510(k) Report

510(k) · Cleared

Cleared

Clavicle and Scapula System

K240181510(k) TraditionalCleared Oct 9, 2024260-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

Auxein Medical Pvt., Ltd. · HRS Plate, Fixation, Bone

Cleared on Oct 9, 2024 as substantially equivalent to K051083 (Acumed, LLC, 2005) and 6 other predicates after a 260-day review. Its family tree reaches back 5 generations to 2000.

Decided
Oct 9, 2024
Review
260 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
7

Its longest line of descent runs back 5 generations to K000684 (2000). 31 ancestors in all, the oldest K890939 (1989). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2023: 1 other ancestor2022: 1 other ancestor2007: 1 other ancestor2006: 1 other ancestor2005: 1 other ancestor2001: 5 other ancestors2020: 1 other ancestor2008: 2 other ancestors2000: 4 other ancestors1995: 1 other ancestor1991: 1 other ancestor1989: 1 other ancestor2004: 1 other ancestor2003: 1 other ancestor1999: 2 other ancestors1998: 2 other ancestorsK000684 · Small Fragment Dynamic Compression Locking (DCL) System · Synthes (Usa) · 2000 · recalledK101536 · 2.7/3.5MM VA-LCP Anteriro Clavicle Plate System · Synthes (Usa), LLC · 2010K111540 · Synthes 3.5MM LCP Clavicle Plate System · Synthes (Usa) · 2011×2: 2 generations cleared close together, K201321 (2020), K203414 (2020) 1990200020102020
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 10 other ancestors3 generations back: 4 other ancestors4 generations back: 3 other ancestors5 generations back: 3 other ancestors K203414 · DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System · DePuy Synthes · 2020K201321 · DePuy Synthes 2.7mm VA LCP Clavicle Plate System · DePuy Synthes · 2020 · recalledK111540 · Synthes 3.5MM LCP Clavicle Plate System · Synthes (Usa) · 2011K101536 · 2.7/3.5MM VA-LCP Anteriro Clavicle Plate System · Synthes (Usa), LLC · 2010K000684 · Small Fragment Dynamic Compression Locking (DCL) System · Synthes (Usa) · 2000 · recalled−50
  1. Root · 5 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
  2. 4 generations backK101536 2.7/3.5MM VA-LCP Anteriro Clavicle Plate SystemSynthes (Usa), LLC · 2010
  3. 3 generations backK111540 Synthes 3.5MM LCP Clavicle Plate SystemSynthes (Usa) · 2011
  4. 2 generations backK201321 DePuy Synthes 2.7mm VA LCP Clavicle Plate SystemDePuy Synthes · 2020 · Recalled
  5. 1 generation backK203414 DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes…DePuy Synthes · 2020
  6. This deviceK240181 Clavicle and Scapula SystemAuxein Medical Pvt., Ltd. · 2024
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K000684Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa)20001
−4K1015362.7/3.5MM VA-LCP Anteriro Clavicle Plate SystemSynthes (Usa), LLC2010—
−3K111540Synthes 3.5MM LCP Clavicle Plate SystemSynthes (Usa)2011—
−2K201321DePuy Synthes 2.7mm VA LCP Clavicle Plate SystemDePuy Synthes20201
−1K203414DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP…DePuy Synthes2020—
0 (this device)K240181Clavicle and Scapula SystemAuxein Medical Pvt., Ltd.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199110
199510
199820
199920
200040
200150
200310
200410
200510
200610
200710
200820
202010
202210
202310
FIG. 1 — Lineage of K240181, 2000–2024Source: 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? (7)

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
*K051083Acumed Scapula Congruent Bone Plate System
Summary page 5
…Fixation, Bone 888.3030 (primary), 888.3040 HRS (primary), HWC 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K051083 Acumed Scapula Congruent Bone Plate System HRS K061753 Synthes (USA) Clavicle Hook Plate HRS K073186 SYNTHES 3.5mm LCP Clavicle P…
Acumed, LLC2005—
*K061753Synthes (Usa) Clavicle Hook Plates
Summary page 5
…mary), HWC 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K051083 Acumed Scapula Congruent Bone Plate System HRS K061753 Synthes (USA) Clavicle Hook Plate HRS K073186 SYNTHES 3.5mm LCP Clavicle Plate System HRS K012655 Acumed Congruent Bone Plate Sys…
Synthes (Usa)2006—
*K073186Synthes 3.5MM LCP Clavicle Plate System
Summary page 5
…redicate Trade Name (Primary Predicate is listed first) Product Code K051083 Acumed Scapula Congruent Bone Plate System HRS K061753 Synthes (USA) Clavicle Hook Plate HRS K073186 SYNTHES 3.5mm LCP Clavicle Plate System HRS K012655 Acumed Congruent Bone Plate System HRS K203414 DePuy Synthes 2.7mm VA LCP Cla…
Synthes (Usa)2007—
*K012655Congruent Bone Plate System
Summary page 5
…st) Product Code K051083 Acumed Scapula Congruent Bone Plate System HRS K061753 Synthes (USA) Clavicle Hook Plate HRS K073186 SYNTHES 3.5mm LCP Clavicle Plate System HRS K012655 Acumed Congruent Bone Plate System HRS K203414 DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy §| | HRS K213059 Tibia and…
Acu Med, Inc.200116
*K203414DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle…
Summary page 5
…nt Bone Plate System HRS K061753 Synthes (USA) Clavicle Hook Plate HRS K073186 SYNTHES 3.5mm LCP Clavicle Plate System HRS K012655 Acumed Congruent Bone Plate System HRS K203414 DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy §| | HRS K213059 Tibia and Fibula System HRS K213108 Humerus & Ulna Syste…
DePuy Synthes2020—
*K213059Tibia and Fibula System
Summary page 5
…73186 SYNTHES 3.5mm LCP Clavicle Plate System HRS K012655 Acumed Congruent Bone Plate System HRS K203414 DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy §| | HRS K213059 Tibia and Fibula System HRS K213108 Humerus & Ulna System HRS Device Description Summary 21 CFR 807.92(a)(4) Clavicle and Scap…
Auxein Medical Private Limited2023—
*K213108Humerus & Ulna System
Summary page 5
…te System HRS K012655 Acumed Congruent Bone Plate System HRS K203414 DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy §| | HRS K213059 Tibia and Fibula System HRS K213108 Humerus & Ulna System HRS Device Description Summary 21 CFR 807.92(a)(4) Clavicle and Scapula System consists various types of…
Auxein Medical Private Limited2022—

Also cleared against K051083: 1 other device →

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 24 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
  • 8 of the 31 ancestors have a recall of any class.
  • 1 other device also cites its predicate K051083.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?

3.5mm Wise-Lock Scapula Medial Border Plate

Indicated to provide fixation during fractures, fusions, and osteotomies for the Scapula.

3.5mm Wise-Lock Clavicle Hook Plate

Indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

2.7/ 3.5mm Wise-Lock Superior Anterior Clavicle Plate with Lateral Extension

Indicated for fixation of fractures, malunions, non-unions, and osteotomies for the clavicle.

3.5mm Wise-Lock S Clavicle Plate

Indicated to provide fixation for fractures, fusion, or osteotomies for the clavicle.

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 K051083

1 other device cites the same predicate.

  • K243275Equinoxe® Scapula Fracture SystemExactech, Inc. · 2025

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/K240181 · printed Nov 6, 2026

Cite this page

510(k) Report. “K240181: Clavicle and Scapula System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240181

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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