FIXIT Threaded Anchor System

FDA 510(k) K170868 · S.B.M Sas Science For Bio Materials

Substantially Equivalent

510(k) numberK170868

Submission

Device name
FIXIT Threaded Anchor System
Applicant
S.B.M Sas Science For Bio Materials
Lourdes, FR
Received
March 23, 2017
Decision date
November 30, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MAI – Fastener, Fixation, Biodegradable, Soft Tissue
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code MAI

510(k)DeviceApplicantDecision
K262357Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Special Arthrex, Inc.08/07/2026SE
K253931Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Traditional Arthrex, Inc.05/28/2026SE
K260294SF Push-in AnchorMAI · Traditional Surgical Fusion Technologies GmbH03/27/2026SE
K254055OSSIOfiber® Suture AnchorMAI · Traditional OSSIO , Ltd.02/24/2026SE
K251680Biosteon® ScrewMAI · Traditional Biocomposites, Ltd.02/17/2026SE
K252946BioBrace® Extra-Articular Ligament Augmentation KitMAI · Special Conmed Corporation10/15/2025SE
K252022OSSIOfiber® Interference ScrewMAI · Traditional OSSIO , Ltd.08/19/2025SE
K251309OSSIOfiber® Suture AnchorMAI · Special OSSIO , Ltd.05/27/2025SE
K250544Knotilus+ Biocomposite Knotless AnchorMAI · Traditional Stryker Endoscopy05/23/2025SE
K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorMAI · Traditional Stryker Endoscopy05/21/2025SE

Questions and answers

When was FIXIT Threaded Anchor System cleared by the FDA?

FIXIT Threaded Anchor System (K170868) received a 510(k) decision of Substantially Equivalent on November 30, 2017, 252 days after the submission was received.

What is the product code of K170868?

The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.