INNOVASIVE DEVICES MENISCAL SCREW

K980681 · Innovasive Devices, Inc. · HWC · Apr 29, 1998 · Orthopedic

Device Facts

• Record ID: K980681
• Device Name: INNOVASIVE DEVICES MENISCAL SCREW
• Applicant: Innovasive Devices, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Apr 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Meniscal Screw is intended for use in the arthroscopic fixation of longitudinal vertical meniscus lesions (bucket handle lesions) located in the vascularized area of the meniscus (red-red and red-white areas).

Device Story

Innovasive Meniscal Screw is a bioabsorbable orthopedic fixation device for meniscal repair. Fabricated from L-PLA, the device features a cannulated, threaded design to secure longitudinal vertical meniscus lesions. It is deployed arthroscopically using a sterile, single-use stainless steel driver mechanism, which is loaded with the screw and inserted through a cannula to the repair site. The screw thread draws tissue edges together during placement. Used by orthopedic surgeons in clinical settings, the device provides mechanical fixation to facilitate healing in vascularized meniscal areas. It benefits patients by enabling minimally invasive repair of bucket handle lesions.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing (fatigue strength, constant load, weight loss, and intrinsic viscosity) and animal testing to demonstrate efficacy and functional performance.

Technological Characteristics

Material: L-PLA. Design: Cannulated, threaded member. Deployment: Stainless steel, single-use driver mechanism. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket handle lesions) in the vascularized (red-red and red-white) zones of the meniscus.

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

• Bionx Arrow (Bioscience Ltd)

Submission Summary (Full Text)

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#### 510(K) SUMMARY

#### 1. SUBMITTER:

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

Contact: Eric Bannon, Vice President of Regulatory Affairs, Quality Assurance Date Prepared: February 10, 1998

#### 2. DEVICE:

Innovasive Meniscal Screw Classification Name: Bioabsorbable Orthopedic Fixation Device Trade Name: Innovasive Devices Meniscal Screw

#### 3. PREDICATE DEVICE:

The predicate devices used to determine substantial equivalence for the Innovasive Devices Meniscal Screw was the Bionx Arrow marketed by Bioscience Ltd, Malvern, PA

#### 4. DEVICE DESCRIPTION:

The Meniscal Screw is a device fabricated from L-PLA which is intended for meniscal repair. The device consists of a cannulated, threaded member designed to be inserted into the meniscus across the tear. The device is screwed into location with the aid of a sterile, single use driver mechanism constructed of stainless steel. The driver is loaded with the Meniscal Screw and placed through a cannula to access the site requiring repair.

#### 5. INTENDED USE:

The intended use of the Meniscal Screw is intended for use in the arthroscopic fixation of longitudinal vertical meniscus lesions (bucket handle lesions) located in the vascularized area of the meniscus (red-red and red-white areas).

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# 6. COMPARISON OF CHARACTERISTICS:

The Meniscal Screw is fabricated from L-PLA, the same material as the Bionx Arrow. The design differs in the use of an external screw thread designed to draw the edges of the tissue together as the device is placed into the meniscus.

The Bionx Arrow uses a different technique to approximate the tear. The Arrow is inserted over a wire using a cannula to establish the device location.

The indications for use of the two devices are identical.

### 7. PERFORMANCE DATA:

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

- 1. Bench Testing: Comparison of the fatigue strength of the Meniscal Screw invitro compared to the predicate device. In addition the performance of the device was assessed under constant load as was the weight loss and intrinsic viscocity.
- 2. Animal Testing: The testing demonstrated the efficacy of the Innovasive Meniscal Screw and confirmed that the device functions adequately to meet its intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures. The symbol is composed of three curved lines that converge and then split into three wavy lines at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 1998

Mr. Eric Bannon ·Vice President of Requlatory Affairs and Quality Assurance Innovasive Devices, Inc. 734 Forest Street 01752 Marlborough, Massachusetts

K980681 Re: Trade Name: Meniscal Screw Regulatory Class: HWC and HRX Product Code: II Dated: February 18, 1998 February 20, 1998 Received:

Dear Mr. Bannon:

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 aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 General requlation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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 requlations.

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#### Page 2 - Mr. Eric Bannon

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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D.

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

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## INDICATIONS FOR USE

The intended use of the Meniscal Screw is intended for use in the arthroscopic fixation of longitudinal vertical meniscus lesions (bucket handle lesions) located in the vascularized area of the meniscus (red-red and red-white areas).

**Prescription Use**
(Per 21 CFR 801.109)

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(Division Sign-Off)

(Division of General Restorative Devices K980681 510(k) Number ________________________________________________________________________________________________________________________________________________________________