(77 days)
Not Found
None
No
The description focuses on mechanical components and surgical instrumentation for ACL reconstruction, with no mention of AI/ML terms or functions.
Yes
The device is described as an "ACL Reconstruction System" intended for "fixation of ligament and tendon grafts in cruciate ligament reconstructions of the knee," directly indicating medical intervention for a condition.
No
The device is described as an "ACL Reconstruction System" intended for fixation of ligament and tendon grafts in the knee, and its description focuses on its components for securing grafts. It does not mention any function related to diagnosing a condition or disease.
No
The device description clearly states it consists of physical implants (graft cleat, washer, fixation screw) and instrumentation, indicating it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The Scandius TriTis ACL Reconstruction System is a surgical implant and associated instrumentation used for fixing grafts during knee surgery. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use is for "fixation of ligament and tendon grafts in cruciate ligament reconstructions of the knee," which is a surgical procedure, not a diagnostic test.
The information provided clearly describes a surgical device used for reconstruction, not a diagnostic test.
N/A
Intended Use / Indications for Use
The intended use of the Scandius TriTis Tibial ACL Reconstruction System is for fixation of ligament and tendon grafts in cruciate ligament reconstructions of the knee.
Product codes
MBI
Device Description
The TriTis Tibial ACL Reconstruction System consists of a three piece implant designed to fixation soft tissue for tibial ACL reconstruction. The graft cleat secures the soft tissue graft in the tunnel. The washer and fixation screw secures the ends of the graft and cleat to the bone.
The System includes instrumentation to prepare the bone tunnel and place the device as well as a sterilization tray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following performance data was provided in support of the substantial equivalence determination:
- Mechanical ultimate failure strength.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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510(k) SUMMARY
1. SUBMITTER:
Scandius Biomedical, Inc. 11A Beaver Brook Road Littleton, MA 01460
Contact: Eric Bannon, Regulatory Consultant Date Prepared: December 19, 2005
2. DEVICE:
Trade Name: Scandius TriTis Tibial ACL Reconstruction System Classification Name: Fastener, Fixation, Non-Degradable, Soft Tissue The Product Code: MBI
3. PREDICATE DEVICE:
The predicate device used to determine substantial equivalence for the Scandius ACL Reconstruction System was the Innovasive Devices Intratunnel Tibial Fixation Fastener.
4. DEVICE DESCRIPTION:
The TriTis Tibial ACL Reconstruction System consists of a three piece implant designed to fixation soft tissue for tibial ACL reconstruction. The graft cleat secures the soft tissue graft in the tunnel. The washer and fixation screw secures the ends of the graft and cleat to the bone.
The System includes instrumentation to prepare the bone tunnel and place the device as well as a sterilization tray.
5. INTENDED USE:
The intended use of the Scandius TriTis Tibial ACL Reconstruction System is for fixation of ligament and tendon grafts in cruciate ligament reconstructions of the knee.
6. COMPARISON OF CHARACTERISTICS:
- The devices have the same intended and indication for use; have similar technical characteristics and principles of operation.
- 트 The devices use similar implant materials
1
- Bench testing demonstrates that any minor technological differences do not .. raise any new questions of safety and effectiveness.
7. PERFORMANCE DATA:
The following performance data was provided in support of the substantial equivalence determination:
- Mechanical ultimate failure strength .
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and a circular border. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged around the top half of the circle.
DEC 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Eric Bannon Regulatory Representative Scandius Biomedical, Inc. 11A Beaver Brook Road Littleton, Massachusetts 01460
Re: K052810
Trade/Device Name: TriTis Tibial ACL Reconstruction System Regulation Number: 21 CFR 888.3040 Regulation Name: Fastener, Fixation, Non-Degradable, Soft Tissue Regulatory Class: II Product Code: MBI Dated: November 28, 2005 Received: November 29, 2005
Dear Mr. Bannon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
3
Page 2 - Mr. Eric Bannon
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) roggistions 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declients on 1 evice as described in your Section 5 10(k) I his letter will anow you w ough mailing of substantial equivalence of your device to a legally premarket notification: "The PDF intains sification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acrice for your as (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
( محمد Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K052810
Device Name: Scandius TriTis Tibial ACL Reconstruction System
Indications for Use: The Scandius TriTis ACL Reconstruction System is intended for use indications for Ober The Beardon grafts in cruciate ligament reconstructions of the knee.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1_of__1
510(k) Number_Ko528|0
(Posted November 13, 2003)