510(k) · Cleared
ClearedAuxano® Wedge Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Auxano Medical, LLC · PLF Bone Wedge
Cleared on Sep 25, 2025 as substantially equivalent to K240461 (Ames Medical Prosthetic Solutions, S.A.U., 2024) and 2 other predicates after a 106-day review. Its family tree reaches back 13 generations to 1981.
- Decided
- Sep 25, 2025
- Review
- 106 days
- Class
- Class II
- Product code
- PLF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K810258 (1981). 94 ancestors in all. No later device cites it as a predicate yet.
- Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 9 generations between
- 3 generations backK141635 Arthrex Ibalance Tka SystemArthrex, Inc. · 2014
- 2 generations backK151256 Arthrex BioSync® Bone WedgeArthex, Inc. · 2015 · Recalled
- 1 generation backK240461 OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U. · 2024
- This deviceK251791 Auxano® Wedge Fixation SystemAuxano Medical, LLC · 2025
Show all 13 generations
- Root · 13 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 12 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 11 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 10 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 9 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 8 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 7 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 6 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- 5 generations backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- 4 generations backK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
- 3 generations backK141635 Arthrex Ibalance Tka SystemArthrex, Inc. · 2014
- 2 generations backK151256 Arthrex BioSync® Bone WedgeArthex, Inc. · 2015 · Recalled
- 1 generation backK240461 OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U. · 2024
- This deviceK251791 Auxano® Wedge Fixation SystemAuxano Medical, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −12 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −11 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −10 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −9 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −8 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −7 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −6 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| −5 | K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners | Zimmer, Inc. | 2012 | — |
| −4 | K121771 | Zimmer Persona the Personalized Knee System | Zimmer, Inc. | 2012 | 2 |
| −3 | K141635 | Arthrex Ibalance Tka System | Arthrex, Inc. | 2014 | — |
| −2 | K151256 | Arthrex BioSync® Bone Wedge | Arthex, Inc. | 2015 | 6 |
| −1 | K240461 | OsteoSinter® EVANS and COTTON wedges and related accessories | Ames Medical Prosthetic Solutions, S.A.U. | 2024 | — |
| 0 (this device) | K251791 | Auxano® Wedge Fixation System | Auxano Medical, LLC | 2025 | — |
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 | 7 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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? (3)
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 |
|---|---|---|---|
| * | K240461 | OsteoSinter® EVANS and COTTON wedges and related accessoriesSummary page 5…ation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: PLF PREDICATE INFORMATION Primary Predicate : K240461 (OsteoSinter® EVANS and COTTON wedge and related accessories; AMES MEDICAL Prosthetic Solutions S.A.U) Additional Predicate : K13… | 2024 |
| * | K130185 | 4WEB Osteotomy Bone WedgeSummary page 5…ATE INFORMATION Primary Predicate : K240461 (OsteoSinter® EVANS and COTTON wedge and related accessories; AMES MEDICAL Prosthetic Solutions S.A.U) Additional Predicate : K130185 (4Web Osteotomy Bone Wedge; 4-Web, Inc.) Additional Predicate : K201314 (Restor3d Utility Wedge; Restor3d, Inc.) INDICATIONS FOR… | 2013 |
| * | K201314 | Restor3d Utility WedgeSummary page 5…ON wedge and related accessories; AMES MEDICAL Prosthetic Solutions S.A.U) Additional Predicate : K130185 (4Web Osteotomy Bone Wedge; 4-Web, Inc.) Additional Predicate : K201314 (Restor3d Utility Wedge; Restor3d, Inc.) INDICATIONS FOR USE: The Auxano® Wedge Fixation System is intended to be used as intern… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 44 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 39 of the 94 ancestors have a recall of any class.
- 1 other device also cites its predicate K240461.
How does its category compare?
All PLF devicesPLF Bone Wedge: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Auxano® Wedge Fixation System is intended to be used as internal bone fixation for bone fractures or osteotomies in the ankle and foot. Specific indications include:
• Cotton (opening wedge) osteotomies of the medial cuneiform
• Evans lengthening osteotomies
The Auxano® Wedge Fixation System is indicated for use with ancillary plating fixation.
The Auxano® Wedge Fixation System is not intended for spinal use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251791 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251791: Auxano® Wedge Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251791
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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