510(k) · Cleared
ClearedVortex5 Tailor's Bunion Correction 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 Mar 25, 2026 as substantially equivalent to K202657 (Nvision Biomedical Technologies, Inc., 2020) and 2 other predicates after a 55-day review. Its family tree reaches back 14 generations to 1996.
- Decided
- Mar 25, 2026
- Review
- 55 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K962616 (1996). 231 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations between
- 3 generations backK151407 RECON systemNormed Medizin-Technik GmbH · 2015
- 2 generations backK152312 RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH · 2015 · Recalled
- 1 generation backK202657 Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc. · 2020
- This deviceK260291 Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc. · 2026
Show all 14 generations
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 13 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 12 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 11 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 8 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 7 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 6 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 5 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 4 generations backK141784 Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 2014 · Recalled
- 3 generations backK151407 RECON systemNormed Medizin-Technik GmbH · 2015
- 2 generations backK152312 RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH · 2015 · Recalled
- 1 generation backK202657 Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc. · 2020
- This deviceK260291 Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −13 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −12 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −11 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −8 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −7 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −6 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −5 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −4 | K141784 | Ortho Solutions Ultos Plating System | Ortho Solutions Limited | 2014 | 2 |
| −3 | K151407 | RECON system | Normed Medizin-Technik GmbH | 2015 | — |
| −2 | K152312 | RECON system-V-TEK-IVP Plates and Screws | Normed Medizin-Technik GmbH | 2015 | 4 |
| −1 | K202657 | Javelin Tailor's Bunion Fixation System | Nvision Biomedical Technologies, Inc. | 2020 | — |
| 0 (this device) | K260291 | Vortex5 Tailor's Bunion Correction System | Nvision Biomedical Technologies, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 4 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 8 | 0 |
| 1993 | 4 | 0 |
| 1994 | 6 | 0 |
| 1995 | 7 | 0 |
| 1996 | 12 | 0 |
| 1997 | 4 | 0 |
| 1998 | 8 | 0 |
| 1999 | 14 | 0 |
| 2000 | 14 | 0 |
| 2001 | 14 | 0 |
| 2002 | 14 | 0 |
| 2003 | 8 | 0 |
| 2004 | 9 | 0 |
| 2005 | 12 | 0 |
| 2006 | 16 | 0 |
| 2007 | 7 | 0 |
| 2008 | 12 | 0 |
| 2009 | 9 | 0 |
| 2010 | 10 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K202657 | Javelin Tailor's Bunion Fixation SystemSummary page 5…1 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code I K202657 J IJavelin Tailor's Bunion Fixation System 1 1 HRS… | 2020 |
| * | K182949 | Healix™ Compression Screw SystemSummary page 5…21 CFR 807.92(a)(6) The :subject device has a similar design, similar dimensions, and uses similar or identical materials as the devices cleared in 1<202657, K182949:, and Kl 71558. The subject device also has the same intended use, as well as similar technological characteristics as these… | 2018 |
| * | K171558 | ExsoMed ITN Cannulated Screw System | 2017 |
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 7 companies; a new generation was cleared every 1.8 years on median.
- 46 of the 231 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 Vortex5 Tailor's Bunion Correction System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the toes (such as 5th metatarsal osteotomies for the correction of Tailor's Bunion). The system may be used in both adults and adolescent patients (13-21 years of age).
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/K260291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260291: Vortex5 Tailor's Bunion Correction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260291
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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