BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN

K081392 · Bioretec, Ltd. · HWC · Jun 18, 2008 · Orthopedic

Device Facts

• Record ID: K081392
• Device Name: BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN
• Applicant: Bioretec, Ltd.
• Product Code: HWC · Orthopedic
• Decision Date: Jun 18, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ActivaScrew™ Products are 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

Bioabsorbable bone fixation screws; used for fractures, osteotomies, arthrodeses, bone grafts, and osteochondral fractures in upper extremities, ankles, and feet. Made of poly(L-lactide-co-glycolide) (PLGA); degrades in vivo via hydrolysis into alpha-hydroxy acids metabolized by body. Maintains strength for at least 8 weeks; fully absorbs within approximately two years, eliminating need for removal surgery. Available in non-cannulated and cannulated versions; diameters 2.0–4.5 mm; lengths 10–90 mm. Used by surgeons in clinical settings requiring internal fixation with appropriate immobilization.

Clinical Evidence

No clinical data. Substantial equivalence supported by in vitro and mechanical bench testing comparing performance to predicate devices.

Technological Characteristics

Material: Bioabsorbable poly(L-lactide-co-glycolide) (PLGA). Form factor: Non-cannulated and cannulated screws, fully or partially threaded. Dimensions: 2.0–4.5 mm diameter, 10–90 mm length. Principle: Mechanical fixation with gradual degradation via hydrolysis. No software or electronic components.

Indications for Use

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

• Bioretec ActivaScrew (K072848)
• Inion OTPS Biodegradable Fixation System (K030900 and K062617)

Submission Summary (Full Text)

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K081392 pge 1 of 2

Image /page/0/Picture/1 description: The image shows the logo for Bioretec. The logo consists of a stylized, curved shape that resembles a wing or a stylized letter 'B'. The shape is filled with a gradient, transitioning from light to dark. Below the shape, the word "bioretec" is written in lowercase letters.

JUN 1 8 2008

#### ઉ SPECIAL 510(k) SUMMARY

For the modification to Bioretec ActivaScrew™ (K072848)

#### MANUFACTURER

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

### Contact person:

Mrs. Mari Ruotsalainen Quality and Regulatory Affairs Manager Phone: [phone] Fax: [phone] [e-mail]

#### Date prepared: May 16th, 2008

#### DEVICE NAME

Trade Names: Bioretec ActivaScrew™, ActivaScrew™ Cannulated and ActivaScrew™M
Cannulated with ActivaPin™

Common Name: Screw, Fixation, Bone

#### ESTABLISHMENT REGISTRATION NUMBER

3005536892

## 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. Bioretec ActivaScrewTM (K072848)
- 2. Inion OTPS™ Biodegradable Fixation System (K030900 and K062617)

Special 510(k): Device Modification, Date: May 16" , 2008

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Image /page/1/Picture/0 description: The image shows the logo for Bioretec. The logo consists of a stylized graphic above the word "bioretec" in lowercase letters. The graphic appears to be an abstract representation of a curved shape, possibly suggesting movement or growth. The overall design is simple and modern.

# DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION

The ActivaScrew™ Products are 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. Screws are available as non-cannulated and cannulated, fully and partially threaded, in several different sizes, including diameters of 2.0 – 4.5 mm and lengths of 10 - 90 mm.

The ActivaScrew™ Products are made of the completely bioabsorbable poly(L-lactide-coglycolide) (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 within approximately two years thus eliminating the need for implant removal surgery.

### EQUIVALENCE TO MARKETED PRODUCTS

The ActivaScrew™ bioabsorbable screw is substantially equivalent to biodegradable screws cited as predicate devices above.

The Bioretec ActivaScrew™ has the same intended use, principles of operation and technological characteristic as the previously cleared Bioretec ActivaScrew™ (K072848). The modifications do not raise any questions of safety and effectiveness.

In vitro and mechanical bench testing determined that the ActivaScrew™ has substantially similar performance as compared to its predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 1 8 2008

Bioretec Ltd. c/o Mrs. Mari Ruotsalainen Quality and Regulatory Affairs Manager Hermiankatu 22, Modulight Building FI-33720 Tampere FINLAND

Re: K081392

Trade/Device Name: ActivaScrew™, ActivaScrew™ Cannulated and
ActivaScrew™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: May 16, 2008 Received: May 19, 2008

Dear Mrs. 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 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); 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 – Mrs. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 vours.

Mark M. Mulhearn

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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K 0813/2

Image /page/4/Picture/1 description: The image shows the logo for Bioretec. The logo consists of a stylized, curved shape that resembles a wing or a wave, positioned above the word "bioretec" in lowercase letters. The curved shape is darker at the top and fades towards the bottom, creating a sense of movement or flow.

#### F Indications for Use Statement

| Submitter: | Bioretec Ltd. |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | |
| Device Name: | ActivaScrew ^TM , ActivaScrew ^TM Cannulated and ActivaScrew ^TM Cannulated with ActivaPin ^TM |

Indications for Use:

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

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) | |
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Nei/RPDal forman

Division of General, Restorative, and Neurological Devices

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510(k) Number K081392

Special 510(k): Device Modification, Date: May 16th, 2008

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