Walter Lorenz Total Temporomandibular Joint Replacement System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM FDA PMA
- Generic Name
- Joint, temporomandibular, implant FDA PMA
Identifiers
- PMA Number
- P020016 FDA PMA
- FDA Product Code
- LZD FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 872.3940 FDA PMA
- Regulation Number
- 872.3940 FDA PMA
- Advisory Committee
- Dental FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Walter Lorenz Total Temporomandibular Joint Replacement System is a temporomandibular joint implant indicated for reconstruction of the temporomandibular joint. It is used in cases involving arthritic conditions, ankylosis, revision procedures, avascular necrosis, fractures, functional deformities, neoplasms, and developmental abnormalities where joint function is severely compromised.
This device is supplied as a sterile, single-use implant for surgical implantation in a hospital or clinical setting. It is regulated under FDA PMA P020016 and classified as a Class III device. The system includes components designed for total joint replacement and is intended for use by qualified oral and maxillofacial surgeons following standard aseptic technique.
Frequently asked questions
What is the Walter Lorenz Total Temporomandibular Joint Replacement System used for?
It is indicated for reconstruction of the temporomandibular joint in patients diagnosed with arthritic conditions such as osteoarthritis, rheumatoid arthritis, or traumatic arthritis; ankylosis including recurrent ankylosis with excessive heterotopic bone formation; revision procedures where prior treatments like alloplastic reconstruction or autogenous grafts have failed; avascular necrosis; multiply operated joints; fractures; functional deformities; benign or malignant neoplasms; and degenerated or resorbed joints with severe anatomic discrepancies or developmental abnormalities.
Is the Walter Lorenz Total Temporomandibular Joint Replacement System a single-use device?
Yes, the device is supplied as a sterile, single-use implant intended for one-time surgical implantation. Reuse is not permitted due to risks of contamination, material degradation, and compromised structural integrity, which could jeopardize patient safety and device performance.
What regulatory pathway was used for the Walter Lorenz Total Temporomandibular Joint Replacement System?
The device received approval through the FDA Premarket Approval (PMA) pathway, as indicated by the authorization code FDA_PMA and the PMA number P020016. This reflects a rigorous evaluation of safety and effectiveness for this Class III implantable device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P020016 | Class III | Active |
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Manufacturer
- Manufacturer
- Biomet Microfixation, Inc
- FDA Applicant
- Biomet Microfixation, Inc.
Sources (1)
- FDA PMA P020016 24 fields · synced Sep 18, 2026