510(k) · Cleared
ClearedTMC Implant Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Treace Medical Concepts, Inc. · HRS Plate, Fixation, Bone
Cleared on Sep 15, 2026 as substantially equivalent to K251135 (Treace Medical Concepts, 2025) and 1 other predicate after a 21-day review. Its family tree reaches back 20 generations to 1996.
- Decided
- Sep 15, 2026
- Review
- 21 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 20 generations to K954385 (1996). 268 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 20 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 16 generations between
- 3 generations backK242415 TMC Compression Implant SystemTreace Medical Concepts · 2024
- 2 generations backK243658 TMC Compression Implant SystemTreace Medical Concepts · 2024
- 1 generation backK251135 Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts · 2025
- This deviceK262963 TMC Implant Fixation SystemTreace Medical Concepts, Inc. · 2026
Show all 20 generations
- Root · 20 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 19 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 18 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 17 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 16 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 15 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 14 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 13 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 12 generations backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- 11 generations backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- 10 generations backK143717 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2015
- 9 generations backK153531 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2016
- 8 generations backK192504 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2019
- 7 generations backK200961 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2020
- 6 generations backK220136 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2022
- 5 generations backK221181 Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc. · 2023
- 4 generations backK240173 Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc. · 2024 · Recalled
- 3 generations backK242415 TMC Compression Implant SystemTreace Medical Concepts · 2024
- 2 generations backK243658 TMC Compression Implant SystemTreace Medical Concepts · 2024
- 1 generation backK251135 Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts · 2025
- This deviceK262963 TMC Implant Fixation SystemTreace Medical Concepts, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −19 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −18 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −17 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −16 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −15 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −14 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −13 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −12 | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | Wrightmedicaltechnologyinc | 2012 | 12 |
| −11 | K121651 | Ortholoc 3DI Midfoot/Flatfoot System | Wrightmedicaltechnologyinc | 2012 | — |
| −10 | K143717 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2015 | — |
| −9 | K153531 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2016 | — |
| −8 | K192504 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2019 | — |
| −7 | K200961 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2020 | — |
| −6 | K220136 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2022 | — |
| −5 | K221181 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | 2023 | — |
| −4 | K240173 | Treace Medical Systems (TMC) Plating System | Treace Medical Concepts, Inc. | 2024 | 1 |
| −3 | K242415 | TMC Compression Implant System | Treace Medical Concepts | 2024 | — |
| −2 | K243658 | TMC Compression Implant System | Treace Medical Concepts | 2024 | — |
| −1 | K251135 | Treace Medical Concepts (TMC) Implant Fixation System | Treace Medical Concepts | 2025 | — |
| 0 (this device) | K262963 | TMC Implant Fixation System | Treace Medical Concepts, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 4 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 18 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 11 | 0 |
| 2000 | 13 | 0 |
| 2001 | 16 | 0 |
| 2002 | 14 | 0 |
| 2003 | 9 | 0 |
| 2004 | 7 | 0 |
| 2005 | 18 | 0 |
| 2006 | 19 | 0 |
| 2007 | 15 | 0 |
| 2008 | 9 | 0 |
| 2009 | 13 | 0 |
| 2010 | 11 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 6 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 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? (2)
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 |
|---|---|---|---|
| * | K251135 | Treace Medical Concepts (TMC) Implant Fixation SystemSummary page 5…Primary: HRS Subsequent: JDR, HWC Predicate Device(s): Primary Predicate: x Treace Medical Concepts (TMC) Implant Fixation System (K251135, S.E. 08/21/2025) Additional Predicates: x Wright Medical Technology Inc., PROSTEP™ TBI™ (Tailors Bunion Implant) System… | 2025 |
| * | K190970 | PROSTEP™ TBI™ (Tailors Bunion Implant) SystemSummary page 5…MC) Implant Fixation System (K251135, S.E. 08/21/2025) Additional Predicates: x Wright Medical Technology Inc., PROSTEP™ TBI™ (Tailors Bunion Implant) System (K190970, S.E. 08/13/2019) Device Description: Treace Medical Concepts (TMC) Implant Fixation System includes straight, L-shaped, H- shap… | 2019 |
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 7 companies; a new generation was cleared every 1.1 years on median.
- 51 of the 268 ancestors have a recall of any class.
How does its category compare?
All HRS devicesHRS Plate, 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 · 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?
The TMC Implant Fixation System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of the feet. The system can be used in pediatric (aged >12 years-21) and adult (aged 22 and over) patients. In the foot, the system can be used for the following specific examples: •Osteotomy of the 1st and/or 5th Metatarsals for the treatment of deformity (e.g., hallux valgus,hallux rigidus, hallux limitus…
Read the full statement (178 words)
The TMC Implant Fixation System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of the feet. The system can be used in pediatric (aged >12 years-21) and adult (aged 22 and over) patients. In the foot, the system can be used for the following specific examples:
•Osteotomy of the 1st and/or 5th Metatarsals for the treatment of deformity (e.g., hallux valgus,hallux rigidus, hallux limitus, tailor's bunion) such as:
- Opening base wedge osteotomy
- Closing base wedge osteotomy
- Crescentic osteotomy
- Proximal Chevron osteotomy
- Distal Chevron osteotomy (Austin)
- Transverse osteotomy
•Arthrodesis of the tarsometatarsal (TMT) joints or the 1st metatarsophalangeal (MTP) joint for the treatment of deformity (e.g., hallux valgus, hallux rigidus, metatarsus adductus) and/or arthritis
•First metatarsal fracture fixation
•Flatfoot Osteotomies
- Lateral Column Lengthening (Evans Osteotomy)
- Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
•Mid / Flatfoot Fusions
- LisFranc Arthrodesis and/or Stabilization
- lntercuneiform Fusions
- Navicular-Cuneiform (NC) Fusion
- Talo-Navicular (TN) Fusion
- Calcaneo-Cuboid (CC) Fusion
- Medial Column Fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K262963 · printed Nov 4, 2026
Cite this page
510(k) Report. “K262963: TMC Implant Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K262963
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026