510(k) · Cleared
ClearedMIS Bunion Plating 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 Apr 12, 2019 as substantially equivalent to K181872 (Crossroads Extremity Systems, LLC, 2019) after a 29-day review. Its family tree reaches back 8 generations to 1990. 2 later devices descend from it.
- Decided
- Apr 12, 2019
- Review
- 29 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K901456 (1990). 36 ancestors in all, the oldest K792670 (1980). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK901456 Orthosorb (R) Absorbable PinJohnson & Johnson International · 1990
- 7 generations backK031712 Inion Otps Biodegradable PinInion, Ltd. · 2003
- 6 generations backK050275 Modification to: Inion Otps Biodegradable PinInion, Ltd. · 2005
- 5 generations backK061164 ActivapinBioretec, Ltd. · 2006
- 4 generations backK133636 Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014
- 3 generations backK141857 CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
- 2 generations backK151270 CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015
- 1 generation backK181872 MIS Bunion SystemCrossroads Extremity Systems, LLC · 2019
- This deviceK190658 MIS Bunion Plating SystemCrossroads Extremity Systems, LLC · 2019
- Descendant · cites it directly · 1 of its ownK253718 enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK262098 EnHAnce PEEK Bunion SystemNvision Biomedical Technologies · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K901456 | Orthosorb (R) Absorbable Pin | Johnson & Johnson International | 1990 | — |
| −7 | K031712 | Inion Otps Biodegradable Pin | Inion, Ltd. | 2003 | — |
| −6 | K050275 | Modification to: Inion Otps Biodegradable Pin | Inion, Ltd. | 2005 | — |
| −5 | K061164 | Activapin | Bioretec, Ltd. | 2006 | — |
| −4 | K133636 | Extremity Medical Hammertoe Device | Extremity Medical, LLC | 2014 | — |
| −3 | K141857 | CrossTie Intraosseous Fixation System | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | 2015 | — |
| −2 | K151270 | CrossTIE Intraosseous Fixation System | Crossroads Extremity Systems, LLC | 2015 | — |
| −1 | K181872 | MIS Bunion System | Crossroads Extremity Systems, LLC | 2019 | — |
| 0 (this device) | K190658 | MIS Bunion Plating System | Crossroads Extremity Systems, LLC | 2019 | — |
| +1 | K253718 | enHAnce PEEK Bunion System | Nvision Biomedical Technologies, Inc. | 2026 | — |
| +2 | K262098 | EnHAnce PEEK Bunion System | Nvision Biomedical Technologies | 2026 | — |
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 |
|---|---|---|
| 2026 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K181872 | MIS Bunion SystemSummary page 4…pliances and accessories) Panel: 87‐ Orthopedic Product Code: HRS Predicate Devices: CrossRoads Extremity Systems, LLC, MIS Bunion System (K181872) Device Description: The CrossRoads MIS Bunion System contains a buttressing implant which can be surgically implanted using a m… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253718 | enHAnce PEEK Bunion System | 2026 | 1 |
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 36 ancestors have a recall of any class.
- Of its descendants, K253718 (Nvision Biomedical Technologies, Inc., 2026) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K181872.
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 as stated in the FDA summary.
https://510kreport.com/device/K190658 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190658: MIS Bunion Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190658
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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