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, Inc. · HRS Plate, Fixation, Bone
Cleared on Apr 1, 2026 as substantially equivalent to K211650 (Nvision Biomedical Technologies, Inc., 2021) and 4 other predicates after a 128-day review. Its family tree reaches back 19 generations to 1996. 1 later device descends from it.
- Decided
- Apr 1, 2026
- Review
- 128 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 19 generations to K962616 (1996). 241 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 19 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 15 generations between
- 3 generations backK191535 CoLink® Mini Plating SystemIn2bones USA, LLC · 2019
- 2 generations backK212487 CoLink Vallux Plating SystemIn2bones USA, LLC · 2021
- 1 generation backK211650 The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc. · 2021
- This deviceK253718 enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK262098 EnHAnce PEEK Bunion SystemNvision Biomedical Technologies · 2026
Show all 19 generations
- Root · 19 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 18 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 17 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 16 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 15 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 14 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 13 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 12 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 11 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 10 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 9 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
- 8 generations backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
- 7 generations backK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
- 6 generations backK143385 Acumed Ankle Plating SystemAcumed, LLC · 2015
- 5 generations backK151886 Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC · 2015
- 4 generations backK181113 CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018
- 3 generations backK191535 CoLink® Mini Plating SystemIn2bones USA, LLC · 2019
- 2 generations backK212487 CoLink Vallux Plating SystemIn2bones USA, LLC · 2021
- 1 generation backK211650 The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc. · 2021
- This deviceK253718 enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −18 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −17 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −16 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −15 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −14 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −13 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −12 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −11 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −10 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −9 | K120070 | Synthes Variable Angle LCP Elbow System | Synthes USA | 2012 | 1 |
| −8 | K120717 | Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal… | Synthes USA | 2012 | — |
| −7 | K120854 | Synthes VA LCP Ankle Trauma System | Synthes USA | 2012 | — |
| −6 | K143385 | Acumed Ankle Plating System | Acumed, LLC | 2015 | — |
| −5 | K151886 | Acumed Ankle and Small Fragment Base Set Update | Acumed, LLC | 2015 | — |
| −4 | K181113 | CoLink™ Afx Plating System | In2bones USA, LLC | 2018 | — |
| −3 | K191535 | CoLink® Mini Plating System | In2bones USA, LLC | 2019 | — |
| −2 | K212487 | CoLink Vallux Plating System | In2bones USA, LLC | 2021 | — |
| −1 | K211650 | The Radian MIS Bunion System | Nvision Biomedical Technologies, Inc. | 2021 | — |
| 0 (this device) | K253718 | enHAnce PEEK Bunion System | Nvision Biomedical Technologies, Inc. | 2026 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K211650 | The Radian MIS Bunion SystemSummary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code I K211650 Radian MIS Bunion System I HRS I K192356… | 2021 |
| * | K192356 | Airlock Centrolock Osteosynthesis Implant SystemSummary page 5…Product Code I K211650 Radian MIS Bunion System I HRS I K192356 Novastep Airlock Osteosynthesis Implant System I HRS I K190658… | 2019 |
| * | K190658 | MIS Bunion Plating SystemSummary page 5…I HRS I K192356 Novastep Airlock Osteosynthesis Implant System I HRS I K190658 CrossRoads MINIBunion System I HRS IK250646… | 2019 |
| * | K250646 | Impact PEEK Union Nail SystemSummary page 5…I HRS I K190658 CrossRoads MINIBunion System I HRS IK250646 Impact PEEK Union Nail I HTY I K241014… | 2025 |
| * | K241014 | Biomet Kirschner Wires (K-Wires)Summary page 5…I HRS IK250646 Impact PEEK Union Nail I HTY I K241014 Biomet Kirschner Wires (K-Wires) I HTY Device Desc… | 2024 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K262098 | EnHAnce PEEK Bunion System | 2026 | 0 |
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 8 companies; a new generation was cleared every 1.6 years on median.
- 42 of the 241 ancestors have a recall of any class.
- Of its descendants, K262098 (Nvision Biomedical Technologies, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K211650.
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 as stated in the FDA summary.
https://510kreport.com/device/K253718 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253718: enHAnce PEEK Bunion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253718
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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