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.

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.

AI/ML Overview

The device discussed in the provided text is Scandius TriTis™ Absorbable Tibial Reconstruction System, which is a mechanical device, not an AI/ML powered device. As such, several categories from the request (2, 3, 4, 5, 6, 7, 8, and 9) are not applicable as they relate to AI/ML device performance and study design.

Here's the information extracted from the provided text, focusing on the mechanical aspects and the relevant performance data:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Design integrity maintained (Simulated use)	Confirmed
Design integrity maintained (System strength)	Confirmed

2. Sample size used for the test set and the data provenance
Not applicable for a mechanical device; no "test set" in the context of data for AI/ML. The performance data was generated through "Simulated use test" and "System strength test," which are bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for a mechanical device; no "ground truth" in this context.

4. Adjudication method for the test set
Not applicable for a mechanical device; no "adjudication method" in this context.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable for a mechanical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable for a mechanical device.

7. The type of ground truth used
Not applicable for a mechanical device. The "ground truth" for a mechanical device is its physical properties and functionality as determined by engineering tests.

8. The sample size for the training set
Not applicable for a mechanical device; no "training set."

9. How the ground truth for the training set was established
Not applicable for a mechanical device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The provided 510(k) summary for the Scandius TriTis™ Absorbable Tibial Reconstruction System indicates that the device's modifications (adding a new 12 mm diameter graft cleat implant size and a new 12 mm Dilator instrument) were assessed through bench testing.

Specifically, the "Performance Data" section states that the following tests were conducted to support the substantial equivalence determination:

Simulated use test: This test was performed to confirm that the design integrity of the device is maintained.
System strength test: This test was conducted to also confirm that the design integrity of the device is maintained.

The results of these tests indicated that the design integrity of the device was "maintained" for both simulated use and system strength. The 510(k) clearance by the FDA implies that these performance data were sufficient to demonstrate that the minor technological differences introduced by the modifications "do not raise any new questions of safety and effectiveness" compared to the predicate device. This confirms the device meets the stated acceptance criteria, which revolve around maintaining design integrity under simulated use and strength conditions.

Summary

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K063497

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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 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

Regulation Number and Section

§ 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.