| Device |
scaffold, partial medial meniscal defects extending into the red/white zone, resorbable bovine collagen |
| Regulation Description |
Surgical mesh. |
| Definition |
Intended for use in surgical procedures for the repair and reinforcement of soft tissue injuries of the medial meniscus. In repairing and reinforcing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site must extend at least into the red/white zone of the meniscus to provide sufficient vascularization. The device reinforces soft tissue and provides a resorbable scaffold that is replaced by the patients own soft tissue. The device is not a prosthetic device and is not intended to replace normal body structure. |
| Physical State |
The device is provided in one configuration: a semi-lunar shape with a triangular cross-section for use in the medial meniscus. The device is a resorbable collagen matrix composed primarily of bovine Type I collagen (~99%) derived from Achilles tendon, and small quantities of glycosaminoglycans, i.e., chondroitin sulfate (~0.04% w/w) and sodium hyaluronate (~0.08% w/w). |
| Technical Method |
The device is a partially resorbable scaffold intended for the repair and reinforcement of soft tissue injuries of the medial meniscus. For proper implantation of the device, a partial meniscectomy is performed and necessary tissue is removed to expose the red/white zone of the meniscus. The patient must have an intact meniscal rim and anterior and posterior horns for attachment of the device. |
| Target Area |
medial meniscus |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
Orthopedic |
|---|
| Product Code | OLC |
|---|
| Premarket Review |
Office of Orthopedic Devices
(OHT6)
Restorative, Repair and Trauma Devices
(DHT6C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.3300
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
