MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM

K063499 · Scandius Biomedical, Inc. · MBI · Dec 19, 2006 · Orthopedic

Device Facts

• Record ID: K063499
• Device Name: MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM
• Applicant: Scandius Biomedical, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Dec 19, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

TriTis Tibial ACL Reconstruction System is a three-piece implant set for soft tissue fixation in knee ACL reconstruction. Components include a graft cleat to secure soft tissue in the bone tunnel, plus a washer and fixation screw to secure graft ends and cleat to bone. System includes specialized instrumentation for bone tunnel preparation and device placement. Used by orthopedic surgeons in clinical settings. Modifications include a 12 mm diameter graft cleat and 12 mm dilator instrument. Device provides mechanical fixation to stabilize grafts during healing.

Clinical Evidence

Bench testing only. Evidence includes simulated use testing and system strength testing to confirm design integrity.

Technological Characteristics

Three-piece implant system consisting of a graft cleat, washer, and fixation screw. Metallic bone fixation fastener. Includes associated surgical instrumentation and sterilization tray. No software or electronic components.

Indications for Use

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

Regulatory Classification

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.

Predicate Devices

• Scandius TriTis Tibial ACL Reconstruction System (K063499)

Submission Summary (Full Text)

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K063499

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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™ 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 modifications to the Scandius TriTis Tibial ACL Reconstruction System was the previously cleared Scandius TriTis Tibial ACL Reconstruction System.

### 4. DEVICE DESCRIPTION:

The TriTis Tibial ACL 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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KO63499 age 2 of 2

# 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 i
- 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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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, to the right. To the left of the caduceus, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the symbol.

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

Re: K063499

Trade/Device Name: Scandius TriTis™ Tibial ACL Reconstruction System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI, 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 [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,

Nabane Bneehup

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):___K063499_

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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Riemensperger
Sign-Off

(Division Sign Restorative, Division of Gener and Neurologica 510(k) Number

(Optional Format 1-2-96)