INION HEXALON BIODEGRADABLE ACL/PCL SCREW

K021280 · Inion , Ltd. · HWC · Jul 17, 2002 · Orthopedic

Device Facts

• Record ID: K021280
• Device Name: INION HEXALON BIODEGRADABLE ACL/PCL SCREW
• Applicant: Inion , Ltd.
• Product Code: HWC · Orthopedic
• Decision Date: Jul 17, 2002
• 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 to be used for interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone or soft tissue grafts.

Device Story

Biodegradable interference screw for ACL/PCL reconstruction; used for fixation of bone-patellar tendon-bone or soft tissue grafts to femoral/tibial bone drill holes. Manufactured from resorbable polylactic acid/trimethylenecarbonate copolymers; available in various lengths/diameters; offered undyed or colored with D&C Green No.6. Device gradually loses strength over 18-36 weeks; bioresorption occurs within 2-4 years. Used by surgeons in clinical settings to secure grafts during ligament reconstruction; provides mechanical fixation while graft heals; eliminates need for secondary removal surgery due to biodegradable nature.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Resorbable polylactic acid/trimethylenecarbonate copolymer interference screw. Available in various lengths and diameters. Colored with D&C Green No.6 (21 CFR 74.3206). Mechanical fixation principle. Biodegradable; strength loss 18-36 weeks; resorption 2-4 years.

Indications for Use

Indicated for interference fixation of bone-tendon-bone or soft tissue grafts in ACL/PCL reconstruction. Contraindicated in patients with insufficient bone quality/quantity, active/potential infection, limited blood supply, chronic disease affecting bone quality, or lack of patient cooperation (e.g., alcoholism, drug abuse).

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

• BioScrew® Absorbable Interference Screw (K973758)
• The Arthrex Bio-Interference Screw (K971358)
• Arthrotek Interference Screw (K982497)
• Sysorb Interference Screw (K983592)

Submission Summary (Full Text)

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JUL 1 7 2002

K021280 page 12

Image /page/0/Picture/2 description: The image shows a logo for a company called INION. The logo is in white text on a black background. Below the company name is the tagline "Intelligent Solution" in a smaller font size. The logo has a simple, modern design.

## 510(k) SUMMARY for the Inion Hexalon™ Biodegradable ACL/PCL Screw

### MANUFACTURER

Inion Ltd. Lääkärinkatu 2 FIN-33520 Tampere

Contact Person: Hanna Marttila Regulatory Affairs Manager Lääkärinkatu 2 FIN-33520 Tampere Phone: [phone] Fax: [phone] [e-mail]

#### DEVICE NAME

Trade name: Inion Hexalon™ Biodegradable ACL/PCL Screw Common/Usual Name: Biodegradable Interference Screw Classification Name: Bone Fixation Screw

### ESTABLISHMENT REGISTRATION NUMBER 9710629

## DEVICE CLASSIFICATION AND PRODUCT CODE

Classification panel: Orthopedic Regulatory Class: Class II 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener, 87-HWC

#### PREDICATE DEVICES

Linvatec Corporation; BioScrew® Absorbable Interference Screw (K973758) Arthrex, Inc .; The Arthrex Bio-Interference Screw (K971358) Biomet Inc .; Arthrotek Interference Screw (K982497) Sulzer Orthopedics Inc .; Sysorb Interference Screw (K983592)

> Date:19.4.2002 Status: Final

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**DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION**

Inion Hexalon™ Biodegradable ACL/PCL Screw is intended for use The in anterior/posterior cruciate ligament (ACL/PCL) reconstruction procedures. The Inion Hexalon™ Biodegradable ACL/PCL Screw is indicated for fixation of bone-patellar tendonbone graft to the femoral/tibial bone drill hole in the anterior cruciate ligament reconstruction, fixation of the soft tissue graft to the femoral/tibial bone drill hole in the anterior cruciate ligament (ACL) reconstruction and reconstruction of posterior cruciate ligament (PCL)

The Inion Hexalon™ Biodegradable ACL/PCL Screw is made of resorbable polylactic acid / trimethylenecarbonate copolymers and it is provided in the various lengths and diameters typical of the other marketed devices. The Inion Hexalon™ Biodegradable ACL/PCL Screw is offered both undyed and coloured for better visualization during surgical operation. Colour additive used for dying the device is FDA approved colourant: D&C Green No.6, in accordance with the Title 21 CFR 74.3206. The Inion Hexalon™ Biodegradable ACL/PCL Screws gradually lose their strength during 18-36 weeks. Bioresorption takes place within two to four years.

#### EQUIVALENCE TO MARKETED PRODUCTS

The Inion Hexalon™ Biodegradable ACL/PCL Screw is substantially equivalent to the biodegradable screws, intended for ACL and PCL reconstruction procedures, which have received 510(k) clearance. The Inion Hexalon™ Biodegradable ACL/PCL Screw and BioScrew® Absorbable Interference Screw (K973758), The Arthrex Bio-Interference Screw (K971358), Arthrotek Interference Screw (K982497) and Sysorb Interference screw (K983592) have the same intended use and principles of operation and very similar design characteristics. Mechanical testing demonstrates that the device is substantially equivalent to the predicate. The differences between the Inion Hexalon™ Biodegradable ACL/PCL Screw and these predicate devices do not raise new questions of safety and effectiveness.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 caduceus symbol, which features a staff with a snake entwined around it, overlaid on three human profiles. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 1 7 2002

Ms. Hanna Marttila Regulatory Affairs Manager Inion Ltd. Lääkärinkatu 2 FIN-33520 Tampere Finland

Re: K021280

Trade/Device Name: Inion Hexalon™ Biodegradable ACL/PCL Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: April 19. 2002 Received: April 22, 2002

Dear Ms. Marttila:

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. Hanna Marttila ·

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

Applicant: Inion Ltd. Applicant. Imon Ltd.
510(k) Number: KOL(ノピ Device Name: Inion Hexalon™ Biodegradable ACL/PCL Screw

#### Indications:

ﺎ ﻓﻲ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ

The Inion Hexalon™ Biodegradable ACL/PCL Screw is intended to be used for interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone or soft tissue grafts.

#### Contraindications:

1. Insufficient quality or quantity of bone for interference screw attachment

- 2. Active or potential infection
3. Patient conditions including limited blood supply, chronic disease which causes insufficient quality of bone, and where patient cooperation cannot be guaranteed (e.g. alcoholism, drug abuse)

Over the Counter use _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Prescription use

Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109)

Mark N Mellzer

Division Sign-()ff) Division of General, Restorative and Neurological Devices

510(k) Number -

Date:17.4.2002 Status: Final