INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENER

K983560 · Innovasive Devices, Inc. · MBI · Jan 28, 1999 · Orthopedic

Device Facts

• Record ID: K983560
• Device Name: INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENER
• Applicant: Innovasive Devices, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Jan 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Intratunnel Tibial Fixation Fastener is for fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee.

Device Story

The Innovasive Devices Intratunnel Tibial Fixation Fastener is a surgical implant system used for soft tissue graft fixation during knee cruciate ligament reconstruction. The system comprises an expansion sheath and an expansion screw, along with associated placement instrumentation. During surgery, the expansion sheath is inserted into the tibia-femoral tunnel; an expansion screw is then driven into the sheath, causing it to expand and compress the graft against the tunnel wall to achieve fixation. The device is intended for use by surgeons in an operating room setting. It provides mechanical stabilization of the graft, facilitating healing and joint reconstruction.

Clinical Evidence

Bench testing only. Static holding strength of the Intratunnel Tibial Fixation Fastener was compared to the predicate device using a porcine model.

Technological Characteristics

System consists of an expansion sheath (High Density Polyethylene) and an expansion screw (Acetal or titanium). Fixation is achieved via mechanical expansion of the sheath against the graft and tunnel wall. Device is non-electronic and non-software based.

Indications for Use

Indicated for fixation of soft tissue 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

• RCI Screw (Smith & Nephen DonJoy)

Submission Summary (Full Text)

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JAN 28 1999

K983560
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: October 8, 1998

#### 2. DEVICE:

Innovasive Devices Intratunnel Tibial Fixation Fastener Classification Name: single/multiple component bone fixation appliances and accessories. Trade Name: Innovasive Devices Intratunnel Tibial Fixation Fastener

#### 3. PREDICATE DEVICE:

The predicate devices used to determine substantial equivalence for the Innovasive Devices Intratunnel Tibial Fixation Fastener was the RCI Screw marketed by Smith & Nephen DonJoy, Carlsbad, CA

#### 4. DEVICE DESCRIPTION:

The Innovasive Intratunnel Tibial Fixation Fastener consists of two components, an Expansion Sheath, and Expansion Screw. Also included with the system is the instrumentation to place the devices and establish the tunnel. The device functions by establishing the tibia-femoral tunnel and placing the Expansion Sheath into the tibial tunnel. This is followed by screwing an Expansion Screw into the Sheath, expanding the Sheath which compresses the graft against the tunnel and creating fixation.

#### 5. INTENDED USE:

The intended use of the Intratunnel Tibial Fixation Fastener is for fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee.

### 6. COMPARISON OF CHARACTERISTICS:

The Innovasive Intratunnel Tibial Fixation Fastener consists of two components: the Expansion Sheath, fabricated from High Density Polyethylene, and the

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Expansion Screw, fabricated from either Acetal, or titanium. The device functions by establishing the tibia-femoral tunnel and placing the Expansion Sheath into the tibial tunnel. This is followed by screwing an Expansion Screw into the Sheath, expanding the Sheath which compresses the graft against the tunnel and creating fixation.

The RCI Screw is fabricated from titanium and provides fixation through interface of the screw threads to the soft tissue graft.

The indications for use of the two devices are the same.

## 7. PERFORMANCE DATA:

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

- 1. Bench Testing: Comparison of the static holding strength of the Intratunnel Tibial Fixation Fastener compared to the predicate device in a porcine model.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 28 1999

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

Re: K983560 Intratunnel Tibial Fixation Fastener Trade Name: Regulatory Class: II Product Code: MBI Dated: January 19, 1999 Received: January 20, 1999

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include reguirements 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. ਸ 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 requlation 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 regulations.

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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 diaqnostic 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,

cola

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 Intratunnel Tibial Fixation Fastener is for fixation of soft tissue I he intended use of the intraturiner reconstruction surgeries of the knee.

Prescription Use (Per 21 CFR 801.109)

Dcocey

(Division Sign-Off) Division of General Restors 510(k) Number