MILAGRO ADVANCE PEEK Interference Screw

K161001 · Medos International SARL · MBI · Jun 9, 2016 · Orthopedic

Device Facts

• Record ID: K161001
• Device Name: MILAGRO ADVANCE PEEK Interference Screw
• Applicant: Medos International SARL
• Product Code: MBI · Orthopedic
• Decision Date: Jun 9, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MILAGRO® ADVANCE PEEK 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 are indicated for: medial and lateral ligament repar , medial patellofemoral ligament reconstruction) of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.

Device Story

Non-absorbable, tapered, cannulated, threaded interference screw; manufactured from PEEK; used for soft tissue or bone-tendon-bone graft fixation to bone. Device implanted by surgeons during orthopedic procedures (cruciate ligament reconstruction, ligament repair, bicep tenodesis). Provides mechanical fixation of grafts to bone; facilitates healing by securing graft in anatomical position. Single-patient use; provided sterile.

Clinical Evidence

Bench testing only. Verification activities included pull-out testing and insertion/failure torque assessments. Bacterial endotoxin testing performed. No clinical data provided.

Technological Characteristics

Material: Polyetheretherketone (PEEK). Design: Tapered, cannulated, threaded fastener. Sterilization: Sterile. Single-patient use. No software or electronic components.

Indications for Use

Indicated for patients requiring soft tissue or bone-tendon-bone graft attachment to the tibia/femur during cruciate ligament reconstruction. Specific sizes (7, 8, 9 mm x 23 mm) indicated for medial/lateral collateral ligament repair, medial patellofemoral ligament reconstruction of the knee, and proximal/distal bicep tenodesis in the shoulder/elbow.

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 ADVANCE™ Interference Screw (K123362)
• MILAGRO ADVANCE™ Interference Screw (K143660)

Reference Devices

• Healix Advance™ Knotless PEEK Anchor (K130539)

Submission Summary (Full Text)

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

June 9, 2016

Medos International SARL % Ms. Kristine Christo Director, Regulatory Affairs Depuy Mitek Inc., a Johnson & Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767

Re: K161001

Trade/Device Name: MILAGRO® ADVANCE PEEK Interference Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener. Regulatory Class: Class II Product Code: MBI Dated: April 7, 2016 Received: April 11, 2016

Dear Ms. Christo:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education 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 -S

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) K161001

Device Name

MILAGRO® ADVANCE PEEK Interference Screw

Indications for Use (Describe)

The MILAGRO® ADVANCE PEEK 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 are indicated for: medial and lateral ligament repar , medial patellofemoral ligament reconstruction) of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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## SECTION 2 - 510(k) SUMMARY

## MILAGRO® ADVANCE PEEK Interference Screw

| Submitter's<br>Name and<br>Address | DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767<br><br>Date Prepared: March 25, 2016 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Kristine Christo<br>Director, Regulatory Affairs<br>DePuy Mitek, Inc.<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767, USA<br><br>Telephone: [phone]<br>Facsimile: 508-977-6911<br>e-mail: [e-mail] |
| Name of<br>Medical Device | Proprietary Name: MILAGRO® ADVANCE PEEK Interference Screw<br>Classification Name: Smooth or threaded metallic bone fixation fasteners<br>Common Name: Fastener, fixation, nondegradable, soft tissue |
| Substantial<br>Equivalence | The MILAGRO® ADVANCE PEEK Interference Screw is substantially equivalent to:<br>■ K123362, K143660, MILAGRO ADVANCE™ Interference Screw<br><br>Reference device:<br>■ K130539 Healix Advance™ Knotless PEEK Anchor |
| Device<br>Classification | Smooth or threaded metallic bone fixation fastener, classified as Class II,<br>product code MBI, regulated under 21 CFR 888.3040. |
| Device<br>Description | The MILAGRO® ADVANCE PEEK Interference Screw is a non-absorbable, tapered,<br>cannulated, threaded fastener for use in interference fixation of soft tissue grafts or<br>bone-tendon-bone grafts. The Interference Screw is made from Polyetheretherkeytone<br>(PEEK). The MILAGRO® ADVANCE PEEK Interference Screw is provided sterile<br>and is for single patient use only. |
| Technological<br>Characteristics | The proposed MILAGRO® ADVANCE PEEK Interference Screw is similar to the<br>predicate MILAGRO ADVANCE™ Interference Screw (K123362, K143660) in that<br>they share the same indication for use, screw design, sterilization method, and shelf<br>life. The proposed MILAGRO® ADVANCE PEEK Interference Screw is similar to the<br>reference device, Healix Advance™ Knotless PEEK Anchor (K130539), in that they<br>share the same PEEK material. |
| Indications for<br>Use | The MILAGRO® ADVANCE PEEK Interference Screw is intended for attachment of<br>soft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur during cruciate<br>ligament reconstruction procedures. |
| | Additionally, the 7, 8 and 9 mm x 23 mm screws will be indicated for: medial and<br>lateral collateral ligament repair, medial patellofemoral ligament reconstruction (femur<br>fixation) of the knee, proximal bicep tenodesis in the shoulder and distal bicep<br>tenodesis in the elbow. |
| Non clinical<br>Testing | Verification activities were performed on the implant and / or its predicate. Testing<br>assessments include pull out testing, and insertion / failure torque. |
| Safety and<br>Performance | Results of performance testing have demonstrated that the proposed devices are<br>suitable for their intended use. |
| | The proposed device also met requirement of bacterial endotoxin testing. |
| | Based on similarities in the indications for use, technological characteristics, and<br>performance in comparison to the predicate devices, the proposed MILAGRO®<br>ADVANCE PEEK Interference Screw has shown to be substantially equivalent to the<br>predicate device under the Federal Food, Drug and Cosmetic Act. |

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