510(k) Report

510(k) · Cleared

Cleared

TDM Plate and Screw Systems

K190391510(k) TraditionalCleared Nov 15, 2019269-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

Tdm Co., Ltd. · HRS Plate, Fixation, Bone

Cleared on Nov 15, 2019 as substantially equivalent to K171808 (Tdm Co., Ltd., 2018) and 16 other predicates after a 269-day review. Its family tree reaches back 13 generations to 1996. 1 later device descends from it.

Decided
Nov 15, 2019
Review
269 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
17

Its longest line of descent runs back 13 generations to K962616 (1996). 218 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2018: 2 other ancestors2017: 2 other ancestors2015: 2 other ancestors2014: 3 other ancestors2012: 2 other ancestors2010: 8 other ancestors2009: 11 other ancestors2008: 12 other ancestors2007: 4 other ancestors2006: 11 other ancestors2005: 11 other ancestors2003: 12 other ancestors2013: 2 other ancestors2011: 8 other ancestors2004: 12 other ancestors2002: 9 other ancestors2001: 18 other ancestors2000: 12 other ancestors1999: 8 other ancestors1998: 8 other ancestors1996: 16 other ancestors1979: 2 other ancestors1995: 7 other ancestors1992: 3 other ancestors1991: 1 other ancestor1990: 3 other ancestors1989: 1 other ancestor1997: 5 other ancestors1994: 7 other ancestors1993: 3 other ancestors2024: 1 descendant clearedK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×3: 3 generations cleared close together, K023007 (2002), K030198 (2003), K032705 (2003) ×2: 2 generations cleared close together, K050932 (2005), K051735 (2005) K071563 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2007K090675 · Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories · Smith & Nephew, Inc. · 2009K100776 · Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System · Synthes (Usa) · 2010×3: 3 generations cleared close together, K120070 (2012), K120717 (2012), K120854 (2012) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 16 other ancestors2 generations back: 46 other ancestors3 generations back: 29 other ancestors4 generations back: 30 other ancestors5 generations back: 30 other ancestors6 generations back: 23 other ancestors7 generations back: 18 other ancestors8 generations back: 9 other ancestors9 generations back: 4 other ancestors 1 generation forward: 1 descendant K120854 · Synthes VA LCP Ankle Trauma System · Synthes USA · 2012K120717 · Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates) · Synthes USA · 2012K120070 · Synthes Variable Angle LCP Elbow System · Synthes USA · 2012 · recalledK100776 · Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System · Synthes (Usa) · 2010K090675 · Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories · Smith & Nephew, Inc. · 2009K071563 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2007K051735 · Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity · Smith & Nephew, Inc. · 2005K050932 · Distal Volar Radius Anatomical Plate System · Hand Innovations, Inc. · 2005 · recalledK032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K030198 · Hand Innovations, Inc. Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K023007 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2002K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998K962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996−10−50
  1. Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 9 generations between
  3. 3 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
  4. 2 generations backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
  5. 1 generation backK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
  6. This deviceK190391 TDM Plate and Screw SystemsTdm Co., Ltd. · 2019
  7. Descendant · cites it directly · 0 of its ownK241128 TDM Plate and Screw SystemTdm Co., Ltd. · 2024
Show all 13 generations
  1. Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 12 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 11 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 10 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 9 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 8 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 7 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 6 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  9. 5 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  10. 4 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  11. 3 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
  12. 2 generations backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
  13. 1 generation backK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
  14. This deviceK190391 TDM Plate and Screw SystemsTdm Co., Ltd. · 2019

