BIO-INTERFERENCE SCREW

K990454 · Innovasive Devices, Inc. · HWC · Jul 1, 1999 · Orthopedic

Device Facts

• Record ID: K990454
• Device Name: BIO-INTERFERENCE SCREW
• Applicant: Innovasive Devices, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Jul 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The proposed Bio-Interference Screw is intended for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.

Device Story

The Bio-Interference Screw is a biodegradable orthopedic implant used during knee cruciate ligament reconstruction. It provides interference fit fixation for soft tissue or bone-tendon-bone grafts. The device is cannulated, threaded, and tapered, available in various diameters and lengths. It is manufactured from Poly-L-Lactide (L-PLA). The screw is intended for use by surgeons in a clinical/OR setting. It functions by mechanically securing the graft within the bone tunnel, facilitating ligament reconstruction and potentially improving patient outcomes by stabilizing the graft during the healing process.

Clinical Evidence

Bench testing only. Ultimate holding strength of the subject device was compared to the predicate Arthrex Bio-Interference Screw using a bone model. Results demonstrated substantially equivalent performance.

Technological Characteristics

Material: Poly-L-Lactide (L-PLA). Design: Cannulated, threaded, tapered screw. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries 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

• Arthrex Bio-Interference Screw (K971358)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logo for Innovasive Devices. The logo includes two triangles stacked on top of each other, with the text "INNOVASIVE" in bold letters and "DEVICES" in smaller letters underneath. Above the logo, the text "JUL - 1 1999" is printed.

# K990454 510(K) SUMMARY

# 1. SUBMITTER:

Innovasive Devices, Inc. 734 Forest St. Marlborough, MA 01752 Telephone: [phone] Fax: [phone]

Contact: Kathleen Morahan, Regulatory Affairs Specialist Date Prepared: February 11, 1999

# 2. DEVICE:

Trade Name: Innovasive Bio-Interference Screw

Common Name: Interference Screw

Classification Name: Not Classified

# 3. PREDICATE DEVICE:

(1) Arthrex Bio-Interference Screw - K971358

### 4. DEVICE DESCRIPTION:

The Bio-Interference Screw is a biodegradable interference screw intended for interference fit fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee. The device is offered in varying diameters and lengths.

### 5. INTENDED USE:

The proposed Bio-Interference Screw is intended for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.

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

Image /page/1/Picture/0 description: The image shows a black-and-white map. The map appears to depict a cluster of islands, possibly an archipelago, scattered across a body of water. The islands vary in size and shape, with some appearing more compact and others more elongated.

# 6. COMPARISON OF CHARACTERISTICS:

The design of Innovasive's proposed Bio-Interference Screw is very similar to the predicate device: both devices are cannulated, threaded, tapered, and are offered in varying diameters and lengths. Innovasive's proposed Bio-Interference Screw and Arthrex's Bio-Interference Screw are also molded from the same material: Poly-L-Lactide (L-PLA).

The indication being requested for the proposed Bio-Interference Screw is already cleared for Arthrex's Bio-Interference Screw.

## 7. PERFORMANCE DATA:

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

Bone Model Testing: the ultimate holding strength of the proposed Bio-Interference Screw was compared to the currently marketed Arthrex Bio-Interference Screw. The testing demonstrates substantially equivalent performance between the two devices.

{2}------------------------------------------------

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 caduceus, a symbol often associated with medicine and healthcare, with three lines representing the staff and a winding snake. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 1 1999

Ms. Kathleen Morahan Regulatory Affairs Specialist Innovasive Devices, Inc. 734 Forest St. Marlborough, Massachusetts 01752

Re: K990454 Trade Name: Innovasive Bio-Interference Screw Regulatory Class: II Product Code: HWC Dated: May 5, 1999 Received: May 6, 1999

Dear Ms. Morahan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic

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

# Page 2 -- Ms. Kathleen Morahan

Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Image /page/4/Picture/0 description: The image shows the word "CONFIDENTIAL" in large, bold letters. Below the word "CONFIDENTIAL" is the text "Page 1 of 1". The text is centered below the word "CONFIDENTIAL".

# 510(k) Number (if known): K990454

Bio-Interference Screw . Device Name:

Indications for Use:

The Bio-Interference Screw is intended for fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use × OR

Over-the-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

poole

(Division Sign-Off)
Division of General Restorative Devices k990454
510(k) Number