510(k) Report

510(k) · Cleared

Cleared

Synthes (Usa) Tomofix Medial Distal Femur Plates

K081353510(k) TraditionalCleared Jul 23, 200870-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 Jul 23, 2008 after a 70-day review. The FDA summary names its predicate without a number. 35 later devices descend from it.

Decided
Jul 23, 2008
Review
70 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
0

35 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2020: 1 descendant cleared2014: 2 descendants cleared2013: 1 descendant cleared2012: 1 descendant cleared2019: 3 descendants cleared2022: 1 descendant cleared2025: 7 descendants cleared2018: 2 descendants cleared2026: 6 descendants cleared2024: 9 descendants cleared2021: 1 descendant cleared2023: 1 descendant cleared20052010201520202025
  1. This deviceK081353 Synthes (Usa) Tomofix Medial Distal Femur PlatesSynthes (Usa) · 2008
  2. Descendant · cites it directly · 14 of its ownK141796 Depuy Synthes Tomofix Osteotomy SystemSynthes (USA) Products, LLC · 2014
  3. Descendant · cites it directly · 11 of its ownK113733 Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A · 2012
  4. Descendant · 2 generations on · 8 of its ownK142419 Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A · 2014
  5. Descendant · cites it directly · 4 of its ownK193614 FINE Osteotomy around the kneeBodycad Laboratories, Inc. · 2020
  6. Descendant · 3 generations on · 4 of its ownK182718 Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda. · 2019

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12014: 22018: 22019: 32020: 12021: 12022: 12023: 12024: 92025: 72026: 6
2012high 9 (2024) · low 0 (2015)2026

Most influential descendants

Showing 5 of 35 · See all
  • K141796Depuy Synthes Tomofix Osteotomy SystemSynthes (USA) Products, LLC · 2014 · cites it directly14descendants
  • K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A · 2012 · cites it directly11descendants
  • K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A · 2014 · 2 generations on8descendants
  • K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc. · 2020 · cites it directly4descendants
  • K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda. · 2019 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K081353Synthes (Usa) Tomofix Medial Distal Femur PlatesSynthes (Usa)2008—
+1K141796Depuy Synthes Tomofix Osteotomy SystemSynthes (USA) Products, LLC2014—
+1K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A2012—
+2K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A2014—
+1K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.2020—
+3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201420
201820
201930
202010
202110
202210
202310
202490
202570
202660
FIG. 1 — Lineage of K081353, 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? (3)

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 TomoFiX Osteotomy System
Named without a submission number
—
*—Synthes Large Fragment Dynamic Compression Locking System
Named without a submission number
—
*—Synthes LCP Distal Femur Plates
Named without a submission number
—

What descends from it? (35)

See all 35

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

NumberDeviceApplicantDecidedDescendants
K141796Depuy Synthes Tomofix Osteotomy SystemSynthes (USA) Products, LLC201414
K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A201211
K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204
K212545FlexitSystem Knee osteotomy systemNeosteo20220
K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190
K131782Loqteq High Tibia Osteotomy Plate 4.5Aap Implantate AG20130

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, K141796 (Synthes (USA) Products, LLC, 2014) has gone furthest, with 14 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?

Synthes TomoFixTM Osteotomy System is intended for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis.

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/K081353 · printed Nov 4, 2026

Cite this page

510(k) Report. “K081353: Synthes (Usa) Tomofix Medial Distal Femur Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081353

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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