510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw

K102429510(k) TraditionalCleared Nov 23, 201090-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 Nov 23, 2010 as substantially equivalent to K091243 (Wrightmedicaltechnologyinc, 2009) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 2008. 97 later devices descend from it. It has been recalled once.

Decided
Nov 23, 2010
Review
90 days
Class
Class II
Product code
HRS
Recalls
1
Predicates
2

Its longest line of descent runs back 1 generation to K082320 (2008). 2 ancestors in all. 97 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2012: 4 descendants cleared2011: 1 descendant cleared2021: 10 descendants cleared2016: 4 descendants cleared2017: 11 descendants cleared2013: 1 descendant cleared2015: 2 descendants cleared2018: 7 descendants cleared2014: 2 descendants cleared2019: 6 descendants cleared2022: 8 descendants cleared2020: 10 descendants cleared2023: 10 descendants cleared2026: 9 descendants cleared2024: 8 descendants cleared2025: 4 descendants clearedK082320 · Darco Small Screw · Wrightmedicaltechnologyinc · 200820052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 9 descendants2 generations forward: 15 descendants3 generations forward: 26 descendants4 generations forward: 16 descendants5 generations forward: 9 descendants6 generations forward: 12 descendants7 generations forward: 5 descendants8 generations forward: 3 descendants9 generations forward: 1 descendant10 generations forward: 1 descendant K082320 · Darco Small Screw · Wrightmedicaltechnologyinc · 20080+5+10
  1. Root · 1 generation backK082320 Darco Small ScrewWrightmedicaltechnologyinc · 2008
  2. This deviceK102429 Ortholoc 3DI Ankle Plating System, Ortholoc Bone ScrewWrightmedicaltechnologyinc · 2010
  3. Descendant · cites it directly · 68 of its ownK112772 Ortholoc (TM) Bone ScrewsWrightmedicaltechnologyinc · 2011
  4. Descendant · 2 generations on · 53 of its ownK121425 Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012
  5. Descendant · 3 generations on · 31 of its ownK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
  6. Descendant · cites it directly · 26 of its ownK131093 Ortholoc (R) 3DI Ankle Plating SystemWrightmedicaltechnologyinc · 2013
  7. Descendant · cites it directly · 13 of its ownK163044 ORTHOLOC® 3Di Ankle Fracture Plating SystemWrightmedicaltechnologyinc · 2017

Showing 5 of 97 descendants. See all descendants

Descendants cleared per year

2011: 12012: 42013: 12014: 22015: 22016: 42017: 112018: 72019: 62020: 102021: 102022: 82023: 102024: 82025: 42026: 9
2011high 11 (2017) · low 1 (2011)2026

Most influential descendants

Showing 5 of 97 · See all
  • K112772Ortholoc (TM) Bone ScrewsWrightmedicaltechnologyinc · 2011 · cites it directly68descendants
  • K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012 · 2 generations on53descendants
  • K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014 · 3 generations on31descendants
  • K131093Ortholoc (R) 3DI Ankle Plating SystemWrightmedicaltechnologyinc · 2013 · cites it directly26descendants
  • K163044ORTHOLOC® 3Di Ankle Fracture Plating SystemWrightmedicaltechnologyinc · 2017 · cites it directly13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K082320Darco Small ScrewWrightmedicaltechnologyinc2008—
0 (this device)K102429Ortholoc 3DI Ankle Plating System, Ortholoc Bone ScrewWrightmedicaltechnologyinc2010—
+1K112772Ortholoc (TM) Bone ScrewsWrightmedicaltechnologyinc2011—
+2K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc2012—
+3K140397Paralock Plating System / Tuffnek ScrewParagon 282014—
+1K131093Ortholoc (R) 3DI Ankle Plating SystemWrightmedicaltechnologyinc2013—
+1K163044ORTHOLOC® 3Di Ankle Fracture Plating SystemWrightmedicaltechnologyinc2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201240
201310
201420
201520
201640
2017110
201870
201960
2020100
2021100
202280
2023100
202480
202540
202690
FIG. 1 — Lineage of K102429, 2008–2026Source: 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? (2)

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
*K091243Ortholoc Ankle Plating System (Aps)
Summary page 1
…HWC: Screw, Fixation Bone 87 Orthopedics A.3. Predicate Device: K091243--~ORTHOLOCTm Ankle Plating System K082320--WrightTm.Compression Screws A.4. Device De…
Wrightmedicaltechnologyinc2009—
*K082320Darco Small Screw
Summary page 1
…87 Orthopedics A.3. Predicate Device: K091243--~ORTHOLOCTm Ankle Plating System K082320--WrightTm.Compression Screws A.4. Device Description The ORTHOLOCTm 3Di Ankle Plating System contains 45 plates belonging to 1 o…
Wrightmedicaltechnologyinc2008—

Also cleared against K091243: 2 other devices →

What descends from it? (97)

See all 97

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

NumberDeviceApplicantDecidedDescendants
K112772Ortholoc (TM) Bone ScrewsWrightmedicaltechnologyinc201168
K131093Ortholoc (R) 3DI Ankle Plating SystemWrightmedicaltechnologyinc201326
K163044ORTHOLOC® 3Di Ankle Fracture Plating SystemWrightmedicaltechnologyinc201713
K120802Ortholoc (TM) 3DI Locking Screws Ortholoc (TM) Bone ScrewsWrightmedicaltechnologyinc201211
K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.20163
K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161
K200062Foot and Ankle SystemLeith Medical, LLC20210
K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc20210
K121682Active Screw Bone ScrewIntelligent Implant Systems, LLC20120

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 8, 2016Class IIZ-0563-2020Process controlThe firm discovered a lack of adequate documentation confirming sterility on certain products.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K112772 (Wrightmedicaltechnologyinc, 2011) has gone furthest, with 68 descendants of its own.
  • 2 other devices also cite its predicate K091243.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 ORTHOLOCTm 3Di Ankle Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as: * Lateral Malleolar Fractures * Syndesmosis injuries * Medial Malleolar Fractures * Bi-Malleolar Fractures * Tri-Malleolar Fractures * Posterior Malleolar Fractures * Distal Anterior Tibia Fractures * Vertical Shear Fractures of the Medial Malleolous * Pilon Fractures * Distal Tibia Shaft Fractures *…

Read the full statement (164 words)

Wright's ORTHOLOCTm 3Di Ankle Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as:

* Lateral Malleolar Fractures

* Syndesmosis injuries

* Medial Malleolar Fractures

* Bi-Malleolar Fractures

* Tri-Malleolar Fractures

* Posterior Malleolar Fractures

* Distal Anterior Tibia Fractures

* Vertical Shear Fractures of the Medial Malleolous

* Pilon Fractures

* Distal Tibia Shaft Fractures

* Distal Fibula Shaft Fractures

* Distal Tibia Periarticular Fractures

* Medial Malleolar Avuision Fractures

* Lateral Malleolar Avusion Fractures

The ORTHOLOCTm 3Di locking screws are intended for use with Wright's ORTHOLOCTM 30i Plating Systems of the same base material.

ORTHOLOCTm 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.

Wright's washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of bone fragments.

Indications for use as stated in the FDA summary.

Also cleared against K091243

2 other devices cite the same predicate.

  • K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. · 2016
  • K142121Valor Hindfoot Fusion Nail SystemWrightmedicaltechnologyinc · 2014

More from Wrightmedicaltechnologyinc

311 FDA decisions under this applicant name. See the company

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  • K212996Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyinc · 2021
  • K202815PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2021
  • K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc · 2021

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https://510kreport.com/device/K102429 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102429: Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102429

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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