510(k) · Cleared
ClearedTDM Large Bone Plate and Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tdm Co., Ltd. · HRS Plate, Fixation, Bone
Cleared on Apr 5, 2024 as substantially equivalent to K141796 (Synthes (USA) Products, LLC, 2014) and 6 other predicates after a 266-day review. Its family tree reaches back 12 generations to 1996.
- Decided
- Apr 5, 2024
- Review
- 266 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 12 generations to K962616 (1996). 102 ancestors in all, the oldest K885250 (1989). No later device cites it as a predicate yet.
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations between
- 3 generations backK171285 ARIX Diaphysis SystemJeil Medical Corporation · 2017
- 2 generations backK172008 ARIX Humerus SystemJeil Medical Corporation · 2017
- 1 generation backK202912 ARIX Ankle Distal Tibia SystemJeil Medical Corporation · 2020
- This deviceK232115 TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2024
Show all 12 generations
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK051567 Aptus Titanium Osteosynthesis SystemMedartis, Inc. · 2005 · Recalled
- 7 generations backK062498 Profyle SystemHowmedica Osteonics Corp. · 2006 · Recalled
- 6 generations backK073527 Variax Elbow SystemHowmedica Osteonics Corp. · 2008
- 5 generations backK101056 Variax Elbow SystemHowmedica Osteonics Corp. · 2010
- 4 generations backK112560 Aptus (R) Distal Humerus SystemMedartis AG · 2011
- 3 generations backK171285 ARIX Diaphysis SystemJeil Medical Corporation · 2017
- 2 generations backK172008 ARIX Humerus SystemJeil Medical Corporation · 2017
- 1 generation backK202912 ARIX Ankle Distal Tibia SystemJeil Medical Corporation · 2020
- This deviceK232115 TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −11 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −10 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −9 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K051567 | Aptus Titanium Osteosynthesis System | Medartis, Inc. | 2005 | 1 |
| −7 | K062498 | Profyle System | Howmedica Osteonics Corp. | 2006 | 1 |
| −6 | K073527 | Variax Elbow System | Howmedica Osteonics Corp. | 2008 | — |
| −5 | K101056 | Variax Elbow System | Howmedica Osteonics Corp. | 2010 | — |
| −4 | K112560 | Aptus (R) Distal Humerus System | Medartis AG | 2011 | — |
| −3 | K171285 | ARIX Diaphysis System | Jeil Medical Corporation | 2017 | — |
| −2 | K172008 | ARIX Humerus System | Jeil Medical Corporation | 2017 | — |
| −1 | K202912 | ARIX Ankle Distal Tibia System | Jeil Medical Corporation | 2020 | — |
| 0 (this device) | K232115 | TDM Large Bone Plate and Screw System | Tdm Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 8 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 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? (7)
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 |
|---|---|---|---|
| * | K141796 | Depuy Synthes Tomofix Osteotomy SystemSummary page 4…(primary) ▪ HWC Identification of the predicate (21 CFR 807.92(a)(3)) 5.2 Primary Predicate Device o K141796, “DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM”, manufactured by “SYNTHES (USA) PRODUCTS LLC” … | 2014 |
| * | K112406 | Peri-Loc Proximal Femur Locking Bone PlatesSummary page 4…THES TOMOFIX OSTEOTOMY SYSTEM”, manufactured by “SYNTHES (USA) PRODUCTS LLC” Additional Predicate Devices o K112406, “PERI-LOC TM Periarticular Lacked Plating System - Proximal Femur Lacking Bone Plate” , manufactured by “S… | 2011 |
| * | K210043 | LOQTEQ Distal Lateral Femur Plate 4.5 SystemSummary page 4…“PERI-LOC TM Periarticular Lacked Plating System - Proximal Femur Lacking Bone Plate” , manufactured by “Smith & Nephew, Inc.” o K210043, "LOQTEQ® Distal Lateral Femur Plate 4.5 System", manufactured by "AAP Implantate AG" o K… | 2021 |
| * | K080522 | Synthes 3.5 MM LCP Distal Tibia T PlatesSummary page 4…Nephew, Inc.” o K210043, "LOQTEQ® Distal Lateral Femur Plate 4.5 System", manufactured by "AAP Implantate AG" o K080522, "Synthes 3.5 mm LCP Distal Tibia T Plates", manufactured by "Synthes (USA)"… | 2008 |
| * | K202912 | ARIX Ankle Distal Tibia SystemSummary page 5…"Synthes (USA)" 1 / 4 o K202912, "ARIX Ankle Distal Tibia System", manufactured by "Jeil Medical Corporation" o K213059, "T… | 2020 |
| * | K213059 | Tibia and Fibula SystemSummary page 5…1 / 4 o K202912, "ARIX Ankle Distal Tibia System", manufactured by "Jeil Medical Corporation" o K213059, "Tibia and Fibula System", manufactured by "Auxein Medical Private Limited" o K082624, "Sy… | 2023 |
| * | K082624 | Synthes (Usa) 3.5MM LCP Posteromedial Proximal Tibia PlatesSummary page 5…Corporation" o K213059, "Tibia and Fibula System", manufactured by "Auxein Medical Private Limited" o K082624, "Synthes (USA) 3.5mm LCP Posteromedial Proximal Tibia PlatesPlates", manufactured by "Synthes (USA)"… | 2008 |
| † | K171808 | TDM Plate and Screw System | 2018 |
| † | K190391 | TDM Plate and Screw Systems | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 28 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- 21 of the 102 ancestors have a recall of any class.
- 6 other devices also cite its predicate K141796.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 TopFix System is indicated for the fixation of fractures and osteotomies of the distal femur and proximal tibia related to the treatment of bone and joint deformities and / or malalignment caused by injury or disease (e.g., osteoarthritis). The Trifix Large System is indicated for the fixation of fractures (including periprosthetic), non-unions, and malunions of the femur and tibia in adult patients with normal or osteopenic bone. The Newnecks System…
Read the full statement (100 words)
The TopFix System is indicated for the fixation of fractures and osteotomies of the distal femur and proximal tibia related to the treatment of bone and joint deformities and / or malalignment caused by injury or disease (e.g., osteoarthritis).
The Trifix Large System is indicated for the fixation of fractures (including periprosthetic), non-unions, and malunions of the femur and tibia in adult patients with normal or osteopenic bone.
The Newnecks System is indicated for the fixation of fractures of the femoral trochanteric region (e.g., simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multi-fragmentary, and fractures with associated medial cortex instability).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232115 · printed Nov 3, 2026
Cite this page
510(k) Report. “K232115: TDM Large Bone Plate and Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K232115
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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