Chrysalis Intelligence · Sponsors · Treace Medical Concepts, Inc.

Treace Medical Concepts, Inc.

Ponte Vedra, FL, US · 13 510(k) clearances · 1 recalls

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Total clearances
13
2020-05-08 → 2026-03-06
Last 12 months
1
Product codes
3
Most recent
2026-03-06
Name variants in FDA filings: Treace Medical Concepts, Inc. / Treace Medical Concepts
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
HRS Plate, Fixation, Bone Class II Orthopedic 5 2025-08-21
HWC Screw, Fixation, Bone Class II Orthopedic 4 2026-03-06
JDR Staple, Fixation, Bone Class II Orthopedic 4 2024-12-26
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
1
Most recent
2024-06-02
DateSeverityStatusRecall # ProductCodeReason
2024-06-02 Class II Ongoing Z-2718-2024 Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as… — Potential issue causing a higher frequency of interference with locking screws and/or inserter rods than anticipated, resulting in screws stripping and/or not f…
Filings

All 510(k) clearances (13)

Date K-number Device Code Class Specialty
2026-03-06 K260361 Treace Medical Concepts (TMC) Screw Fixation System HWC Class II Orthopedic
2025-08-21 K251135 Treace Medical Concepts (TMC) Implant Fixation System HRS Class II Orthopedic
2024-12-26 K243658 TMC Compression Implant System JDR Class II Orthopedic
2024-10-04 K242671 Treace Medical Concepts (TMC) Screw Fixation System HWC Class II Orthopedic
2024-09-06 K242415 TMC Compression Implant System JDR Class II Orthopedic
2024-02-22 K240173 Treace Medical Systems (TMC) Plating System HRS Class II Orthopedic
2023-08-28 K232387 Treace Medical Concepts (TMC) Compression Implant System JDR Class II Orthopedic
2023-01-05 K221181 Treace Medical Concepts (TMC) Plating System HRS Class II Orthopedic
2022-11-21 K222645 Treace Medical Concepts (TMC) Implant Fixation System JDR Class II Orthopedic
2022-11-15 K222564 Treace Medical Concepts (TMC) Hammertoe Fixation System HWC Class II Orthopedic
2022-02-16 K220136 Treace Medical Concepts (TMC) Plating System HRS Class II Orthopedic
2021-10-21 K213036 Treace Medical Concepts (TMC) Screw Fixation System HWC Class II Orthopedic
2020-05-08 K200961 Treace Medical Concepts (TMC) Plating System HRS Class II Orthopedic
Data source: openFDA · Generated 2026-08-24 09:26 · Last ingest 2026-08-24T13:26:51.728045 · Pipeline: Chrysalis Intelligence