510(k) · Cleared
ClearedFootmotion Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Newclip Technics · HRS Plate, Fixation, Bone
Cleared on Oct 31, 2016 as substantially equivalent to K083447 (Memometal Technologies, 2009) and 2 other predicates after a 159-day review. Its family tree reaches back 10 generations to 1996. 5 later devices descend from it.
- Decided
- Oct 31, 2016
- Review
- 159 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K954385 (1996). 52 ancestors in all, the oldest K895117 (1990). 5 later devices descend from it, 4 citing it directly.
- Root · 10 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 2 generations backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- 1 generation backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- This deviceK161448 Footmotion Plating SystemNewclip Technics · 2016
- Descendant · cites it directly · 1 of its ownK171510 Footmotion Plating SystemNewclip Technics · 2017
- Descendant · cites it directly · 1 of its ownK170843 Alians Fragment SpecificNewclip Technics · 2017
- Descendant · cites it directly · 0 of its ownK221395 Footmotion Plating SystemNewclip Technics · 2022
- Descendant · 2 generations on · 0 of its ownK213214 Xpert WristNewclip Technics · 2021
- Descendant · cites it directly · 0 of its ownK170012 Foot and Hand MotionNewclip Technics · 2017
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 backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 4 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 3 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 2 generations backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- 1 generation backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- This deviceK161448 Footmotion Plating SystemNewclip Technics · 2016
Most influential descendants
Showing 5 of 5 · See all- K171510Footmotion Plating SystemNewclip Technics · 2017 · cites it directly1descendant
- K170843Alians Fragment SpecificNewclip Technics · 2017 · cites it directly1descendant
- K221395Footmotion Plating SystemNewclip Technics · 2022 · cites it directly0descendants
- K213214Xpert WristNewclip Technics · 2021 · 2 generations on0descendants
- K170012Foot and Hand MotionNewclip Technics · 2017 · cites it directly0descendants
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 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −4 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −3 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −2 | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | Wrightmedicaltechnologyinc | 2012 | 12 |
| −1 | K121651 | Ortholoc 3DI Midfoot/Flatfoot System | Wrightmedicaltechnologyinc | 2012 | — |
| 0 (this device) | K161448 | Footmotion Plating System | Newclip Technics | 2016 | — |
| +1 | K171510 | Footmotion Plating System | Newclip Technics | 2017 | — |
| +1 | K170843 | Alians Fragment Specific | Newclip Technics | 2017 | — |
| +1 | K221395 | Footmotion Plating System | Newclip Technics | 2022 | — |
| +2 | K213214 | Xpert Wrist | Newclip Technics | 2021 | — |
| +1 | K170012 | Foot and Hand Motion | Newclip Technics | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083447 | Memometal Anchorage Bone Plate System, Models PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50Summary page 5…K161448 - Page 2 of 3 3. Primary predicate or legally marketed devices which are substantially equivalent: ● The Anchorage® Bone Plate System of Memometal (K083447), 4. Secondary predicate or legally marketed devices which are substantially equivalent: ● The Ortholoc® 3Di Midfoot/Flatf… | 2009 |
| * | K121651 | Ortholoc 3DI Midfoot/Flatfoot SystemSummary page 5…Secondary predicate or legally marketed devices which are substantially equivalent: ● The Ortholoc® 3Di Midfoot/Flatfoot System of Wright Medical Technology (K121651), ● The Plantar Lapidus Plate System 2.7/3.5 of Normed (K152256). 5. Description of the device: The Footmotion Plati… | 2012 |
| * | K152256 | RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and ScrewsSummary page 5…antially equivalent: ● The Ortholoc® 3Di Midfoot/Flatfoot System of Wright Medical Technology (K121651), ● The Plantar Lapidus Plate System 2.7/3.5 of Normed (K152256). 5. Description of the device: The Footmotion Plating System consists of a plat… | 2015 |
What descends from it? (5)
4 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?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 12 of the 52 ancestors have a recall of any class.
- Of its descendants, K171510 (Newclip Technics, 2017) has gone furthest, with 1 descendant of its own.
- 9 other devices also cite its predicate K083447.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Footmotion Plating System is intended for arthrodeses, fractures and osteotomies fixation and revision surgeries of the foot in adults.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161448: Footmotion Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161448
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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