510(k) Report

510(k) · Cleared

Cleared

MotoCLIP/HiMAX Implant System

K181410510(k) SpecialCleared Jun 29, 201830-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Crossroads Extremity Systems, LLC · JDR Staple, Fixation, Bone

Cleared on Jun 29, 2018 as substantially equivalent to K142727 (Orthodiscovery Group, LLC (D.B.A. Crossroads Extremity Systems, 2014) after a 30-day review. Its family tree reaches back 5 generations to 1990. 6 later devices descend from it.

Decided
Jun 29, 2018
Review
30 days
Class
Class II
Product code
JDR
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K902307 (1990). 6 ancestors in all. 6 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor2018: 1 descendant cleared2019: 1 descendant cleared2020: 1 descendant cleared2023: 2 descendants cleared2026: 1 descendant clearedK902307 · Shaw II Hemostatic Surgery System · Hemostatic Surgery Corp. · 1990 · recalledK993714 · Memograph Staple, Warm System · Biomedical Ent., Inc. · 2000K070031 · Memometal Memory Staples · Memometal Technologies · 2007K124045 · Fuseforce Implant System · Solana Surgical, LLC · 2013K142727 · CrossCLIP Implant System · Orthodiscovery Group, LLC (D.B.A. Crossroads Extremity Systems · 2014 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant K142727 · CrossCLIP Implant System · Orthodiscovery Group, LLC (D.B.A. Crossroads Extremity Systems · 2014 · recalledK124045 · Fuseforce Implant System · Solana Surgical, LLC · 2013K070031 · Memometal Memory Staples · Memometal Technologies · 2007K993714 · Memograph Staple, Warm System · Biomedical Ent., Inc. · 2000K902307 · Shaw II Hemostatic Surgery System · Hemostatic Surgery Corp. · 1990 · recalled−50
  1. Root · 5 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
  2. 4 generations backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
  3. 3 generations backK070031 Memometal Memory StaplesMemometal Technologies · 2007
  4. 2 generations backK124045 Fuseforce Implant SystemSolana Surgical, LLC · 2013
  5. 1 generation backK142727 CrossCLIP Implant SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extremity Systems · 2014 · Recalled
  6. This deviceK181410 MotoCLIP/HiMAX Implant SystemCrossroads Extremity Systems, LLC · 2018
  7. Descendant · cites it directly · 3 of its ownK193452 MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC · 2020
  8. Descendant · 2 generations on · 2 of its ownK223342 MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion…Crossroads Extremity Systems, LLC · 2023
  9. Descendant · 3 generations on · 1 of its ownK230591 TriLEAP Plating SystemCrossroads Extremity Systems · 2023
  10. Descendant · 4 generations on · 0 of its ownK253178 TRILEAP Plating SystemCrossroads Extremity Systems · 2026
  11. Descendant · cites it directly · 0 of its ownK190722 TriMAX Implant SystemCrossroads Extemity Systems, LLC · 2019

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2018: 12019: 12020: 12023: 22026: 1
2018high 2 (2023) · low 0 (2021)2026

Most influential descendants

Showing 5 of 6 · See all
  • K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC · 2020 · cites it directly3descendants
  • K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC · 2023 · 2 generations on2descendants
  • K230591TriLEAP Plating SystemCrossroads Extremity Systems · 2023 · 3 generations on1descendant
  • K253178TRILEAP Plating SystemCrossroads Extremity Systems · 2026 · 4 generations on0descendants
  • K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K902307Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp.19902
−4K993714Memograph Staple, Warm SystemBiomedical Ent., Inc.2000—
−3K070031Memometal Memory StaplesMemometal Technologies2007—
−2K124045Fuseforce Implant SystemSolana Surgical, LLC2013—
−1K142727CrossCLIP Implant SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extremity Systems20141
0 (this device)K181410MotoCLIP/HiMAX Implant SystemCrossroads Extremity Systems, LLC2018—
+1K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC2020—
+2K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System…Crossroads Extremity Systems, LLC2023—
+3K230591TriLEAP Plating SystemCrossroads Extremity Systems2023—
+4K253178TRILEAP Plating SystemCrossroads Extremity Systems2026—
+1K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
201910
202010
202320
202610
FIG. 1 — Lineage of K181410, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 JDR? 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 JDR device

