Identity
- Trade Name
- ACTIVL ARTIFICIAL DISC FDA PMA
- Generic Name
- Prosthesis, intervertebral disc FDA PMA
Identifiers
- PMA Number
- P120024 FDA PMA
- FDA Product Code
- MJO FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Orthopedic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The ACTIVL Artificial Disc is a Prosthesis, Intervertebral Disc designed for single-level lumbar disc replacement (L4-L5 or L5-S1) in skeletally mature patients with symptomatic degenerative disc disease (DDD). It is intended to restore disc function following discectomy, where patients exhibit discogenic back pain confirmed by clinical history, physical examination, and radiographic studies, with no more than Grade I spondylolisthesis at the involved level.
Implanted via an anterior retroperitoneal approach, the device requires patients to have failed at least six months of nonoperative treatment prior to implantation. Supplied sterile and intended for single-use, the ACTIVL Artificial Disc is classified as a Class III medical device under FDA regulations (PMA: P120024). It is distributed with multiple FEI numbers and registration identifiers, reflecting its regulatory filing and tracking within the FDA system.
Frequently asked questions
What specific lumbar levels is the ACTIVL Artificial Disc approved for replacement, and what are the key patient criteria for implantation?
The ACTIVL Artificial Disc is approved for single-level replacement at L4-L5 or L5-S1 only. It is intended for skeletally mature patients with symptomatic degenerative disc disease (DDD) who have failed at least six months of nonoperative treatment. Patients must also exhibit discogenic back pain confirmed by clinical history, physical examination, and radiographic studies, with no more than Grade I spondylolisthesis at the involved level.
How is the ACTIVL Artificial Disc supplied, and is it intended for single-use or reusable applications?
The ACTIVL Artificial Disc is supplied sterile and explicitly intended for single-use only. This ensures patient safety and compliance with medical device regulations, as reuse is not supported or approved for this Class III device.
What surgical approach is required for implantation of the ACTIVL Artificial Disc, and why is this important?
The ACTIVL Artificial Disc is implanted via an anterior retroperitoneal approach, which is a key aspect of its design and surgical technique. This approach minimizes disruption to surrounding tissues and structures, reducing the risk of complications while ensuring proper positioning and function of the artificial disc.
What regulatory pathway was followed for FDA approval of the ACTIVL Artificial Disc, and what does this mean for its use in clinical practice?
The ACTIVL Artificial Disc underwent a Premarket Approval (PMA) process (PMA: P120024), which is the rigorous regulatory pathway for Class III medical devices. This approval means the device has been thoroughly evaluated for safety and effectiveness by the FDA, ensuring it meets strict standards for use in reconstructing the disc at one level (L4-L5 or L5-S1) following single-level discectomy in eligible patients.
Are there multiple sizes or models of the ACTIVL Artificial Disc, and if so, how does this affect its customization for patients?
While the device data does not specify exact sizes or models, the presence of multiple FEI numbers and registration identifiers suggests variability in the product line to accommodate different patient anatomies. This likely allows for some degree of customization to fit individual lumbar disc replacements at the approved levels (L4-L5 or L5-S1).
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. Sources consulted: Aesculap, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P120024 | Class III | Active |
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Manufacturer
- Manufacturer
- Highridge Medical, LLC
Sources (1)
- FDA PMA P120024 24 fields · synced Sep 18, 2026