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TREACE MEDICAL CONCEPTS, INC.

Last updated September 17, 2026

Information

Country: US
Address: 100 Palmetto Park Place, PONTE VEDRA, FL, 32081
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3011623994
DUNS Number: —

Catalogue (493)

Page 10 of 10

Device	Model / Reference	Registries	Class	Status
Derotation Pin Guide	01-1000-009	FDA UDI	Class I	Active
TMC PSI Cut Guide System	NK23	FDA UDI	Class II	Active
Saw Blade	02-00342	FDA UDI	Class I	Active
K-Wire	1405-2603	FDA UDI	Class I	Active
Joint Seeker	1405-2135	FDA UDI	Class I	Active
Drill	01-1000-004	FDA UDI	Class I	Active
Ratchet Handle	02-00176	FDA UDI	Class I	Active
Cut Guide	1405-2367	FDA UDI	Class I	Active
Targeter	02-00286	FDA UDI	Class I	Active
TMC PSI Cut Guide System	PSI-01-2029-021	FDA UDI	Class II	Active
Targeter	02-00278	FDA UDI	Class I	Active
Nanoplasty System	02-00200	FDA UDI	Class II	Active
Drill Bit	1405-2609	FDA UDI	Class I	Active
Saw Blade	SN32	FDA UDI	Class I	Active
Osteotome	SN25	FDA UDI	Class I	Active
Lapiplasty SpeedPlate	02-00099	FDA UDI	Class II	Active
Drill Guide	02-00219	FDA UDI	Class I	Active
Cut Guide	1405-2563	FDA UDI	Class I	Active
Cut Guide	1405-2437	FDA UDI	Class I	Active
Seeker-Fulcrum	1405-2476	FDA UDI	Class I	Active
K-Wire	1405-2319	FDA UDI	Class I	Active
Seeker-Fulcrum	1405-2483	FDA UDI	Class I	Active
Cut Guide	02-00268	FDA UDI	Class I	Active
Treace Medical Concepts (TMC) Plating System	K221181	FDA 510(k)	Class II	Active
Treace Medical Concepts (TMC) Screw Fixation System	K242671	FDA 510(k)	Class II	Active
Treace Medical Concepts (TMC) Plating System	K183321	FDA 510(k)	Class II	Active
Treace Medical Concepts (TMC) Plating System	K192504	FDA 510(k)	Class II	Active
Treace Medical Concepts (TMC) Implant Fixation System	K222645	FDA 510(k)	Class II	Active
Treace Medical Concepts (TMC) Plating System	K153531	FDA 510(k)	Class II	Active
Treace Medical Concepts (TMC) Screw Fixation System	K260361	FDA 510(k)	Class II	Active
Treace Medical Concepts (TMC) Plating System	K200961	FDA 510(k)	Class II	Active
Treace Medical Concepts (TMC) Implant Fixation System	K251135	FDA 510(k)	Class II	Active
Treace Medical Concepts (TMC) Compression Implant System	K232387	FDA 510(k)	Class II	Active
Treace Medical Concepts (TMC) Plating System	K220136	FDA 510(k)	Class II	Active
Treace Medical Concepts (TMC) Snap-Off Screw System	K183363	FDA 510(k)	Class II	Active
Treace Medical Concepts (TMC) Compression Screw System	K172617	FDA 510(k)	Class II	Active
TMC Compression Implant System	K242415	FDA 510(k)	Class II	Active
Treace Medical Concepts (TMC) Hammertoe Fixation System	K222564	FDA 510(k)	Class II	Active
TMC Compression Implant System	K243658	FDA 510(k)	Class II	Active
Treace Medical Systems (TMC) Plating System	K240173	FDA 510(k)	Class II	Active
Treace Medical Concepts(TMC) Plating System	K143717	FDA 510(k)	Class II	Active
PYTHON Plate Trial Instruments	K173930	FDA 510(k)	Class II	Active
Treace Medical Concepts (TMC) Screw Fixation System	K213036	FDA 510(k)	Class II	Active

Related Companies

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jun 2, 2024	Z-2718-2024	—	open, classified	Potential issue causing a higher frequency of interference with locking screws and/or inserter rods than anticipated, resulting in screws stripping and/or not fully seating in the plates and/or interface issues between inserter rods and plates.