  1. #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K142727CrossCLIP Implant System
Summary page 4
…appliances and accessories) Panel: 87- Orthopedic Product Code: JDR Predicate Devices: CrossRoads Extremity Systems, LLC CrossCLIP™ Implants (K142727) Device Description: MotoCLIP™/HiMAX™ Implant System is a staple system which gives the surgeon a means of bone fixation in the…
Orthodiscovery Group, LLC (D.B.A. Crossroads Extremity Systems20141

Also cleared against K142727: 2 other devices →

What descends from it? (6)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203
K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190
K181866MotoCLIP/HiMAX Step Staple Implant SystemCrossroads Extremity Systems, LLC20180

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 28 years and passes through 6 companies; a new generation was cleared every 6.3 years on median.
  • 2 of the 6 ancestors have a recall of any class.
  • Of its descendants, K193452 (Crossroads Extemity Systems, LLC, 2020) has gone furthest, with 3 descendants of its own.
  • 2 other devices also cite its predicate K142727.

How does its category compare?

All JDR devices

JDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · JDR

3in 2025

2007: 82008: 52010: 22011: 12012: 12013: 92014: 112015: 72016: 62017: 92018: 82019: 52020: 42021: 32022: 52023: 92024: 42025: 32026 (partial year): 2
2007high 11 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDR

65in 2025

2007: 70 days median2008: 89 days median2013: 137 days median2014: 97 days median2015: 111 days median2016: 101 days median2017: 172 days median2018: 107 days median2019: 149 days median2020: 161 days median2021: 62 days median2022: 107 days median2023: 72 days median2024: 29 days median2025: 65 days median
2007high 172 (2017) · low 29 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JDR

11in 2022

2008: 12015: 12018: 12020: 12022: 112026 (partial year): 2
2007high 11 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JDR

314in 2025

2007: 32008: 142009: 102010: 352011: 622012: 342013: 272014: 492015: 482016: 762017: 1162018: 2392019: 2422020: 2342021: 2102022: 2022023: 1752024: 2062025: 314
2007high 314 (2025) · low 3 (2007)2025

MAUDE reports naming product code JDR, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200787003
2008589114
20090—010
20102—035
20111—062
20121—034
20139137027
20141197049
20157111148
20166101076
201791720116
201881071239
201951490242
202041611234
20213620210
2022510711202
20239720175
20244290206
20253650314
20262—2—

What is it indicated for?

The MotoCLIP™/HiMAX™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.

Indications for use as stated in the FDA summary.

Also cleared against K142727

2 other devices cite the same predicate.

  • K181866MotoCLIP/HiMAX Step Staple Implant SystemCrossroads Extremity Systems, LLC · 2018
  • K171703PUMA SystemPanther Orthopedics, Inc. · 2018

More from Crossroads Extremity Systems, LLC

13 FDA decisions under this applicant name. See the company

  • K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion SystemCrossroads Extremity Systems, LLC · 2023
  • K220797FootHold SystemCrossroads Extremity Systems, LLC · 2022
  • K202268CrossRoads Tray SystemCrossroads Extremity Systems, LLC · 2020
  • K190658MIS Bunion Plating SystemCrossroads Extremity Systems, LLC · 2019
  • K181872MIS Bunion SystemCrossroads Extremity Systems, LLC · 2019

Recent decisions in JDR

The JDR category page

  • K262451Arthrex DynaNite StaplesArthrex, Inc. · 2026
  • K261121Megalodon Dynamic Compression SystemParagon 28, Inc. · 2026
  • K250712Linkt Compression Staple SystemTrax Surgical · 2025
  • K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP · 2025
  • K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc. · 2025

https://510kreport.com/device/K181410 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181410: MotoCLIP/HiMAX Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181410

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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