Barricaid Anular Closure Device (ACD)
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- BARRICAID ANULAR CLOSURE DEVICE (ACD) FDA PMA
- Generic Name
- Reherniation reduction device FDA PMA
Identifiers
- PMA Number
- P160050 FDA PMA
- FDA Product Code
- QES FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Orthopedic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Barricaid Anular Closure Device (ACD) is a Class III Reherniation Reduction Device, designed to reduce the risk of reherniation and subsequent reoperation in skeletally mature patients. It is intended for use in patients with radiculopathy (with or without back pain) caused by a posterior or posterolateral herniation, confirmed via MRI, following a primary discectomy at a single lumbar level (L4–S1). The device targets large annular defects measuring between 4–6 mm in height and 6–10 mm in width.
The Barricaid ACD is implanted following a primary discectomy procedure and is supplied sterile for single-use. It is approved under FDA PMA (P160050) and is intended for use in the orthopedic setting. Storage and handling must comply with sterile medical device protocols, and its design adheres to regulatory standards for spinal implants. No additional regulatory status beyond the stated PMA is implied.
Frequently asked questions
What specific types of patients is the Barricaid Anular Closure Device intended for, and what conditions must be confirmed before use?
The Barricaid ACD is intended for skeletally mature patients experiencing radiculopathy (with or without back pain) caused by a posterior or posterolateral herniation. Before implantation, the condition must be confirmed via MRI showing neural compression, and the patient must have undergone a primary discectomy at a single lumbar level (L4–S1). The device targets large annular defects measuring between 4–6 mm in height and 6–10 mm in width.
Is the Barricaid Anular Closure Device reusable, or is it designed for single-use only?
The Barricaid ACD is supplied sterile and explicitly designed for single-use only, adhering to standard sterile medical device protocols for spinal implants.
How should the Barricaid Anular Closure Device be stored, and what precautions should be taken?
The Barricaid ACD must be stored and handled according to sterile medical device protocols to maintain its integrity and sterility. Since it is a single-use device, proper packaging and environmental controls are critical to prevent contamination before implantation.
What are the key size requirements for the annular defect that the Barricaid ACD is intended to address?
The device is specifically designed for large annular defects measuring between **4–6 mm in height** and **6–10 mm in width** following a primary discectomy at a single lumbar level (L4–S1). These dimensions are critical for proper placement and intended reherniation reduction.
What regulatory pathway was followed for the approval of the Barricaid Anular Closure Device, and how does this affect its use?
The Barricaid ACD was approved via the FDA’s **Premarket Approval (PMA) pathway** under PMA number **P160050**, meaning it underwent a rigorous review process to demonstrate safety and effectiveness for its intended use in reducing reherniation risk in eligible patients. This approval does not imply broader indications beyond what is explicitly stated in the labeling.
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: Fachkreise - Barricaid, Lumbar Discectomy With Barricaid Device Implantation in Patients at ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P160050 | Class III | Active |
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Manufacturer
- Manufacturer
- Intrinsic Therapeutics
Sources (1)
- FDA PMA P160050 24 fields · synced Sep 18, 2026