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 Oct 21, 2021 as substantially equivalent to K172617 (Treace Medical Concepts, Inc., 2017) after a 30-day review. Its family tree reaches back 12 generations to 1996. 7 later devices descend from it.
- Decided
- Oct 21, 2021
- Review
- 30 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K962616 (1996). 178 ancestors in all, the oldest K792022 (1979). 7 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations between
- 3 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 2 generations backK124027 Monster Screw SystemApogee Orthosolutions · 2013
- 1 generation backK172617 Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc. · 2017
- This deviceK213036 Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc. · 2021
- Descendant · cites it directly · 4 of its ownK240173 Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc. · 2024 · Recalled
- Descendant · 2 generations on · 3 of its ownK242415 TMC Compression Implant SystemTreace Medical Concepts · 2024
- Descendant · 3 generations on · 2 of its ownK243658 TMC Compression Implant SystemTreace Medical Concepts · 2024
- Descendant · 2 generations on · 1 of its ownK251135 Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts · 2025
- Descendant · cites it directly · 1 of its ownK242671 Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc. · 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 backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 2 generations backK124027 Monster Screw SystemApogee Orthosolutions · 2013
- 1 generation backK172617 Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc. · 2017
- This deviceK213036 Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc. · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc. · 2024 · cites it directly4descendants
- K242415TMC Compression Implant SystemTreace Medical Concepts · 2024 · 2 generations on3descendants
- K243658TMC Compression Implant SystemTreace Medical Concepts · 2024 · 3 generations on2descendants
- K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts · 2025 · 2 generations on1descendant
- K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc. · 2024 · cites it directly1descendant
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 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| −2 | K124027 | Monster Screw System | Apogee Orthosolutions | 2013 | — |
| −1 | K172617 | Treace Medical Concepts (TMC) Compression Screw System | Treace Medical Concepts, Inc. | 2017 | — |
| 0 (this device) | K213036 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | 2021 | — |
| +1 | K240173 | Treace Medical Systems (TMC) Plating System | Treace Medical Concepts, Inc. | 2024 | 1 |
| +2 | K242415 | TMC Compression Implant System | Treace Medical Concepts | 2024 | — |
| +3 | K243658 | TMC Compression Implant System | Treace Medical Concepts | 2024 | — |
| +2 | K251135 | Treace Medical Concepts (TMC) Implant Fixation System | Treace Medical Concepts | 2025 | — |
| +1 | K242671 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | 2024 | — |
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 | 4 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 14 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 9 | 0 |
| 2000 | 10 | 0 |
| 2001 | 12 | 0 |
| 2002 | 11 | 0 |
| 2003 | 6 | 0 |
| 2004 | 6 | 0 |
| 2005 | 14 | 0 |
| 2006 | 15 | 0 |
| 2007 | 8 | 0 |
| 2008 | 6 | 0 |
| 2009 | 7 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 4 | 0 |
| 2025 | 1 | 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 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? (1)
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 |
|---|---|---|---|
| * | K172617 | Treace Medical Concepts (TMC) Compression Screw SystemSummary page 4…tallic bone fixation fastener) Panel: 87- Orthopedic Product Code: HWC Primary Predicate: K172617 TMC Compression Screw System Device Description: Treace Medical Concepts (TMC) Screw Fixation System includes headed and headles… | 2017 |
What descends from it? (7)
2 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 25 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 32 of the 178 ancestors have a recall of any class.
- Of its descendants, K240173 (Treace Medical Concepts, Inc., 2024) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K172617.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Treace Medical Concepts (TMC) Screw Fixation System is intended for use for adult and pediatric patients aged >12 years, and indicated for small or long bones requiring fixation of fractures, fracture repair, revision procedures, joint fusions (arthrodesis), bone reconstructions, osteotomy, ligament fixation, and pseudoarthrosis (non-unions) of bones, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, phalanges, patella…
Read the full statement (132 words)
The Treace Medical Concepts (TMC) Screw Fixation System is intended for use for adult and pediatric patients aged >12 years, and indicated for small or long bones requiring fixation of fractures, fracture repair, revision procedures, joint fusions (arthrodesis), bone reconstructions, osteotomy, ligament fixation, and pseudoarthrosis (non-unions) of bones, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, phalanges, patella, ulnar styloid, capitellum, radial head and radial styloid.
In the foot, the following specific examples are indicated with screws appropriate for the size of the device:
• mono or bicortical osteotomies
• distal or proximal metatarsal osteotomies
• weil osteotomy
• fusion of the metatarsalphalangeal joint
• fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
• Akin type osteotomy
• talonavicular fusions
• cuboid fusions
Not for spinal use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213036 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213036: 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/K213036
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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