510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

CrossCLIP Implant System

K142727510(k) TraditionalCleared Oct 24, 201431-day reviewClass II21 CFR 888.3030Recalls 1

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

Orthodiscovery Group, LLC (D.B.A. Crossroads Extremity Systems · JDR Staple, Fixation, Bone

Cleared on Oct 24, 2014 as substantially equivalent to K070031 (Memometal Technologies, 2007) and 1 other predicate after a 31-day review. Its family tree reaches back 4 generations to 1990. 8 later devices descend from it. It has been recalled once.

Decided
Oct 24, 2014
Review
31 days
Class
Class II
Product code
JDR
Recalls
1
Predicates
2

Its longest line of descent runs back 4 generations to K902307 (1990). 5 ancestors in all. 8 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor2018: 3 descendants 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 · 20131990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant K124045 · 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 · recalled0+5
  1. Root · 4 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
  2. 3 generations backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
  3. 2 generations backK070031 Memometal Memory StaplesMemometal Technologies · 2007
  4. 1 generation backK124045 Fuseforce Implant SystemSolana Surgical, LLC · 2013
  5. This deviceK142727 CrossCLIP Implant SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extremity Systems · 2014
  6. Descendant · cites it directly · 6 of its ownK181410 MotoCLIP/HiMAX Implant SystemCrossroads Extremity Systems, LLC · 2018
  7. Descendant · 2 generations on · 3 of its ownK193452 MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC · 2020
  8. Descendant · 3 generations on · 2 of its ownK223342 MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion…Crossroads Extremity Systems, LLC · 2023
  9. Descendant · 4 generations on · 1 of its ownK230591 TriLEAP Plating SystemCrossroads Extremity Systems · 2023
  10. Descendant · 5 generations on · 0 of its ownK253178 TRILEAP Plating SystemCrossroads Extremity Systems · 2026

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2018: 32019: 12020: 12023: 22026: 1
2018high 3 (2018) · low 0 (2021)2026

Most influential descendants

Showing 5 of 8 · See all
  • K181410MotoCLIP/HiMAX Implant SystemCrossroads Extremity Systems, LLC · 2018 · cites it directly6descendants
  • K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC · 2020 · 2 generations on3descendants
  • K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC · 2023 · 3 generations on2descendants
  • K230591TriLEAP Plating SystemCrossroads Extremity Systems · 2023 · 4 generations on1descendant
  • K253178TRILEAP Plating SystemCrossroads Extremity Systems · 2026 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K902307Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp.19902
−3K993714Memograph Staple, Warm SystemBiomedical Ent., Inc.2000—
−2K070031Memometal Memory StaplesMemometal Technologies2007—
−1K124045Fuseforce Implant SystemSolana Surgical, LLC2013—
0 (this device)K142727CrossCLIP Implant SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extremity Systems2014—
+1K181410MotoCLIP/HiMAX Implant SystemCrossroads Extremity Systems, LLC2018—
+2K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC2020—
+3K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System…Crossroads Extremity Systems, LLC2023—
+4K230591TriLEAP Plating SystemCrossroads Extremity Systems2023—
+5K253178TRILEAP Plating SystemCrossroads Extremity Systems2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201830
201910
202010
202320
202610
FIG. 1 — Lineage of K142727, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K070031Memometal Memory Staples
Summary page 4
…21 CFR 888.3030 Classification Class II Appropriate Classification Panel 87 - Orthopedic Predicate Devices K070031 – MemoMetal Memory Staples (MemoClip – EasyClip – For Fusion); MemoMetal Technologies…
Memometal Technologies2007—
*K124045Fuseforce Implant System
Summary page 4
…0031 – MemoMetal Memory Staples (MemoClip – EasyClip – For Fusion); MemoMetal Technologies K124045 – FuseForce Implant System; Solana Surgical, LLC Reason For Submission New Device Substantial Equivalence:…
Solana Surgical, LLC2013—

Also cleared against K070031: 12 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K181410MotoCLIP/HiMAX Implant SystemCrossroads Extremity Systems, LLC20186
K181866MotoCLIP/HiMAX Step Staple Implant SystemCrossroads Extremity Systems, LLC20180
K171703PUMA SystemPanther Orthopedics, Inc.20180

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 16, 2017Class IIZ-1487-2017Labeling mix-upsSeven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 14mm.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 7.1 years on median.
  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K181410 (Crossroads Extremity Systems, LLC, 2018) has gone furthest, with 6 descendants of its own.
  • 12 other devices also cite its predicate K070031.

How does its category compare?

All JDR devices

JDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 CrossCLIP™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K070031

12 other devices cite the same predicate.

  • K192447Superelastic StapleNeosteo · 2020
  • K153770OS2(R)-VP Varisation StapleIn2bones Sas · 2016
  • K153395OS2-C Compression StapleIn2bones Sas · 2016
  • K142148Orthohelix Staple SystemOrthohelix Surgical Designs, Inc. · 2014
  • K133523Stapix Superelastic Implant Bone StaplesInstratek, Inc. · 2014
  • K130832Orthohelix Staple SystemOrthohelix Surgical Designs, Inc. · 2013

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/K142727 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142727: CrossCLIP 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/K142727

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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