510(k) · Cleared
ClearedTDM 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 Mar 15, 2018 as substantially equivalent to K123241 (Arthrex, Inc., 2013) and 8 other predicates after a 269-day review. Its family tree reaches back 12 generations to 2000. 6 later devices descend from it.
- Decided
- Mar 15, 2018
- Review
- 269 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 12 generations to K000684 (2000). 95 ancestors in all, the oldest K792022 (1979). 6 later devices descend from it, 4 citing it directly.
- Root · 12 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 8 generations between
- 3 generations backK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- 2 generations backK141478 Arthrex Fracture Plates and ScrewsArthrex, Inc. · 2014 · Recalled
- 1 generation backK151732 Arthrex Fracture PlatesArthrex, Inc. · 2015
- This deviceK171808 TDM Plate and Screw SystemTdm Co., Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
- Descendant · cites it directly · 1 of its ownK190391 TDM Plate and Screw SystemsTdm Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK261830 FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate…Ortler Global Tibbi Gerecler Anonim Sirketi · 2026
- Descendant · 2 generations on · 0 of its ownK260277 Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti. · 2026
- Descendant · cites it directly · 0 of its ownK241128 TDM Plate and Screw SystemTdm Co., Ltd. · 2024
Show all 12 generations
- Root · 12 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 11 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 10 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 9 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 8 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 7 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 6 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
- 5 generations backK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- 4 generations backK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- 3 generations backK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- 2 generations backK141478 Arthrex Fracture Plates and ScrewsArthrex, Inc. · 2014 · Recalled
- 1 generation backK151732 Arthrex Fracture PlatesArthrex, Inc. · 2015
- This deviceK171808 TDM Plate and Screw SystemTdm Co., Ltd. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024 · cites it directly2descendants
- K190391TDM Plate and Screw SystemsTdm Co., Ltd. · 2019 · cites it directly1descendant
- K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi · 2026 · 2 generations on0descendants
- K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti. · 2026 · 2 generations on0descendants
- K241128TDM Plate and Screw SystemTdm Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −11 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −10 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −9 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −8 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −7 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −6 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| −5 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| −4 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
| −3 | K123241 | Arthrex Fracture Plates | Arthrex, Inc. | 2013 | — |
| −2 | K141478 | Arthrex Fracture Plates and Screws | Arthrex, Inc. | 2014 | 1 |
| −1 | K151732 | Arthrex Fracture Plates | Arthrex, Inc. | 2015 | — |
| 0 (this device) | K171808 | TDM Plate and Screw System | Tdm Co., Ltd. | 2018 | — |
| +1 | K242939 | ARTFX Trauma Bone Plate and Screw System | Artfx Medical | 2024 | — |
| +1 | K190391 | TDM Plate and Screw Systems | Tdm Co., Ltd. | 2019 | — |
| +2 | K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System… | Ortler Global Tibbi Gerecler Anonim Sirketi | 2026 | — |
| +2 | K260277 | Mikron Trauma Bone Plate& Screw System | Mikron Makina San. ve Tic. Ltd. Sti. | 2026 | — |
| +1 | K241128 | TDM Plate and Screw System | Tdm Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 13 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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? (9)
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 |
|---|---|---|---|
| * | K123241 | Arthrex Fracture PlatesSummary page 4…ies 21 CFR§888.3040 Smooth or threaded metallic bone fixation Fastener PREDICATE DEVICE(S) Arthrex Fracture Plates (K123241 (subsequently cleared under K141478 & K151732) Arthrex Ankle Fusion Plating Syste… | 2013 |
| * | K141478 | Arthrex Fracture Plates and ScrewsSummary page 4…ded metallic bone fixation Fastener PREDICATE DEVICE(S) Arthrex Fracture Plates (K123241 (subsequently cleared under K141478 & K151732) Arthrex Ankle Fusion Plating System (K141735) Biomet A.L.P.S Calcaneal… | 2014 |
| * | K151732 | Arthrex Fracture PlatesSummary page 4…ic bone fixation Fastener PREDICATE DEVICE(S) Arthrex Fracture Plates (K123241 (subsequently cleared under K141478 & K151732) Arthrex Ankle Fusion Plating System (K141735) Biomet A.L.P.S Calcaneal Plating S… | 2015 |
| * | K141735 | Arthrex Ankle Fusion Plating SystemSummary page 4…) Arthrex Fracture Plates (K123241 (subsequently cleared under K141478 & K151732) Arthrex Ankle Fusion Plating System (K141735) Biomet A.L.P.S Calcaneal Plating System (K132898) Hand Innovations Distal Radius… | 2014 |
| * | K132898 | A.L.P.S. Calcaneal Plating SystemSummary page 4…K141478 & K151732) Arthrex Ankle Fusion Plating System (K141735) Biomet A.L.P.S Calcaneal Plating System (K132898) Hand Innovations Distal Radius Fracture Repair Kit (K030198) Synthes Calcaneal P… | 2013 |
| * | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair SystemSummary page 4…ng System (K141735) Biomet A.L.P.S Calcaneal Plating System (K132898) Hand Innovations Distal Radius Fracture Repair Kit (K030198) Synthes Calcaneal Plate (K020401) Synthes (USA) Clavicle Hook Plate (K061753)… | 2003 |
| * | K020401 | Synthes Calcaneal PlateSummary page 4…Calcaneal Plating System (K132898) Hand Innovations Distal Radius Fracture Repair Kit (K030198) Synthes Calcaneal Plate (K020401) Synthes (USA) Clavicle Hook Plate (K061753) Synthes (USA) 1.5mm Mini Fragment LC… | 2002 |
| * | K061753 | Synthes (Usa) Clavicle Hook PlatesSummary page 4…ovations Distal Radius Fracture Repair Kit (K030198) Synthes Calcaneal Plate (K020401) Synthes (USA) Clavicle Hook Plate (K061753) Synthes (USA) 1.5mm Mini Fragment LCP System (K090047) DEVICE DESCRIPTION The TDM Plates and Screw… | 2006 |
| * | K090047 | Synthes (Usa) 1.5MM Mini Fragment LCP SystemSummary page 4…nthes Calcaneal Plate (K020401) Synthes (USA) Clavicle Hook Plate (K061753) Synthes (USA) 1.5mm Mini Fragment LCP System (K090047) DEVICE DESCRIPTION The TDM Plates and Screw System consists of a family of flat and contoured plat… | 2009 |
What descends from it? (6)
4 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?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 16 of the 95 ancestors have a recall of any class.
- Of its descendants, K242939 (Artfx Medical, 2024) has gone furthest, with 2 descendants of its own.
- 13 other devices also cite its predicate K123241.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
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, calcaneous, fibula and other small bones.
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, calcaneous, femur and fibula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171808 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171808: TDM Plate and Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171808
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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