INION TRINION BIODEGRADABLE MENISCUS SCREW

K031714 · Inion , Ltd. · HWC · Aug 16, 2004 · Orthopedic

Device Facts

• Record ID: K031714
• Device Name: INION TRINION BIODEGRADABLE MENISCUS SCREW
• Applicant: Inion , Ltd.
• Product Code: HWC · Orthopedic
• Decision Date: Aug 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Inion Trinion™ Biodegradable Meniscus Screw is indicated for use in the fixation of longitudinal vertical meniscus lesions (bucket handle) located in the vascularized area of the meniscus (red-red and red-white areas).

Device Story

Inion Trinion™ Biodegradable Meniscus Screw is a resorbable fixation device for longitudinal vertical meniscus lesions. Device consists of polylactic acid/trimethylenecarbonate copolymers; offered in various lengths; available undyed or colored for surgical visualization. Device provides mechanical fixation; gradually loses strength over 18-36 weeks; undergoes bioresorption within 2-3 years. Used by surgeons in clinical settings; implanted using customized instrumentation. Output is physical stabilization of meniscal tissue; facilitates healing in vascularized zones. Benefits include secure fixation without need for secondary removal surgery due to bioresorbable nature.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by biomechanical testing comparing subject device to predicate devices.

Technological Characteristics

Materials: Poly(L-lactide-co-D,L-lactide) and poly(L-lactide-co-trimethylenecarbonate) copolymers. Form factor: Threaded screw. Sterilization: Provided sterile, single-use. No software or electronic components.

Indications for Use

Indicated for fixation of longitudinal vertical (bucket handle) meniscus lesions in the vascularized (red-red and red-white) zones of the meniscus.

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

• Innovasive Meniscal Screw (K980681)
• Mitek Clearfix (K980681)
• LactoSorb Meniscal Screw (K002020)
• BioStinger -V Bioabsorbable Meniscal Repair Device (K991715)
• Biofix Biodegradable Meniscus Arrow System (K955768)

Submission Summary (Full Text)

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AUG 1 6 2004

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Image /page/0/Picture/2 description: The image is a logo for INION, which is written in large, bold, white letters against a black background. Below the word INION, in a smaller font size, is the phrase "Intelligent Solution", also in white. The overall design is simple and modern, emphasizing the company's name and its focus on providing smart solutions.

510(k) SUMMARY for the Inion Trinion™ Biodegradable Meniscus 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] Hanna. Marttila@Inion. fi

#### DEVICE NAME

Trade name: Inion Trinion™ Biodegradable Meniscus Screw Common/Usual Name: Biodegradable Meniscal Screw

ESTABLISHMENT REGISTRATION NUMBER 9710629

## DEVICE CLASSIFICATION AND PRODUCT CODE

Classification panel: Orthopedic Regulatory Class: Class II, MAI

### PREDICATE DEVICES

Innovasive Devices, Inc.; Innovasive Meniscal Screw (K980681) Mitek Clearfix Biomet, Inc .; LactoSorb Meniscal Screw (K002020) Linvatec Corp .; BioStinger -V Bioabsorbable Meniscal Repair Device (K991715) Bioscience, Inc.; Biofix Biodegradable Meniscus Arrow System (K955768)

> Date: 15.5.2003 Status: Final

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K031714 pge \frac{2}{2}

# DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION

The Inion Trinion™ Biodegradable Meniscus Screw is intended for use in the fixation of I he Infon Trinon - Diodcepadable Monised - Decated in the vascularized area of the longhudmal vertion membeds renoms ( Screws are offered in different lengths typical for this application. The system will be provided sterile to the user and is not to be re-sterilized. this upplication. " The oyengiscus Screw is designed to be used with customized instrumentation.

The Inion Trinion™ Biodegradable Screw is made of resorbable polylactic acid / trimethylenecarbonate copoylmers [Poly (L-lactide-co-D,L-lactide) and poly (L-lactide-cotrimethylenecarbonate)]. The Inion Trinion™ Biodegradable Meniscus Screws are offered both undyed and coloured for better visualization during surgical operation. The Trinion™ Biodegradable Meniscus Screw gradually looses its strength during 18-36 weeks. Bioresorption takes place within two to three years.

### EQUIVALENCE TO MARKETED PRODUCTS

The properties of the Inion Trinion™ Biodegradable Meniscus Screw are substantially equivalent to those of the previously accepted and clinically successfully used biodegradable meniscal repair devices.

Inion Trinion™ Biodegradable Meniscus Screw, Innovasive Meniscal Screw (Mitek Clearfix), LactoSorb Meniscal Screw, BioStinger -V Bioabsorbable Meniscal Repair Device and Biofix Biodegradable Meniscus Arrow System have the same intended use and principles of operation and very similar design characteristics. Biomechanical testing demonstrates that the device is substantially equivalent to the predicate ones. Differences between The Inion Trinion™ Biodegradable Meniscus Screw and predicate devices do not raise new questions of safety and effectiveness.

> Date: 15.5.2003 Status: Final

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 6 2004

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

Re: K031714

R031714
Trade/Device Name: Inion Trinion™ Biodegradable Meniscus Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 27, 2004 Received: June 1, 2004

Dear Ms. Marttila:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosale) to regars) to regars the Medical Device Americal processed on the connineres phor to may 20, 1978) in accordance with the provisions of the Federal Food, Drug, de rices that have been recises in at require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mercrore, manel and not include requirements for annual registration, listing of general controls proficions 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 If your device is clusioned (600 a00 ro) als. Existing major regulations affecting your device can may be subject to satil additions, 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 Flease be advised that I Dris issualite or our device complies with other requirements of the Act that I Dri has made a actionments in administered by other Federal agencies. You must of any I catal states and equirements, including, but not limited to: registration and listing (21 Comply with an the Hot of equaliements, and manufacturing practice requirements as set CFN i at 607), adoling (21 OFF 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 Marttilla

This letter will allow you to begin marketing your device as described in your device to 1 low I his letter will anow you to begin maneting of substantial equivalence of your device to a legally premarket notification. The PDA midnig of substantial equive 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 If you desire specific advice for your ac (1) 594-4639. Also, please note the regulation entitled, a Colliact the Office of Compilance w (2 st notification" (21CFR Part 807.97) you may obtain. Misoraliding of telefone to premation on your responsibilities under the Act may be obtained from the Other general information on your responsional 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 A. Milbern

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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# Indications for Use

510(k) Number (if known).

Device Name: Inion Trinion™ Biodegradable Meniscus Screw

#### Indications:

The Inion Trinion™ Biodegradable Meniscus Screw is indicated for use in the fixation of longitudinal vertical meniscus lesions (bucket handle) located in the vascularized area of the meniscus (red-red and red-white areas).

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Millerson

(Division Sign-Off, Restorative, Division " " " " " " " " " and Neurological Devices

510(k) Number K031714

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