510(k) · Cleared
ClearedMotoBAND CP Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crossroads Extemity Systems, LLC · HRS Plate, Fixation, Bone
Cleared on Jan 10, 2020 as substantially equivalent to K173710 (Crossroads Extremity Systems, LLC, 2018) and 1 other predicate after a 28-day review. Its family tree reaches back 10 generations to 1996. 3 later devices descend from it.
- Decided
- Jan 10, 2020
- Review
- 28 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K954385 (1996). 71 ancestors in all, the oldest K800806 (1980). 3 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK152306 MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC · 2015
- 2 generations backK160300 MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC · 2016
- 1 generation backK173710 MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC · 2018 · Recalled
- This deviceK193452 MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC · 2020
- Descendant · cites it directly · 2 of its ownK223342 MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion…Crossroads Extremity Systems, LLC · 2023
- Descendant · 2 generations on · 1 of its ownK230591 TriLEAP Plating SystemCrossroads Extremity Systems · 2023
- Descendant · 3 generations on · 0 of its ownK253178 TRILEAP Plating SystemCrossroads Extremity Systems · 2026
Show all 10 generations
- Root · 10 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 9 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 8 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 7 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 6 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 5 generations backK123562 Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation · 2013 · Recalled
- 4 generations backK131657 Flower Small and Medium Implant SetFlower Orthopedics Corporation · 2013 · Recalled
- 3 generations backK152306 MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC · 2015
- 2 generations backK160300 MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC · 2016
- 1 generation backK173710 MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC · 2018 · Recalled
- This deviceK193452 MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC · 2020
Most influential descendants
Showing 3 of 3 · See all- K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC · 2023 · cites it directly2descendants
- K230591TriLEAP Plating SystemCrossroads Extremity Systems · 2023 · 2 generations on1descendant
- K253178TRILEAP Plating SystemCrossroads Extremity Systems · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −9 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −8 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −7 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −6 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −5 | K123562 | Flower Small and Medium Bone Implants | Flower Orthopedics Corporation | 2013 | 2 |
| −4 | K131657 | Flower Small and Medium Implant Set | Flower Orthopedics Corporation | 2013 | 1 |
| −3 | K152306 | MotoBand¿ CP Implant System | Crossroads Extremity Systems, LLC | 2015 | — |
| −2 | K160300 | MotoBand (TM) CP Implant System | Crossroads Extremity Systems, LLC | 2016 | — |
| −1 | K173710 | MotoBAND CP Implant System | Crossroads Extremity Systems, LLC | 2018 | 1 |
| 0 (this device) | K193452 | MotoBAND CP Implant System | Crossroads Extemity Systems, LLC | 2020 | — |
| +1 | K223342 | MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System… | Crossroads Extremity Systems, LLC | 2023 | — |
| +2 | K230591 | TriLEAP Plating System | Crossroads Extremity Systems | 2023 | — |
| +3 | K253178 | TRILEAP Plating System | Crossroads Extremity Systems | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 8 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2026 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K173710 | MotoBAND CP Implant SystemSummary page 4…Code: HRS HWC JDR Predicate Devices: Primary Predicate: K173710 MotoBAND CP Implant System Additional Predicate: K181410 MotoCLIPTM/Hi… | 2018 |
| * | K181410 | MotoCLIP/HiMAX Implant SystemSummary page 4…Primary Predicate: K173710 MotoBAND CP Implant System Additional Predicate: K181410 MotoCLIPTM/HiMAXTM Implant System Device Description: The subject MotoBAND CP Implant System is comprised… | 2018 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223342 | MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™… | 2023 | 2 |
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 24 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 19 of the 71 ancestors have a recall of any class.
- Of its descendants, K223342 (Crossroads Extremity Systems, LLC, 2023) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K173710.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 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. When used for these indications, the MotoBAND™ Implant System with the exception of the 2-hole plate may be used with the MotoCLIP™/HiMAX™ Implant System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193452 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193452: MotoBAND CP Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193452
Report an extraction error
Are you the manufacturer?
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