SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM

K060522 · Scandius Biomedical, Inc. · MAI · Apr 11, 2006 · Orthopedic

Device Facts

• Record ID: K060522
• Device Name: SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
• Applicant: Scandius Biomedical, Inc.
• Product Code: MAI · Orthopedic
• Decision Date: Apr 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

The Scandius TriTis Absorbable Tibial Reconstruction System is a three-piece implant set used for soft tissue fixation during ACL knee reconstruction. The system includes a graft cleat to secure the soft tissue graft within the bone tunnel, and a washer and fixation screw to secure the graft and cleat to the bone. The system also includes specialized instrumentation for bone tunnel preparation and device placement, along with a sterilization tray. It is intended for use by surgeons in a clinical or operating room setting. The device provides mechanical fixation of the graft to facilitate healing.

Clinical Evidence

Bench testing only. Mechanical ultimate failure strength testing was performed to support substantial equivalence.

Technological Characteristics

Three-piece implant system consisting of a graft cleat, washer, and fixation screw. Materials are absorbable. Includes instrumentation for bone tunnel preparation and a sterilization tray. Mechanical fixation principle.

Indications for Use

Indicated for fixation of ligament and tendon grafts during anterior cruciate ligament (ACL) reconstructions of the knee.

Regulatory Classification

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.

Predicate Devices

• Scandius TriTis Non-Absorbable Reconstruction System

Submission Summary (Full Text)

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K060522

# APR 1 1 2006

#### 510(k) SUMMARY

## 1. SUBMITTER:

Scandius Biomedical, Inc. 11A Beaver Brook Road Littleton, MA 01460

Contact: Eric Bannon, Regulatory Consultant Date Prepared: September 30, 2005

#### 2. DEVICE:

Trade Name: Scandius TriTis Absorbable Tibial Reconstruction System Classification Name: Fastener, Fixation, Biodegradable, Soft Tissue The Product Code: MAI, HWC

### 3. PREDICATE DEVICE:

The predicate device used to determine substantial equivalence for the Scandius TriTis Absorbable Reconstruction System was the Scandius TriTis Non-Absorbable Reconstruction System

## 4. DEVICE DESCRIPTION:

The TriTis Absorbable Tibial 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 trav.

## 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:

- 이 The devices have the same intended and indication for use; have similar technical characteristics and principles of operation.
- The devices use different implant materials ■

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- Bench testing demonstrates that any minor technological differences do not . raise any new questions of safety and effectiveness.
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## 7. PERFORMANCE DATA:

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The following performance data was provided in support of the substantial equivalence determination:

- . Mechanical ultimate failure strength
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three legs. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 1 2006

Scandius BioMedical, Inc. c/o Mr. Eric Bannon Regulatory Consultant 11A Beaver Brook Road Littleton, Massachusetts 01460

Re: K060522

Trade/Device Name: Scandius TriTis Absorbable Tibial Reconstruction System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, HWC Dated: February 16, 2006 Received: February 27, 2006

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

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Page 2 - Mr. Eric Bannon

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 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson 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): K060522

Device Name: Scandius TriTis Absorbable Tibial Reconstruction System

Indications for Use:

The Scandius TriTis Absorbable Tibial Reconstruction System is intended for use in the fixation of ligament and tendon grafts during anterior cruciate ligament (ACL) 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)

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(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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KO60522 510(k) Number_

(Posted November 13, 2003)