Scandius Absorbable ACL Reconstruction System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K041961 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Scandius Acl Reconstruction System

  Class II

  FDA 510(k) K041749 Active Cleared 8 Sep 2004

• Scandius Tritis Absorbable Tibial Reconstruction System

  Class II

  FDA 510(k) K060522 Active Cleared 11 Apr 2006

• Scandius Tritis Tibial Acl Reconstruction System

  Class II

  FDA 510(k) K052810 Active Cleared 20 Dec 2005

• Modification to Scandius Tritis Tibial Acl Reconstruction System

  Class II

  FDA 510(k) K063499 Active Cleared 19 Dec 2006

• Modification to Scandius Tritis Absorbable Tibial Reconstruction System

  Class II

  FDA 510(k) K063497 Active Cleared 19 Dec 2006

• What types of surgical procedures is the Scandius Absorbable ACL Reconstruction System intended for, and how does it function during the healing process?

  The Scandius Absorbable ACL Reconstruction System is specifically designed for anterior cruciate ligament (ACL) reconstructions, where it provides temporary fixation for ligament or tendon grafts. It stabilizes the graft during the critical healing phase to ensure proper integration with surrounding tissues, gradually dissolving as the graft matures. This makes it ideal for orthopedic surgeries requiring absorbable fixation solutions.

• Is the Scandius Absorbable ACL Reconstruction System reusable, and what precautions should be taken to maintain its sterility?

  The Scandius Absorbable ACL Reconstruction System is a sterile, single-use device, meaning it is intended for one surgical procedure only. To maintain sterility and functionality, it must be stored and handled according to the manufacturer’s guidelines, which likely include keeping the packaging intact until use and avoiding contamination.

• What storage conditions are recommended for the Scandius Absorbable ACL Reconstruction System to ensure it remains effective?

  While the exact storage conditions are not detailed in the provided data, absorbable orthopedic devices like this typically require protection from moisture, extreme temperatures, and direct light. The manufacturer’s guidelines (not specified here) should specify whether refrigeration or room-temperature storage is required, but generally, the device should be stored in its original, unopened packaging until use.

• Can the Scandius Absorbable ACL Reconstruction System be used in MRI scans, and why might this be important for patients?

  No, the Scandius Absorbable ACL Reconstruction System is not MRI-safe. This is important for patients because MRI scans are commonly used for postoperative imaging to monitor healing progress, and the presence of non-MRI-safe materials could interfere with imaging quality or pose safety risks during the scan.

• How do I confirm the regulatory approval status of this device before purchasing or using it?

  The Scandius Absorbable ACL Reconstruction System holds FDA 510(k) clearance (K041961), meaning it has been deemed substantially equivalent to a legally marketed predicate device. To confirm its current regulatory status, you can verify its listing in the FDA’s database (e.g., via the [FDA Device Listing Search](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm)) using the device name or 510(k) number. Always check for recalls or updates from the manufacturer or regulatory bodies before use.