| Device |
resorbable implant for anterior cruciate ligament (acl) repair |
| Definition |
A resorbable implant for anterior cruciate ligament (ACL) repair is a degradable material that allows for healing of a torn ACL that is biomechanically stabilized by traditional suturing procedures. The device is intended to protect the biological healing process from the surrounding intraarticular environment and not intended to replace biomechanical fixation via suturing. This classification includes devices that bridge or surround the torn ends of a ruptured ACL. |
| Physical State |
The device is a gel, moldable solid, or rigid solid that is resorbable. |
| Technical Method |
The device is intended to protect the biological healing process from the surrounding intraarticular environment and not to replace biomechanical fixation via suturing. |
| Target Area |
Knee (ACL) |
| Regulation Medical Specialty |
Orthopedic |
| Review Panel |
Orthopedic |
|---|
| Product Code | QNI |
|---|
| Premarket Review |
Orthopedic Devices
(OHT6)
Stereotaxic, Trauma and Restorative Devices
(DHT6C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
888.3044
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
