Incompass Total Ankle System 3385016M

GUDID 00889797113847

Tibial Stem

WRIGHT MEDICAL TECHNOLOGY, INC.

Fixed-bearing total ankle prosthesis

• Primary Device ID: 00889797113847
• NIH Device Record Key: f1ec351e-4581-4a17-8367-ad833507811c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Incompass Total Ankle System
• Version Model Number: 3385016M
• Catalog Number: 3385016M
• Company DUNS: 807201207
• Company Name: WRIGHT MEDICAL TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com

Device Dimensions

• Device Size Text, specify: 0
• Outer Diameter: 16 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 16 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 16 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 16 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889797113847 [Primary]

FDA Product Code

• HSN: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

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: 2025-08-22
• Device Publish Date: 2025-08-14

On-Brand Devices [Incompass Total Ankle System]

• 00889797114257: Tibial Stem
• 00889797114240: Tibial Stem
• 00889797114233: Tibial Stem
• 00889797114226: Tibial Stem
• 00889797114219: Tibial Stem
• 00889797114202: Tibial Stem
• 00889797114110: Tibial Stem
• 00889797114103: Tibial Stem
• 00889797114097: Tibial Stem
• 00889797114080: Tibial Stem
• 00889797114073: Tibial Stem
• 00889797114066: Tibial Stem
• 00889797114059: Tibial Stem
• 00889797114042: Tibial Stem
• 00889797114035: Tibial Stem
• 00889797113861: Tibial Stem
• 00889797113854: Tibial Stem
• 00889797113847: Tibial Stem
• 00889797113830: Tibial Stem
• 00889797113823: Tibial Stem
• 00889797113816: Tibial Stem
• 00889797113809: Tibial Stem