ACTIVASCREW

K062980 · Bioretec, Ltd. · HWC · Nov 22, 2006 · Orthopedic

Device Facts

• Record ID: K062980
• Device Name: ACTIVASCREW
• Applicant: Bioretec, Ltd.
• Product Code: HWC · Orthopedic
• Decision Date: Nov 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ActivaScrew™ is indicated for fixation of bone fractures, osteotomies, arthrodeses, bone grafts and osteochondral fractures of upper extremity, ankle and foot in the presence of appropriate immobilization.

Device Story

ActivaScrew™ is a bioabsorbable bone fixation screw used for fractures, osteotomies, arthrodeses, and bone grafts in the upper extremity, ankle, and foot. Made of poly(L-lactide-co-glycolide) (PLGA), the screw provides mechanical fixation while the bone heals; it maintains strength for at least 8 weeks and degrades via hydrolysis into alpha-hydroxy acids over approximately two years, eliminating the need for removal surgery. Available in diameters of 2.0–4.5 mm and lengths of 10–90 mm, the device is used by surgeons in clinical settings to provide internal fixation. The device functions as a temporary mechanical support that gradually transfers load to the healing bone as it resorbs.

Clinical Evidence

Bench testing only. Non-clinical and in vitro testing determined that the ActivaScrew™ has substantially similar performance compared to its predicate devices.

Technological Characteristics

Material: Poly(L-lactide-co-glycolide) (PLGA). Form factor: Fully and partially threaded screws, 2.0–4.5 mm diameter, 10–90 mm length. Principle: Bioabsorbable internal fixation via hydrolysis. Sterilization: Not specified.

Indications for Use

Indicated for fixation of bone fractures, osteotomies, arthrodeses, bone grafts, and osteochondral fractures of the upper extremity, ankle, and foot requiring immobilization. Contraindicated for diaphyseal bone fractures/osteotomies (except hand/foot), active or potential infection, and cases where patient cooperation is not guaranteed.

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

• Inion OTPS™ Biodegradable Fixation System (K030900)
• Bioretec ActivaPin™ (K061164)

Submission Summary (Full Text)

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K062980

#### G 510(k) SUMMARY

For the Bioretec ActivaScrew™

### MANUFACTURER

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

Contact person: Ms. Mari Ruotsalainen Quality Manager Phone: [phone] [phone] Fax: Mari. [e-mail]

Date prepared: September 27th, 2006

#### DEVICE NAME

Trade Name: Bioretec ActivaScrew™ Common Name: Bone, Fixation, Screw

### ESTABLISHMENT REGISTRATION NUMBER

Bioretec Ltd. will register following FDA clearance.

## DEVICE CLASSIFICATION AND PRODUCT CODE

Device Classification Name: Screw, Fixation, Bone Classification Panel: Orthopedic Regulation Number: 21 CFR 888.3040 Product Code: HWC

#### PREDICATE DEVICES

1. Inion OTPS™ Biodegradable Fixation System (K030900) 2. Bioretec ActivaPin™ (K061164)

## DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION

The ActivaScrew™ is indicated for fixation of bone fractures, osteotomies, arthrodeses, bone grafts and osteochondral fractures of upper extremity, ankle and foot in the presence of

Traditional 510(k) Date: September 27th, 2006

NOW 2 2 2006

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appropriate immobilization. Screws are available as fully and partially threaded in several different sizes, including diameters of 2.0 – 4.5 mm and lengths of 10 – 90 mm.

The ActivaScrew™ is made of the completely bioabsorbable poly(L-lactide-co-glycolide) (PLGA) material, and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the ActivaScrew™ gradually loses its strength, however, maintaining its function at least 8 weeks. Bioabsorption takes place approximately within two years thus eliminating the need for implant removal surgery.

# EQUIVALENCE TO MARKETED PRODUCTS

The ActivaScrew™ bioabsorbable screw is substantially equivalent to biodegradable screws, intended for similar indications, which have received 510(k) clearance.

The Bioretec ActivaScrew™ has the same intended use and principles of operation, and very similar design characteristic as the predicate device INION OTPS™ Biodegradable Fixation System screw implants (K030900). The material of the ActivaScrew™ is same as the material of the previously cleared ActivaPin™ (K061164). Any differences between ActivaScrew™ and these predicate devices do not raise any questions of safety and effectiveness.

Non-clinical tests and in vitro -testing determined that the ActivaScrew™ has substantially similar performance as compared to its predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bioretec Ltd. % Ms. Mari Ruotsalainen Quality Manger l·lermiankatu 22, Modulight Building FI-33720 Tampere Finland

NOV 2 2 2006

Re: K062980

Trade/Device Name: ActivaScrewTM Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 27, 2006 Received: September 29, 2006

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 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 devire 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 af 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); 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. Mari Ruotsalainen

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 a legally 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Claban buene

PV MXM

Mark N. Melkers 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 Statement F

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

Indications for Use:

The ActivaScrew™ is indicated for fixation of bone fractures, osteotomies, arthrodeses, bone grafts and osteochondral fractures of upper extremity, ankle and foot in the presence of appropriate immobilization.

#### Contraindications:

1. Fractures and osteotomies of diaphyseal bone (except those in the hand and foot).

2. Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient's co-operation cannot be guaranteed.

Prescription Use _ ×

AND/OR

Over-The-Counter Use _

(Part 21 CFR 801 Subpart D)

(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)

Seibare Brechtdor nem

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

**510(k) Number** K062980

Traditional 510(k) Date: September 27th, 2006