510(k) · Cleared
ClearedEnHAnce PEEK Bunion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nvision Biomedical Technologies · HRS Plate, Fixation, Bone
Cleared on Sep 18, 2026 as substantially equivalent to K253718 (Nvision Biomedical Technologies, Inc., 2026) and 1 other predicate after an 88-day review. Its family tree reaches back 20 generations to 1996.
- Decided
- Sep 18, 2026
- Review
- 88 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 20 generations to K962616 (1996). 242 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 20 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 16 generations between
- 3 generations backK212487 CoLink Vallux Plating SystemIn2bones USA, LLC · 2021
- 2 generations backK211650 The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc. · 2021
- 1 generation backK253718 enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc. · 2026
- This deviceK262098 EnHAnce PEEK Bunion SystemNvision Biomedical Technologies · 2026
Show all 20 generations
- Root · 20 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 19 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 18 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 17 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 16 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 15 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 14 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 13 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 12 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 11 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 10 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
- 9 generations backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
- 8 generations backK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
- 7 generations backK143385 Acumed Ankle Plating SystemAcumed, LLC · 2015
- 6 generations backK151886 Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC · 2015
- 5 generations backK181113 CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018
- 4 generations backK191535 CoLink® Mini Plating SystemIn2bones USA, LLC · 2019
- 3 generations backK212487 CoLink Vallux Plating SystemIn2bones USA, LLC · 2021
- 2 generations backK211650 The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc. · 2021
- 1 generation backK253718 enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc. · 2026
- This deviceK262098 EnHAnce PEEK Bunion SystemNvision Biomedical Technologies · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −19 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −18 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −17 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −16 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −15 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −14 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −13 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −12 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −11 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −10 | K120070 | Synthes Variable Angle LCP Elbow System | Synthes USA | 2012 | 1 |
| −9 | K120717 | Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal… | Synthes USA | 2012 | — |
| −8 | K120854 | Synthes VA LCP Ankle Trauma System | Synthes USA | 2012 | — |
| −7 | K143385 | Acumed Ankle Plating System | Acumed, LLC | 2015 | — |
| −6 | K151886 | Acumed Ankle and Small Fragment Base Set Update | Acumed, LLC | 2015 | — |
| −5 | K181113 | CoLink™ Afx Plating System | In2bones USA, LLC | 2018 | — |
| −4 | K191535 | CoLink® Mini Plating System | In2bones USA, LLC | 2019 | — |
| −3 | K212487 | CoLink Vallux Plating System | In2bones USA, LLC | 2021 | — |
| −2 | K211650 | The Radian MIS Bunion System | Nvision Biomedical Technologies, Inc. | 2021 | — |
| −1 | K253718 | enHAnce PEEK Bunion System | Nvision Biomedical Technologies, Inc. | 2026 | — |
| 0 (this device) | K262098 | EnHAnce PEEK Bunion System | Nvision Biomedical Technologies | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1983 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 7 | 0 |
| 1996 | 18 | 0 |
| 1997 | 7 | 0 |
| 1998 | 8 | 0 |
| 1999 | 9 | 0 |
| 2000 | 13 | 0 |
| 2001 | 17 | 0 |
| 2002 | 10 | 0 |
| 2003 | 9 | 0 |
| 2004 | 11 | 0 |
| 2005 | 13 | 0 |
| 2006 | 10 | 0 |
| 2007 | 8 | 0 |
| 2008 | 10 | 0 |
| 2009 | 6 | 0 |
| 2010 | 8 | 0 |
| 2011 | 8 | 0 |
| 2012 | 8 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2019 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K253718 | enHAnce PEEK Bunion SystemSummary page 5…r 888.3030 Product Code(s) HRS I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K253718 enHAnce PEEK Bunion System HRS K241014 K-Wire HTY Device Description Summary 21 CFR 807.92(a)(4) The enHANnce PEEK Bunion System… | 2026 |
| * | K241014 | Biomet Kirschner Wires (K-Wires)Summary page 5…y Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K253718 enHAnce PEEK Bunion System HRS K241014 K-Wire HTY Device Description Summary 21 CFR 807.92(a)(4) The enHANnce PEEK Bunion System is a single-use bone fixation device i… | 2024 |
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 30 years and passes through 9 companies; a new generation was cleared every 1.6 years on median.
- 42 of the 242 ancestors have a recall of any class.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 enHAnce PEEK Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders, such as hallux valgus.
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/K262098 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262098: EnHAnce PEEK Bunion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262098
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026