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Affinity Cage System

by Medtronic Sofamor Danek USA, Inc.

PMA P000028

Active European Union and United States

CE MDR PMA

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

PMA P000028↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPRL PMA NumberP000028 Date13 Jun 2002DecidedStatusActive
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  • Withdrawn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 PMA Active

Specification

EUDAMED · PMA

Full name
Affinity (Tm) Cage System
Generic Name
Intervertebral fusion device with bone graft, lumbar
PMA Number
FDA Product Code
MAX
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
APRL

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 Affinity Cage System is an intervertebral fusion device designed for anterior cervical interbody fusion procedures. It is intended for use in skeletally mature patients with cervical disc disease, including radiculopathy and/or myelopathy caused by herniated discs or osteophyte formation, resulting in nerve root or spinal cord compression. The device is implanted via an open, anterior surgical approach and is paired with autogenous bone graft to facilitate spinal fusion.

This system is supplied sterile and intended for single-use. It is regulated under FDA PMA (P000028) and MDR authorisations, with approval for use between the C2-C3 and C7-T1 disc levels. Storage and handling must comply with sterile medical device protocols, and its design adheres to orthopedic surgical standards for spinal stabilization. No MRI safety information is specified in the data.

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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 specific spinal levels is the Affinity Cage System approved for use in anterior cervical fusion procedures?

    The Affinity Cage System is approved for use between the C2-C3 and C7-T1 disc levels. This includes all single-level fusions within that range, as outlined in the FDA PMA authorization (P000028) and the advisory committee description.

  • Is the Affinity Cage System intended for reuse, or is it designed for single-use only?

    The Affinity Cage System is explicitly intended for single-use. The manufacturer’s documentation states it is supplied sterile and must comply with sterile medical device protocols, reinforcing its non-reusable nature.

  • How is the Affinity Cage System implanted, and what additional materials are required for its use?

    The Affinity Cage System is implanted via an open, anterior surgical approach. It is designed to be paired with autogenous bone graft to facilitate spinal fusion, as specified in the device description and AO statement.

  • What storage and handling precautions should be taken for the Affinity Cage System?

    The Affinity Cage System must be stored and handled according to sterile medical device protocols due to its sterile packaging. This ensures proper sterility and integrity before surgical use, as implied by its single-use designation and regulatory requirements.

  • Can the Affinity Cage System be used in patients with cervical disc disease at multiple levels?

    No, the Affinity Cage System is approved for use at one level only, specifically between C2-C3 and C7-T1. The AO statement and PMA authorization explicitly define its indication as single-level anterior cervical interbody fusion for intractable radiculopathy or myelopathy caused by herniated discs or osteophytes.