INION HEXALON BIODEGRADABLE ACL/PCL SCREW

K071464 · Inion OY · HWC · Aug 3, 2007 · Orthopedic

Device Facts

• Record ID: K071464
• Device Name: INION HEXALON BIODEGRADABLE ACL/PCL SCREW
• Applicant: Inion OY
• Product Code: HWC · Orthopedic
• Decision Date: Aug 3, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Inion Hexalon™ Biodegradable ACL/PCL Screw is intended for soft tissue (including ligament, tendon, and bone-tendon-bone graft) fixation to bone in surgeries of the knee, shoulder, elbow, ankle, foot, hand and wrist where the offered screw sizes are patient appropriate.

Device Story

Biodegradable interference screw; used for soft tissue-to-bone fixation in orthopedic surgeries (knee, shoulder, elbow, ankle, foot, hand, wrist). Manufactured from resorbable polylactic acid/trimethylenecarbonate copolymer; green-colored for surgical visualization. Device provides mechanical fixation; gradually loses strength over 18-36 weeks; undergoes bioresorption within 2-4 years. Sterile, non-collagenous implant. Used by surgeons in clinical settings.

Clinical Evidence

No clinical data provided; substantial equivalence based on material composition, mechanical properties, and degradation profile comparisons.

Technological Characteristics

Material: Resorbable polylactic acid/trimethylenecarbonate copolymer. Form: Biodegradable interference screw. Color: Green. Sterilization: Sterile. Shelf life: 3 years. Mechanical: Gradual strength loss (18-36 weeks); bioresorption (2-4 years).

Indications for Use

Indicated for soft tissue (ligament, tendon, bone-tendon-bone graft) fixation to bone in knee, shoulder, elbow, ankle, foot, hand, and wrist surgeries where screw sizes are patient appropriate.

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

• Arthrex Interference Screw (K062466)
• Arthrex Tenodesis Screw Family (K041356)
• Biomet Bio-Core Interference Screw (K042552)
• Biomet Resorbable Interference Screw (K041274)

Submission Summary (Full Text)

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# 510(k) SUMMARY

Image /page/0/Picture/1 description: The image shows the word "INION" in large, bold, white letters. Below the word "INION" is the phrase "Intelligent Solution" in a smaller, italicized font. The background of the image is black.

K071464 pg. 192

Inion Hexalon™ Biodegradable ACL/PCL Screw

AUG - 3 2007

Manufacturer and submitter Inion Oy, Lääkärinkatu 2, FIN-33520 Tampere, FINLAND

#### Contact Person

Kati Marttinen. Regulatory Affairs Specialist Phone: [phone] Fax: [phone] [e-mail]

Establishment registration number 9710629

Trade name of the device Inion Hexalon™ Biodegradable ACL/PCL Screw

## Device classification and product code

Class II Classification Panel: Orthopedic Product Code: HWC Common name: Biodegradable Interference Screw Regulation number: 21 CFR 888.3040

#### Predicate devices

Arthrex Interference Screw (K062466) Arthrex Tenodesis Screw Family (K041356) Biomet Bio-Core Interference Screw (K042552) Biomet Resorbable Interference Screw (K041274)

#### Conformance with performance standards

No applicable mandatory performance standards exist for this device. Compliance to voluntary consensus standards is listed in the application.

#### Device description and principles of operation

Inion Hexalon™ Biodegradable ACL/PCL Screw is made of resorbable polylactic acid / trimethylenecarbonate copolymer. The Inion Hexalon™ Biodegradable Screws are coloured green for better visualization during surgical operation.

Inion Hexalon™ Biodegradable ACL/PCL Screws gradually lose their strength during 18-36 weeks. Bioresorption takes place within two to four years. Inion Hexalon™ Biodegradable ACL/PCL Screw is sterile and non-collagenous. The shelf life of the product is three years.

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Image /page/1/Picture/2 description: The image shows the logo for INION, with the words "INION" in large, bold, white letters at the top. Below the main title, in a smaller font size, is the tagline "Intelligent Solution." The background is black, providing a strong contrast that makes the text stand out.

Inion Hexalon™ Biodegradable ACL/PCL Screw

#### Indications for use

The Inion Hexalon™M Biodegradable ACL/PCL Screw is intended for soft tissue (including ligament, tendon, and bone-tendon-bone graft) fixation to bone in surgeries of the knee, shoulder, elbow, ankle, foot, hand and wrist where the offered screw sizes are patient appropriate.

## Substantial equivalence to marketed products

The evidence demonstrates that the intended use, material composition and scientific technology, degradation profile and mechanical properties of Inion Hexalon™ Biodegradable ACL/PCL Screw are substantially equivalent with the predicate devices.

Inion Hexalon™ Biodegradable ACL/PCL Screw is substantially equivalent to predicate Class II devices, when used for soft tissue (including ligament, tendon, and bone-tendonbone graft) fixation to bone in surgeries of the knee, shoulder, elbow, ankle, foot, hand and wrist where the offered screw sizes are patient appropriate, because the differences between Inion Hexalon™ Biodegradable ACL/PCL Screw and the predicate devices do not raise new questions of safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG = 3 2007

Inion Oy % Ms. Kati Marttinen Regulatory Affairs Specialist Lääkärinkatu 2, FIN-33520 Tampere, FINLAND

Re: K071464 Trade/Device Name: Inion Hexalon™ Biodegradable ACL/PCL Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, JDR, MAI Dated: May 25, 2007

Received: May 29, 2007

Dear Ms. Marttinen:

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 - Ms. Kati Marttinen

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" (21 CFR 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 the reporting 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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Miller

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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# Indications for Use

510(k) Number:

K 071464

Device Name:

Inion Hexalon™ Biodegradable ACL/PCL Screw

Indications for use:

The Inion Hexalon™ Biodegradable ACL/PCL Screw is intended for soft tissue (including ligament, tendon, and bone-tendon-bone graft) fixation to bone in surgeries of the knee, shoulder, elbow, ankle, tendon, and other that offered screw sizes are patient appropriate.

> Prescription Use X (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Murk A. Milham

(Division Sign-Of eral Restorative. Division of Gen and Neurologi

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