510(k) Report

510(k) · Cleared

Cleared

Foot and Ankle System

K200062510(k) TraditionalCleared Feb 22, 2021406-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

Leith Medical, LLC · HRS Plate, Fixation, Bone

Cleared on Feb 22, 2021 as substantially equivalent to K102429 (Wrightmedicaltechnologyinc, 2010) and 8 other predicates after a 406-day review. Its family tree reaches back 16 generations to 1996.

Decided
Feb 22, 2021
Review
406 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
9

Its longest line of descent runs back 16 generations to K962616 (1996). 155 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2015: 2 other ancestors2013: 5 other ancestors2012: 6 other ancestors2011: 4 other ancestors2010: 8 other ancestors2006: 10 other ancestors2009: 8 other ancestors2008: 7 other ancestors2007: 4 other ancestors2005: 10 other ancestors2004: 12 other ancestors2003: 5 other ancestors2001: 11 other ancestors2000: 12 other ancestors1998: 4 other ancestors2014: 1 other ancestor2002: 3 other ancestors1996: 6 other ancestors1999: 4 other ancestors1992: 1 other ancestor1990: 3 other ancestors1994: 4 other ancestors1993: 2 other ancestors1979: 1 other ancestor1995: 2 other ancestors1991: 1 other ancestor1989: 1 other ancestor1997: 2 other ancestorsK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×2: 2 generations cleared close together, K023007 (2002), K030198 (2003) K032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003×2: 2 generations cleared close together, K050932 (2005), K051735 (2005) K071563 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2007K090675 · Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories · Smith & Nephew, Inc. · 2009K100776 · Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System · Synthes (Usa) · 2010×3: 3 generations cleared close together, K120070 (2012), K120717 (2012), K120854 (2012) K143385 · Acumed Ankle Plating System · Acumed, LLC · 2015K160177 · Gridlock Ankle Plating System · Trilliant Surgical, Ltd. · 2016 · recalledK191009 · Arsenal Plating System · Trilliant Surgical · 201919801990200020102020
Other ancestors, by generation 1 generation back: 7 other ancestors2 generations back: 29 other ancestors3 generations back: 31 other ancestors4 generations back: 23 other ancestors5 generations back: 23 other ancestors6 generations back: 13 other ancestors7 generations back: 5 other ancestors8 generations back: 6 other ancestors9 generations back: 2 other ancestors K191009 · Arsenal Plating System · Trilliant Surgical · 2019K160177 · Gridlock Ankle Plating System · Trilliant Surgical, Ltd. · 2016 · recalledK143385 · Acumed Ankle Plating System · Acumed, LLC · 2015K120854 · Synthes VA LCP Ankle Trauma System · Synthes USA · 2012K120717 · Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates) · Synthes USA · 2012K120070 · Synthes Variable Angle LCP Elbow System · Synthes USA · 2012 · recalledK100776 · Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System · Synthes (Usa) · 2010K090675 · Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories · Smith & Nephew, Inc. · 2009K071563 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2007K051735 · Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity · Smith & Nephew, Inc. · 2005K050932 · Distal Volar Radius Anatomical Plate System · Hand Innovations, Inc. · 2005 · recalledK032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K030198 · Hand Innovations, Inc. Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K023007 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2002K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998K962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996−15−10−50
  1. Root · 16 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 12 generations between
  3. 3 generations backK143385 Acumed Ankle Plating SystemAcumed, LLC · 2015
  4. 2 generations backK160177 Gridlock Ankle Plating SystemTrilliant Surgical, Ltd. · 2016 · Recalled
  5. 1 generation backK191009 Arsenal Plating SystemTrilliant Surgical · 2019
  6. This deviceK200062 Foot and Ankle SystemLeith Medical, LLC · 2021
Show all 16 generations
  1. Root · 16 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 15 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 14 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 13 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 12 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 11 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 10 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 9 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  9. 8 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  10. 7 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  11. 6 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
  12. 5 generations backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
  13. 4 generations backK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
  14. 3 generations backK143385 Acumed Ankle Plating SystemAcumed, LLC · 2015
  15. 2 generations backK160177 Gridlock Ankle Plating SystemTrilliant Surgical, Ltd. · 2016 · Recalled
  16. 1 generation backK191009 Arsenal Plating SystemTrilliant Surgical · 2019
  17. This deviceK200062 Foot and Ankle SystemLeith Medical, LLC · 2021
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−16K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−15K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−14K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−13K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−12K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−11K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−10K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−9K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007—
−8K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
−7K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010—
−6K120070Synthes Variable Angle LCP Elbow SystemSynthes USA20121
−5K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal…Synthes USA2012—
−4K120854Synthes VA LCP Ankle Trauma SystemSynthes USA2012—
−3K143385Acumed Ankle Plating SystemAcumed, LLC2015—
−2K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.20161
−1K191009Arsenal Plating SystemTrilliant Surgical2019—
0 (this device)K200062Foot and Ankle SystemLeith Medical, LLC2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198910
199030
199110
199210
199320
199440
199520
199660
199720
199840
199940
2000120
2001110
200230
200350
2004120
2005100
2006100
200740
200870
200980
201080
201140
201260
201350
201410
201520
FIG. 1 — Lineage of K200062, 1996–2021Source: 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? (9)

