INTRAFIX TIBIAL SHEATH

K102443 · Depuy Mitek, A Johnson & Johnson Company · MBI · Oct 20, 2010 · Orthopedic

Device Facts

• Record ID: K102443
• Device Name: INTRAFIX TIBIAL SHEATH
• Applicant: Depuy Mitek, A Johnson & Johnson Company
• Product Code: MBI · Orthopedic
• Decision Date: Oct 20, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intrafix Sheath is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee.

Device Story

Intrafix Tibial Sheath system comprises non-absorbable expansion sheath and expansion screw; used for soft tissue graft fixation in knee cruciate ligament reconstruction. Surgeon creates tibial tunnel; inserts sheath via sheath inserter; screws expansion screw into sheath to expand it; compresses graft against tunnel wall to achieve fixation. Device provides mechanical stability for ligament reconstruction. Used in surgical settings by orthopedic surgeons.

Clinical Evidence

Bench testing only. Verification activities included insertion torque, pullout strength, and displacement testing comparing the modified device to the predicate. Results demonstrated substantial equivalence.

Technological Characteristics

Non-absorbable expansion sheath and screw system. Material: Polypropylene (Ethicon Prolene). Mechanical fixation principle via expansion of sheath against graft and tunnel wall. Includes dedicated instrumentation for tunnel establishment and device placement.

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

• Intrafix Tibial Sheath (K983560)
• Femoral Intrafix (K063577)

Submission Summary (Full Text)

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K102443(1/2)

| RIFER HER | never stop moving . |
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PRODUCT: INTRAFIX TIBIAL SHEATH SUBMISSION DATE: AUGUST 20, 2010 SUBMISSION TYPE: SPECIAL

## ATTACHMENT 1

# 5 I O(k) SUMMARY - INTRAFIX TIBIAL SHEATH

## SUBMITTER'S NAME AND ADDRESS

DePuy Mitek, Inc. a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767

## CONTACT PERSON

Deep Pal Regulatory Affairs Specialist II DePuy Mitek, Inc. a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767 TELEPHONE [phone]

| FACSIMILE | 508-977-6911 |
|---------------|-------------------|
| E-MAIL | [e-mail] |
| DATE PREPARED | 8/25/2010 |

## NAME OF MEDICAL DEVICE

CLASSIFICATION NAME

Fastener, Fixation, Nondegradable, Soft Tissue

#### COMMON/USUAL NAME

Bone Anchor

#### PROPRIETARY NAME

Intrafix Tibial Sheath

### SUBSTANTIAL EQUIVALENCE

Intrafix Tibial Sheath is substantially equivalent to the following devices.

Intrafix Tibial Sheath (K983560) - Modified Device .

- Femoral Intrafix (K063577) .
### FDA PRODUCT CODE

MBI

### DEVICE CLASSIFICATION

This type of fixation sheath was originally classified as a Class II medical device by the Orthopedic Review Panel, regulated as 21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener.

OCT 2 0 2010

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K102443(²/₂)

Image /page/1/Picture/1 description: The image shows the DePuy Synthes logo with the tagline "never stop moving". The logo is black and white and features the DePuy name in a bold font. Below the name is the text "Synthes Inc. a Johnson & Johnson company". The tagline is in a smaller font and is located to the right of the logo.

PRODUCT: INTRAFIX TIBIAL SHEATH SUBMISSION DATE: AUGUST 20, 2010 SUBMISSION TYPE: SPECIAL

Continues ...

## ATTACHMENT 1

# 5 I O(k) SUMMARY - Intrafix TIBIAL SHEATH

## DEVICE DESCRIPTION

The proposed Intrafix System consists of two components, a non-absorbable Intrafix Expansion Sheath and a non-absorbable Intrafix Expansion Screw. Also included within the system is the instrumentation to place devices and establish the tunnel. The device functions by establishing the tunnel and placing the expansion Sheath into the tibial tunnel by the use of Sheath Inserter. This is followed by screwing an Expansion Screw into the Sheath expanding the Sheath which compresses the graft against the tunnel and creating fixation.

### INDICATIONS FOR USE

Intrafix Sheath is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee.

## TECHNOLOGICAL CHARACTERSTICS

The design specifications of the proposed Intrafix Tibial Sheath is substantially equivalent to the existing Intrafix Tibial Sheath cleared under 510(k) K983560, except that the proposed Intrafix Tibial Sheath design include the same Sheath material - Polypropylene (Ethicon Prolene) used in the Femoral Intrafix Sheath cleared under K063577. Technological characteristics including design, packaging and indications are the same as the predicate cleared device and use similar or identical material and packaging as the predicates.

### NONCLINICAL TESTING

Verification activities, such as, Insertion Torque, Pullout Strength, Displacement Test were performed on the implant and its predicate device.

### SAFETY AND PERFORMANCE

Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices.

Based on the indications for use, technological characteristics, and comparison to predicate devices, the proposed Intrafix Tibial Sheath has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002

DePuy Mitek, A Johnson & Johnson Company. % Mr. Deep Pal Regulatory Affairs Specialist II 325 Paramount Drive Raynham, MA 02767

OCT 2 0 2010

Re: K102443

Trade/Device Name: Intrafix Tibial Sheath Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: October 7, 2010 Received: October 12, 2010

Dear Mr. Pal:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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### Page 2 - Mr. Deep Pal

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Clabare Buchus

Mark N. Melke Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| DePuy<br>Mitek Inc.<br>a johnson&johnson company | never stop moving- |
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PRODUCT: INTRAFIX TIBIAL SHEATH SUBMISSION DATE: AUGUST 20, 2010 SUBMISSION TYPE: SPECIAL

# ATTACHMENT 2

| <b>INDICATIONS FOR USE</b> |
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| 510(k) Number (if known): | K102443 | OCT 20 2010 |
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| Device Names: | Intrafix Tibial Sheath | |

Indications for Use: Intrafix Tibial Sheath is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee.

| Prescription Use | √ | AND/OR | Over-The-Counter Use |
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(Part 21 CFR 801 Subpart D)

AND/OR

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1

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Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102443