ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM

K080879 · Bioretec, Ltd. · HTY · Jun 24, 2008 · Orthopedic

Device Facts

• Record ID: K080879
• Device Name: ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM
• Applicant: Bioretec, Ltd.
• Product Code: HTY · Orthopedic
• Decision Date: Jun 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The devices of Bioretec ActivaPin™ Product Group including ActivaPin™, ActivaPin™ Fusion, ActivaNail™ Conical and ActivaNail™ Flat are indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.

Device Story

Bioretec ActivaPin™ Product Group consists of bioabsorbable fixation pins and nails (ActivaPin™, ActivaPin™ Fusion, ActivaNail™ Conical, ActivaNail™ Flat). Devices are manufactured from poly(L-lactide-co-glycolide) (PLGA). Principle of operation involves mechanical fixation of bone segments; implants degrade in vivo via hydrolysis into alpha-hydroxy acids, which are metabolized by the body. Strength is maintained for at least 8 weeks; complete bioabsorption occurs within approximately two years, eliminating the need for secondary removal surgery. Used by surgeons in clinical settings for orthopedic procedures. Benefits include stable fixation during healing and avoidance of hardware removal procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and functional similarity to the predicate device.

Technological Characteristics

Bioabsorbable fixation pins/nails made of poly(L-lactide-co-glycolide) (PLGA). Dimensions: 1.5–3.2 mm diameter, 5–70 mm length. Mechanical fixation principle. Degradation via hydrolysis. No software or electronic components.

Indications for Use

Indicated for fixation of bone fractures, osteotomies, arthrodeses, and osteochondral fractures in patients requiring bone stabilization, provided appropriate immobilization is maintained.

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 ActivaPin™ (K061164)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/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 is composed of three curved shapes, with the middle shape being black and the other two shapes being white.

K080879 *lld

#### 510(k) SUMMARY G

For the Bioretec ActivaPin™ Product Group

JUN 2 4 2008

## 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: March 28th, 2008

### DEVICE NAME

Bioretec ActivaPin™ Trade Name:

Bioretec ActivaPin™ Fusion

Bioretec ActivaNail™ Conical

Bioretec ActivaNail™ Flat

Common Name: Pin, Fixation

## ESTABLISHMENT REGISTRATION NUMBER

Bioretec Ltd. Establishment Registration Number is 3005536892.

### DEVICE CLASSIFICATION AND PRODUCT CODE

Device Classification Name: Pin, Fixation, Smooth Classification Panel: Orthopedic Regulation Number: 21 CFR 888.3040 Product Code: HTY

Traditional 510(k) Date: March 28th, 2008

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a logo with a stylized, abstract design. The design features three curved shapes that resemble brush strokes or stylized wings, arranged in a way that suggests movement or upward direction. Below the abstract design, the word "bioretec" is written in a sans-serif font. The logo appears to be for a company named Bioretec.

Image /page/1/Picture/1 description: The image shows a handwritten string of characters. The string starts with the letters 'KO', followed by the numbers '80879'. After the numbers, there is an asterisk symbol followed by the numbers '2/2'. The characters are written in black ink on a white background.

PREDICATE DEVICES

Bioretec ActivaPin™ (K061164)

# DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION

Bioretec ActivaPin™ Product Group covers Bioretec's bioabsorbable devices ActivaPin™ ActivaPin™ Fusion, ActivaNail™ Conical and ActivaNail™ Flat.

The Bioretec ActivaPin™ products do not differ significantly or at all in purpose, design, materials, function or any other feature related to safety and effectiveness. ActivaPin" is identical with a predicate device and the other devices of Bioretec's ActivaPin™ Product Group are its modifications. ActivaPin™ Fusion is the same as ActivaPin™, but its both ends are tapered. ActivaNail™ Conical and ActivaNail™ Flat are also ActivaPin™'s modifications with conical and flat heads. All pins of Bioretec ActivaPin™ Product Group are available in several different dimensions, including diameters of 1.5 - 3.2 mm and lengths of 5 - 70 mm.

The devices of Bioretec ActivaPin" Product Group are indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.

The Bioretec ActivaPin™ Product Group devices are made of completely bioabsorbable poly(L-lactide-co-glycolide) (PLGA), and they degrade in vivo by hydrolysis into alphahydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the Bioretec ActivaPin™ products gradually loses their strength, however, maintaining their 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 devices of Bioretec ActivaPin™ Product Group are substantially equivalent to the previously cleared Bioretec ActivaPin™ (K061164).

The Bioretec ActivaPin™ products have the same intended use and principles of operation, and also the same technological characteristic and performance as the previously cleared Bioretec ActivaPin™ (K061164). Any differences between Bioretec ActivaPin™ products and predicate device do not raise any questions of safety and effectiveness.

{2}------------------------------------------------

Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol. The logo is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bioretec Ltd. % Ms. Mari Ruotsalainen Hermiankatu 22, Modulight Building FI-33720 Tampere Finland

Re: K080879 Trade/Device Name: Activa™ Product group Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: March 28, 2008 Received: March 31, 2008

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.

JUN 2 4 2008

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

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 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 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Mark H. Miller

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Image /page/4/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 is composed of three curved shapes, with the middle shape being filled in with a darker color than the other two.

#### Indications for Use Statement F

Submitter: Bioretec Ltd. 510(k) Number:

Device Name:

ActivaPin™ ActivaPin™ Fusion ActivaNail™ Conical ActivaNail™ Flat

Indications for Use:

The devices of Bioretec ActivaPin™ Product Group including ActivaPin™, ActivaPin™ Fusion, ActivaNail™ Conical and ActivaNail™ Flat are indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.

Prescription Use X {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)

Varlare Brienm

Division of General, Restorative, and Neurological Devices

Page __ of

510(k) Number K080879

Traditional 510(k) Date: March 280, 2008