MILAGRO ADVANCE INTERFERENCE SCREW

K123362 · Depuy Mitek, A Johnson & Johnson Company · HWC · Feb 1, 2013 · Orthopedic

Device Facts

• Record ID: K123362
• Device Name: MILAGRO ADVANCE INTERFERENCE SCREW
• Applicant: Depuy Mitek, A Johnson & Johnson Company
• Product Code: HWC · Orthopedic
• Decision Date: Feb 1, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MILAGRO ADVANCE Interference Screw is intended for attachment of soft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur during cruciate ligament reconstruction procedures. 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 tenodesis in the shoulder and distal bicep tenodesis in the elbow.

Device Story

Absorbable, tapered, cannulated, threaded interference screw; used for soft tissue or bone-tendon-bone graft fixation in orthopedic procedures (cruciate ligament reconstruction, collateral ligament repair, bicep tenodesis). Device composed of Poly(lactide-co-glycolide) and Tricalcium Phosphate (TCP). Provided sterile for single-patient use. Implanted by surgeons in clinical settings. Provides mechanical fixation of grafts to bone to facilitate healing.

Clinical Evidence

Bench testing only. Testing included screw fixation strength (time zero and in vitro throughout healing period) and screw torque testing to confirm insertion suitability. No clinical data presented.

Technological Characteristics

Absorbable, tapered, cannulated, threaded fastener. Material: Composite of Poly(lactide-co-glycolide) and Tricalcium Phosphate (TCP). Sterile, single-use. Mechanical fixation principle.

Indications for Use

Indicated for patients requiring soft tissue or bone-tendon-bone graft attachment to the tibia/femur during cruciate ligament reconstruction, medial/lateral collateral ligament repair of the knee, or proximal/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

• MILAGRO Interference Screw (K060830)
• Biocryl Rapide Interference Screw (K032717)

Submission Summary (Full Text)

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## K123362 (page 1 of 2)

## SECTION 2 - 510(k) SUMMARY

## MILAGRO ADVANCE Interference Screw

| Submitter's<br>Name and<br>Address | DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Yayoi Fujimaki<br>Regulatory Affairs Senior Associate<br>DePuy Mitek, Inc.<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767, USA<br>Telephone: [phone]<br>Facsimile: 508-977-6911<br>e-mail: [e-mail] |
| Name of<br>Medical Device | MILAGRO ADVANCE Interference Screw<br>Proprietary Name:<br>Classification Name: Smooth or threaded metallic bone fixation fastener<br>Common Name: fastener, fixation, biodegradable, soft tissue |
| Substantial<br>Equivalence<br>Facility | The MILAGRO ADVANCE Interference Screw is substantially equivalent to:<br>K060830: MILAGRO Interference Screw<br>K032717: Biocryl Rapide Interference Screw |
| Device<br>Classification | HWC - Smooth or threaded metallic bone fixation fastener, classified as Class II,<br>regulated under 21 CFR 888.3040<br>MAI - Single/multiple component metallic bone fixation appliances and accessories,<br>classified as Class II, regulated under 21 CFR 888.3030. |

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### K123362 (Page 2 of 2)

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| Device<br>Description | The MILAGRO ADVANCE Interference Screw is an absorbable, tapered, cannulated,<br>threaded fastener for use in interference fixation of soft tissue grafts or bone-tendon<br>grafts. The Interference Screw is made from a composite made of absorbable Poly<br>(lactide-co-glycolide) polymer and Tricalcium Phosphate (TCP).<br>The MILAGRO ADVANCE Interference Screw is provided sterile and is for single<br>patient use only. |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The MILAGRO ADVANCE Interference Screw is intended for attachment of soft<br>tissue grafts or bone-tendon-bone grafts to the tibia and/or femur during cruciate<br>ligament reconstruction procedures.<br>Additionally, the 7, 8 and 9 mm x 23 mm screws will be indicated for: medial and<br>lateral collateral ligament repair of the knee, proximal bicep tenodesis in the shoulder<br>and distal bicep tenodesis in the elbow. |
| Safety and<br>Performance | Non-clinical Testing<br>Screw fixation strength testing (at time zero and in vitro testing throughout healing.<br>period) was performed to confirm that the proposed screws perform similarly to the<br>predicate screws or meet the acceptance criteria. Screw torque testing was performed<br>to confirm that there is no issue for screw insertion into the bone. Results of the testing<br>have demonstrated that the proposed screws are suitable for the intended use.<br>Based on the indications for use, technological characteristics, and comparison to the<br>predicate devices, the proposed MILAGRO ADVANCE Interference Screw has been<br>shown to be substantially equivalent to the predicate device under the Federal Food,<br>Drug and Cosmetic Act. |

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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract image of an eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

DePuy Mitek, a Johnson and Johnson Company % Yayoi Fujimaki Regulatory Affairs Senior Associate 325 Paramount Drive Raynham, Massachusetts 02767

Letter dated: February 1, 2013

Re: K123362

Trade/Device Name: MILAGRO ADVANCE 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: January 8, 2013 Received: January 11, 2013 ·

Dear Yayoi Fujimaki:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 – Yayoi Fujimaki

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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Mark N. Melkerson

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K123362

Device Name: MILAGRO ADVANCE Interference Screw

Indications for Use:

The MILAGRO ADVANCE Interference Screw is intended for attachment of soft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur during cruciate ligament reconstruction procedures.

Additionally, the 7, 8 and 9 mm x 23 mm screws will be indicated for: medial and lateral ligament repair of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use_

(Part 21 CFR 801 Subpart D)

(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)

Anton E. Dmitriev, PhD Division of Orthopedic Devices 2013.02.01 14:22:01 -05'00'

Page 1 of 1

Premarket Notification: Traditional MILAGRO ADVANC Interference Screw