510(k) Report

510(k) · Cleared

Cleared

Clavicle Plating System

K090289510(k) TraditionalCleared Jun 15, 2009130-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

Orthohelix Surgical Designs, Inc. · HRS Plate, Fixation, Bone

Cleared on Jun 15, 2009 after a 130-day review. The FDA summary names no predicate by number. 340 later devices descend from it.

Decided
Jun 15, 2009
Review
130 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
0

340 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2010: 3 descendants cleared2012: 14 descendants cleared2011: 2 descendants cleared2014: 13 descendants cleared2017: 29 descendants cleared2016: 13 descendants cleared2015: 24 descendants cleared2019: 19 descendants cleared2023: 28 descendants cleared2021: 24 descendants cleared2024: 39 descendants cleared2018: 15 descendants cleared2013: 5 descendants cleared2020: 27 descendants cleared2022: 24 descendants cleared2025: 24 descendants cleared2026: 37 descendants cleared20052010201520202025
  1. This deviceK090289 Clavicle Plating SystemOrthohelix Surgical Designs, Inc. · 2009
  2. Descendant · cites it directly · 339 of its ownK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
  3. Descendant · 2 generations on · 228 of its ownK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  4. Descendant · 2 generations on · 119 of its ownK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
  5. Descendant · 3 generations on · 118 of its ownK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
  6. Descendant · 2 generations on · 97 of its ownK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled

Showing 5 of 340 descendants. See all descendants

Descendants cleared per year

2010: 32011: 22012: 142013: 52014: 132015: 242016: 132017: 292018: 152019: 192020: 272021: 242022: 242023: 282024: 392025: 242026: 37
2010high 39 (2024) · low 2 (2011)2026

Most influential descendants

Showing 5 of 340 · See all
  • K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc. · 2010 · cites it directly339descendants
  • K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010 · 2 generations on228descendants
  • K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc. · 2010 · 2 generations on119descendants
  • K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011 · 3 generations on118descendants
  • K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · 2 generations on97descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K090289Clavicle Plating SystemOrthohelix Surgical Designs, Inc.2009—
+1K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc.2010—
+2K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010—
+2K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc.20101
+3K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011—
+2K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc201212

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201030
201120
2012140
201350
2014130
2015240
2016130
2017290
2018150
2019190
2020270
2021240
2022240
2023280
2024390
2025240
2026370
FIG. 1 — Lineage of K090289, 2009–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (340)

See all 340

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

NumberDeviceApplicantDecidedDescendants
K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc.2010339
K113048Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201252

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?

  • Of its descendants, K100618 (Orthohelix Surgical Designs, Inc., 2010) has gone furthest, with 339 descendants of its own.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 OrthoHelix Clavicle Plating System Plates are indicated for fixation of fractures, fusions and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle.

Indications for use as stated in the FDA summary.

More from Orthohelix Surgical Designs, Inc.

25 FDA decisions under this applicant name. See the company

  • K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc. · 2014
  • K142148Orthohelix Staple SystemOrthohelix Surgical Designs, Inc. · 2014
  • K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc. · 2014
  • K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc. · 2014
  • K132591Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013

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/K090289 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090289: Clavicle 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/K090289

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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