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 4
…21 CFR section 888.3030 / 888.3040 Device Panel Orthopedic Primary Predicate ORTHOLOC 3Di Ankle Plating System – Wright Medical Technology (K102429 / K131093) Device ORTHOLOC ® 3Di MTP Fusion Plate / ORTHOLOC® 3Di Foot Reconstruction System –…
Wrightmedicaltechnologyinc20101
*K131093Ortholoc (R) 3DI Ankle Plating System
Summary page 4
…1 CFR section 888.3030 / 888.3040 Device Panel Orthopedic Primary Predicate ORTHOLOC 3Di Ankle Plating System – Wright Medical Technology (K102429 / K131093) Device ORTHOLOC ® 3Di MTP Fusion Plate / ORTHOLOC® 3Di Foot Reconstruction System –…
Wrightmedicaltechnologyinc2013—
*K152974ORTHOLOC® 3Di Foot Plating Reconstruction System
Summary page 4
…131093) Device ORTHOLOC ® 3Di MTP Fusion Plate / ORTHOLOC® 3Di Foot Reconstruction System – Wright Medical Technology (K152974 / K120359) Secondary Predicate Small Fragment Set – Stryker (K060514) Devices LCP Anterolateral Distal Tibi…
Wrightmedicaltechnologyinc2015—
*K120359Ortholoc 3DI Hallux System
Summary page 4
…vice ORTHOLOC ® 3Di MTP Fusion Plate / ORTHOLOC® 3Di Foot Reconstruction System – Wright Medical Technology (K152974 / K120359) Secondary Predicate Small Fragment Set – Stryker (K060514) Devices LCP Anterolateral Distal Tibia Plates /…
Wrightmedicaltechnologyinc20122
*K060514Stryker Plating System
Summary page 4
…ORTHOLOC® 3Di Foot Reconstruction System – Wright Medical Technology (K152974 / K120359) Secondary Predicate Small Fragment Set – Stryker (K060514) Devices LCP Anterolateral Distal Tibia Plates / Variable Angle LCP TMT Fusion Plates /…
Howmedica Osteonics Corp.2006—
*K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia Plate
Summary page 4
…LCP Anterolateral Distal Tibia Plates / Variable Angle LCP TMT Fusion Plates / 2.4/2.7Synthes 2.7mm/3.5mm Cortex Screw – Synthes (K121601 / K100776 / K112583 ARSENAL Foot Plating System – Trilliant Surgical (K191009)…
Synthes USA2012—
*K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System
Summary page 4
…LCP Anterolateral Distal Tibia Plates / Variable Angle LCP TMT Fusion Plates / 2.4/2.7Synthes 2.7mm/3.5mm Cortex Screw – Synthes (K121601 / K100776 / K112583 ARSENAL Foot Plating System – Trilliant Surgical (K191009) The Leit…
Synthes (Usa)2010—
*K112583Synthes Cortical Screws
Summary page 4
…nterolateral Distal Tibia Plates / Variable Angle LCP TMT Fusion Plates / 2.4/2.7Synthes 2.7mm/3.5mm Cortex Screw – Synthes (K121601 / K100776 / K112583 ARSENAL Foot Plating System – Trilliant Surgical (K191009) The Leith Medical…
Synthes (USA) Products, LLC2011—
*K191009Arsenal Plating System
Summary page 4
…2.4/2.7Synthes 2.7mm/3.5mm Cortex Screw – Synthes (K121601 / K100776 / K112583 ARSENAL Foot Plating System – Trilliant Surgical (K191009) The Leith Medical Foot and Ankle System consists of various shape and size plates for…
Trilliant Surgical2019—

Also cleared against K102429: 8 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 25 years and passes through 9 companies; a new generation was cleared every 1.6 years on median.
  • 40 of the 155 ancestors have a recall of any class.
  • 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. 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 Leith Medical Ankle Fracture Plates are intended and designed for open reduction, internal fixation of ankle fractures, revision of ankle fractures, as well as osteotomies, and non-unions of the distal tibia and fibula. The Leith Medical First Tarsal-Metatarsal Joint (1st TMT) Arthrodesis Plates are intended and designed for primary arthrodesis of the 1st TMT joint due to degenerative joint disease and/or halluxvalgus, or revision of prior 1st TMT…

Read the full statement (169 words)

The Leith Medical Ankle Fracture Plates are intended and designed for open reduction, internal fixation of ankle fractures, revision of ankle fractures, as well as osteotomies, and non-unions of the distal tibia and fibula.

The Leith Medical First Tarsal-Metatarsal Joint (1st TMT) Arthrodesis Plates are intended and designed for primary arthrodesis of the 1st TMT joint due to degenerative joint disease and/or halluxvalgus, or revision of prior 1st TMT joint arthrodesis.

The Leith Medical Medial Malleolar Fracture Plates are intended and designed for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula.

The Leith Medical First Metatarsal Phalangeal Joint Arthrodesis Plates are intended and designed for primary arthrodesis of the 1st MTP joint due to degenerative joint disease and/or hallux valgus, revision of prior 1st MTP joint arthrodesis, or revision of failed 1st MTP joint implant arthroplasty.

The Leith Medical Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

Indications for use as stated in the FDA summary.

Also cleared against K102429

8 other devices cite the same predicate.

  • 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
  • K131093Ortholoc (R) 3DI Ankle Plating SystemWrightmedicaltechnologyinc · 2013
  • K121682Active Screw Bone ScrewIntelligent Implant Systems, LLC · 2012

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/K200062 · printed Nov 6, 2026

Cite this page

510(k) Report. “K200062: Foot and Ankle System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200062

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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