510(k) · Cleared
Recalled · Class II · 2019MotoBAND CP Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crossroads Extremity Systems, LLC · HWC Screw, Fixation, Bone
Cleared on Feb 12, 2018 as substantially equivalent to K160300 (Crossroads Extremity Systems, LLC, 2016) and 1 other predicate after a 70-day review. Its family tree reaches back 9 generations to 1996. 4 later devices descend from it. It has been recalled once.
- Decided
- Feb 12, 2018
- Review
- 70 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 9 generations to K954385 (1996). 63 ancestors in all, the oldest K800806 (1980). 4 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 5 generations between
- 3 generations backK131657 Flower Small and Medium Implant SetFlower Orthopedics Corporation · 2013 · Recalled
- 2 generations backK152306 MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC · 2015
- 1 generation backK160300 MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC · 2016
- This deviceK173710 MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC · 2018
- Descendant · cites it directly · 3 of its ownK193452 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 9 generations
- Root · 9 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 8 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 7 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 6 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 5 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 4 generations backK123562 Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation · 2013 · Recalled
- 3 generations backK131657 Flower Small and Medium Implant SetFlower Orthopedics Corporation · 2013 · Recalled
- 2 generations backK152306 MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC · 2015
- 1 generation backK160300 MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC · 2016
- This deviceK173710 MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC · 2018
Most influential descendants
Showing 4 of 4 · 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 · 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 |
|---|---|---|---|---|---|
| −9 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −8 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −7 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −6 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −5 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −4 | K123562 | Flower Small and Medium Bone Implants | Flower Orthopedics Corporation | 2013 | 2 |
| −3 | K131657 | Flower Small and Medium Implant Set | Flower Orthopedics Corporation | 2013 | 1 |
| −2 | K152306 | MotoBand¿ CP Implant System | Crossroads Extremity Systems, LLC | 2015 | — |
| −1 | K160300 | MotoBand (TM) CP Implant System | Crossroads Extremity Systems, LLC | 2016 | — |
| 0 (this device) | K173710 | MotoBAND CP Implant System | Crossroads Extremity Systems, LLC | 2018 | — |
| +1 | 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 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K160300 | MotoBand (TM) CP Implant SystemSummary page 4…fixation appliances and accessories Panel: Orthopedic Product Code: HWC, HRS Predicate Devices: Primary Predicate: K160300 MotoBAND™ CP Implant System Page 1 of 3… | 2016 |
| * | K152306 | MotoBand¿ CP Implant SystemSummary page 5…K173710 Additional Predicate: K152306 MotoBAND™ CP Implant System Device Description: The MotoBAND™ CP Implant System is comprised of… | 2015 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 19, 2019 | Class II | Z-0212-2020 | Labeling mix-ups | Potentially includes a 3.0mm x 30mm screw instead of 3.0mm x 28mm screw. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 16 of the 63 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.
- 1 other device also cites its predicate K160300.
How does its category compare?
All HWC devicesHWC Screw, 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 · 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 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 MTP plates and 2-hole plate may be used with the MotoCLIP™ Implant System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173710 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173710: MotoBAND CP 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/K173710
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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