510(k) · Cleared
ClearedCrossTie Intraosseous Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem · HWC Screw, Fixation, Bone
Cleared on Jan 8, 2015 as substantially equivalent to K133636 (Extremity Medical, LLC, 2014) and 3 other predicates after a 182-day review. Its family tree reaches back 5 generations to 1990. 16 later devices descend from it.
- Decided
- Jan 8, 2015
- Review
- 182 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K901456 (1990). 32 ancestors in all, the oldest K792670 (1980). 16 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK901456 Orthosorb (R) Absorbable PinJohnson & Johnson International · 1990
- 4 generations backK031712 Inion Otps Biodegradable PinInion, Ltd. · 2003
- 3 generations backK050275 Modification to: Inion Otps Biodegradable PinInion, Ltd. · 2005
- 2 generations backK061164 ActivapinBioretec, Ltd. · 2006
- 1 generation backK133636 Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014
- This deviceK141857 CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
- Descendant · cites it directly · 15 of its ownK151270 CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015
- Descendant · 2 generations on · 14 of its ownK181872 MIS Bunion SystemCrossroads Extremity Systems, LLC · 2019
- Descendant · 3 generations on · 7 of its ownK221181 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2023
- Descendant · 3 generations on · 4 of its ownK240173 Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc. · 2024 · Recalled
- Descendant · 3 generations on · 4 of its ownK212487 CoLink Vallux Plating SystemIn2bones USA, LLC · 2021
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015 · cites it directly15descendants
- K181872MIS Bunion SystemCrossroads Extremity Systems, LLC · 2019 · 2 generations on14descendants
- K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2023 · 3 generations on7descendants
- K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc. · 2024 · 3 generations on4descendants
- K212487CoLink Vallux Plating SystemIn2bones USA, LLC · 2021 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K901456 | Orthosorb (R) Absorbable Pin | Johnson & Johnson International | 1990 | — |
| −4 | K031712 | Inion Otps Biodegradable Pin | Inion, Ltd. | 2003 | — |
| −3 | K050275 | Modification to: Inion Otps Biodegradable Pin | Inion, Ltd. | 2005 | — |
| −2 | K061164 | Activapin | Bioretec, Ltd. | 2006 | — |
| −1 | K133636 | Extremity Medical Hammertoe Device | Extremity Medical, LLC | 2014 | — |
| 0 (this device) | 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 | — |
| +2 | K181872 | MIS Bunion System | Crossroads Extremity Systems, LLC | 2019 | — |
| +3 | K221181 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2023 | — |
| +3 | K240173 | Treace Medical Systems (TMC) Plating System | Treace Medical Concepts, Inc. | 2024 | 1 |
| +3 | K212487 | CoLink Vallux Plating System | In2bones USA, LLC | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 2 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K133636 | Extremity Medical Hammertoe DeviceSummary page 4…21 CFR 888.3040 Classification Class II Appropriate Classification Panel 87 - Orthopedic Predicate Devices K133636 – HammerFix IP Fusion System (Extremity Medical) K113006 – PhaLinx Hammer Toe System (Orth… | 2014 |
| * | K113006 | I-Fuse Hammer Toe SystemsSummary page 4…tion Panel 87 - Orthopedic Predicate Devices K133636 – HammerFix IP Fusion System (Extremity Medical) K113006 – PhaLinx Hammer Toe System (OrthoPro) K120165 – CannuLink Instraosseous Fixation System (… | 2012 |
| * | K120165 | Intraosseous Fixation SystemSummary page 4…mmerFix IP Fusion System (Extremity Medical) K113006 – PhaLinx Hammer Toe System (OrthoPro) K120165 – CannuLink Instraosseous Fixation System (Orthohelix) K073674 – Kirchner Wires (Signal Me… | 2012 |
| * | K073674 | Bone Fixation Wire (Kirschner Wire)Summary page 4…Hammer Toe System (OrthoPro) K120165 – CannuLink Instraosseous Fixation System (Orthohelix) K073674 – Kirchner Wires (Signal Medical Corp) Reason For Submission New Device Substantial Equivalence: Th… | 2008 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151270 | CrossTIE Intraosseous Fixation System | 2015 | 15 |
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 25 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 5 of the 32 ancestors have a recall of any class.
- Of its descendants, K151270 (Crossroads Extremity Systems, LLC, 2015) has gone furthest, with 15 descendants of its own.
- 8 other devices also cite its predicate K133636.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The CrossTie™ Intraosseous Fixation System is indicated to aid in the fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe, mallet toe and inter-digital fusions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141857 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141857: CrossTie Intraosseous Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141857
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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