510(k) · Cleared
ClearedMotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crossroads Extremity Systems, LLC · HRS Plate, Fixation, Bone
Cleared on Mar 30, 2023 as substantially equivalent to K193452 (Crossroads Extemity Systems, LLC, 2020) and 1 other predicate after a 149-day review. Its family tree reaches back 11 generations to 1996. 2 later devices descend from it.
- Decided
- Mar 30, 2023
- Review
- 149 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K954385 (1996). 72 ancestors in all, the oldest K800806 (1980). 2 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 7 generations between
- 3 generations backK160300 MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC · 2016
- 2 generations backK173710 MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC · 2018 · Recalled
- 1 generation backK193452 MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC · 2020
- This deviceK223342 MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion…Crossroads Extremity Systems, LLC · 2023
- Descendant · cites it directly · 1 of its ownK230591 TriLEAP Plating SystemCrossroads Extremity Systems · 2023
- Descendant · 2 generations on · 0 of its ownK253178 TRILEAP Plating SystemCrossroads Extremity Systems · 2026
Show all 11 generations
- Root · 11 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 10 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 9 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 8 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 7 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 6 generations backK123562 Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation · 2013 · Recalled
- 5 generations backK131657 Flower Small and Medium Implant SetFlower Orthopedics Corporation · 2013 · Recalled
- 4 generations backK152306 MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC · 2015
- 3 generations backK160300 MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC · 2016
- 2 generations backK173710 MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC · 2018 · Recalled
- 1 generation backK193452 MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC · 2020
- This deviceK223342 MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion…Crossroads Extremity Systems, LLC · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −10 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −9 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −8 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −7 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −6 | K123562 | Flower Small and Medium Bone Implants | Flower Orthopedics Corporation | 2013 | 2 |
| −5 | K131657 | Flower Small and Medium Implant Set | Flower Orthopedics Corporation | 2013 | 1 |
| −4 | K152306 | MotoBand¿ CP Implant System | Crossroads Extremity Systems, LLC | 2015 | — |
| −3 | K160300 | MotoBand (TM) CP Implant System | Crossroads Extremity Systems, LLC | 2016 | — |
| −2 | K173710 | MotoBAND CP Implant System | Crossroads Extremity Systems, LLC | 2018 | 1 |
| −1 | K193452 | MotoBAND CP Implant System | Crossroads Extemity Systems, LLC | 2020 | — |
| 0 (this device) | K223342 | MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System… | Crossroads Extremity Systems, LLC | 2023 | — |
| +1 | K230591 | TriLEAP Plating System | Crossroads Extremity Systems | 2023 | — |
| +2 | 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 | 1 | 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 |
|---|---|---|---|
| * | K193452 | MotoBAND CP Implant SystemSummary page 3…union System and DynaMet™ Lesser TMT Fusion plates are compatible with fracture fixation staples from the MotoCLIP™/HiMAX™ Implant System cleared in K142727, K181410 and K193452. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) O… | 2020 |
| * | K173710 | MotoBAND CP Implant SystemSummary page 5…Predicate Devices: Primary Predicate: K193452 MotoBAND CP Implant System Additional Predicate: K173710 MotoBAND CP Implant System Device Description: The subject devices branded as DynaBunion and DynaMet… | 2018 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230591 | TriLEAP Plating System | 2023 | 1 |
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 27 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 19 of the 72 ancestors have a recall of any class.
- Of its descendants, K230591 (Crossroads Extremity Systems, 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 includes DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion System, which include plates and screws 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. DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion plates are compatible with fracture fixation staples from the MotoCLIP™/HiMAX™ Implant System cleared in K142727, K181410 and K193452.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223342: MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223342
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