MILAGRO INTERFERENCE SCREW

K060830 · Depuy Mitek, A Johnson & Johnson Company · HWC · Jun 15, 2006 · Orthopedic

Device Facts

• Record ID: K060830
• Device Name: MILAGRO INTERFERENCE SCREW
• Applicant: Depuy Mitek, A Johnson & Johnson Company
• Product Code: HWC · Orthopedic
• Decision Date: Jun 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MILAGRO Interference Screw is indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee. The 7, 8 and 9mm x 23mm screws are also indicated for: medial and lateral collateral ligament repair of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.

Device Story

MILAGRO Interference Screw is a cannulated, threaded, tapered fastener used for interference fixation of soft tissue or bone-tendon-bone grafts. Used by surgeons in orthopedic procedures including knee ligament reconstruction, shoulder bicep tenodesis, and elbow bicep tenodesis. Device provides mechanical fixation of grafts to bone to facilitate healing. Operates as a physical implant; no electronic or software components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Cannulated, threaded, tapered fastener. Material: Copolymer of absorbable Poly(lactide-co-glycolide) (PLA PGA) compounded with beta-Tricalcium Phosphate (β-TCP). Available in multiple sizes and lengths.

Indications for Use

Indicated for fixation of soft tissue or bone-tendon-bone grafts in knee cruciate ligament reconstruction. Specific sizes (7, 8, 9mm x 23mm) indicated for knee medial/lateral collateral ligament repair, shoulder proximal bicep tenodesis, and elbow distal bicep tenodesis.

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-Corkscrew Suture Anchor (K003227)

Submission Summary (Full Text)

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Ka0830

### (JUN 15 2006

# SECTION 6 - 510(k) SUMMARY

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| Submitter's Name and<br>Address: | DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive,<br>Raynham, MA 02767 USA |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ruth Forstadt, RAC<br>Project Management Lead, Regulatory Affairs<br>DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive,<br>Raynham, MA 02767 USA<br>Telephone: [phone]<br>Facsimile: [phone]<br>e-mail: [e-mail] |
| Name of Medical Device | Device Regulation:<br>Fastener, Fixation, Non-Degradable, Soft Tissue<br>(21 CFR 888.3040)<br>Product code: HWC and MAI<br>Common/Usual Name: Interference Screw<br>Proprietary Name:<br>MILAGRO Interference Screw |
| Device Classification | In accordance with per 21 CFR 888.3040, interference screws are<br>classified by the FDA as Class II Medical Devices. |
| Indications for Use | The MILAGRO Interference Screw is indicated for the fixation of soft<br>tissue grafts or bone-tendon-bone grafts during cruciate ligament<br>reconstruction surgeries of the knee. The 7, 8 and 9mm x 23mm screws<br>are also indicated for: medial and lateral collateral ligament repair of the<br>knee, proximal bicep tenodesis in the shoulder and distal bicep<br>tenodesis in the elbow. |

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## 510(k) SUMMARY

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| Device Description | The MILAGRO Interference Screw is a cannulated, threaded, tapered<br>fastener for use in interference fixation of soft tissue grafts or bone-<br>tendon-bone grafts. The device is made from a copolymer of<br>absorbable Poly(lactide-co-glycolide) (PLA PGA) compounded with<br>beta-Tricalcium Phosphate (β-TCP) and is available in several sizes and<br>varied lengths. |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence | The MILAGRO Interference Screw is a commercially marketed device<br>that was subject of K032717 (cleared March 31, 2004). When used for<br>the proposed indications the device is substantially equivalent to the<br>Arthrex Bio-Corkscrew Suture Anchor (K003227, cleared 1/8/2001). |
| Safety and Performance | The determination of substantial equivalence for this device was based<br>on a detailed device description. Non-clinical laboratory testing was<br>performed demonstrating that the device is safe and can be considered<br>substantially equivalent to the predicate devices for the proposed new<br>intended uses. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 15 2006

DePuy Mitek % Ms. Ruth Forstadt Project Management Lead, Regulatory Affairs 325 Paramont Drive Raynham, Massachusetts 02767

Re: K060830

Trade/Device Name: MILAGRO Interference Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MAI Dated: March 24, 2006 Received: March 27, 2006

Dear Ms. Forstadt:

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 mav. 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 such 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 Pari 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set 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.

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Page 2 - Ms. Ruth Forstadt

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 10(a)/ 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), please contact the Office of Compliance at (240-276-0120). Also, please note the regulation vote), proc "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtained, general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free rumber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/suport/index.html.

Sincerely yours.

Ваввае Висит

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): Device Name: Milagro Interference Screw

Indications for Use:

The MILAGRO Interference Screw is indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries af the knee. Additionally, the 7, 8 and 9 mm x 23 mm screws will be indicated for medial and lateral collateral ligament repair of the knee, proximal bicep teoo to'. in the shoulder and distal bicep tenodesis in the elbow.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Vize-Präsident)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number**