510(k) · Cleared
ClearedDepuy Synthes Tomofix Osteotomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (USA) Products, LLC · HRS Plate, Fixation, Bone
Cleared on Aug 29, 2014 as substantially equivalent to K081353 (Synthes (Usa), 2008) and 2 other predicates after a 57-day review. Its family tree reaches back 1 generation to 2000. 14 later devices descend from it.
- Decided
- Aug 29, 2014
- Review
- 57 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K000682 (2000). 3 ancestors in all. 14 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK000682 Synthes Large Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000
- This deviceK141796 Depuy Synthes Tomofix Osteotomy SystemSynthes (USA) Products, LLC · 2014
- Descendant · cites it directly · 4 of its ownK180310 DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK241356 Fine Osteotomy™Bodycad Laboratories, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK250923 Fine Osteotomy™Bodycad Laboratories, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK243995 Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK190391 TDM Plate and Screw SystemsTdm Co., Ltd. · 2019
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2018 · cites it directly4descendants
- K241356Fine Osteotomy™Bodycad Laboratories, Inc. · 2024 · cites it directly3descendants
- K250923Fine Osteotomy™Bodycad Laboratories, Inc. · 2025 · 2 generations on1descendant
- K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc. · 2025 · 2 generations on1descendant
- K190391TDM Plate and Screw SystemsTdm Co., Ltd. · 2019 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000682 | Synthes Large Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | — |
| 0 (this device) | K141796 | Depuy Synthes Tomofix Osteotomy System | Synthes (USA) Products, LLC | 2014 | — |
| +1 | K180310 | DePuy Synthes Trauma Orthopedic Plates and Screws | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2018 | — |
| +1 | K241356 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2024 | — |
| +2 | K250923 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2025 | — |
| +2 | K243995 | Arthrex Humeral Plating System and Cerclage Button | Arthrex, Inc. | 2025 | — |
| +2 | K190391 | TDM Plate and Screw Systems | Tdm Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 2 | 0 |
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 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K081353 | Synthes (Usa) Tomofix Medial Distal Femur PlatesSummary page 4…Single / multiple component metallic bone fixation appliance and accessories. Predicate Devices: Synthes TOMOFIX Medial Distal Femur Plates (K081353) Synthes TOMOFIX Osteotomy System (K023941) Synthes Large Fragment Dynamic Compress… | 2008 |
| * | K023941 | Synthes Tomofix Osteotomy SystemSummary page 4…accessories. Predicate Devices: Synthes TOMOFIX Medial Distal Femur Plates (K081353) Synthes TOMOFIX Osteotomy System (K023941) Synthes Large Fragment Dynamic Compression Locking System (K000682) Device Descr… | 2003 |
| * | K000682 | Synthes Large Fragment Dynamic Compression Locking (DCL) SystemSummary page 4…Synthes TOMOFIX Osteotomy System (K023941) Synthes Large Fragment Dynamic Compression Locking System (K000682) Device Description: The DePuy Synthes TOMOFIX Osteotomy System consists of five different titanium pl… | 2000 |
What descends from it? (14)
See all 147 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The DePuy Synthes TOMOFIX Osteotomy System is intended for osteotomies, treatment of bone and joint deformities, fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia. Specifically, - The TOMOFIX Medial Proximal Tibia Plates are indicated for open- and closed-wedge osteotomies fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the…
Read the full statement (162 words)
The DePuy Synthes TOMOFIX Osteotomy System is intended for osteotomies, treatment of bone and joint deformities, fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia.
Specifically,
- The TOMOFIX Medial Proximal Tibia Plates are indicated for open- and closed-wedge osteotomies fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the medial proximal tibia
- The TOMOFIX Lateral Proximal Tibia Plates are indicated for open- and closed-wedge osteotomies, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the lateral proximal tibia
- The TOMOFIX Lateral Distal Femur Plates are indicated for open-and closed-wedge osteotomies, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the lateral distal femur
- The TOMOFIX Medial Distal Femur Plates are indicated for closed-wedge osteotomies, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the medial distal femur
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141796 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141796: Depuy 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/K141796
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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