510(k) · Cleared
ClearedTDM Screw Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tdm Co., Ltd. · HWC Screw, Fixation, Bone
Cleared on Sep 13, 2019 as substantially equivalent to K161616 (Synthes USA Products, LLC, 2017) and 5 other predicates after a 165-day review. Its family tree reaches back 12 generations to 1996. 1 later device descends from it.
- Decided
- Sep 13, 2019
- Review
- 165 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 12 generations to K962616 (1996). 141 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations between
- 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 2 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- 1 generation backK161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm…Synthes USA Products, LLC · 2017
- This deviceK190830 TDM Screw SystemsTdm Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK231860 TDM 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 backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 5 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 4 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 2 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- 1 generation backK161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm…Synthes USA Products, LLC · 2017
- This deviceK190830 TDM Screw SystemsTdm Co., Ltd. · 2019
Most influential descendants
Showing 1 of 1 · See all- K231860TDM 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 | 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 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −6 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −5 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −4 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −3 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −2 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| −1 | K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated… | Synthes USA Products, LLC | 2017 | — |
| 0 (this device) | K190830 | TDM Screw Systems | Tdm Co., Ltd. | 2019 | — |
| +1 | K231860 | TDM Screw System | Tdm Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1981 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 7 | 0 |
| 1996 | 14 | 0 |
| 1997 | 1 | 0 |
| 1998 | 7 | 0 |
| 1999 | 6 | 0 |
| 2000 | 10 | 0 |
| 2001 | 11 | 0 |
| 2002 | 8 | 0 |
| 2003 | 6 | 0 |
| 2004 | 5 | 0 |
| 2005 | 7 | 0 |
| 2006 | 9 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Summary page 4…NAME HTN; 21 CFR§888.3030 Single/multiple component metallic bone fixation appliances and accessories PRIMARY PREDICATE K161616 Synthes Cannulated, Cortex, and Headless DEVICES Compression Screws ADDITIONAL PREDICATE K123890 Acumed Cannu… | 2017 |
| * | K123890 | Acumed Cannulated Screw SystemSummary page 4…appliances and accessories PRIMARY PREDICATE K161616 Synthes Cannulated, Cortex, and Headless DEVICES Compression Screws ADDITIONAL PREDICATE K123890 Acumed Cannulated Screw System DEVICES K021556 Synthes 2.4mm Cannulated Compression Screw… | 2013 |
| * | K021556 | Synthes 2.4 MM Cannulated Compression ScrewSummary page 4…nthes Cannulated, Cortex, and Headless DEVICES Compression Screws ADDITIONAL PREDICATE K123890 Acumed Cannulated Screw System DEVICES K021556 Synthes 2.4mm Cannulated Compression Screw K050636 Synthes 3.0mm Headless Compression Screws… | 2002 |
| * | K050636 | Synthes 3.0MM Headless Compression ScrewsSummary page 4…Screws ADDITIONAL PREDICATE K123890 Acumed Cannulated Screw System DEVICES K021556 Synthes 2.4mm Cannulated Compression Screw K050636 Synthes 3.0mm Headless Compression Screws K080943 Synthes 4.5 mm and 6.5 mm Headless Compression… | 2005 |
| * | K080943 | Synthes 4.5 MM and 6.5 MM Headless Compression ScrewsSummary page 4…VICES K021556 Synthes 2.4mm Cannulated Compression Screw K050636 Synthes 3.0mm Headless Compression Screws K080943 Synthes 4.5 mm and 6.5 mm Headless Compression Screws K063020 INTAI Bone Screw Sy… | 2008 |
| * | K063020 | Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate SystemSummary page 4…s 3.0mm Headless Compression Screws K080943 Synthes 4.5 mm and 6.5 mm Headless Compression Screws K063020 INTAI Bone Screw System DEVICE DESCRIPTION The TDM Screw Systems consist of a family of devices intended… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231860 | TDM Screw System | 2024 | 0 |
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 7 companies; a new generation was cleared every 1.8 years on median.
- 23 of the 141 ancestors have a recall of any class.
- Of its descendants, K231860 (Tdm Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 17 other devices also cite its predicate K161616.
How does its category compare?
All HWC devicesHWC Screw, 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 · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The TDM Screw Systems are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of bones appropriate for the size of the device. Cannulated Screw System: The Cannulated Screw System is intended to be used for fracture of small bones of the hand or foot (2.5mm) or small and large bones (4.0mm larger). Headless Compression Cannulated Screw System: The Headless Compression Cannulated Screw System is intended to be used for a…
Read the full statement (135 words)
The TDM Screw Systems are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of bones appropriate for the size of the device.
Cannulated Screw System:
The Cannulated Screw System is intended to be used for fracture of small bones of the hand or foot (2.5mm) or small and large bones (4.0mm larger).
Headless Compression Cannulated Screw System:
The Headless Compression Cannulated Screw System is intended to be used for a wide range of different indications in the hand, wrist and joint fusion (arthrodeses) in the foot (2.3mm & 3.5mm, 3.0mm & 4.0mm) and fixation of intra-articular fractures of the humerus, femur and tibia (3.5mm & 5.0mm).
Limited Sliding Screw System:
The Limited Sliding Screw System is intended to be used for fracture fixation of the proximal femur, large bones and large bone fragments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190830 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190830: TDM Screw Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190830
Report an extraction error
Are you the manufacturer?
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