BIORETEC ACTIVASCREW INTERFERENCE

K130716 · Bioretec, Ltd. · MAI · Aug 28, 2013 · Orthopedic

Device Facts

• Record ID: K130716
• Device Name: BIORETEC ACTIVASCREW INTERFERENCE
• Applicant: Bioretec, Ltd.
• Product Code: MAI · Orthopedic
• Decision Date: Aug 28, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ActivaScrew™ Interference is indicated for fixation of tissue, including ligament or tendon to bone, or a bone-tendon to bone in the presence of appropriate immobilization / controlled mobilization. Interference fixation is intended for surgeries of knee, shoulder, elbow, ankle, foot and hand/wrist.

Device Story

ActivaScrew™ Interference is a fully threaded, bioabsorbable interference screw used for orthopedic soft tissue-to-bone or bone-to-bone fixation. Constructed from poly(L-lactide-co-glycolide) (PLGA), the device provides mechanical fixation during surgical procedures in the knee, shoulder, elbow, ankle, foot, and hand/wrist. It is intended for use by surgeons in clinical settings. The screw functions by providing interference fixation, securing tissue in place while the patient undergoes appropriate immobilization or controlled mobilization. The device is designed to degrade over time, eliminating the need for secondary removal. Clinical benefit is derived from its mechanical stability during the healing process and its bioabsorbable nature.

Clinical Evidence

Bench testing only. Performance was verified through comparative non-clinical testing against predicate devices, including pull-out testing, shear strength testing, inherent viscosity, and dimensional stability testing. Results confirmed the device's mechanical properties and degradation profile are sufficient for its intended use and substantially similar to the predicate devices.

Technological Characteristics

Constructed of bioabsorbable poly(L-lactide-co-glycolide) (PLGA). Fully threaded screw design with diameters of 4-10 mm and lengths of 10-33 mm. Mechanical fixation principle. No software or electronic components.

Indications for Use

Indicated for fixation of tissue (ligament or tendon to bone) or bone-tendon to bone in knee, shoulder, elbow, ankle, foot, and hand/wrist surgeries, requiring immobilization or controlled mobilization.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Inion Hexalon™ Biodegradable ACL/PCL Screw (K071464)
• Arthrex Bio-Tenodesis™ Screw from Tenodesis™ Screw Family (K010525, K011007, K020043, K041356, K051726)
• Bioretec ActivaScrew™ (K062980, K072848, K081392)

Submission Summary (Full Text)

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#### G 510(k) SUMMARY ·

For the Bioretec ActivaScrew™ Interference

### MANUFACTURER .

Bioretec Ltd. Hermiankatu 22, Modulight Building FI-33720 Tampere FINLAND

Contact person: Ms. Minna Räsänen Quality and Regulatory Affairs Manager Direct: [phone] Mobile: [phone] Fax: [phone] E-mail: [e-mail]

Date prepared: March 13", 2013

### DEVICE NAME

Trade Name: Bioretec ActivaScrew™ Interference

Common Name: Biodegradable interference screw

AUG 2 8 2013

## DEVICE CLASSIFICATION AND PRODUCT CODE

Product Code: MAI

Regulation Number: 21 CFR 888.3030

Device Classification Name: Single/multiple component metallic bone fixation appliances and accessories

Classification Panel: Orthopedic

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### PREDICATE DEVICES

- Inion Hexalon™ Biodegradable ACL/PCL Screw (K071464) 1.
- Arthrex Bio-Tenodesis™ Screw from Tenodesis™ Screw Family (K010525, K011007, 2. K020043, K041356, K051726)
- 3. Bioretec ActivaScrew™ (K062980, K072848, K081392)

### DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION

The ActivaScrew™ Interference is indicated for fixation of tissue, including ligament or tendon to bone, or a bone-tendon to bone in the presence of appropriate immobilization / controlled mobilization. Interference fixation is intended for surgeries of knee, shoulder, elbow, ankle, foot and hand/wrist.

The product family consists of fully threaded ActivaScrew™ Interference, diameters 4 - 10 mm and lengths 10 - 33 mm.

The ActivaScrew™ Interference is constructed of bioabsorbable poly(L-lactide-co-glycolide) (PLGA).

#### SUBSTANTIAL EQUIVALENCE TO MARKETED PRODUCTS

The ActivaScrew™ Interference bioabsorbable screw is substantially equivalent to biodegradable screws, intended for similar indications, which have been cleared through a 510(k) pre-market notification pathway.

The Bioretec ActivaScrew™ Interference has the same intended use and principles of operation, and very similar design characteristic as the predicate devices Inion Hexalon™ Biodegradable ACL/PCL Screw (K071464) and Arthrex Bio-Tenodesis™ Screw from Tenodesis™ Screw Family (K010525, K011007, K020043, K041356, K051726). The material of the ActivaScrew™ Interference is the same as the material of the previously cleared ActivaScrew™ (K062980, K072848, K081392).

The performance of the ActivaScrew™ Interference was compared to the predicate devices by pull-out testing, shear strength testing, inherent viscosity and dimensional stability testing.

These test results also verify that the performance of ActivaScrew™ Interference is sufficient for its indications, and that the device is substantially similar to its predicates with regard to its mechanical properties, and long term degradation properties. This performance testing does not raise any new questions of safety or effectiveness of the ActivaScrew™ Interference and demonstrates that the ActivaScrew™ Interference performs mechanically in a manner

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K130716 (3/3)

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substantially similar to the tested predicate device. Thus, non-clinical tests and in vitro testing determined that the ActivaScrew™ Interference has substantially similar performance as compared to its predicate devices.

:

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

August 28, 2013

Biorectec Limited Ms. Mari Ruotsalainen Quality and Regulatory Affairs Manager Hermiankatu 22, Modulight Building FI-33720 Tampere Finland

Re: K130716

Trade/Device Name: Bioretec ActivaScrew 131 Interference Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: July 5, 2013 Received: July 5, 2013

Dear Ms. Ruotsalainen:

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 r ne general ochariting 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 docs 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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/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/Reportal?roblem/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/Industrs/default.htm.

Sincercly yours,

Mark N. Melkerson -S

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

Enclosure

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#### F Indications for Use Statement

Submitter: Bioretec Ltd. K130716 510(k) Number: ActivaScrew™ Interference Device Name:

Indications for Use:

The ActivaScrew™ Interference is indicated for fixation of tissue, including ligament or tendon to bone, or a bone-tendon to bone in the presence of appropriate immobilization / controlled mobilization. Interference fixation is intended for surgeries of knee, shoulder, elbow, ankle, foot and hand/wrist.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

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Traditional 510(k) Date: March 13th, 2013

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