510(k) Report

510(k) · Cleared

Cleared

Synthes 3.5 MM LCP Distal Tibia T Plates

K080522510(k) TraditionalCleared May 23, 200887-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

Synthes (Usa) · HRS Plate, Fixation, Bone

Cleared on May 23, 2008 after an 87-day review. The FDA summary names its predicate without a number. 113 later devices descend from it.

Decided
May 23, 2008
Review
87 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
0

113 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2025: 12 descendants cleared2024: 19 descendants cleared2014: 3 descendants cleared2009: 3 descendants cleared2010: 3 descendants cleared2008: 1 descendant cleared2019: 7 descendants cleared2026: 14 descendants cleared2016: 3 descendants cleared2020: 9 descendants cleared2023: 15 descendants cleared2015: 2 descendants cleared2017: 8 descendants cleared2011: 2 descendants cleared2022: 5 descendants cleared2012: 1 descendant cleared2018: 3 descendants cleared2021: 3 descendants cleared20052010201520202025
  1. This deviceK080522 Synthes 3.5 MM LCP Distal Tibia T PlatesSynthes (Usa) · 2008
  2. Descendant · cites it directly · 65 of its ownK081407 Orthopediatrics Pediplates SystemOrthoPediatrics Corp. · 2008
  3. Descendant · 2 generations on · 60 of its ownK083286 Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · Recalled
  4. Descendant · cites it directly · 55 of its ownK092812 Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSynthes (Usa) · 2010
  5. Descendant · 3 generations on · 28 of its ownK120689 Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC · 2012
  6. Descendant · 2 generations on · 19 of its ownK162674 BioPro Foot Plating SystemsBiopro, Inc. · 2017

Showing 5 of 113 descendants. See all descendants

Descendants cleared per year

2008: 12009: 32010: 32011: 22012: 12014: 32015: 22016: 32017: 82018: 32019: 72020: 92021: 32022: 52023: 152024: 192025: 122026: 14
2008high 19 (2024) · low 0 (2013)2026

Most influential descendants

Showing 5 of 113 · See all
  • K081407Orthopediatrics Pediplates SystemOrthoPediatrics Corp. · 2008 · cites it directly65descendants
  • K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · 2 generations on60descendants
  • K092812Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSynthes (Usa) · 2010 · cites it directly55descendants
  • K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC · 2012 · 3 generations on28descendants
  • K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017 · 2 generations on19descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K080522Synthes 3.5 MM LCP Distal Tibia T PlatesSynthes (Usa)2008—
+1K081407Orthopediatrics Pediplates SystemOrthoPediatrics Corp.2008—
+2K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp.20095
+1K092812Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSynthes (Usa)2010—
+3K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC2012—
+2K162674BioPro Foot Plating SystemsBiopro, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200930
201030
201120
201210
201430
201520
201630
201780
201830
201970
202090
202130
202250
2023150
2024190
2025120
2026140
FIG. 1 — Lineage of K080522, 2008–2026Source: 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? (2)

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
*—Synthes One Third Tubular LCP Plate
Named without a submission number
—
*—Synthes 3.5 mm LCP Straight Plate
Named without a submission number
—

What descends from it? (113)

See all 113

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

NumberDeviceApplicantDecidedDescendants
K081407Orthopediatrics Pediplates SystemOrthoPediatrics Corp.200865
K092812Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSynthes (Usa)201055
K090666PediplatesOrthoPediatrics Corp.200915
K100240Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp.201013
K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142
K261511Xpert AnkleNewclip Technics20260
K242988Genostis Osteosynthesis SystemGenostis AF20250
K243050TriMed Posterior Malleolus Fixation SystemTriMed, Inc.20240
K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240
K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190

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, K081407 (OrthoPediatrics Corp., 2008) has gone furthest, with 65 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. 2008, 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 Synthes 3.5 mm LCP Distal Tibia T Plates are indicated for fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone.

Indications for use as stated in the FDA summary.

More from Synthes (Usa)

406 FDA decisions under this applicant name. See the company

  • K131984Synthes Synsonic Ulna NailSynthes (Usa) · 2014
  • K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 20111 recall
  • K111540Synthes 3.5MM LCP Clavicle Plate SystemSynthes (Usa) · 2011
  • K110789Synthes Sternal Zipfix SystemSynthes (Usa) · 20113 recalls
  • K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 20112 recalls

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/K080522 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080522: Synthes 3.5 MM LCP Distal Tibia T Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080522

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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