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6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor

by Medos International SARL

510(k) K201883

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201883↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Special NumberK201883 Date7 Aug 2020ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 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, 18 Sep 2026

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

The Healix Advance SP Anchor is a surgical fixation device classified as an orthopedic anchor under the FDA’s orthopedic nomenclature. It is designed for securing soft tissue to bone, providing stable attachment in ligament or tendon repair procedures. Constructed in two variants—one using PEKK (polyether ether ketone) and the other a biocomposite material—the anchors feature a 6.5 mm diameter for precise placement and integration with surrounding tissue.

These anchors are supplied sterile and intended for single-use in orthopedic surgeries. They are compatible with MRI environments and must be stored in a dry, protected environment until use. The device holds FDA 510(k) clearance under Special 510(k) review and is compliant with the EU Medical Device Regulation (MDR). No third-party certification is required for its use.

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Questions

AI-generated answers, 18 Sep 2026

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

  • What types of surgical procedures are the Healix Advance SP anchors intended for use in?

    The Healix Advance SP anchors are designed specifically for securing soft tissue—such as ligaments or tendons—to bone during orthopedic surgeries. They provide stable fixation in repair procedures where secure attachment is critical, such as ACL reconstruction or other tendon/ligament reattachments.

  • Are the Healix Advance SP anchors reusable or single-use, and how should they be stored?

    These anchors are intended for single-use only and are supplied sterile. To maintain sterility and integrity, they must be stored in a dry, protected environment away from moisture or contamination until use. Avoid exposure to extreme temperatures or direct sunlight.

  • What materials are the Healix Advance SP anchors made from, and how does that affect their use?

    The anchors come in two material variants: one made from PEKK (polyether ether ketone), a high-performance polymer, and another from a biocomposite material. Both are designed for biocompatibility and integration with surrounding tissue, ensuring stable fixation in soft-tissue-to-bone repairs. The biocomposite option may offer additional advantages in specific clinical scenarios.

  • Can these anchors be used in MRI environments, and if so, what precautions should be taken?

    Yes, the Healix Advance SP anchors are MRI-compatible, meaning they can be used in MRI environments without interference. However, standard MRI safety protocols should still be followed, including ensuring the device is properly positioned and avoiding any metallic components that could cause artifacts or heating during scanning.

  • What regulatory pathways have these anchors undergone, and what does that mean for clinical use?

    The anchors hold FDA 510(k) clearance under Special 510(k) review, meaning they were determined to be substantially equivalent to a legally marketed predicate device. They also comply with the EU Medical Device Regulation (MDR), ensuring they meet stringent safety, performance, and quality standards for clinical use in both the U.S. and EU markets. No additional third-party certification is required for their use.