(29 days)
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No
The 510(k) summary describes a mechanical fixation system for ACL reconstruction and does not mention any software, algorithms, or AI/ML capabilities. The modifications are limited to adding new implant and instrument sizes.
Yes
The TriTis Tibial Fixation System is detailed as a device for the fixation of ligament and tendon grafts during ACL reconstruction of the knee, which is a medical procedure to repair or replace a damaged ACL and restore function. This constitutes a therapeutic intervention.
No
Explanation: The device is a system for fixing ligament and tendon grafts during ACL reconstruction, which is a treatment procedure, not a diagnostic one.
No
The device description clearly states it is a "three piece implant" and includes "instrumentation to prepare the bone tunnel and place the device," indicating it is a physical medical device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The TriTis Tibial Fixation System is an implantable device used to physically fix ligament and tendon grafts during ACL reconstruction surgery. It is used in the body, not to test specimens from the body.
- Intended Use: The intended use clearly states it's for "fixation of ligament and tendon grafts during anterior cruciate ligament (ACL) reconstruction of the knee." This is a surgical procedure, not a diagnostic test.
The information provided describes a surgical implant and associated instruments, which falls under the category of a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The TriTis Tibial Fixation System is intended for use in the fixation of ligament and tendon grafts during anterior cruciate ligament (ACL) reconstruction of the knee.
Product codes (comma separated list FDA assigned to the subject device)
MAI, HWC
Device Description
The TriTis Absorbable Tibial Reconstruction System consists of a three piece implant designed to provide soft tissue fixation for tibial anterior cruciate ligament (ACL) reconstruction. The graft cleat secures the soft tissue graft in the tunnel. The washer and fixation screw secure 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.
The modifications made to the device that are the subject of this submission are:
Add a new, 12 mm diameter graft cleat implant size, and a new, 12 mm Dilator instrument. All other device features and instruments remain unchanged.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Knee
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data was generated in support of the substantial equivalence determination:
- Simulated use test to confirm that design integrity is maintained .
- System strength test to confirm that design integrity is maintained .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached 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
DEC 1 9 2006
Contact: Ralph Zimmerman, Quality Assurance Manager Date Prepared: November 17, 2006
2. DEVICE:
Trade Name: Scandius TriTis™ Absorbable Tibial Reconstruction System Classification Name: Fastener, Fixation, Biodegradable, Soft Tissue The Product Code: MAI
3. PREDICATE DEVICE:
The predicate device used to determine substantial equivalence for modifications to the Scandius TriTis Absorbable Tibial Reconstruction System was the previously cleared Scandius TriTis Absorbable Tibial Reconstruction System.
4. DEVICE DESCRIPTION:
The TriTis Absorbable Tibial Reconstruction System consists of a three piece implant designed to provide soft tissue fixation for tibial anterior cruciate ligament (ACL) reconstruction. The graft cleat secures the soft tissue graft in the tunnel. The washer and fixation screw secure 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.
The modifications made to the device that are the subject of this submission are:
Add a new, 12 mm diameter graft cleat implant size, and a new, 12 mm Dilator instrument. All other device features and instruments remain unchanged.
5. INTENDED USE:
The TriTis Tibial Fixation System is intended for use in the fixation of ligament and tendon grafts during anterior cruciate ligament (ACL) reconstruction of the knee.
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Kcc3497
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6. COMPARISON OF CHARACTERISTICS:
- 트 The devices have the same intended and indication for use, and have similar technical characteristics and principles of operation
- The devices use the same implant materials
- 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 generated in support of the substantial equivalence determination:
- Simulated use test to confirm that design integrity is maintained .
- System strength test to confirm that design integrity is maintained .
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with outstretched wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted in a simple, black-and-white design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Scandius Biomedical, Inc. c/o Mr. Ralph Zimmerman Quality Assurance Manager 11A Beaver Brook Road Littleton, MA 01460
DEC 1 9 2006
K063497 Re:
Trade/Device Name: Scandius TriTisTM Absorbable Tibial Reconstruction System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MAI, HWC Dated: November 17, 2006 Received: November 20, 2006
Dear Mr. Zimmerman:
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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product
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Page 2 -- Mr. Ralph Zimmerman
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buehrig
Mark N. Melkerson. M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):K063497
Device Name:
Indications for Use: The TriTis Tibial Fixation System is intended for use in the fixation of ligament and tendon grafts during anterior cruciate ligament (ACL) reconstruction of the knee.
Prescription Use __ X_ (Per 21 C.F.R. 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
_ Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbave Buchen
(Division Sign-Ott) Division of General, Restorative, and Neurological Devices
(Optional Format 1-2-96)
510(k) Number