510(k) Report

510(k) · Cleared

Cleared

Ortholoc 3DI Ankle Fusion Plating System

K121425510(k) TraditionalCleared Oct 1, 2012140-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

Wrightmedicaltechnologyinc · HRS Plate, Fixation, Bone

Cleared on Oct 1, 2012 as substantially equivalent to K110670 (Smith & Nephew, Inc., 2011) and 6 other predicates after a 140-day review. Its family tree reaches back 11 generations to 2001. 53 later devices descend from it.

Decided
Oct 1, 2012
Review
140 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
7

Its longest line of descent runs back 11 generations to K010612 (2001). 96 ancestors in all, the oldest K792022 (1979). 53 later devices descend from it, 10 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2010: 2 other ancestors2009: 3 other ancestors2008: 3 other ancestors2006: 7 other ancestors2007: 2 other ancestors2004: 4 other ancestors2003: 4 other ancestors2002: 10 other ancestors2001: 11 other ancestors1999: 3 other ancestors2005: 6 other ancestors2000: 9 other ancestors1998: 6 other ancestors1996: 4 other ancestors1995: 2 other ancestors1992: 1 other ancestor1991: 1 other ancestor1990: 1 other ancestor1989: 1 other ancestor1994: 1 other ancestor1993: 2 other ancestors1979: 1 other ancestor2021: 5 descendants cleared2026: 7 descendants cleared2017: 7 descendants cleared2023: 9 descendants cleared2016: 1 descendant cleared2018: 3 descendants cleared2019: 5 descendants cleared2014: 1 descendant cleared2020: 7 descendants cleared2024: 5 descendants cleared2022: 1 descendant cleared2025: 2 descendants clearedReference device: K102429 · Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw · Wrightmedicaltechnologyinc · 2010 · recalledK010612 · Vectorvision Knee · Brainlab AG · 2001K021306 · Vectorvision CT-Free Knee · Brainlab AG · 2002K040368 · Vectorvision Hip 3.0 · Brainlab AG · 2004×2: 2 generations cleared close together, K052213 (2005), K060468 (2006) K070731 · Pigalileo Total Hip Replacement (THR) System · Plus Orthopedics AG · 2007K080875 · Pigalileo 4TH Generation System · Smith & Nephew, Inc. · 2008×3: 3 generations cleared close together, K090420 (2009), K092497 (2009), K100107 (2010) K110670 · VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws, Peri-Loc Ankle Fusion Plates · Smith & Nephew, Inc. · 201119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 9 other ancestors3 generations back: 18 other ancestors4 generations back: 19 other ancestors5 generations back: 13 other ancestors6 generations back: 9 other ancestors7 generations back: 4 other ancestors8 generations back: 2 other ancestors9 generations back: 3 other ancestors10 generations back: 2 other ancestors 1 generation forward: 10 descendants2 generations forward: 10 descendants3 generations forward: 10 descendants4 generations forward: 13 descendants5 generations forward: 5 descendants6 generations forward: 3 descendants7 generations forward: 1 descendant8 generations forward: 1 descendant K110670 · VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws, Peri-Loc Ankle Fusion Plates · Smith & Nephew, Inc. · 2011K100107 · Smith & Nephew Sureshot Distal Targeting System V2.0 · Smith & Nephew, Inc. · 2010 · recalledK092497 · Smith & Nephew Pigalileo Screw Targeting System, Version 1.1 · Smith & Nephew, Inc. · 2009K090420 · Smith & Nephew Pigalileo Screw Targeting System V 1.0 · Smith & Nephew, Inc. · 2009K080875 · Pigalileo 4TH Generation System · Smith & Nephew, Inc. · 2008K070731 · Pigalileo Total Hip Replacement (THR) System · Plus Orthopedics AG · 2007K060468 · Vectorvision Hip · Brainlab AG · 2006K052213 · Navigation SW Hip 3.1 on CI · Brainlab AG · 2005K040368 · Vectorvision Hip 3.0 · Brainlab AG · 2004K021306 · Vectorvision CT-Free Knee · Brainlab AG · 2002K010612 · Vectorvision Knee · Brainlab AG · 2001−10−50+5
  1. Root · 11 generations backK010612 Vectorvision KneeBrainlab AG · 2001
  2. 7 generations between
  3. 3 generations backK092497 Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009
  4. 2 generations backK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
  5. 1 generation backK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
  6. This deviceK121425 Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012
  7. Descendant · cites it directly · 31 of its ownK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
  8. Descendant · cites it directly · 12 of its ownK163650 ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc · 2017
  9. Descendant · 2 generations on · 9 of its ownK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
  10. Descendant · 2 generations on · 9 of its ownK170693 Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc. · 2017
  11. Descendant · 3 generations on · 8 of its ownK222381 PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti…Stryker GmbH · 2023
Show all 11 generations
  1. Root · 11 generations backK010612 Vectorvision KneeBrainlab AG · 2001
  2. 10 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
  3. 9 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
  4. 8 generations backK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
  5. 7 generations backK060468 Vectorvision HipBrainlab AG · 2006
  6. 6 generations backK070731 Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007
  7. 5 generations backK080875 Pigalileo 4TH Generation SystemSmith & Nephew, Inc. · 2008
  8. 4 generations backK090420 Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009
  9. 3 generations backK092497 Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009
  10. 2 generations backK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
  11. 1 generation backK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
  12. This deviceK121425 Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012

