510(k) Report

510(k) · Cleared

Cleared

ORTHOLOC® 3Di Ankle Fracture Plating System

K163044510(k) TraditionalCleared Jan 26, 201787-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 Jan 26, 2017 as substantially equivalent to K131093 (Wrightmedicaltechnologyinc, 2013) and 3 other predicates after an 87-day review. Its family tree reaches back 3 generations to 2008. 13 later devices descend from it.

Decided
Jan 26, 2017
Review
87 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K082320 (2008). 6 ancestors in all, the oldest K000684 (2000). 13 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2000: 1 other ancestor2009: 1 other ancestor2021: 3 descendants cleared2017: 1 descendant cleared2020: 2 descendants cleared2022: 4 descendants cleared2023: 1 descendant cleared2024: 2 descendants clearedK082320 · Darco Small Screw · Wrightmedicaltechnologyinc · 2008K102429 · Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw · Wrightmedicaltechnologyinc · 2010 · recalledK131093 · Ortholoc (R) 3DI Ankle Plating System · Wrightmedicaltechnologyinc · 2013200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor 1 generation forward: 7 descendants2 generations forward: 5 descendants3 generations forward: 1 descendant K131093 · Ortholoc (R) 3DI Ankle Plating System · Wrightmedicaltechnologyinc · 2013K102429 · Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw · Wrightmedicaltechnologyinc · 2010 · recalledK082320 · Darco Small Screw · Wrightmedicaltechnologyinc · 20080
  1. Root · 3 generations backK082320 Darco Small ScrewWrightmedicaltechnologyinc · 2008
  2. 2 generations backK102429 Ortholoc 3DI Ankle Plating System, Ortholoc Bone ScrewWrightmedicaltechnologyinc · 2010 · Recalled
  3. 1 generation backK131093 Ortholoc (R) 3DI Ankle Plating SystemWrightmedicaltechnologyinc · 2013
  4. This deviceK163044 ORTHOLOC® 3Di Ankle Fracture Plating SystemWrightmedicaltechnologyinc · 2017
  5. Descendant · cites it directly · 2 of its ownK221558 ALPHALOK Plating SystemVilex, LLC · 2022
  6. Descendant · cites it directly · 2 of its ownK170313 ARIX Ankle Distal Tibia SystemJeil Medical Corporation · 2017
  7. Descendant · cites it directly · 1 of its ownK213005 Apollo Ankle Fracture Plating SystemGlw Medical, Inc. · 2022
  8. Descendant · cites it directly · 1 of its ownK212297 Omni Foot and Ankle Plating SystemExtremity Medical, LLC · 2021
  9. Descendant · cites it directly · 1 of its ownK202764 Ortho Solutions Plating SystemOrtho Solutions UK, Ltd. · 2020

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2017: 12020: 22021: 32022: 42023: 12024: 2
2017high 4 (2022) · low 0 (2018)2026

Most influential descendants

Showing 5 of 13 · See all
  • K221558ALPHALOK Plating SystemVilex, LLC · 2022 · cites it directly2descendants
  • K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation · 2017 · cites it directly2descendants
  • K213005Apollo Ankle Fracture Plating SystemGlw Medical, Inc. · 2022 · cites it directly1descendant
  • K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC · 2021 · cites it directly1descendant
  • K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd. · 2020 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K082320Darco Small ScrewWrightmedicaltechnologyinc2008—
−2K102429Ortholoc 3DI Ankle Plating System, Ortholoc Bone ScrewWrightmedicaltechnologyinc20101
−1K131093Ortholoc (R) 3DI Ankle Plating SystemWrightmedicaltechnologyinc2013—
0 (this device)K163044ORTHOLOC® 3Di Ankle Fracture Plating SystemWrightmedicaltechnologyinc2017—
+1K221558ALPHALOK Plating SystemVilex, LLC2022—
+1K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation2017—
+1K213005Apollo Ankle Fracture Plating SystemGlw Medical, Inc.2022—
+1K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC2021—
+1K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200810
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
202020
202130
202240
202310
202420
FIG. 1 — Lineage of K163044, 2008–2024Source: 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? (4)

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
*K131093Ortholoc (R) 3DI Ankle Plating System
Summary page 4
…dic HWC – Orthopedic (a)(3). Predicate Device: ORTHOLOC® 3Di Ankle Fracture: K131093 K102429…
Wrightmedicaltechnologyinc2013—
*K102429Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw
Summary page 4
…ce: ORTHOLOC® 3Di Ankle Fracture: K131093 K102429 Synthes LCP Distal Fibula Plates: K073460…
Wrightmedicaltechnologyinc20101
*K073460Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates
Summary page 4
…K102429 Synthes LCP Distal Fibula Plates: K073460 Synthes Small Fragment DCL: K000684 (a)(4). Device Description T…
Synthes (Usa)2008—
*K000684Small Fragment Dynamic Compression Locking (DCL) System
Summary page 4
…Synthes LCP Distal Fibula Plates: K073460 Synthes Small Fragment DCL: K000684 (a)(4). Device Description The ORTHOLOC® 3Di Ankle Plating System consists of plates belonging to 1 of 2 general categories--dis…
Synthes (Usa)20001

Also cleared against K131093: 4 other devices →

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K221558ALPHALOK Plating SystemVilex, LLC20222
K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172
K213005Apollo Ankle Fracture Plating SystemGlw Medical, Inc.20221
K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211
K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201
K230204ALPHALOK Plating SystemVilex, LLC20230
K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc20210

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 9 years and passes through 1 company; a new generation was cleared every 2.5 years on median.
  • 2 of the 6 ancestors have a recall of any class.
  • Of its descendants, K221558 (Vilex, LLC, 2022) has gone furthest, with 2 descendants of its own.
  • 4 other devices also cite its predicate K131093.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Malleolus • Pilon Fractures • Distal Tibia Shaft Fractures • Distal…

Read the full statement (163 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 Malleolus

• Pilon Fractures

• Distal Tibia Shaft Fractures

• Distal Fibula Shaft Fractures

• Distal Tibia Periarticular Fractures

• Medial Malleolar Avulsion Fractures

• Lateral Malleolar Avulsion Fractures

ORTHOLOC® 3Di Locking Screws are intended for use with Wright’s ORTHOLOC® 3Di Plating Systems of the same base material.

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.

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 K131093

4 other devices cite the same predicate.

  • K200062Foot and Ankle SystemLeith Medical, LLC · 2021
  • K173641Activ AnkleNewclip Technics · 2018
  • K143061Activ Ankle Locking Plating SystemNewclip Technics · 2015
  • K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc · 20141 recall

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

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https://510kreport.com/device/K163044 · printed Nov 5, 2026

Cite this page

510(k) Report. “K163044: ORTHOLOC® 3Di Ankle Fracture Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163044

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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