ABSOLUTE ABSORBABLE INTERFERENCE SCREW

K993975 · Innovasive Devices, Inc. · HWC · Dec 20, 1999 · Orthopedic

Device Facts

• Record ID: K993975
• Device Name: ABSOLUTE ABSORBABLE INTERFERENCE SCREW
• Applicant: Innovasive Devices, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Dec 20, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Absolute™ Absorbable 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

Biodegradable interference screw for cruciate ligament reconstruction of knee; provides interference fit fixation for soft tissue or bone-tendon-bone grafts. Device is cannulated, threaded, and tapered; manufactured from Poly-L-Lactide (L-PLA). Used by orthopedic surgeons in surgical setting. Provides mechanical graft fixation to facilitate healing. Offered in 11mm and 12mm diameters.

Clinical Evidence

Bench testing only. Bone model testing evaluated ultimate holding strength, specifically force required to insert and strip the screw, demonstrating performance equivalent to the predicate device.

Technological Characteristics

Cannulated, threaded, tapered interference screw. Material: Poly-L-Lactide (L-PLA). Dimensions: 11mm and 12mm diameter, 30mm length. Mechanical fixation principle.

Indications for Use

Indicated for fixation of soft tissue or bone-tendon-bone grafts during knee cruciate ligament reconstruction surgery.

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

• Innovasive Bio-Interference Screw (K900454)

Submission Summary (Full Text)

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# K993975

# DEC 20 1999

## 510(K) SUMMARY Special 510(k)

#### 1. SUBMITTER:

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

Contact: Kathleen Morahan, Regulatory Affairs Specialist Date Prepared: November 19, 1999

#### 2. DEVICE:

Trade Name: Innovasive Absolute™ Absorbable Interference Screw (11mm and 12mm)

Common Name: Interference Screw

Classification Name: Not Classified

### 3. PREDICATE DEVICE:

(1) Innovasive Bio-Interference Screw - K900454

#### 4. DEVICE DESCRIPTION:

The Absolute™ Absorbable Interference Screw is a biodegradable interference screw intended for interference fit fixation of soft tissue grafts or bone-tendonbone grafts during cruciate ligament reconstruction surgeries of the knee. The device is offered in 11mm and 12mm diameters and 30mm in length.

#### 5. INTENDED USE:

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

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#### 6. COMPARISON OF CHARACTERISTICS:

The design of Innovasive's Absolute™ Absorbable Interference Screw is identical to the Bio-absorbable Interference Screw with the exception of the outside diameter. Both devices are cannulated, threaded, tapered, and molded from the same material: Poly-L-Lactide (L-PLA).

The indication being requested for the Absolute™ Absorbable Interference Screw is already cleared for predicate Bio-Interference Screw.

#### 7. PERFORMANCE DATA:

The following performance testing was performed in support of the substantial equivalence determination:

Bone Model Testing: the ultimate holding strength of the Absolute™ Absorbable Interference Screw, the force to insert and strip the screw.

The testing demonstrates substantially equivalent performance between the proposed and predicate devices.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 1999

Ms. Kathleen Morahan Regulatory Affairs Specialist Innovasive Device, Inc. 734 Forest St. Marlborough, MA 01752

Re: K993975

Trade Name: Absolute Absorbable Interference Screw Regulatory Class: II Product Code: HWC Dated: November 19, 1999 Received: November 24, 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 Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Kathleen Morahan

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 toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

Neil R.P. Ogden
James E. Dillard III for

Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K993975

# INDICATIONS FOR USE

11mm & 12mm Absolute™ Absorbable Interference Screw

The 11mm & 12mm Absolute™ Absorbable Interference Screws are intended for fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.

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