510(k) Report

510(k) · Cleared

Cleared

Ortholoc Ankle Plating System (Aps)

K091243510(k) TraditionalCleared Jun 26, 200959-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 Jun 26, 2009 after a 59-day review. The FDA summary names no predicate by number. 102 later devices descend from it.

Decided
Jun 26, 2009
Review
59 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
0

102 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2014: 3 descendants cleared2010: 1 descendant cleared2016: 4 descendants cleared2012: 4 descendants cleared2011: 1 descendant cleared2021: 10 descendants cleared2017: 11 descendants cleared2013: 1 descendant cleared2023: 11 descendants cleared2022: 9 descendants cleared2015: 2 descendants cleared2018: 7 descendants cleared2019: 6 descendants cleared2020: 10 descendants cleared2024: 9 descendants cleared2026: 9 descendants cleared2025: 4 descendants cleared20052010201520202025
  1. This deviceK091243 Ortholoc Ankle Plating System (Aps)Wrightmedicaltechnologyinc · 2009
  2. Descendant · cites it directly · 97 of its ownK102429 Ortholoc 3DI Ankle Plating System, Ortholoc Bone ScrewWrightmedicaltechnologyinc · 2010 · Recalled
  3. Descendant · 2 generations on · 68 of its ownK112772 Ortholoc (TM) Bone ScrewsWrightmedicaltechnologyinc · 2011
  4. Descendant · 3 generations on · 53 of its ownK121425 Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012
  5. Descendant · 4 generations on · 31 of its ownK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
  6. Descendant · 2 generations on · 26 of its ownK131093 Ortholoc (R) 3DI Ankle Plating SystemWrightmedicaltechnologyinc · 2013

Showing 5 of 102 descendants. See all descendants

Descendants cleared per year

2010: 12011: 12012: 42013: 12014: 32015: 22016: 42017: 112018: 72019: 62020: 102021: 102022: 92023: 112024: 92025: 42026: 9
2010high 11 (2017) · low 1 (2010)2026

Most influential descendants

Showing 5 of 102 · See all
  • K102429Ortholoc 3DI Ankle Plating System, Ortholoc Bone ScrewWrightmedicaltechnologyinc · 2010 · cites it directly97descendants
  • K112772Ortholoc (TM) Bone ScrewsWrightmedicaltechnologyinc · 2011 · 2 generations on68descendants
  • K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012 · 3 generations on53descendants
  • K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014 · 4 generations on31descendants
  • K131093Ortholoc (R) 3DI Ankle Plating SystemWrightmedicaltechnologyinc · 2013 · 2 generations on26descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K091243Ortholoc Ankle Plating System (Aps)Wrightmedicaltechnologyinc2009—
+1K102429Ortholoc 3DI Ankle Plating System, Ortholoc Bone ScrewWrightmedicaltechnologyinc20101
+2K112772Ortholoc (TM) Bone ScrewsWrightmedicaltechnologyinc2011—
+3K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc2012—
+4K140397Paralock Plating System / Tuffnek ScrewParagon 282014—
+2K131093Ortholoc (R) 3DI Ankle Plating SystemWrightmedicaltechnologyinc2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
201240
201310
201430
201520
201640
2017110
201870
201960
2020100
2021100
202290
2023110
202490
202540
202690
FIG. 1 — Lineage of K091243, 2009–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (102)

See all 102

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

NumberDeviceApplicantDecidedDescendants
K102429Ortholoc 3DI Ankle Plating System, Ortholoc Bone ScrewWrightmedicaltechnologyinc201097
K142121Valor Hindfoot Fusion Nail SystemWrightmedicaltechnologyinc20144
K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161

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?

  • Of its descendants, K102429 (Wrightmedicaltechnologyinc, 2010) has gone furthest, with 97 descendants of its own.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 ORTHOLOC® Ankle Plating System (APS) is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula.

Indications for use as stated in the FDA summary.

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/K091243 · printed Nov 5, 2026

Cite this page

510(k) Report. “K091243: Ortholoc Ankle Plating System (Aps).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091243

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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