510(k) · Cleared
ClearedActivmotion S DTO
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 Dec 16, 2021 as substantially equivalent to K073375 (Newdeal Sas, 2008) and 1 other predicate after a 449-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Dec 16, 2021
- Review
- 449 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K000684 (2000). 23 ancestors in all, the oldest K890939 (1989). No later device cites it as a predicate yet.
- Root · 5 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 4 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 3 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 2 generations backK033639 Acumed Lower Extremity Congruent Plate SystemAcumed, LLC · 2004 · Recalled
- 1 generation backK073375 Newdeal Tibiaxys SystemNewdeal Sas · 2008 · Recalled
- This deviceK202803 Activmotion S DTONewclip Technics · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −4 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −3 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −2 | K033639 | Acumed Lower Extremity Congruent Plate System | Acumed, LLC | 2004 | 10 |
| −1 | K073375 | Newdeal Tibiaxys System | Newdeal Sas | 2008 | 2 |
| 0 (this device) | K202803 | Activmotion S DTO | Newclip Technics | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K073375 | Newdeal Tibiaxys SystemSummary page 5…K202803 3. Primary predicate or legally marketed devices which are substantially equivalent: • TIBIAXYS System by NEWDEAL (Integra Lifesciences) (K073375) Secondary predicate or legally marketed devices which are substantially equivalent: • LOQTEQ Small Fragment set by AAP I… | 2008 |
| * | K113652 | Loqteq Small Fragment Set Loqteq Cortical SCREW3.5, Small Head, T15, Self Tapping Loqteq…Summary page 5…gra Lifesciences) (K073375) Secondary predicate or legally marketed devices which are substantially equivalent: • LOQTEQ Small Fragment set by AAP IMPLANTATE AG (K113652) Reference device: • Activ ankle (K143061, K173641) of Newclip Technics. 4. Description of the device: The Activmotion… | 2012 |
| † | K143061 | Activ Ankle Locking Plating System | 2015 |
| † | K173641 | Activ Ankle | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 9 of the 23 ancestors have a recall of any class.
- 5 other devices also cite its predicate K073375.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 implants of the Activmotion S DTO range are intended for bone reconstruction of the ankle joint in adults, including fixation of fractures and osteotomies of ankle, distal tibia and fibula.
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/K202803 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202803: Activmotion S DTO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202803
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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