510(k) · Cleared
ClearedMIS Bunion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crossroads Extremity Systems, LLC · HRS Plate, Fixation, Bone
Cleared on Feb 19, 2019 as substantially equivalent to K151270 (Crossroads Extremity Systems, LLC, 2015) and 1 other predicate after a 222-day review. Its family tree reaches back 7 generations to 1990. 14 later devices descend from it.
- Decided
- Feb 19, 2019
- Review
- 222 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K901456 (1990). 35 ancestors in all, the oldest K792670 (1980). 14 later devices descend from it, 6 citing it directly.
- Root · 7 generations backK901456 Orthosorb (R) Absorbable PinJohnson & Johnson International · 1990
- 6 generations backK031712 Inion Otps Biodegradable PinInion, Ltd. · 2003
- 5 generations backK050275 Modification to: Inion Otps Biodegradable PinInion, Ltd. · 2005
- 4 generations backK061164 ActivapinBioretec, Ltd. · 2006
- 3 generations backK133636 Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014
- 2 generations backK141857 CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
- 1 generation backK151270 CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015
- This deviceK181872 MIS Bunion SystemCrossroads Extremity Systems, LLC · 2019
- Descendant · cites it directly · 7 of its ownK221181 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2023
- Descendant · cites it directly · 4 of its ownK240173 Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc. · 2024 · Recalled
- Descendant · cites it directly · 4 of its ownK212487 CoLink Vallux Plating SystemIn2bones USA, LLC · 2021
- Descendant · 2 generations on · 3 of its ownK242415 TMC Compression Implant SystemTreace Medical Concepts · 2024
- Descendant · cites it directly · 3 of its ownK211650 The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc. · 2021
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2023 · cites it directly7descendants
- K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc. · 2024 · cites it directly4descendants
- K212487CoLink Vallux Plating SystemIn2bones USA, LLC · 2021 · cites it directly4descendants
- K242415TMC Compression Implant SystemTreace Medical Concepts · 2024 · 2 generations on3descendants
- K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc. · 2021 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K901456 | Orthosorb (R) Absorbable Pin | Johnson & Johnson International | 1990 | — |
| −6 | K031712 | Inion Otps Biodegradable Pin | Inion, Ltd. | 2003 | — |
| −5 | K050275 | Modification to: Inion Otps Biodegradable Pin | Inion, Ltd. | 2005 | — |
| −4 | K061164 | Activapin | Bioretec, Ltd. | 2006 | — |
| −3 | K133636 | Extremity Medical Hammertoe Device | Extremity Medical, LLC | 2014 | — |
| −2 | K141857 | CrossTie Intraosseous Fixation System | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | 2015 | — |
| −1 | K151270 | CrossTIE Intraosseous Fixation System | Crossroads Extremity Systems, LLC | 2015 | — |
| 0 (this device) | K181872 | MIS Bunion System | Crossroads Extremity Systems, LLC | 2019 | — |
| +1 | K221181 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2023 | — |
| +1 | K240173 | Treace Medical Systems (TMC) Plating System | Treace Medical Concepts, Inc. | 2024 | 1 |
| +1 | K212487 | CoLink Vallux Plating System | In2bones USA, LLC | 2021 | — |
| +2 | K242415 | TMC Compression Implant System | Treace Medical Concepts | 2024 | — |
| +1 | K211650 | The Radian MIS Bunion System | Nvision Biomedical Technologies, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 4 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K151270 | CrossTIE Intraosseous Fixation SystemSummary page 4…ne fixation appliances and accessories) Panel: 87- Orthopedic Product Code: HRS Predicate Devices: CrossTIE Intraosseous Fixation System (K151270) In2Bones Kirschner Wires (K153204) Device Description: The CrossRoads MIS Bunion System contains a buttr… | 2015 |
| * | K153204 | In2Bones Kirschner wireSummary page 4…87- Orthopedic Product Code: HRS Predicate Devices: CrossTIE Intraosseous Fixation System (K151270) In2Bones Kirschner Wires (K153204) Device Description: The CrossRoads MIS Bunion System contains a buttressing implant which can be surgically implanted using a m… | 2016 |
What descends from it? (14)
See all 146 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 29 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 5 of the 35 ancestors have a recall of any class.
- Of its descendants, K221181 (Treace Medical Concepts, Inc., 2023) has gone furthest, with 7 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 MIS Bunion Plating 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/K181872 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181872: MIS Bunion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181872
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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