510(k) Report

510(k) · Cleared

Cleared

Synthes 3.5MM Titanium LCP Proximal Tibia Plates

K030597510(k) TraditionalCleared Mar 20, 200323-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 Mar 20, 2003 after a 23-day review. The FDA summary names its predicate without a number. 56 later devices descend from it.

Decided
Mar 20, 2003
Review
23 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
0

56 later devices descend from it, 13 citing it directly.

Descendants, by year cleared 2022: 3 descendants cleared2023: 6 descendants cleared2025: 5 descendants cleared2016: 5 descendants cleared2020: 4 descendants cleared2019: 3 descendants cleared2015: 4 descendants cleared2006: 1 descendant cleared2017: 3 descendants cleared2024: 7 descendants cleared2010: 1 descendant cleared2014: 1 descendant cleared2013: 3 descendants cleared2011: 1 descendant cleared2018: 2 descendants cleared2021: 2 descendants cleared2026: 5 descendants cleared200020052010201520202025
  1. This deviceK030597 Synthes 3.5MM Titanium LCP Proximal Tibia PlatesSynthes (Usa) · 2003
  2. Descendant · cites it directly · 25 of its ownK061211 NCB Plating System, Proximal Tibia PlatesZimmer GmbH · 2006 · Recalled
  3. Descendant · cites it directly · 15 of its ownK153716 GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating…Gpc Medical, Ltd. · 2016
  4. Descendant · 2 generations on · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
  5. Descendant · 2 generations on · 11 of its ownK192217 NCB Plating System Distal Femur and Proximal TibiaZimmer GmbH · 2019
  6. Descendant · 3 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017

Showing 5 of 56 descendants. See all descendants

Descendants cleared per year

2006: 12010: 12011: 12013: 32014: 12015: 42016: 52017: 32018: 22019: 32020: 42021: 22022: 32023: 62024: 72025: 52026: 5
2006high 7 (2024) · low 0 (2007)2026

Most influential descendants

Showing 5 of 56 · See all
  • K061211NCB Plating System, Proximal Tibia PlatesZimmer GmbH · 2006 · cites it directly25descendants
  • K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd. · 2016 · cites it directly15descendants
  • K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · 2 generations on14descendants
  • K192217NCB Plating System Distal Femur and Proximal TibiaZimmer GmbH · 2019 · 2 generations on11descendants
  • K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 3 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K030597Synthes 3.5MM Titanium LCP Proximal Tibia PlatesSynthes (Usa)2003—
+1K061211NCB Plating System, Proximal Tibia PlatesZimmer GmbH20064
+1K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.2016—
+2K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.2017—
+2K192217NCB Plating System Distal Femur and Proximal TibiaZimmer GmbH2019—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201010
201110
201330
201410
201540
201650
201730
201820
201930
202040
202120
202230
202360
202470
202550
202650
FIG. 1 — Lineage of K030597, 2003–2026Source: 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 3.5mm SS LCP Proximal Tibia Plate
Named without a submission number
—
*—Synthes Large Fragment LCP T- Plate
Named without a submission number
—

What descends from it? (56)

See all 56

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

NumberDeviceApplicantDecidedDescendants
K061211NCB Plating System, Proximal Tibia PlatesZimmer GmbH200625
K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615
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
K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161
K141680AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN…Auxein Medical20151
K242988Genostis Osteosynthesis SystemGenostis AF20250
K250155Xpert KneeNewclip Technics20250
K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230
K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation20220

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, K061211 (Zimmer GmbH, 2006) has gone furthest, with 25 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?

Synthes Titanium LCP Proximal Tibia Plate is intended

treatment of non-unions, malunions, and fractures of the

proximal tibia, including simple, comminuted, lateral

wedge, depression, medial wedge, bicondylar,

combinations of lateral wedge and depression, and

fractures with associated shaft fractures.

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/K030597 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030597: Synthes 3.5MM Titanium LCP Proximal Tibia Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030597

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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