510(k) Report

510(k) · Cleared

Cleared

ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System

K201259510(k) TraditionalCleared Jan 8, 2021242-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 8, 2021 as substantially equivalent to K163044 (Wrightmedicaltechnologyinc, 2017) and 6 other predicates after a 242-day review. Its family tree reaches back 4 generations to 2008.

Decided
Jan 8, 2021
Review
242 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
7

Its longest line of descent runs back 4 generations to K082320 (2008). 20 ancestors in all, the oldest K961413 (1996). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2019: 1 other ancestor2017: 1 other ancestor2012: 1 other ancestor2009: 2 other ancestors2008: 1 other ancestor2006: 2 other ancestors2004: 1 other ancestor2000: 2 other ancestors2003: 2 other ancestors2002: 1 other ancestor2001: 1 other ancestor1996: 1 other ancestorK082320 · Darco Small Screw · Wrightmedicaltechnologyinc · 2008K102429 · Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw · Wrightmedicaltechnologyinc · 2010 · recalledK131093 · Ortholoc (R) 3DI Ankle Plating System · Wrightmedicaltechnologyinc · 2013K163044 · ORTHOLOC® 3Di Ankle Fracture Plating System · Wrightmedicaltechnologyinc · 2017199520002005201020152020
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 6 other ancestors3 generations back: 6 other ancestors K163044 · ORTHOLOC® 3Di Ankle Fracture Plating System · Wrightmedicaltechnologyinc · 2017K131093 · 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 · 4 generations backK082320 Darco Small ScrewWrightmedicaltechnologyinc · 2008
  2. 3 generations backK102429 Ortholoc 3DI Ankle Plating System, Ortholoc Bone ScrewWrightmedicaltechnologyinc · 2010 · Recalled
  3. 2 generations backK131093 Ortholoc (R) 3DI Ankle Plating SystemWrightmedicaltechnologyinc · 2013
  4. 1 generation backK163044 ORTHOLOC® 3Di Ankle Fracture Plating SystemWrightmedicaltechnologyinc · 2017
  5. This deviceK201259 ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc · 2021
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K082320Darco Small ScrewWrightmedicaltechnologyinc2008—
−3K102429Ortholoc 3DI Ankle Plating System, Ortholoc Bone ScrewWrightmedicaltechnologyinc20101
−2K131093Ortholoc (R) 3DI Ankle Plating SystemWrightmedicaltechnologyinc2013—
−1K163044ORTHOLOC® 3Di Ankle Fracture Plating SystemWrightmedicaltechnologyinc2017—
0 (this device)K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200020
200110
200210
200320
200410
200620
200810
200920
201210
201710
201910
FIG. 1 — Lineage of K201259, 2008–2021Source: 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? (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
*K163044ORTHOLOC® 3Di Ankle Fracture Plating System
Summary page 4
…HWC— Orthopedic (a)(3) PREDICATE DEVICE INFORMATION ORTHOLOC 3Di Ankle Fracture Plating System K163044 (primary) ORTHOLOC 3Di Small Bones Forefoot System K163039 (additional) DARCO Small Screw…
Wrightmedicaltechnologyinc2017—
*K163039ORTHOLOC® 3Di Small Bones Plating
Summary page 4
…EVICE INFORMATION ORTHOLOC 3Di Ankle Fracture Plating System K163044 (primary) ORTHOLOC 3Di Small Bones Forefoot System K163039 (additional) DARCO Small Screw K082320 (additional) ORTHOLOC 2.0/2.4 Plate…
Wrightmedicaltechnologyinc2017—
*K082320Darco Small Screw
Summary page 4
…3044 (primary) ORTHOLOC 3Di Small Bones Forefoot System K163039 (additional) DARCO Small Screw K082320 (additional) ORTHOLOC 2.0/2.4 Plate System K090692 (additional) ORTHOLOC 3Di Ankle Plat…
Wrightmedicaltechnologyinc2008—
*K090692Ortholoc 2.0/2.4 Plate System
Summary page 4
…9 (additional) DARCO Small Screw K082320 (additional) ORTHOLOC 2.0/2.4 Plate System K090692 (additional) ORTHOLOC 3Di Ankle Plating System, ORTHOLOC Bone Screw K102429 (additional) ORTHOLOC 3Di Hallux Sys…
Wrightmedicaltechnologyinc20091
*K102429Ortholoc 3DI Ankle Plating System, Ortholoc Bone Screw
Summary page 4
…0 (additional) ORTHOLOC 2.0/2.4 Plate System K090692 (additional) ORTHOLOC 3Di Ankle Plating System, ORTHOLOC Bone Screw K102429 (additional) ORTHOLOC 3Di Hallux System K120359 (additional) NCB Plating System Dist…
Wrightmedicaltechnologyinc20101
*K120359Ortholoc 3DI Hallux System
Summary page 4
…2 (additional) ORTHOLOC 3Di Ankle Plating System, ORTHOLOC Bone Screw K102429 (additional) ORTHOLOC 3Di Hallux System K120359 (additional) NCB Plating System Distal Femur and Proximal Tibia K192217 (additional)…
Wrightmedicaltechnologyinc20122
*K192217NCB Plating System Distal Femur and Proximal Tibia
Summary page 4
…9 (additional) ORTHOLOC 3Di Hallux System K120359 (additional) NCB Plating System Distal Femur and Proximal Tibia K192217 (additional)…
Zimmer GmbH2019—

Also cleared against K163044: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 13 years and passes through 1 company; a new generation was cleared every 3.7 years on median.
  • 8 of the 20 ancestors have a recall of any class.
  • 6 other devices also cite its predicate K163044.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 ORTHOLOCTm 2 with 3Di Technology Pilon Fracture Plating System is indicated for complex intra- and extra-articular fractures, osteotomies, and non-unions of the distal tibia, and fracture fixation of the fibula in skeletally mature patients. This includes periarticular stabilization and fixation of fragments in fresh fractures. ORTHOLOCm 3Di Locking Screws are intended for use with Wright's ORTHOLOC 3Di Plating Systems of the same base material.…

Read the full statement (124 words)

The ORTHOLOCTm 2 with 3Di Technology Pilon Fracture Plating System is indicated for complex intra- and extra-articular fractures, osteotomies, and non-unions of the distal tibia, and fracture fixation of the fibula in skeletally mature patients. This includes periarticular stabilization and fixation of fragments in fresh fractures.

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

ORTHOLOCm 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 K163044

6 other devices cite the same predicate.

  • K230204ALPHALOK Plating SystemVilex, LLC · 2023
  • K221558ALPHALOK Plating SystemVilex, LLC · 2022
  • K213005Apollo Ankle Fracture Plating SystemGlw Medical, Inc. · 2022
  • K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC · 2021
  • K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd. · 2020
  • K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation · 2017

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
  • K200507PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2020

Recent decisions in HRS

The HRS category page

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https://510kreport.com/device/K201259 · printed Nov 6, 2026

Cite this page

510(k) Report. “K201259: ORTHOLOC 2 with 3Di Technology Pilon Fracture 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/K201259

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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