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Unity Beta Anchor System

by Bonutti Research, Inc. 510(k)

Active United States

510(k) K082906

Overview

The Unity Beta Anchor System is a suture anchor designed for orthopedic fixation in bone and soft tissue. It provides secure attachment for ligament or tendon repair, leveraging a self-drilling, self-tapping mechanism to anchor sutures within cortical bone, ensuring stable fixation during healing.

This device is supplied sterile and intended for single-use in orthopedic surgical settings. It is classified under FDA product code HWC and has received a Special 510(k) clearance for orthopedic applications. The system is regulated under FDA regulation number 888.3040 and is intended for use by trained surgeons in procedures requiring secure tissue and bone fixation.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK082906 Date30 Oct 2008ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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