510(k) · Cleared
ClearedFoot and Hand Motion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Newclip Technics · HWC Screw, Fixation, Bone
Cleared on Dec 16, 2009 after a 243-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 31 later devices descend from it.
- Decided
- Dec 16, 2009
- Review
- 243 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 4 citing it directly.
- This deviceK091118 Foot and Hand Motion SystemNewclip Technics · 2009
- Descendant · cites it directly · 24 of its ownK121277 Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire…Z-Medical GmbH & Co. KG · 2012
- Descendant · 2 generations on · 15 of its ownK131061 Restore Bunion Correction SystemNextremity Solutions · 2013
- Descendant · 3 generations on · 8 of its ownK170214 Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC · 2017
- Descendant · 2 generations on · 6 of its ownK222645 Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts · 2022
- Descendant · 4 generations on · 5 of its ownK183011 Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics · 2019
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K121277Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-StapleZ-Medical GmbH & Co. KG · 2012 · cites it directly24descendants
- K131061Restore Bunion Correction SystemNextremity Solutions · 2013 · 2 generations on15descendants
- K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC · 2017 · 3 generations on8descendants
- K222645Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts · 2022 · 2 generations on6descendants
- K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics · 2019 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091118 | Foot and Hand Motion System | Newclip Technics | 2009 | — |
| +1 | K121277 | Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-Staple | Z-Medical GmbH & Co. KG | 2012 | — |
| +2 | K131061 | Restore Bunion Correction System | Nextremity Solutions | 2013 | — |
| +3 | K170214 | Additive Orthopaedics Locking Lattice Plate | Additive Orthopaedics, LLC | 2017 | — |
| +2 | K222645 | Treace Medical Concepts (TMC) Implant Fixation System | Treace Medical Concepts | 2022 | — |
| +4 | K183011 | Additive Orthopaedics Patient Specific 3D Locking Lattice Plates | Additive Orthopaedics | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2015 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (31)
See all 314 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K121277 (Z-Medical GmbH & Co. KG, 2012) has gone furthest, with 24 descendants of its own.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 implants of the Foot and Hand Motion System are indicated for the fixation of
bone fractures and for bone reconstruction in the hand and forefoot surgery.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K091118 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091118: Foot and Hand Motion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091118
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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