510(k) Report

510(k) · Cleared

Cleared

Activmotion Range

K173746510(k) TraditionalCleared Feb 27, 201881-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Newclip Technics · HRS Plate, Fixation, Bone

Cleared on Feb 27, 2018 as substantially equivalent to K141796 (Synthes (USA) Products, LLC, 2014) and 2 other predicates after an 81-day review. Its family tree reaches back 13 generations to 1996. 1 later device descends from it.

Decided
Feb 27, 2018
Review
81 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
3

Its longest line of descent runs back 13 generations to K962616 (1996). 239 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2015: 3 other ancestors2014: 4 other ancestors2016: 1 other ancestor2011: 5 other ancestors2010: 7 other ancestors2009: 9 other ancestors2008: 9 other ancestors2007: 7 other ancestors2006: 13 other ancestors2004: 20 other ancestors2003: 14 other ancestors2001: 19 other ancestors2000: 13 other ancestors1995: 12 other ancestors2012: 1 other ancestor2005: 13 other ancestors2002: 10 other ancestors1999: 10 other ancestors1998: 10 other ancestors1996: 18 other ancestors1997: 9 other ancestors1991: 2 other ancestors1989: 2 other ancestors1994: 4 other ancestors1990: 4 other ancestors1988: 1 other ancestor1982: 1 other ancestor1993: 3 other ancestors1992: 1 other ancestor1979: 1 other ancestor2024: 1 descendant clearedReference device: K152289 · Alians Elbow Locking Plating System · Newclip Technics · 2016K962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×3: 3 generations cleared close together, K023007 (2002), K030198 (2003), K032705 (2003) ×2: 2 generations cleared close together, K050932 (2005), K051735 (2005) K061352 · Peri-Loc Periarticular Locked Plating System for the Upper Extremity · Smith & Nephew, Inc. · 2006×2: 2 generations cleared close together, K082516 (2008), K083032 (2009) K123055 · Smith & Nephew, Inc Screw and Plate System Instrumentation · Smith & Nephew, Inc. · 2013K140814 · Evos Mini-Fragment Plating System · Smith & Nephew, Inc. · 2014 · recalledK163361 · ANTHEM™ Fracture System · Globus Medical, Inc. · 201719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 28 other ancestors3 generations back: 50 other ancestors4 generations back: 61 other ancestors5 generations back: 41 other ancestors6 generations back: 29 other ancestors7 generations back: 12 other ancestors8 generations back: 3 other ancestors 1 generation forward: 1 descendant K163361 · ANTHEM™ Fracture System · Globus Medical, Inc. · 2017K140814 · Evos Mini-Fragment Plating System · Smith & Nephew, Inc. · 2014 · recalledK123055 · Smith & Nephew, Inc Screw and Plate System Instrumentation · Smith & Nephew, Inc. · 2013K083032 · Peri-Loc Bone Plating and Screw System · Smith & Nephew, Inc. · 2009 · recalledK082516 · Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws · Smith & Nephew, Inc. · 2008K061352 · Peri-Loc Periarticular Locked Plating System for the Upper Extremity · Smith & Nephew, Inc. · 2006K051735 · Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity · Smith & Nephew, Inc. · 2005K050932 · Distal Volar Radius Anatomical Plate System · Hand Innovations, Inc. · 2005 · recalledK032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K030198 · Hand Innovations, Inc. Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K023007 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2002K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998K962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996−10−50
  1. Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 9 generations between
  3. 3 generations backK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
  4. 2 generations backK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
  5. 1 generation backK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
  6. This deviceK173746 Activmotion RangeNewclip Technics · 2018
  7. Descendant · cites it directly · 0 of its ownK241539 Activmotion SNewclip Technics · 2024
Show all 13 generations
  1. Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 12 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 11 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 10 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 9 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 8 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 7 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 6 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
  9. 5 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
  10. 4 generations backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
  11. 3 generations backK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
  12. 2 generations backK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
  13. 1 generation backK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
  14. This deviceK173746 Activmotion RangeNewclip Technics · 2018

Most influential descendants

Showing 1 of 1 · See all
  • K241539Activmotion SNewclip Technics · 2024 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−12K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−11K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−10K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−9K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−8K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−7K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−6K061352Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc.2006—
−5K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc.2008—
−4K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.20092
−3K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.2013—
−2K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.20142
−1K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.2017—
0 (this device)K173746Activmotion RangeNewclip Technics2018—
+1K241539Activmotion SNewclip Technics2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198210
198810
198920
199040
199120
199210
199330
199440
1995120
1996180
199790
1998100
1999100
2000130
2001190
2002100
2003140
2004200
2005130
2006130
200770
200890
200990
201070
201150
201210
201440
201530
201610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
FIG. 1 — Lineage of K173746, 1996–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K141796Depuy Synthes Tomofix Osteotomy System
Summary page 4
…888.3040) 3. Primary predicate or legally marketed devices which are substantially equivalent: • Depuy Synthes Tomofix Osteotomy System of Synthes (K141796) Secondary predicate or legally marketed devices which are substantially equivalent: • High Tibial Osteotom…
Synthes (USA) Products, LLC2014—
*K141548High Tibial Osteotomy System
Summary page 4
…s (K141796) Secondary predicate or legally marketed devices which are substantially equivalent: • High Tibial Osteotomy System of Newclip Technics (K141548) • Anthem™ Fracture System of Globus Medical Inc (K163361)…
Newclip Technics2015—
*K163361ANTHEM™ Fracture System
Summary page 4
…s which are substantially equivalent: • High Tibial Osteotomy System of Newclip Technics (K141548) • Anthem™ Fracture System of Globus Medical Inc (K163361) K173746 Page 2/3 Reference predicate : • Alians Elb…
Globus Medical, Inc.2017—
†K152289Alians Elbow Locking Plating SystemNewclip Technics2016—

Also cleared against K141796: 6 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K241539Activmotion SNewclip Technics20240

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 22 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
  • 48 of the 239 ancestors have a recall of any class.
  • Of its descendants, K241539 (Newclip Technics, 2024) has gone furthest, with 0 descendants of its own.
  • 6 other devices also cite its predicate K141796.

How does its category compare?

All HRS devices

HRS Plate, 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 · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

The Activmotion range is intended for knee osteotomy in adults.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K173746: Activmotion Range.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173746

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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