Lapiplasty Mini Incision System

GUDID 00853114006211

Anatomic Biplanar Implants

TREACE MEDICAL CONCEPTS, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00853114006211
• NIH Device Record Key: 91b985d7-2e6c-4f16-9de1-0e7ffd407f52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lapiplasty Mini Incision System
• Version Model Number: SK30
• Company DUNS: 054808082
• Company Name: TREACE MEDICAL CONCEPTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853114006211 [Primary]

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-25
• Device Publish Date: 2021-01-15

Devices Manufactured by TREACE MEDICAL CONCEPTS, INC.

• 00810111225366 - Saw Blade: 2026-02-03 Dorsal Akin Saw Blade - ZMS
• 00810111225236 - Lapiplasty SpeedPlate - TMT: 2026-02-02 Locking Screws
• 00810111225397 - Guide: 2026-02-02 Targeting Guide
• 00810111225403 - Guide: 2026-02-02 Targeting Guide
• 00810111225472 - Drill Guide: 2026-02-02 Drill Guide and Template
• 00810111225342 - Saw Blade: 2026-01-15 DORSAL AKINATOR™ BLADE - ZMS
• 00810111226677 - Positioner / Compressor: 2026-01-13 Lightning Block - 3-N-1 adapter
• 00810111226684 - Positioner / Compressor: 2026-01-13 Lightning Block - Distal Left