WedgeSummary page 4…and accessories 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener Predicate Device K140531: Wright Medical Technology, Inc. BIOFOAM® Bone Wedge K141635: Arthrex iBalance® TKA System Pur… | 2014 |
| * | K141635 | Arthrex Ibalance Tka SystemSummary page 4…ooth or threaded metallic bone fixation fastener Predicate Device K140531: Wright Medical Technology, Inc. BIOFOAM® Bone Wedge K141635: Arthrex iBalance® TKA System Purpose of Submission This traditional 510(k) premarket notification is submitted to obtain… | 2014 |
What descends from it? (10)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 22, 2016 | Class II | Z-1960-2016 | Material/Component Contamination | Potential for polystyrene particulate presence. |
| Apr 22, 2016 | Class II | Z-1962-2016 | Material/Component Contamination | Potential for polystyrene particulate presence. |
| Apr 22, 2016 | Class II | Z-1958-2016 | Material/Component Contamination | Potential for polystyrene particulate presence. |
| Apr 22, 2016 | Class II | Z-1963-2016 | Material/Component Contamination | Potential for polystyrene particulate presence. |
| Apr 22, 2016 | Class II | Z-1961-2016 | Material/Component Contamination | Potential for polystyrene particulate presence. |
| Apr 22, 2016 | Class II | Z-1959-2016 | Material/Component Contamination | Potential for polystyrene particulate presence. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 38 of the 82 ancestors have a recall of any class.
- Of its descendants, K192645 (Nvision Biomedical Technologies, Inc., 2019) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K140531.
How does its category compare?
All PLF devicesPLF Bone Wedge: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Anthrex BioSync 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 Cunciform or Cotton osteotomies + Lateral Column Lengthening (Evans Lengthening Osteotomy of Calcaneal Z Osteotomy) * Metatarsal/Cuneifrom arthrodesis…
Read the full statement (121 words)
The Anthrex BioSync 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 Cunciform or Cotton osteotomies
+ Lateral Column Lengthening (Evans Lengthening Osteotomy of Calcaneal Z Osteotomy)
* Metatarsal/Cuneifrom 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 Arthrex BioSync Bone Wedge is not intended for use in the spine.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151256 · printed Nov 4, 2026
Cite this page
510(k) Report. “K151256: Arthrex BioSync® Bone Wedge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K151256
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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