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Infinity Fixation System

by Conmed Corporation

510(k) K191204

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

No date given

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) K191204↗

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 NumberK191204 Date3 Jul 2019ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive
European UnionCE/MDD 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  • Withdrawn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, CE/MDD 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 Infinity Fixation System is a Fastener, Fixation, Nondegradable, Soft Tissue device, designed for orthopedic applications. It provides secure attachment of soft tissue to bone or implant surfaces, ensuring stable fixation in surgical procedures.

This system is supplied as a sterile, single-use device and is classified under FDA classification MBI (soft tissue fixation fasteners and anchoring systems) as a Class II – Special Controls device. It is regulated under FDA 510(k) clearance (K191204), MDD, and MDR, with regulatory submissions reviewed by the Orthopedic Advisory Committee.

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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 is the Infinity Fixation System intended for, and how does it function in those settings?

    The Infinity Fixation System is designed for orthopedic applications where secure attachment of soft tissue to bone or implant surfaces is required. It ensures stable fixation during surgical procedures, which is particularly useful in cases involving tendon or ligament reattachment, such as rotator cuff repairs or ACL reconstructions. Its nondegradable nature provides long-term stability, making it ideal for procedures where durable fixation is critical.

  • Is the Infinity Fixation System reusable, or is it intended for single-use only? How does this affect its sterility?

    The Infinity Fixation System is explicitly supplied as a sterile, single-use device. This design ensures patient safety by preventing cross-contamination and maintaining sterility between procedures, which is critical in orthopedic surgeries where infection risk must be minimized.

  • What regulatory pathways has the Infinity Fixation System undergone, and which advisory committee reviewed its submission?

    The Infinity Fixation System has been cleared via FDA 510(k) (K191204) under the Orthopedic Advisory Committee (OR). It is also compliant with MDD (Medical Device Directive) and MDR (Medical Device Regulation) standards. The submission was reviewed by the Orthopedic Advisory Committee, which specializes in evaluating orthopedic devices like soft tissue fixation systems.

  • Are there different sizes or models available for the Infinity Fixation System, and if so, how might a clinician determine the appropriate one for a patient?

    While the provided data does not specify exact sizes or models, the Infinity Fixation System is designed as a soft tissue fixation fastener, implying variability in length, diameter, or thread pitch to accommodate different anatomical needs. Clinicians would typically select the appropriate size based on surgical requirements, such as tissue thickness, bone density, or implant specifications, often guided by manufacturer documentation or intraoperative assessment.