510(k) Report

510(k) · Cleared

Recalled · Class II · 2022

Ortholoc 2.0/2.4 Plate System

K090692510(k) TraditionalCleared May 8, 200953-day reviewClass II21 CFR 888.3030Recalls 1

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

Wrightmedicaltechnologyinc · HRS Plate, Fixation, Bone

Cleared on May 8, 2009 after a 53-day review. The FDA summary names no predicate by number. 170 later devices descend from it. It has been recalled once.

Decided
May 8, 2009
Review
53 days
Class
Class II
Product code
HRS
Recalls
1
Predicates
0

170 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2021: 13 descendants cleared2023: 15 descendants cleared2014: 6 descendants cleared2017: 15 descendants cleared2019: 13 descendants cleared2018: 9 descendants cleared2011: 2 descendants cleared2015: 5 descendants cleared2013: 3 descendants cleared2020: 17 descendants cleared2026: 25 descendants cleared2012: 1 descendant cleared2016: 2 descendants cleared2022: 11 descendants cleared2025: 14 descendants cleared2024: 19 descendants cleared20052010201520202025
  1. This deviceK090692 Ortholoc 2.0/2.4 Plate SystemWrightmedicaltechnologyinc · 2009
  2. Descendant · cites it directly · 135 of its ownK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
  3. Descendant · 2 generations on · 91 of its ownK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
  4. Descendant · 2 generations on · 71 of its ownK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
  5. Descendant · 3 generations on · 38 of its ownK141735 Arthrex Ankle Fusion Plating SystemArthrex, Inc. · 2014 · Recalled
  6. Descendant · 2 generations on · 31 of its ownK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014

Showing 5 of 170 descendants. See all descendants

Descendants cleared per year

2011: 22012: 12013: 32014: 62015: 52016: 22017: 152018: 92019: 132020: 172021: 132022: 112023: 152024: 192025: 142026: 25
2011high 25 (2026) · low 1 (2012)2026

Most influential descendants

Showing 5 of 170 · See all
  • K111253Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011 · cites it directly135descendants
  • K112437Arthrex Fracture SystemArthrex, Inc. · 2011 · 2 generations on91descendants
  • K123241Arthrex Fracture PlatesArthrex, Inc. · 2013 · 2 generations on71descendants
  • K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc. · 2014 · 3 generations on38descendants
  • K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014 · 2 generations on31descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K090692Ortholoc 2.0/2.4 Plate SystemWrightmedicaltechnologyinc2009—
+1K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011—
+2K112437Arthrex Fracture SystemArthrex, Inc.2011—
+2K123241Arthrex Fracture PlatesArthrex, Inc.2013—
+3K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.20141
+2K140397Paralock Plating System / Tuffnek ScrewParagon 282014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201210
201330
201460
201550
201620
2017150
201890
2019130
2020170
2021130
2022110
2023150
2024190
2025140
2026250
FIG. 1 — Lineage of K090692, 2009–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (170)

See all 170

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

NumberDeviceApplicantDecidedDescendants
K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011135
K162674BioPro Foot Plating SystemsBiopro, Inc.201719
K163039ORTHOLOC® 3Di Small Bones PlatingWrightmedicaltechnologyinc201715
K143717Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201512
K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc.20182
K140876View Plating System,Reduce Fracture Plating System,Bone ScrewIcon Orthopedic Concepts, LLC Dba Edge Orthopaedic20142
K221150Advanced Bone PlateDouble Medical Technology, Inc.20231
K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc20210
K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190
K170771VariAx 2 Foot SystemStryker GmbH20170

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 15, 2022Class IIZ-0786-2022Process controlAn incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K111253 (Arthrex, Inc., 2011) has gone furthest, with 135 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 ORTHOLOC® 2.0 / 2.4 Plate System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system can be used in both adult and pediatric patients. Examples include:

Metatarsal or metacarpal fractures and osteotomies

Phalanges fractures and osteotomies

Indications for use as stated in the FDA summary.

More from Wrightmedicaltechnologyinc

311 FDA decisions under this applicant name. See the company

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  • K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2022
  • K212996Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyinc · 2021
  • K202815PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2021
  • K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc · 2021

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/K090692 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090692: Ortholoc 2.0/2.4 Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090692

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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