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Threvo Anchor, Disposable Driver, Hi-Fi Sutures

by Conmed Linvatec

510(k) K073481

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK073481 Date7 Jan 2008ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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 Threvo Anchor is a suture anchor designed for orthopedic fixation, classified under the FDA’s orthopedic product code (MBI). It features a titanium implant pre-threaded with three non-absorbable #2 ultra-high-molecular-weight polyethylene sutures, enabling secure tissue attachment in bone. The device is intended for arthroscopic or mini-open shoulder procedures, particularly rotator cuff repairs, where precise fixation is critical. Its self-punching mechanism allows for insertion without pre-drilling, simplifying surgical workflows.

Supplied as a single-use, sterile device, the Threvo Anchor includes a disposable driver with a stainless steel shaft and ABS handle. It is regulated under FDA 510(k) clearance (K073481) as substantially equivalent to predicate devices, with no third-party review. The anchor is available in a 5.0 mm diameter configuration, as referenced in product codes like CF6160HB, and is intended for use in controlled surgical environments. Storage and handling must comply with sterile medical device protocols to maintain integrity.

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Questions

AI-generated answers, 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.

  • What is the Threvo Anchor designed for in orthopedic surgery?

    The Threvo Anchor is specifically engineered for arthroscopic or mini-open shoulder procedures, particularly rotator cuff repairs. Its self-punching titanium design allows for secure tissue attachment in bone without requiring pre-drilling, making it ideal for cases where precise fixation is critical. The pre-threaded #2 ultra-high-molecular-weight polyethylene sutures ensure stable anchoring, streamlining the surgical workflow.

  • How is the Threvo Anchor supplied and what does the packaging include?

    The Threvo Anchor is supplied as a single-use, sterile device. Each package includes the titanium anchor itself and a disposable driver with a stainless steel shaft and ABS handle. This combination ensures sterility and ease of use, as the driver is designed to work exclusively with the anchor for optimal performance during surgery.

  • Is the Threvo Anchor reusable or intended for single-use?

    The Threvo Anchor is explicitly intended for single-use only. This design choice aligns with sterile medical device protocols, reducing the risk of cross-contamination and ensuring patient safety. The disposable driver further supports this single-use application, as it is not designed for reprocessing or reuse.

  • What size and model configurations are available for the Threvo Anchor?

    The Threvo Anchor is currently available in a single diameter configuration: 5.0 mm. This size is referenced in product codes such as CF6160HB and is optimized for common orthopedic fixation needs in shoulder procedures. The anchor’s self-punching mechanism accommodates this specific diameter for reliable insertion.

  • How should the Threvo Anchor be stored to maintain its integrity?

    The Threvo Anchor must be stored in accordance with sterile medical device protocols to preserve its integrity. This includes maintaining the original packaging until immediate preoperative use, protecting it from physical damage, and ensuring it remains in a clean, controlled environment. Proper storage prevents contamination and ensures the device remains ready for sterile surgical procedures.