Artelon Convenience Kits— 510(k) K260317
Substantially EquivalentInternational Life Sciences
FDA 510(k) clearance K260317 for Artelon Convenience Kits, Substantially Equivalent on 2026-04-09. Applicant: International Life Sciences. Device class: 2.
Summary
Artelon Convenience Kits are filed under QWJ, resorbable polymeric surgical mesh for reinforcing ligaments in orthopedic repairs. Artelon makes a degradable synthetic scaffold for soft tissue and ligament reconstruction. "Convenience kit" means the implant ships with other components, which the record doesn't list.
Class II, 21 CFR 878.3300. The General and Plastic Surgery panel reviewed it as a Traditional 510(k).
International Life Sciences filed from Sandy Springs, Georgia. Review took 69 days (January 30 to April 9, 2026). Kits built around an already cleared implant usually move fast.
Clearance details
- Applicant
- International Life Sciences
- Product code
- Code QWJ
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sandy Springs, GA, US
More clearances from International Life Sciences
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