510(k) · Cleared
ClearedTreace Medical Concepts (TMC) Screw Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Treace Medical Concepts, Inc. · HWC Screw, Fixation, Bone
Cleared on Mar 6, 2026 as substantially equivalent to K242671 (Treace Medical Concepts, Inc., 2024) and 2 other predicates after a 30-day review. Its family tree reaches back 14 generations to 1996.
- Decided
- Mar 6, 2026
- Review
- 30 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K962616 (1996). 242 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations between
- 3 generations backK172617 Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc. · 2017
- 2 generations backK213036 Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc. · 2021
- 1 generation backK242671 Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc. · 2024
- This deviceK260361 Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc. · 2026
Show all 14 generations
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 13 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 12 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 11 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 8 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 7 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 6 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 5 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 4 generations backK124027 Monster Screw SystemApogee Orthosolutions · 2013
- 3 generations backK172617 Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc. · 2017
- 2 generations backK213036 Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc. · 2021
- 1 generation backK242671 Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc. · 2024
- This deviceK260361 Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −13 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −12 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −11 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −8 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −7 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −6 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −5 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| −4 | K124027 | Monster Screw System | Apogee Orthosolutions | 2013 | — |
| −3 | K172617 | Treace Medical Concepts (TMC) Compression Screw System | Treace Medical Concepts, Inc. | 2017 | — |
| −2 | K213036 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | 2021 | — |
| −1 | K242671 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | 2024 | — |
| 0 (this device) | K260361 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 4 | 0 |
| 1991 | 1 | 0 |
| 1992 | 6 | 0 |
| 1993 | 4 | 0 |
| 1994 | 8 | 0 |
| 1995 | 9 | 0 |
| 1996 | 20 | 0 |
| 1997 | 7 | 0 |
| 1998 | 9 | 0 |
| 1999 | 13 | 0 |
| 2000 | 10 | 0 |
| 2001 | 18 | 0 |
| 2002 | 12 | 0 |
| 2003 | 9 | 0 |
| 2004 | 10 | 0 |
| 2005 | 17 | 0 |
| 2006 | 15 | 0 |
| 2007 | 9 | 0 |
| 2008 | 6 | 0 |
| 2009 | 8 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2020 | 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? (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 |
|---|---|---|---|
| * | K242671 | Treace Medical Concepts (TMC) Screw Fixation SystemSummary page 5…l: 87- Orthopedic Product Code(s): HWC Predicate Device(s): Primary Predicate: Treace Medical Concepts (TMC) Screw Fixation System (K242671, S.E. 10/04/2024) Additional Predicates: Arthrex Inc., Arthrex Compression FT Screws (K201132, S.E. 07/27/2020) Skeletal Dynamic… | 2024 |
| * | K201132 | Arthrex Compression ScrewsSummary page 5…): Primary Predicate: Treace Medical Concepts (TMC) Screw Fixation System (K242671, S.E. 10/04/2024) Additional Predicates: Arthrex Inc., Arthrex Compression FT Screws (K201132, S.E. 07/27/2020) Skeletal Dynamics, REDUCT™ Headless Compression Screw System (K143624, S.E. 01/13/2015) Device Description: Tr… | 2020 |
| * | K143624 | Headless Compression Screw SystemSummary page 5…10/04/2024) Additional Predicates: Arthrex Inc., Arthrex Compression FT Screws (K201132, S.E. 07/27/2020) Skeletal Dynamics, REDUCT™ Headless Compression Screw System (K143624, S.E. 01/13/2015) Device Description: Treace Medical Concepts (TMC) Screw Fixation System includes headed and headless, cannulat… | 2015 |
| † | K251135 | Treace Medical Concepts (TMC) Implant Fixation System | 2025 |
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 30 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 40 of the 242 ancestors have a recall of any class.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 TMC Screw Fixation System is intended for primary and revision fracture fixation and repair, joint fusions (arthrodesis), bone reconstructions, osteotomies, pseudoarthroses (non-unions), and ligament fixation. The System is indicated for use in adult and pediatric patients > 12 years of age at the following anatomical sites: * Upper extremity: glenoid, humerus, ulna, radius, and hand * Lower extremity: tibia, fibula, patella, ankle, and foot.…
Read the full statement (109 words)
The TMC Screw Fixation System is intended for primary and revision fracture fixation and repair, joint fusions (arthrodesis), bone reconstructions, osteotomies, pseudoarthroses (non-unions), and ligament fixation. The System is indicated for use in adult and pediatric patients > 12 years of age at the following anatomical sites:
* Upper extremity: glenoid, humerus, ulna, radius, and hand
* Lower extremity: tibia, fibula, patella, ankle, and foot. Indicated procedures include:
o Fusions (e.g., talocalcaneal, talonavicular, naviculocuneiform, calcanealcuboid, tarsometatarsal, metatarsophalangeal, and interphalangeal)
o Mono or bi-cortical osteotomies of the tarsals, metatarsals, and phalanges (e.g., Scarf, Chevron, Akin, Weil, and Transverse osteotomies for hallux valgus, tailor's bunion, metatarsus adductus, flatfoot, and hammertoe deformities).
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/K260361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260361: Treace Medical Concepts (TMC) Screw Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260361
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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