510(k) · Cleared
ClearedOsteoSinter® EVANS and COTTON wedges and related accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ames Medical Prosthetic Solutions, S.A.U. · PLF Bone Wedge
Cleared on Dec 6, 2024 as substantially equivalent to K142724 (Wrightmedicaltechnologyinc, 2015) and 1 other predicate after a 294-day review. Its family tree reaches back 12 generations to 1981. 2 later devices descend from it.
- Decided
- Dec 6, 2024
- Review
- 294 days
- Class
- Class II
- Product code
- PLF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K810258 (1981). 86 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 8 generations between
- 3 generations backK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
- 2 generations backK141635 Arthrex Ibalance Tka SystemArthrex, Inc. · 2014
- 1 generation backK151256 Arthrex BioSync® Bone WedgeArthex, Inc. · 2015 · Recalled
- This deviceK240461 OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U. · 2024
- Descendant · cites it directly · 0 of its ownK252254 Osteotomy Wedge SystemSinaptic Surgical · 2025
- Descendant · cites it directly · 0 of its ownK251791 Auxano® Wedge Fixation SystemAuxano Medical, LLC · 2025
Show all 12 generations
- Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 11 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 10 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 9 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 8 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 7 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 6 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 5 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- 4 generations backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
- 3 generations backK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
- 2 generations backK141635 Arthrex Ibalance Tka SystemArthrex, Inc. · 2014
- 1 generation backK151256 Arthrex BioSync® Bone WedgeArthex, Inc. · 2015 · Recalled
- This deviceK240461 OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −11 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −10 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −9 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −8 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −7 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −6 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −5 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| −4 | K120370 | Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners | Zimmer, Inc. | 2012 | — |
| −3 | K121771 | Zimmer Persona the Personalized Knee System | Zimmer, Inc. | 2012 | 2 |
| −2 | K141635 | Arthrex Ibalance Tka System | Arthrex, Inc. | 2014 | — |
| −1 | K151256 | Arthrex BioSync® Bone Wedge | Arthex, Inc. | 2015 | 6 |
| 0 (this device) | K240461 | OsteoSinter® EVANS and COTTON wedges and related accessories | Ames Medical Prosthetic Solutions, S.A.U. | 2024 | — |
| +1 | K252254 | Osteotomy Wedge System | Sinaptic Surgical | 2025 | — |
| +1 | 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 | 6 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K142724 | BIOFOAM Bone WedgeSummary page 5…Class II (Special Controls) REGULATION NUMBER: 21 CFR 888.3030 PRODUCT CODE: PLF REFERENCE PRODUCT CODE:HRS PREDICATE DEVICE K142724 BIOFOAM® Bone Wedge K151256 Arthrex BioSync® Bone Wedge DEVICE DESCRIPTION: The OsteoSinter®… | 2015 |
| * | K151256 | Arthrex BioSync® Bone WedgeSummary page 5…R: 21 CFR 888.3030 PRODUCT CODE: PLF REFERENCE PRODUCT CODE:HRS PREDICATE DEVICE K142724 BIOFOAM® Bone Wedge K151256 Arthrex BioSync® Bone Wedge DEVICE DESCRIPTION: The OsteoSinter® EVANS and COTTON wedges are sterile, single use porou… | 2015 |
What descends from it? (2)
2 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?
- The line of descent spans 43 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 39 of the 86 ancestors have a recall of any class.
- Of its descendants, K252254 (Sinaptic Surgical, 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K142724.
How does its category compare?
All PLF devicesPLF Bone Wedge: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
OsteoSinter® EVANS and COTTON wedges are intended to be used for internal bone fixation of bone fractures, fusions, or osteotomies in the foot. Specific Indications include:
* 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.
OsteoSinter® EVANS and COTTON wedges are indicated for use with ancillary bone fixation.
OsteoSinter® EVANS and COTTON wedges are not indicated 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/K240461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240461: OsteoSinter® EVANS and COTTON wedges and related accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240461
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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