SCANDIUS ACL RECONSTRUCTION SYSTEM

K041749 · Scandius Biomedical, Inc. · HWC · Sep 8, 2004 · Orthopedic

Device Facts

• Record ID: K041749
• Device Name: SCANDIUS ACL RECONSTRUCTION SYSTEM
• Applicant: Scandius Biomedical, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Sep 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Scandius ACL Reconstruction System is intended for use in fixation of ligament and tendon grafts in cruciate ligament reconstructions.

Device Story

Scandius ACL Reconstruction System is a two-piece implant system for soft tissue fixation during ACL reconstruction. System comprises a graft block to secure soft tissue graft and a fixation pin placed transversely to the femoral tunnel to lock the block. Includes specialized instrumentation for bone tunnel creation and device placement, plus a sterilization tray. Used by surgeons in clinical settings. Provides mechanical fixation of grafts to bone to facilitate ligament reconstruction.

Clinical Evidence

Bench testing only. Mechanical ultimate failure strength data provided to support substantial equivalence.

Technological Characteristics

Two-piece implant system consisting of a graft block and a transverse fixation pin. Metallic bone fixation fastener. Includes associated surgical instrumentation and sterilization tray.

Indications for Use

Indicated for fixation of ligament and tendon grafts in cruciate ligament reconstructions.

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

• Depuy Linx HT

Submission Summary (Full Text)

{0}------------------------------------------------

K041749

Irgelfs

# SEP - 8 2004

### 510(k) SUMMARY

#### 1. SUBMITTER:

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

Contact: Eric Bannon, Regulatory Consultant Date Prepared: June 28, 2004

## 2. DEVICE:

Trade Name: Scandius ACL Reconstruction System Classification Name: Fastener, Fixation, Non-Degradable, Soft Tissue The Product Code: MBI HASC

## 3. PREDICATE DEVICE:

The predicate device used to determine substantial equivalence for the Scandius ACL Reconstruction System was the Depuy Linx HT.

#### 4. DEVICE DESCRIPTION:

The ACL Reconstruction System consists of a two piece implant designed to fixation soft tissue for ACL reconstruction. The graft block secures the soft tissue graft. A fixation pin placed transversely to the femoral tunnel secures the graft block in place.

The System includes instrumentation to create the bone tunnel and place the device as well as a sterilization tray.

#### 5. INTENDED USE:

The intended use of the Scandius ACL Reconstruction System is for fixation of ligament and tendon grafts in cruciate ligament reconstructions.

## 6. COMPARISON OF CHARACTERISTICS:

- 트 The devices have the same intended and indication for use, have similar technical characteristics and principles of operation.
- The devices use similar implant materials

{1}------------------------------------------------

K07749 pge >gl

- Bench testing demonstrate 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

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 8 2004

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

Re: K041749

Trade/Device Name: Scandius ACL Reconstruction System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: June 28, 2004 Received: June 29, 2004

Dear Mr. Bannon:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative) it stgmy and ment date of the Medical Device American of to conninered processified in accordance with the provisions of the Federal Food, Drug, devices mat have been reciasined require approval of a premarket approval application (PMA). and Cosmetic real (110.) that to neview, subject to the general controls provisions of the Act. The r ou may, mereleve, mains of the Act include requirements for annual registration, listing of general controls proving 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 If your device is blussined (600 as cotrols. 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 r loase be devilode that i 1977 minution that your device complies with other requirements of the Act that I Dr has made a and regulations administered by other Federal agencies. You must or any I oderal butther and strequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OFF Part 8077, accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in also qualisms by by the estions 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

## Page 2 - Mr. Eric Bannon

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter whil anow you to begin manteeing your antial equivalence of your device to a legally premarket notification. The PDA maing of basification 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 advice for your ac [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. IMisoranding of reference to pressessibilities under the Act may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark A Millburn

Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Number (if known):_K (041749

Device Name: Scandius ACL Reconstruction System

Indications for Use: The Scandius ACL Reconstruction System is intended for use in fixation of ligament and tendon grafts in cruciate ligament reconstructions.

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 C.F.R. 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

Mark N. Milliken

(Division Sign-Off) (Division org-

Neurological Devices

**510(k) Number** K041749

12