510(k) Report

510(k) · Cleared

Cleared

Ortholoc (R) 3DI Ankle Plating System

K131093510(k) SpecialCleared May 21, 201333-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 May 21, 2013 as substantially equivalent to K102429 (Wrightmedicaltechnologyinc, 2010) after a 33-day review. Its family tree reaches back 2 generations to 2008. 26 later devices descend from it.

Decided
May 21, 2013
Review
33 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K082320 (2008). 3 ancestors in all. 26 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2018: 2 descendants cleared2015: 1 descendant cleared2021: 6 descendants cleared2017: 3 descendants cleared2014: 1 descendant cleared2024: 2 descendants cleared2022: 5 descendants cleared2016: 1 descendant cleared2020: 2 descendants cleared2023: 1 descendant cleared2026: 2 descendants clearedK082320 · Darco Small Screw · Wrightmedicaltechnologyinc · 2008K102429 · Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw · Wrightmedicaltechnologyinc · 2010 · recalled20052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 14 descendants3 generations forward: 6 descendants4 generations forward: 1 descendant K102429 · Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw · Wrightmedicaltechnologyinc · 2010 · recalledK082320 · Darco Small Screw · Wrightmedicaltechnologyinc · 20080
  1. Root · 2 generations backK082320 Darco Small ScrewWrightmedicaltechnologyinc · 2008
  2. 1 generation backK102429 Ortholoc 3DI Ankle Plating System, Ortholoc Bone ScrewWrightmedicaltechnologyinc · 2010 · Recalled
  3. This deviceK131093 Ortholoc (R) 3DI Ankle Plating SystemWrightmedicaltechnologyinc · 2013
  4. Descendant · cites it directly · 13 of its ownK163044 ORTHOLOC® 3Di Ankle Fracture Plating SystemWrightmedicaltechnologyinc · 2017
  5. Descendant · cites it directly · 8 of its ownK143061 Activ Ankle Locking Plating SystemNewclip Technics · 2015
  6. Descendant · 2 generations on · 6 of its ownK152289 Alians Elbow Locking Plating SystemNewclip Technics · 2016
  7. Descendant · cites it directly · 3 of its ownK173641 Activ AnkleNewclip Technics · 2018
  8. Descendant · 2 generations on · 2 of its ownK221558 ALPHALOK Plating SystemVilex, LLC · 2022

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12016: 12017: 32018: 22020: 22021: 62022: 52023: 12024: 22026: 2
2014high 6 (2021) · low 0 (2019)2026

Most influential descendants

Showing 5 of 26 · See all
  • K163044ORTHOLOC® 3Di Ankle Fracture Plating SystemWrightmedicaltechnologyinc · 2017 · cites it directly13descendants
  • K143061Activ Ankle Locking Plating SystemNewclip Technics · 2015 · cites it directly8descendants
  • K152289Alians Elbow Locking Plating SystemNewclip Technics · 2016 · 2 generations on6descendants
  • K173641Activ AnkleNewclip Technics · 2018 · cites it directly3descendants
  • K221558ALPHALOK Plating SystemVilex, LLC · 2022 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K082320Darco Small ScrewWrightmedicaltechnologyinc2008—
−1K102429Ortholoc 3DI Ankle Plating System, Ortholoc Bone ScrewWrightmedicaltechnologyinc20101
0 (this device)K131093Ortholoc (R) 3DI Ankle Plating SystemWrightmedicaltechnologyinc2013—
+1K163044ORTHOLOC® 3Di Ankle Fracture Plating SystemWrightmedicaltechnologyinc2017—
+1K143061Activ Ankle Locking Plating SystemNewclip Technics2015—
+2K152289Alians Elbow Locking Plating SystemNewclip Technics2016—
+1K173641Activ AnkleNewclip Technics2018—
+2K221558ALPHALOK Plating SystemVilex, LLC2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
201610
201730
201820
202020
202160
202250
202310
202420
202620
FIG. 1 — Lineage of K131093, 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? (1)

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
*K102429Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw
Summary page 1
…Device Product Code, Device Panel: H-RS: Plate, Fixation Bone (a)(3). Predicate Device: K1 02429 ORTHOLOC®D 3Di Ankle Plating System (a)(4). Devi…
Wrightmedicaltechnologyinc20101

Also cleared against K102429: 8 other devices →

What descends from it? (26)

See all 26

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

NumberDeviceApplicantDecidedDescendants
K163044ORTHOLOC® 3Di Ankle Fracture Plating SystemWrightmedicaltechnologyinc201713
K143061Activ Ankle Locking Plating SystemNewclip Technics20158
K173641Activ AnkleNewclip Technics20183
K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc20142
K200062Foot and Ankle SystemLeith Medical, LLC20210

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 5 years and passes through 1 company; a new generation was cleared every 2.5 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K163044 (Wrightmedicaltechnologyinc, 2017) has gone furthest, with 13 descendants of its own.
  • 8 other devices also cite its predicate K102429.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 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 * Piton Fractures * Distal Tibia Shaft Fractures *…

Read the full statement (170 words)

Wright's ORTHOLOC®)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

* Piton Fractures

* Distal Tibia Shaft Fractures

* Distal Fibula Shaft Fractures

* Distal Tibia Periarticular Fractures

* Medial Malleolar Avulsion Fractures

* Lateral Malleolar Axusian Fractures

ORTHOLOC® 3Di Locking Screws:

The ORTHOLOC® 3Di locking screws are intended for use with Wright's ORTHOLOC® 3Di Plating Systems of the same base material.

ORTHOLOC® Bone Screws:

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

Washer

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 K102429

8 other devices cite the same predicate.

  • K200062Foot and Ankle SystemLeith Medical, LLC · 2021
  • K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc · 2021
  • K163044ORTHOLOC® 3Di Ankle Fracture Plating SystemWrightmedicaltechnologyinc · 2017
  • K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. · 2016
  • K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd. · 20161 recall
  • K121682Active Screw Bone ScrewIntelligent Implant Systems, LLC · 2012

More from Wrightmedicaltechnologyinc

311 FDA decisions under this applicant name. See the company

  • K222835Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2023
  • 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/K131093 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131093: Ortholoc (R) 3DI Ankle 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/K131093

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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