Showing 5 of 53 descendants. See all descendants

Descendants cleared per year

2014: 12016: 12017: 72018: 32019: 52020: 72021: 52022: 12023: 92024: 52025: 22026: 7
2014high 9 (2023) · low 0 (2015)2026

Most influential descendants

Showing 5 of 53 · See all
  • K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014 · cites it directly31descendants
  • K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc · 2017 · cites it directly12descendants
  • K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020 · 2 generations on9descendants
  • K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc. · 2017 · 2 generations on9descendants
  • K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH · 2023 · 3 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K010612Vectorvision KneeBrainlab AG2001—
−10K021306Vectorvision CT-Free KneeBrainlab AG2002—
−9K040368Vectorvision Hip 3.0Brainlab AG2004—
−8K052213Navigation SW Hip 3.1 on CIBrainlab AG2005—
−7K060468Vectorvision HipBrainlab AG2006—
−6K070731Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG2007—
−5K080875Pigalileo 4TH Generation SystemSmith & Nephew, Inc.2008—
−4K090420Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc.2009—
−3K092497Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc.2009—
−2K100107Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc.20101
−1K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone…Smith & Nephew, Inc.2011—
0 (this device)K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc2012—
+1K140397Paralock Plating System / Tuffnek ScrewParagon 282014—
+1K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc2017—
+2K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH2020—
+2K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.2017—
+3K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker…Stryker GmbH2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198910
199010
199110
199210
199320
199410
199520
199640
199860
199930
200090
2001110
2002100
200340
200440
200560
200670
200720
200830
200930
201020
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201610
201770
201830
201950
202070
202150
202210
202390
202450
202520
202670
FIG. 1 — Lineage of K121425, 2001–2026Source: 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? (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
*K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.2011—
*K100176Ascension Ankle Fusion Plate System
Summary page 1
…HWC: Orthopedic 3. Predicate Devices: KI 10670 - PERT-LOG Ankle Fusion Bone Plates K100176 - Ascension® Ankle Fusion Plate System…
Ascension Orthopedics, Inc.2010—
*K090139Ankle Arthrodesis Plate System
Summary page 1
…K100176 - Ascension® Ankle Fusion Plate System K090139 - TorrieiA StabilisTm Ankle Arilirodesis Plate System…
Tornier, Inc.2009—
*K073375Newdeal Tibiaxys System
Summary page 1
…- TorrieiA StabilisTm Ankle Arilirodesis Plate System K073375 - Integra& I Newdeal® TibiazySTM System…
Newdeal Sas20082
*K060473TTC Plate
Summary page 1
…K073375 - Integra& I Newdeal® TibiazySTM System K060473 - Newdeal® AdvanssTm fl7C Plate K06 1940 - Synthes® LCP Ankle Arthrdesis…
New Deal, S.A.2006—
*K061940Synthes LCP Ankle Arthrodesis Plates
Summary page 1
…System K060473 - Newdeal® AdvanssTm fl7C Plate K06 1940 - Synthes® LCP Ankle Arthrdesis Plates…
Synthes (Usa)2006—
*K112772Ortholoc (TM) Bone ScrewsWrightmedicaltechnologyinc2011—
†K102429Ortholoc 3DI Ankle Plating System, Ortholoc Bone ScrewWrightmedicaltechnologyinc20101

Also cleared against K110670: 8 other devices →

What descends from it? (53)

See all 53

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

NumberDeviceApplicantDecidedDescendants
K140397Paralock Plating System / Tuffnek ScrewParagon 28201431
K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712
K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165
K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183
K173121Ankle Fusion Plating SystemIn2bones Sas20172
K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211
K260274Airlock® Ankle Plating SystemNovastep SAS20260
K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230
K202307Activ FuseNewclip Technics20200
K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190

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 11 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
  • 21 of the 96 ancestors have a recall of any class.
  • Of its descendants, K140397 (Paragon 28, 2014) has gone furthest, with 31 descendants of its own.
  • 8 other devices also cite its predicate K110670.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?

Wright's ORTHOLOC 3Di Ankle Fusion Plating System is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints and tibiocalcaneal arthrodeses, in conjunction with osteotomies and fractures of the distal tibia, talus, and calcaneus.

ORTHOLOC Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

Indications for use as stated in the FDA summary.

Also cleared against K110670

8 other devices cite the same predicate.

  • K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip…Smith & Nephew, Inc. · 20221 recall
  • K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 20211 recall
  • K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc. · 2015
  • K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc · 20141 recall
  • K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc · 2014
  • K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation · 20146 recalls

More from Wrightmedicaltechnologyinc

311 FDA decisions under this applicant name. See the company

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  • K202815PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2021
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Recent decisions in HRS

The HRS category page

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  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
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  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K121425 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121425: Ortholoc 3DI Ankle Fusion 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/K121425

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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