Most influential descendants

Showing 1 of 1 · See all
  • K241128TDM Plate and Screw SystemTdm Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−12K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−11K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−10K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−9K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−8K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−7K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−6K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007—
−5K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
−4K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010—
−3K120070Synthes Variable Angle LCP Elbow SystemSynthes USA20121
−2K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal…Synthes USA2012—
−1K120854Synthes VA LCP Ankle Trauma SystemSynthes USA2012—
0 (this device)K190391TDM Plate and Screw SystemsTdm Co., Ltd.2019—
+1K241128TDM Plate and Screw SystemTdm Co., Ltd.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197920
198910
199030
199110
199230
199330
199470
199570
1996160
199750
199880
199980
2000120
2001180
200290
2003120
2004120
2005110
2006110
200740
2008120
2009110
201080
201180
201220
201320
201430
201520
201720
201820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
FIG. 1 — Lineage of K190391, 1996–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (17)

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
*K171808TDM Plate and Screw System
Summary page 4
…n appliances and accessories 21 CFR§888.3040 Smooth or threaded metallic bone fixation Fastener PRIMARY PREDICATE K171808 TDM Plate and Screw System DEVICE ADDITIONAL PREDICATE K030310 Synthes Stainless Steel Modular Hand System DEVICES…
Tdm Co., Ltd.2018—
*K030310Synthes Stainless Steel Modular Hand System
Summary page 4
…0 Smooth or threaded metallic bone fixation Fastener PRIMARY PREDICATE K171808 TDM Plate and Screw System DEVICE ADDITIONAL PREDICATE K030310 Synthes Stainless Steel Modular Hand System DEVICES K050110 Synthes (USA) LCP Modular Foot Plates…
Synthes (Usa)2003—
*K050110Synthes (Usa) LCP Modular Foot Plates
Summary page 4
…PRIMARY PREDICATE K171808 TDM Plate and Screw System DEVICE ADDITIONAL PREDICATE K030310 Synthes Stainless Steel Modular Hand System DEVICES K050110 Synthes (USA) LCP Modular Foot Plates K060514 Stryker Plating System K061753 Synt…
Synthes (Usa)20052
*K060514Stryker Plating System
Summary page 4
…ADDITIONAL PREDICATE K030310 Synthes Stainless Steel Modular Hand System DEVICES K050110 Synthes (USA) LCP Modular Foot Plates K060514 Stryker Plating System K061753 Synthes (USA) Clavicle Hook Plate K063049 Synthes…
Howmedica Osteonics Corp.2006—
*K061753Synthes (Usa) Clavicle Hook Plates
Summary page 4
…Modular Hand System DEVICES K050110 Synthes (USA) LCP Modular Foot Plates K060514 Stryker Plating System K061753 Synthes (USA) Clavicle Hook Plate K063049 Synthes (USA) Modular Mini Fragment LCP System…
Synthes (Usa)2006—
*K063049Synthes (Usa) Modular Mini Fragment LCP System
Summary page 4
…LCP Modular Foot Plates K060514 Stryker Plating System K061753 Synthes (USA) Clavicle Hook Plate K063049 Synthes (USA) Modular Mini Fragment LCP System K073186 Synthes 3.5mm LCP Clavicle Plate System…
Synthes (Usa)20064
*K073186Synthes 3.5MM LCP Clavicle Plate System
Summary page 4
…K061753 Synthes (USA) Clavicle Hook Plate K063049 Synthes (USA) Modular Mini Fragment LCP System K073186 Synthes 3.5mm LCP Clavicle Plate System K082807 Synthes (USA) 3.5mm and 4.5mm Locking…
Synthes (Usa)2007—
*K082807Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications
Summary page 4
…K063049 Synthes (USA) Modular Mini Fragment LCP System K073186 Synthes 3.5mm LCP Clavicle Plate System K082807 Synthes (USA) 3.5mm and 4.5mm Locking Compression Plate (LCP) System with Expanded Indications…
Synthes (Usa)2008—
*K083213Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates
Summary page 4
…K082807 Synthes (USA) 3.5mm and 4.5mm Locking Compression Plate (LCP) System with Expanded Indications K083213 Synthes 2.7 mm and 3.5 mm LCP Distal Fibula Plates – Modifications K090047 Synthe…
