510(k) Report

510(k) · Cleared

Cleared

Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia Plates

K032269510(k) TraditionalCleared Sep 17, 200356-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 Sep 17, 2003 after a 56-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.

Decided
Sep 17, 2003
Review
56 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
0

12 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2023: 2 descendants cleared2019: 1 descendant cleared2020: 1 descendant cleared2017: 1 descendant cleared2022: 1 descendant cleared2024: 3 descendants cleared2026: 3 descendants cleared200020052010201520202025
  1. This deviceK032269 Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia PlatesSynthes (Usa) · 2003
  2. Descendant · cites it directly · 3 of its ownK191793 Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating…Nebula Surgical Private Limited · 2019
  3. Descendant · cites it directly · 3 of its ownK163383 GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating…Greens Surgicals Pvt., Ltd. · 2017
  4. Descendant · 2 generations on · 2 of its ownK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
  5. Descendant · cites it directly · 1 of its ownK242399 Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2024
  6. Descendant · cites it directly · 1 of its ownK222282 HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating…Hospital Equipment Manufacturing Company · 2022

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2017: 12019: 12020: 12022: 12023: 22024: 32026: 3
2017high 3 (2024) · low 0 (2018)2026

Most influential descendants

Showing 5 of 12 · See all
  • K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited · 2019 · cites it directly3descendants
  • K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd. · 2017 · cites it directly3descendants
  • K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024 · 2 generations on2descendants
  • K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2024 · cites it directly1descendant
  • K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company · 2022 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K032269Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia PlatesSynthes (Usa)2003—
+1K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System…Nebula Surgical Private Limited2019—
+1K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System…Greens Surgicals Pvt., Ltd.2017—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical2024—
+1K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG2024—
+1K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201910
202010
202210
202320
202430
202630
FIG. 1 — Lineage of K032269, 2003–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (1)

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 (USA) Large Fragment LCP T- Plate
Named without a submission number
—

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193
K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173
K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241
K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221
K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260
K232394Internal Locking Plate and Screw Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230
K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230
K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200

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, K191793 (Nebula Surgical Private Limited, 2019) has gone furthest, with 3 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.

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 (USA) 3.5 / 4.5 mm LCP Medial Proximal Tibia Plates are intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibia shaft.

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/K032269 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032269: Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032269

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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