510(k) · Cleared

Recalled · Class II · 2013

Synthes Tomofix Osteotomy System

K023941510(k) TraditionalCleared Jan 23, 200358-day reviewClass II21 CFR 888.3030Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Synthes (Usa) · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Jan 23, 2003 after a 58-day review. The FDA summary names its predicate without a number. 39 later devices descend from it. It has been recalled once.

Decided: Jan 23, 2003
Review: 58 days
Class: Class II
Product code: KTT
Recalls: 1
Predicates: 0

39 later devices descend from it, 9 citing it directly.

This deviceK023941 Synthes Tomofix Osteotomy SystemSynthes (Usa) · 2003
Descendant · cites it directly · 14 of its ownK141796 Depuy Synthes Tomofix Osteotomy SystemSynthes (USA) Products, LLC · 2014
Descendant · cites it directly · 11 of its ownK113733 Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A · 2012
Descendant · 2 generations on · 8 of its ownK142419 Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A · 2014
Descendant · cites it directly · 5 of its ownK041601 Surfix Knee Osteotomy SystemSurfix Technologies · 2004
Descendant · cites it directly · 4 of its ownK193614 FINE Osteotomy around the kneeBodycad Laboratories, Inc. · 2020

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

2004high 9 (2024) · low 0 (2005)2026

Most influential descendants

Showing 5 of 39 · 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
K041601Surfix Knee Osteotomy SystemSurfix Technologies · 2004 · cites it directly5descendants
K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc. · 2020 · cites it directly4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K023941	Synthes Tomofix Osteotomy System	Synthes (Usa)	2003	—
+1	K141796	Depuy Synthes Tomofix Osteotomy System	Synthes (USA) Products, LLC	2014	—
+1	K113733	Small and Large Fragments Osteosynthesis System Neofix	Neoortho Produtos Ortopedicos S/A	2012	—
+2	K142419	Mini and Micro Fragments Reconstruction System-NEOFIX	Neoortho Productos Orthopedicos S/A	2014	—
+1	K041601	Surfix Knee Osteotomy System	Surfix Technologies	2004	—
+1	K193614	FINE Osteotomy around the knee	Bodycad Laboratories, Inc.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2012	1	0
2013	1	0
2014	2	0
2015	1	0
2018	3	0
2019	2	0
2020	1	0
2021	2	0
2022	1	0
2023	1	0
2024	9	0
2025	8	0
2026	6	0

FIG. 1 — Lineage of K023941, 2003–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 KTT? 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 KTT device

#1 K242861 TrueLok Elevatescore 21.3 · 14 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (4)

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.

Type	Number	Device	Recalls
*	—	Anatomical Locking Plate System Named without a submission number	—
*	—	Synthes Locking Condylar Plates Named without a submission number	—
*	—	Synthes Large Fragment LCP System Named without a submission number	—
*	—	Synthes LCP Proximal Tibia Plate Named without a submission number	—

What descends from it? (39)

See all 39

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

Number	Device	Applicant	Decided	Descendants
K141796	Depuy Synthes Tomofix Osteotomy System	Synthes (USA) Products, LLC	2014	14
K113733	Small and Large Fragments Osteosynthesis System Neofix	Neoortho Produtos Ortopedicos S/A	2012	11
K041601	Surfix Knee Osteotomy System	Surfix Technologies	2004	5
K193614	FINE Osteotomy around the knee	Bodycad Laboratories, Inc.	2020	4
K180310	DePuy Synthes Trauma Orthopedic Plates and Screws	Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.	2018	4
K252897	APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation…	A Plus Biotechnology Co., Ltd.	2025	0
K212545	FlexitSystem Knee osteotomy system	Neosteo	2022	0
K180213	Titanium TomoFix Medial High Tibia Plate Anatomical	Synthes (USA) Products, LLC	2018	0
K131782	Loqteq High Tibia Osteotomy Plate 4.5	Aap Implantate AG	2013	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 9, 2013	Class II	Z-0473-2014	Labeling False and Misleading	A labeling correction was initiated related to the Surgical Technique Guide J5606-C "TomoFix Osteotomy System" due to the potential for a surgical delay if the surgeon inserts the superior screws at a lesser angle (4 or 6 degrees) and is…

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 KTT devices

KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KTT

10in 2025

2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007high 200 (2020) · low 25 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KTT

2in 2021

2007high 14 (2018) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KTT

673in 2025

2007high 961 (2021) · low 45 (2007)2025

MAUDE reports naming product code KTT, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	9	55	2	45
2008	11	73	1	66
2009	11	94	2	45
2010	12	148	1	121
2011	10	157	0	196
2012	9	140	4	527
2013	7	87	7	898
2014	14	129	0	445
2015	12	60	0	401
2016	10	142	0	400
2017	11	184	1	485
2018	6	149	14	597
2019	8	110	3	800
2020	9	200	0	942
2021	10	83	2	961
2022	3	25	0	627
2023	7	29	0	554
2024	5	90	0	523
2025	10	88	0	673
2026	5	68	11	—

What is it indicated for?

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023941 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023941: Synthes Tomofix Osteotomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023941

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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