Synthes (Usa)2008—
*K090047Synthes (Usa) 1.5MM Mini Fragment LCP System
Summary page 4
…h Expanded Indications K083213 Synthes 2.7 mm and 3.5 mm LCP Distal Fibula Plates – Modifications K090047 Synthes (USA) 1.5mm Mini Fragment LCP System P…
Synthes (Usa)2009—
*K1026942.4MM VA-LCP Dorsal Distal Radius Plates
Summary page 5
…Traditional 510(k) Notification K190391 TDM Plate and Screw Systems K102694 Synthes 2.4mm Variable Angle LCP Dorsal Distal Radius Plates K120689 Synthes 3.5 mm…
Synthes (Usa)20103
*K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate System
Summary page 5
…TDM Plate and Screw Systems K102694 Synthes 2.4mm Variable Angle LCP Dorsal Distal Radius Plates K120689 Synthes 3.5 mm VA-LCP Proximal Tibia Plate System K120854 Synthes Variable Angle LCP Ankle Trauma System…
Synthes (USA) Products, LLC2012—
*K120854Synthes VA LCP Ankle Trauma System
Summary page 5
…able Angle LCP Dorsal Distal Radius Plates K120689 Synthes 3.5 mm VA-LCP Proximal Tibia Plate System K120854 Synthes Variable Angle LCP Ankle Trauma System K141735 Arthrex Ankle Fusion Plating System…
Synthes USA2012—
*K141735Arthrex Ankle Fusion Plating System
Summary page 5
…K120689 Synthes 3.5 mm VA-LCP Proximal Tibia Plate System K120854 Synthes Variable Angle LCP Ankle Trauma System K141735 Arthrex Ankle Fusion Plating System K150099 DePuy Synthes Variable Angle Locking Hand System…
Arthrex, Inc.20141
*K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)
Summary page 5
…m K120854 Synthes Variable Angle LCP Ankle Trauma System K141735 Arthrex Ankle Fusion Plating System K150099 DePuy Synthes Variable Angle Locking Hand System (1.3mm and 2.0mm Plates and Screws)…
Synthes (USA) Products, LLC2015—
*K163293Colink™ Plating System
Summary page 5
…System K150099 DePuy Synthes Variable Angle Locking Hand System (1.3mm and 2.0mm Plates and Screws) K163293 In2Bones Colink Plating System K180310 DePuy Synthes Trauma Orthopedic Plates and Screws DEVICE DESCRIPT…
In2bones USA, LLC20172
*K180310DePuy Synthes Trauma Orthopedic Plates and Screws
Summary page 5
…Angle Locking Hand System (1.3mm and 2.0mm Plates and Screws) K163293 In2Bones Colink Plating System K180310 DePuy Synthes Trauma Orthopedic Plates and Screws DEVICE DESCRIPTION The TDM Plates and Screw System consists of a family of…
Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.2018—

Also cleared against K171808: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K241128TDM Plate and Screw SystemTdm Co., Ltd.20240

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 23 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
  • 37 of the 218 ancestors have a recall of any class.
  • Of its descendants, K241128 (Tdm Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K171808.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?

Mini and Mid Locking Plate and Screw System:

The Mini and Mid Locking Plate and Screw System is intended to be used in the hands, wrist, and small bones in the foot.

Small Locking Plate and Screw System:

The Small Locking Plate and Screw System is indicated for the clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula.

The TDM Screws (1.5mm and larger, solid) are intended to be used with the plate for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K171808

3 other devices cite the same predicate.

  • K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
  • K241128TDM Plate and Screw SystemTdm Co., Ltd. · 2024
  • K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc. · 2022

More from Tdm Co., Ltd.

14 FDA decisions under this applicant name. See the company

  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K241128TDM Plate and Screw SystemTdm Co., Ltd. · 2024
  • K230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus…Tdm Co., Ltd. · 2024

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/K190391 · printed Nov 4, 2026

Cite this page

510(k) Report. “K190391: TDM Plate and Screw Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190391

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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