Versalok Anchor with Free Strands of Orthocord Suture (210808), Ethibond Suture (210809), and Panacryl Suture (210810)

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

510(k) Number

K063478 ↗

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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• What types of suture materials are available with the Versalok Anchor, and how do they differ in application?

  The Versalok Anchor is available with three suture types: Orthocord (model 210808), Ethibond (model 210809), and Panacryl (model 210810). Orthocord is a braided polyester suture known for its strength and flexibility, ideal for soft tissue repair requiring durability. Ethibond is a braided polyester suture with a higher tensile strength, often used for long-term stability in orthopedic procedures. Panacryl is a braided polyester suture with a monofilament core, offering a balance of strength and reduced tissue reactivity, suitable for applications where a smoother pull is beneficial.

• Is the Versalok Anchor system single-use or reusable, and how is it deployed?

  The Versalok Anchor itself is designed for single-use, as it is a metallic bone fixation fastener intended for one-time implantation. Deployment is achieved using a reusable deployment gun, which allows for repeated use across multiple anchors. The inserter shaft, anvil, and threader tab are part of the disposable anchor system, while the deployment gun is engineered for durability and multiple procedures.

• What are the key differences between the three model numbers (210808, 210809, 210810) of the Versalok Anchor?

  The three model numbers correspond to the type of suture pre-mounted on the anchor: model 210808 uses Orthocord suture, 210809 uses Ethibond suture, and 210810 uses Panacryl suture. The only functional difference lies in the suture material itself, which affects properties like tensile strength, tissue reactivity, and absorption characteristics. The anchor mechanism and deployment process remain identical across all three models.

• How was the Versalok Anchor determined to be substantially equivalent, and what does this mean for its use in clinical settings?

  The Versalok Anchor received FDA 510(k) clearance under K063478 with a determination of substantial equivalence (SESE) on December 15, 2006, under the orthopedic product code HWC. This means the device was compared to a legally marketed predicate and found to have the same intended use, technological characteristics, and performance as the predicate device. Clinically, this clearance indicates that the device meets regulatory standards for safety and effectiveness, but it does not imply any specific indication or limitation beyond what was evaluated in the submission.