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Betta Link Knotless Implant System

by T.A.G. Medical products corporation LTD.

510(k) K210498

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK210498 Date24 Mar 2021ClearedStatusActive

Official records

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2060-2023 FDA Class II initiated 4 May 2023

    Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.

Timeline

2 dated events

  1. Cleared FDA 510(k) K210498
  2. Recall initiated FDA recalls Z-2060-2023

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MBI
FDA applicant
T.A.G. Medical Products Corporation, Ltd.
Device class
Class II
Regulation
21 CFR Part 888.3040
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Betta Link Knotless Implant System is a knotless soft tissue fixation device classified as a MBI (Meniscus, Bone, and Ligament) implant under FDA nomenclature. It features a PEEK (polyether-ether-ketone) non-absorbable anchor designed for secure attachment of soft tissues, enabling surgeon-controlled tensioning during repair procedures. The system leverages a fork-tipped inserter to facilitate precise placement within bone, reducing the need for traditional knot tying. Its modular design supports applications in both hip and shoulder arthroscopy, offering versatility in orthopedic reconstructions.

This manual surgical device is supplied as a reusable inserter paired with single-use PEEK anchors, requiring no additional sterilization beyond standard surgical protocols. The system is intended for use in MRI-safe environments, as confirmed by its PEEK material composition and non-metallic construction. Available in configurations tailored for specific anatomical sites, it adheres to FDA 510(k) clearance (K210498) under the Orthopedic (OR) advisory committee. Storage and handling follow standard orthopedic implant guidelines to maintain sterility and functionality.

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