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Novus LC Interbody Fusion Device

by Sofamor Danek PMA

Active United States

PMA P970015

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPRL NumberP970015 Date14 May 1999DecidedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Recalls

1 recall · FDA

    • Terminated Z-1090-05 FDA Unclassified (pre-2012) initiated 27 May 2005

    The product is labeled as sterile, but this lot was not sterilized.

Specification

PMA

Full name
Novus (Tm) Lc Interbody Fusion Device
Trade Name
Inter Fix Threaded Fusion Device
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, 20 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 Novus LC Interbody Fusion Device is an expandable interbody fusion implant designed for lumbar spinal fusion procedures. Classified as an intervertebral fusion device with bone graft, it is intended for use in skeletally mature patients with degenerative disc disease (DDD) at a single level from L2 to S1, including those with up to Grade I spondylolisthesis or retrolisthesis. The device is configured for anterior placement and is typically used in conjunction with autogenous bone graft.

This device is supplied as a reusable surgical implant and is regulated under FDA Premarket Approval (PMA P970015). It is intended for open anterior surgical approaches and is not indicated for MRI use. The device’s expandable design allows for secure placement within the intervertebral space, and its specifications align with Product Code MAX under 21 CFR 888.3080. Sterility and single-use instructions are not applicable, as the device is intended for surgical reuse under sterile conditions.

Other devices from Sofamor Danek

Questions

AI-generated answers, 20 Sep 2026

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

  • Is the Novus LC Interbody Fusion Device intended for use in patients with more severe spinal conditions like Grade II spondylolisthesis?

    No, the device is specifically indicated for skeletally mature patients with degenerative disc disease (DDD) at a single lumbar level (L2 to S1), including those with up to Grade I spondylolisthesis or retrolisthesis only. Grade II or higher conditions are not covered by the approved clinical use.

  • How is the Novus LC Interbody Fusion Device supplied, and is it reusable or single-use?

    The device is supplied as a reusable surgical implant, meaning it is intended to be sterilized and reused under sterile conditions for multiple procedures. Unlike single-use implants, it requires proper cleaning and reprocessing between cases.

  • Can this device be used in posterior spinal approaches, or is it strictly for anterior placement?

    The Novus LC Interbody Fusion Device is explicitly designed for anterior surgical approaches only. It is not approved for posterior placement or alternative access routes.

  • What types of bone graft are recommended for use with the Novus LC Interbody Fusion Device?

    The device is intended for use with autogenous bone graft (patient’s own bone) as part of the fusion procedure. No other graft types are specified in the approved indications.

  • Is the Novus LC Interbody Fusion Device compatible with MRI imaging for postoperative monitoring?

    No, the device is not indicated for MRI use after implantation. This limitation should be considered when planning postoperative imaging protocols.