510(k) · Cleared
ClearedRedPoint Medical's Better Bunion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Redpoint Medical, LLC · PBF Orthopaedic Surgical Planning And Instrument Guides
Cleared on Jun 9, 2022 as substantially equivalent to K163156 (Materialise NV, 2017) and 1 other predicate after a 90-day review. Its family tree reaches back 7 generations to 1993. 3 later devices descend from it.
- Decided
- Jun 9, 2022
- Review
- 90 days
- Class
- Class II
- Product code
- PBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K924630 (1993). 13 ancestors in all, the oldest K924810 (1993). 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 6 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 5 generations backK033849 Simplant SystemMaterialise NV · 2004
- 4 generations backK073449 SurgicaseMaterialise NV · 2008
- 3 generations backK112389 Surgicase Connect, Surgicase GuideMaterialise NV · 2012
- 2 generations backK132290 Surgicase Orthopaedics System, Surgicase Connect, Surgicase GuidesMaterialise NV · 2014
- 1 generation backK163156 SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase GuidesMaterialise NV · 2017
- This deviceK220717 RedPoint Medical's Better Bunion SystemRedpoint Medical, LLC · 2022
- Descendant · cites it directly · 2 of its ownK241811 MedCAD® AccuStride™ SystemMedcad · 2025
- Descendant · 2 generations on · 0 of its ownK252064 MedCAD® AccuStride™ SystemMedcad · 2026
- Descendant · 2 generations on · 0 of its ownK251709 MedCAD® AccuStride™ SystemMedcad · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −6 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −5 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −4 | K073449 | Surgicase | Materialise NV | 2008 | — |
| −3 | K112389 | Surgicase Connect, Surgicase Guide | Materialise NV | 2012 | — |
| −2 | K132290 | Surgicase Orthopaedics System, Surgicase Connect, Surgicase Guides | Materialise NV | 2014 | — |
| −1 | K163156 | SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides | Materialise NV | 2017 | — |
| 0 (this device) | K220717 | RedPoint Medical's Better Bunion System | Redpoint Medical, LLC | 2022 | — |
| +1 | K241811 | MedCAD® AccuStride™ System | Medcad | 2025 | — |
| +2 | K252064 | MedCAD® AccuStride™ System | Medcad | 2026 | — |
| +2 | K251709 | MedCAD® AccuStride™ System | Medcad | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 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 PBF? 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 PBF device
- #1 K241811 MedCAD® AccuStride™ Systemscore 17.1 · 8 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 |
|---|---|---|---|
| * | K163156 | SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase GuidesSummary page 4…ruments guide Classification Code: PBF Classification Panel: Orthopedic Regulation Number: 21 CFR 888.3030. C1. PRIMARY PREDICATE DEVICE K163156 Materialise Surgicase Guides C2. PREDICATE DEVICE K211244 3D System’s VSP Orthopedics… | 2017 |
| * | K211244 | VSP® Orthopedics SystemSummary page 4…dic Regulation Number: 21 CFR 888.3030. C1. PRIMARY PREDICATE DEVICE K163156 Materialise Surgicase Guides C2. PREDICATE DEVICE K211244 3D System’s VSP Orthopedics System D. DEVICE DESCRIPTION The RedPoint Medical Better Bunion sys… | 2021 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241811 | MedCAD® AccuStride™ System | 2025 | 2 |
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 29 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K241811 (Medcad, 2025) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K163156.
How does its category compare?
All PBF devicesPBF Orthopaedic Surgical Planning And Instrument Guides: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · PBF
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PBF
227in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PBF
No recall names PBF since 2007.
Adverse event reports per year · PBF
62in 2025
MAUDE reports naming product code PBF, 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 | 1 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 2 | — | 0 | 12 |
| 2022 | 3 | 435 | 0 | 53 |
| 2023 | 5 | 314 | 0 | 45 |
| 2024 | 3 | 62 | 0 | 34 |
| 2025 | 8 | 227 | 0 | 62 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Better Bunion System is intended to be used as a surgical instrument to assist in pre-operative planning and/or in guiding the marking of bone and/or guide surgical instruments in non-acute, non-joint replacing osteotomies in the foot and ankle for adult and pediatric patients 12 years of age and older. Better Bunion cutting guides are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220717 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220717: RedPoint Medical's Better 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/K220717
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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