510(k) Report

510(k) · Cleared

Cleared

MotoBand¿ CP Implant System

K152306510(k) TraditionalCleared Dec 11, 2015119-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 · HRS Plate, Fixation, Bone

Cleared on Dec 11, 2015 as substantially equivalent to K083447 (Memometal Technologies, 2009) and 2 other predicates after a 119-day review. Its family tree reaches back 7 generations to 1996. 7 later devices descend from it.

Decided
Dec 11, 2015
Review
119 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
3

Its longest line of descent runs back 7 generations to K954385 (1996). 61 ancestors in all, the oldest K800806 (1980). 7 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 2 other ancestors2011: 2 other ancestors2008: 1 other ancestor2006: 1 other ancestor2010: 1 other ancestor2004: 3 other ancestors2003: 1 other ancestor2002: 3 other ancestors2001: 7 other ancestors2000: 7 other ancestors1999: 5 other ancestors1996: 5 other ancestors1994: 3 other ancestors2007: 1 other ancestor1998: 4 other ancestors1995: 2 other ancestors1992: 1 other ancestor1980: 1 other ancestor1997: 1 other ancestor1991: 1 other ancestor1989: 2 other ancestors2016: 1 descendant cleared2018: 1 descendant cleared2024: 1 descendant cleared2023: 2 descendants cleared2020: 1 descendant cleared2026: 1 descendant clearedK954385 · Synthes Mandibular Modular Fixation System · Synthes (Usa) · 1996K974555 · Synthes 2.0 MM Locking Plate System (2.0 LPS) · Synthes (Usa) · 1998×2: 2 generations cleared close together, K030448 (2003), K032442 (2003) K040598 · KLS Martin Hand Plating System · KLS-Martin L.P. · 2004×2: 2 generations cleared close together, K123562 (2013), K131657 (2013) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 5 other ancestors3 generations back: 16 other ancestors4 generations back: 15 other ancestors5 generations back: 15 other ancestors6 generations back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K131657 · Flower Small and Medium Implant Set · Flower Orthopedics Corporation · 2013 · recalledK123562 · Flower Small and Medium Bone Implants · Flower Orthopedics Corporation · 2013 · recalledK040598 · KLS Martin Hand Plating System · KLS-Martin L.P. · 2004K032442 · KLS-Martin Mandibular/Reconstruction System II · KLS-Martin L.P. · 2003K030448 · Osteomed 2.0 Locking Plates and Screws · Osteomed LP · 2003K974555 · Synthes 2.0 MM Locking Plate System (2.0 LPS) · Synthes (Usa) · 1998K954385 · Synthes Mandibular Modular Fixation System · Synthes (Usa) · 1996−50
  1. Root · 7 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
  2. 6 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
  3. 5 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
  4. 4 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
  5. 3 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
  6. 2 generations backK123562 Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation · 2013 · Recalled
  7. 1 generation backK131657 Flower Small and Medium Implant SetFlower Orthopedics Corporation · 2013 · Recalled
  8. This deviceK152306 MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC · 2015
  9. Descendant · cites it directly · 6 of its ownK160300 MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC · 2016
  10. Descendant · cites it directly · 4 of its ownK173710 MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC · 2018 · Recalled
  11. Descendant · 2 generations on · 3 of its ownK193452 MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC · 2020
  12. Descendant · 2 generations on · 2 of its ownK223342 MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion…Crossroads Extremity Systems, LLC · 2023
  13. Descendant · 3 generations on · 1 of its ownK230591 TriLEAP Plating SystemCrossroads Extremity Systems · 2023

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2016: 12018: 12020: 12023: 22024: 12026: 1
2016high 2 (2023) · low 0 (2017)2026

Most influential descendants

Showing 5 of 7 · See all
  • K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC · 2016 · cites it directly6descendants
  • K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC · 2018 · cites it directly4descendants
  • 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 · 2 generations on2descendants
  • K230591TriLEAP Plating SystemCrossroads Extremity Systems · 2023 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K954385Synthes Mandibular Modular Fixation SystemSynthes (Usa)1996—
−6K974555Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa)1998—
−5K030448Osteomed 2.0 Locking Plates and ScrewsOsteomed LP2003—
−4K032442KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P.2003—
−3K040598KLS Martin Hand Plating SystemKLS-Martin L.P.2004—
−2K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation20132
−1K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation20131
0 (this device)K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC2015—
+1K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC2016—
+1K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC20181
+2K193452MotoBAND 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—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198920
199110
199210
199430
199520
199650
199710
199840
199950
200070
200170
200230
200310
200430
200610
200710
200810
200920
201010
201120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201810
202010
202320
202410
202610
FIG. 1 — Lineage of K152306, 1996–2026Source: 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 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. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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? (3)

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
*K083447Memometal Anchorage Bone Plate System, Models PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50
Summary page 4
…88.3040, Smooth or threaded metallic bone fixation fastener Panel: Orthopedic Product Code: HRS, HWC Predicate Devices: K083447 ANCHORAGETM CP K131657 and K123562 Flower Small and Medium Implant Set Device Description:…
Memometal Technologies2009—
*K131657Flower Small and Medium Implant Set
Summary page 4
…astener Panel: Orthopedic Product Code: HRS, HWC Predicate Devices: K083447 ANCHORAGETM CP K131657 and K123562 Flower Small and Medium Implant Set Device Description: The MotoBAND™ CP Implant System is comprised of imp…
Flower Orthopedics Corporation20131
*K123562Flower Small and Medium Bone Implants
Summary page 4
…el: Orthopedic Product Code: HRS, HWC Predicate Devices: K083447 ANCHORAGETM CP K131657 and K123562 Flower Small and Medium Implant Set Device Description: The MotoBAND™ CP Implant System is comprised of implant…
Flower Orthopedics Corporation20132

Also cleared against K083447: 9 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166
K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC20184

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 19 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
  • 16 of the 61 ancestors have a recall of any class.
  • Of its descendants, K160300 (Crossroads Extremity Systems, LLC, 2016) has gone furthest, with 6 descendants of its own.
  • 9 other devices also cite its predicate K083447.

How does its category compare?

All HRS devices

HRS Plate, 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 · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

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

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

The MotoBand™ CP Implant System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K152306: MotoBand¿ CP Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K152306

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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