510(k) Report

510(k) · Cleared

Cleared

Distal Radius Locking Plating System

K061917510(k) TraditionalCleared Aug 28, 200653-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 Aug 28, 2006 as substantially equivalent to K030198 (Hand Innovations, Inc., 2003) and 2 other predicates after a 53-day review. Its family tree reaches back 4 generations to 1996. 6 later devices descend from it.

Decided
Aug 28, 2006
Review
53 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K962616 (1996). 8 ancestors in all, the oldest K955472 (1996). 6 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1996: 2 other ancestors2000: 1 other ancestor2014: 1 descendant cleared2013: 1 descendant cleared2017: 1 descendant cleared2021: 2 descendants cleared2026: 1 descendant clearedK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×2: 2 generations cleared close together, K023007 (2002), K030198 (2003) 1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors3 generations back: 1 other ancestor4 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants K030198 · 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) · 19960
  1. Root · 4 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 3 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 2 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 1 generation backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. This deviceK061917 Distal Radius Locking Plating SystemNewclip Technics · 2006
  6. Descendant · cites it directly · 5 of its ownK130774 Universal Distal Radius SystemNewclip Technics · 2013
  7. Descendant · cites it directly · 2 of its ownK142502 Alians Ulna Locking Plating SystemNewclip Technics · 2014
  8. Descendant · 2 generations on · 1 of its ownK211592 Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc. · 2021
  9. Descendant · 2 generations on · 1 of its ownK170843 Alians Fragment SpecificNewclip Technics · 2017
  10. Descendant · 3 generations on · 0 of its ownK261145 Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC · 2026

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2013: 12014: 12017: 12021: 22026: 1
2013high 2 (2021) · low 0 (2015)2026

Most influential descendants

Showing 5 of 6 · See all
  • K130774Universal Distal Radius SystemNewclip Technics · 2013 · cites it directly5descendants
  • K142502Alians Ulna Locking Plating SystemNewclip Technics · 2014 · cites it directly2descendants
  • K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc. · 2021 · 2 generations on1descendant
  • K170843Alians Fragment SpecificNewclip Technics · 2017 · 2 generations on1descendant
  • K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−3K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−2K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−1K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
0 (this device)K061917Distal Radius Locking Plating SystemNewclip Technics2006—
+1K130774Universal Distal Radius SystemNewclip Technics2013—
+1K142502Alians Ulna Locking Plating SystemNewclip Technics2014—
+2K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.2021—
+2K170843Alians Fragment SpecificNewclip Technics2017—
+3K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
200010
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201410
201710
202120
202610
FIG. 1 — Lineage of K061917, 1996–2026Source: 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
*K030198Hand Innovations, Inc. Distal Radius Fracture Repair System
Summary page 2
…tended for the fixation of intra and extra-articular fractures as well as distal radius osteotomy. K. Predicate device: e Volar Radius Plate System of HAND INNOVATIONS (K030198) ¢ Synthes Locking Distal Radius Plating System of SYNTHES (K012114) e Ace Humerus and Radius Plates of ACE MEDICAL COMPANY (K955…
Hand Innovations, Inc.2003—
*K012114Synthes Locking Distal Radius Plating System
Summary page 2
…ll as distal radius osteotomy. K. Predicate device: e Volar Radius Plate System of HAND INNOVATIONS (K030198) ¢ Synthes Locking Distal Radius Plating System of SYNTHES (K012114) e Ace Humerus and Radius Plates of ACE MEDICAL COMPANY (K955472) Section 4 Page2/2 Sy, & & % “(C DEPARTMENT O…
Synthes (Usa)20013
*K955472Ace Humerus & Radius Plates
Summary page 2
…us Plate System of HAND INNOVATIONS (K030198) ¢ Synthes Locking Distal Radius Plating System of SYNTHES (K012114) e Ace Humerus and Radius Plates of ACE MEDICAL COMPANY (K955472) Section 4 Page2/2 Sy, & & % “(C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service B . 4, Food and…
Ace Medical Co.1996—

Also cleared against K030198: 3 other devices →

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K130774Universal Distal Radius SystemNewclip Technics20135
K142502Alians Ulna Locking Plating SystemNewclip Technics20142

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 10 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • Of its descendants, K130774 (Newclip Technics, 2013) has gone furthest, with 5 descendants of its own.
  • 3 other devices also cite its predicate K030198.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 Distal Radius Locking Plating System is intended for the fixation of intra and extra-articular fractures as well as distal radius ostecotomy.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K030198

3 other devices cite the same predicate.

  • K171808TDM Plate and Screw SystemTdm Co., Ltd. · 2018
  • K051567Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 20051 recall
  • K032705Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003

More from Newclip Technics

35 FDA decisions under this applicant name. See the company

  • K262649Alians ForearmNewclip Technics · 2026
  • K261511Xpert AnkleNewclip Technics · 2026
  • K261191Alians Elbow SNewclip Technics · 2026
  • K261038Xpert PFPNewclip Technics · 2026
  • K253906Xpert HandNewclip Technics · 2026

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K061917 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061917: Distal Radius Locking 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/K061917

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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