510(k) Report

510(k) · Cleared

Cleared

Alians Ulna Locking Plating System

K142502510(k) TraditionalCleared Dec 23, 2014109-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 Dec 23, 2014 as substantially equivalent to K011335 (Synthes (Usa), 2001) and 3 other predicates after a 109-day review. Its family tree reaches back 10 generations to 1996. 2 later devices descend from it.

Decided
Dec 23, 2014
Review
109 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
4

Its longest line of descent runs back 10 generations to K962616 (1996). 41 ancestors in all, the oldest K890939 (1989). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2001: 5 other ancestors2011: 1 other ancestor2010: 1 other ancestor2009: 1 other ancestor2007: 2 other ancestors2005: 1 other ancestor2000: 5 other ancestors1996: 2 other ancestors2003: 2 other ancestors1995: 1 other ancestor1991: 1 other ancestor1989: 1 other ancestor2004: 3 other ancestors1999: 2 other ancestors1998: 2 other ancestors2021: 1 descendant 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) K032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 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. · 2006K100944 · Clavicle Locking Plate System · Newclip Technics · 2010K130774 · Universal Distal Radius System · Newclip Technics · 20131990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 9 other ancestors3 generations back: 8 other ancestors4 generations back: 9 other ancestors5 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K130774 · Universal Distal Radius System · Newclip Technics · 2013K100944 · Clavicle Locking Plate System · Newclip Technics · 2010K061352 · 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 · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 6 generations between
  3. 3 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
  4. 2 generations backK100944 Clavicle Locking Plate SystemNewclip Technics · 2010
  5. 1 generation backK130774 Universal Distal Radius SystemNewclip Technics · 2013
  6. This deviceK142502 Alians Ulna Locking Plating SystemNewclip Technics · 2014
  7. Descendant · cites it directly · 1 of its ownK211592 Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc. · 2021
  8. Descendant · 2 generations on · 0 of its ownK261145 Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC · 2026
Show all 10 generations
  1. Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 9 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 8 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 7 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 6 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 5 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 4 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 3 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
  9. 2 generations backK100944 Clavicle Locking Plate SystemNewclip Technics · 2010
  10. 1 generation backK130774 Universal Distal Radius SystemNewclip Technics · 2013
  11. This deviceK142502 Alians Ulna Locking Plating SystemNewclip Technics · 2014

Most influential descendants

Showing 2 of 2 · See all
  • K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc. · 2021 · cites it directly1descendant
  • K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−9K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−8K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−7K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−6K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−5K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−4K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−3K061352Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc.2006—
−2K100944Clavicle Locking Plate SystemNewclip Technics2010—
−1K130774Universal Distal Radius SystemNewclip Technics2013—
0 (this device)K142502Alians Ulna Locking Plating SystemNewclip Technics2014—
+1K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.2021—
+2K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199110
199510
199620
199820
199920
200050
200150
200320
200430
200510
200610
200720
200910
201010
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
202610
FIG. 1 — Lineage of K142502, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (4)

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
*K011335Synths One-Third Tubular DCL Plate
Summary page 5
…Page 2 of 3 3. Predicate or legally marketed devices which are substantially equivalent:  The Synthes One-Third Tubular DCL Plate (K011335).  Newclip Radius Plates (K061917)  Newclip Clavicle Plate System (K100944)  Newclip Distal Radius Plate (K130774) 4.…
Synthes (Usa)20012
*K061917Distal Radius Locking Plating System
Summary page 5
…2 of 3 3. Predicate or legally marketed devices which are substantially equivalent:  The Synthes One-Third Tubular DCL Plate (K011335).  Newclip Radius Plates (K061917)  Newclip Clavicle Plate System (K100944)  Newclip Distal Radius Plate (K130774) 4. Description of the device: The…
Newclip Technics2006—
*K100944Clavicle Locking Plate System
Summary page 5
…evices which are substantially equivalent:  The Synthes One-Third Tubular DCL Plate (K011335).  Newclip Radius Plates (K061917)  Newclip Clavicle Plate System (K100944)  Newclip Distal Radius Plate (K130774) 4. Description of the device: The Alians Ulna Locking Plating system…
Newclip Technics2010—
*K130774Universal Distal Radius System
Summary page 5
… The Synthes One-Third Tubular DCL Plate (K011335).  Newclip Radius Plates (K061917)  Newclip Clavicle Plate System (K100944)  Newclip Distal Radius Plate (K130774) 4. Description of the device: The Alians Ulna Locking Plating system consists of a…
Newclip Technics2013—

Also cleared against K011335: 42 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211

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 18 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
  • 11 of the 41 ancestors have a recall of any class.
  • Of its descendants, K211592 (Avanti Orthopaedics, Inc., 2021) has gone furthest, with 1 descendant of its own.
  • 42 other devices also cite its predicate K011335.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Alians Ulna Locking Plating System is intended for ulnar shortening osteotomy.

Indications for use as stated in the FDA summary.

Also cleared against K011335

42 other devices cite the same predicate.

  • K262649Alians ForearmNewclip Technics · 2026
  • K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemSynthes GmbH · 2026
  • K242988Genostis Osteosynthesis SystemGenostis AF · 2025
  • K243469SignexOsteonic Co., Ltd. · 2025
  • K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2024
  • K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating SystemDePuy Synthes · 2024

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/K142502 · printed Nov 5, 2026

Cite this page

510(k) Report. “K142502: Alians Ulna Locking Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142502

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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