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TMJ Fossa-Eminence Prosthesis System

by Nexus CMF, LLC

PMA P000035

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 6 Oct 2026

Documents

PMA P000035↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP000035 Date27 Feb 2001ApprovedStatusActive
European UnionCE/MDR Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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

PMA

Trade Name
Tmj Fossa-Eminence Prosthesis(Tm)
Generic Name
Glenoid fossa prosthesis
PMA Number
FDA Product Code
MPI
Device Class
Class III
Regulation
21 CFR Part 872.3950
Advisory Committee
Dental
FDA Decision
APPR Approved

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 TMJ Fossa-Eminence Prosthesis System is a glenoid fossa prosthesis designed for the surgical treatment of severe temporomandibular joint disease. It is indicated for patients suffering from inflammatory arthritis, recurrent fibrosis, bony ankylosis, failed tissue grafts, failed alloplastic joint reconstruction, or pathological internal derangement that has not responded to less invasive conventional therapies.

This device is manufactured by Nexus CMF, LLC and has received FDA PMA approval. It is intended for use in cases where patients experience moderate to severe pain or disabling dysfunction. Clinical application is determined by both clinical observation and radiographic findings to confirm the pathological origin of the joint condition.

Other devices from Nexus CMF, LLC

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 is the primary indication for the TMJ Fossa-Eminence Prosthesis?

    The device is indicated for the treatment of severe temporomandibular joint disease, specifically for conditions such as inflammatory arthritis, recurrent fibrosis, bony ankylosis, failed tissue grafts, or failed alloplastic joint reconstruction that have not responded to other treatment modalities.

  • Is this device suitable for all patients with TMJ pain?

    No, the prosthesis is intended for patients with moderate to severe pain or disabling dysfunction who have not responded to less invasive conventional therapy and have a confirmed pathological origin for their internal derangement.

  • What regulatory status does this device hold?

    The TMJ Fossa-Eminence Prosthesis System has received FDA PMA approval, as indicated by its classification as a Class 3 medical device under regulation number 872.3950.