TMJ Fossa-Eminence and Condylar Prosthesis System
PMA P000023
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP000023 | Date5 Jan 2001 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade Name
- Tmj Fossa-Eminence/Condylar Prostheses
- Generic Name
- Joint, temporomandibular, implant
- PMA Number
- FDA Product Code
- LZD
- Device Class
- Class III
- Regulation
- 21 CFR Part 872.3940
- Advisory Committee
- Dental
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The TMJ Fossa-Eminence and Condylar Prosthesis System is a joint implant used for reconstruction of the temporomandibular joint. It is indicated for patients with conditions such as inflammatory arthritis involving the TMJ not responsive to other treatments, recurrent fibrous and/or bony ankylosis, failed tissue graft, failed alloplastic joint reconstruction, or loss of vertical mandibular height and/or occlusal relationship due to bone resorption, trauma, developmental abnormality, or pathologic lesion.
The system is supplied as a prosthetic device for surgical implantation. It is a Class III device authorized by FDA PMA. The device is manufactured by Nexus CMF, LLC in Golden, Colorado, and is intended for use in dental procedures requiring TMJ reconstruction.
Other devices from Nexus CMF, LLC
Questions
AI-generated answers, 18 Sep 2026
What specific medical conditions is this TMJ prosthesis designed to address in patients who have not responded to other treatments?
This device is specifically authorized for patients with inflammatory arthritis of the temporomandibular joint (TMJ) that hasn’t improved with other treatments, recurrent fibrous or bony ankylosis (joint stiffness) that also hasn’t responded to alternative approaches, failed tissue grafts, prior alloplastic joint reconstructions that didn’t work, or cases involving loss of vertical mandibular height or occlusal (bite) relationship due to bone resorption, trauma, developmental abnormalities, or pathologic lesions.
How is the TMJ Fossa-Eminence and Condylar Prosthesis System supplied, and is it intended for single-use or reusable applications?
The system is supplied as a prosthetic device intended for surgical implantation, meaning it is designed for one-time use per patient. Since it is a Class III implant, it is not intended for reuse after sterilization or cleaning, as its structural integrity and biocompatibility are critical for long-term joint reconstruction.
What regulatory pathway was followed for this device, and who authorized its use in the U.S.?
The TMJ Fossa-Eminence and Condylar Prosthesis System underwent a **Premarket Approval (PMA)** process, which is the FDA’s most stringent review for high-risk medical devices like implants. Approval was granted by the FDA under PMA number **P000023**, confirming its safety and effectiveness for the specified indications.
Are there multiple sizes or models available for this prosthesis, and how might a clinician determine the appropriate fit for a patient?
The device is listed under multiple **FEI numbers** (e.g., 1032347, 3002821504), which typically correspond to different sizes or configurations to accommodate varying patient anatomies. While exact sizing details aren’t provided, the system is designed to address a range of TMJ reconstruction needs, and a clinician would select the appropriate model based on preoperative imaging, patient anatomy, and surgical planning to ensure proper joint alignment and function.