INION OTPS BIODEGRADABLE MESH PLATING SYSTEM

K031961 · Inion , Ltd. · HRS · Mar 1, 2004 · Orthopedic

Device Facts

• Record ID: K031961
• Device Name: INION OTPS BIODEGRADABLE MESH PLATING SYSTEM
• Applicant: Inion , Ltd.
• Product Code: HRS · Orthopedic
• Decision Date: Mar 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Inton OTPS™ Biodegradable Mesh Plating System is intended to sustain the relative position of weak bony tissue, e.g. bone grafts, bone graft substitutes, or bone fragments position of weak bony chsode, eightsm Biodegradable Mesh Plating System is also indicated for cement restriction in total joint arthroplasty procedures. Only when used in conjunction with traditional rigid fixation, the Inion OTPSTM Biodegradable Mesh Plating System is intended to sustain the relative position of weak bony tissue in trauma and reconstructive orthopaedic procedures involving the following: - Long bones - Flat bones - Short bones - · Irregular bones - · Appendicular skeleton - Thorax When used alone (without traditional rigid fixation), the Inion OTPS™ Biodegradable when used arone (without and to maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopaedic procedures involving: · Tumor resections where bone strength has not been compromised. - · Iliac crest harvest sites.

Device Story

Inion OTPS™ Biodegradable Mesh Plating System consists of resorbable mesh and fixation screws; composed of polylactic acid copolymers [Poly (L-lactide-co-D,L-lactide) and poly (L-lactide-co-trimethylenecarbonate)]. Device maintains relative position of bone fragments, grafts, or substitutes; provides cement restriction in joint arthroplasty. Implants lose strength over 18-36 weeks; complete resorption occurs within 2-4 years. Used by orthopedic surgeons in trauma and reconstructive procedures. Provides temporary structural support to bony tissues; used either as an adjunct to traditional rigid fixation or alone for specific non-load-bearing applications like iliac crest harvest sites. Benefits include elimination of secondary removal surgery due to biodegradable nature.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Resorbable mesh and fixation screws. Materials: Poly(L-lactide-co-D,L-lactide) and poly(L-lactide-co-trimethylenecarbonate). Mechanical strength profile: 18-36 weeks in vivo; full resorption 2-4 years. Non-metallic, biodegradable fixation system.

Indications for Use

Indicated for patients requiring stabilization of weak bony tissue, bone grafts, or bone graft substitutes in orthopedic trauma and reconstructive procedures. Used for cement restriction in total joint arthroplasty. When used with rigid fixation, indicated for long, flat, short, and irregular bones, appendicular skeleton, and thorax. When used alone, indicated for tumor resections (where bone strength is not compromised) and iliac crest harvest sites.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• MacroPore OS Trauma System (K021164)
• MacroPoreOS Protective Sheet (K994158)
• Synthes Resorbable Meshes and Sheets (K003788)

Submission Summary (Full Text)

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K03196/ P42 '14

MAR - 1 2004

Image /page/0/Picture/2 description: The image shows a logo with the word "INION" in bold, white letters. Below "INION" is the phrase "ligent Solution" in a smaller, white font. The background is black, and there is a white circle to the left of the word "INION".

510(k) SUMMARY for the Inion OTPS™ Biodegradable Mesh Plating System

### MANUFACTURER

Inion Ltd. Lääkärinkatu 2 FIN-33520 Tampere

Contact Person: Hanna Marttila Regulatory Affairs Manager Lääkärinkatu 2 FIN-33520 Tampere Phone: [phone] Fax: [phone] Harma. Marttila@ Inion. fi

#### DEVICE NAME

Trade name: Inion OTPS™ Biodegradable Mesh Plating System Classification Name: Bone, Plate

ESTABLISHMENT REGISTRATION NUMBER 9710629

DEVICE CLASSIFICATION AND PRODUCT CODE

Classification panel: Orthopedic Regulatory Class: Class II 21 CFR 888.3030, 87 HRS (plate)

### PREDICATE DEVICES

(1) MacroPore OS Trauma System (K021164)

- (2) MacroPoreOS Protective Sheet (K994158)
(3) Synthes Resorbable Meshes and Sheets (K003788)

Date: 18.6.2003 Status: Final

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Kos 1961 page 72

## DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION

The Inion OTPS™ Biodegradable Mesh Plating System is intended to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures.

The Inion OTPS™ Biodegradable Mesh Plating System is composed of various size mesh Internation associated fixations screws made of resorbable polylactic acid / pianes and associate a copolymers [Poly (L-lactide-co-D,L-lactide) and poly (L-lactide-cotrimethylenecarbonate)]. The Inion OTPS™ Biodegradable Mesh Plating System implants armlually lose their strength during 18-36 weeks in vivo with complete strength loss and resorption within two to four years.

### EQUIVALENCE TO MARKETED PRODUCTS

The Inion OTPS™ Mesh Biodegradable Plating System is substantially equivalent to I in implants, indicated for the reinforcing of weak bony tissues in orthopaedic brodegradures and when used in conjunction with traditional rigid fixation., which have proodal 50 0(k) clearance, including MacroPoreOS Trauma System (K021164),

16ccroPoreOS Protective Sheet (K994158) and Synthes Resorbable Meshes and Sheets (KNO3788). These devices have the same intended use and principles of operation and very (1000700). Incol arrecteristics. Mechanical testing demonstrates that the device is substantially equivalent to the predicate ones. Differences between The Inion OTPS™ surstandary "Equirations on "The System and predicate devices do not raise any new questions of safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is an abstract emblem resembling an eagle or bird-like figure with three horizontal lines above it, possibly representing feathers or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 1 2004

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

Re: K031961

Trade/Device Name: Inion OTPS™ Biodegradable Mesh Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: December 2, 2003 Received: December 4, 2003

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 rcclassified 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 complics 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 CHR 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) I ins icter will anow you to ogin maing of substantial equivalence of your device to a legally premarket notineation: The Price 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 If you desire specific acrise for your as [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Oinci general mionnation on Journational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincercly yours,

Miriam C. Provost

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): K031961

Device Name: INION OTPS™ Biodegradable Mesh Plating System

### Indications For Use:

The Inton OTPS™ Biodegradable Mesh Plating System is intended to sustain the relative position of weak bony tissue, e.g. bone grafts, bone graft substitutes, or bone fragments position of weak bony chsode, eightsm Biodegradable Mesh Plating System is also indicated for cement restriction in total joint arthroplasty procedures.

Only when used in conjunction with traditional rigid fixation, the Inion OTPSTM Biodegradable Mesh Plating System is intended to sustain the relative position of weak bony tissue in trauma and reconstructive orthopaedic procedures involving the following:

- Long bones
- Flat bones
- Short bones
- · Irregular bones
- · Appendicular skeleton
- Thorax

When used alone (without traditional rigid fixation), the Inion OTPS™ Biodegradable when used arone (without and to maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopaedic procedures involving:

· Tumor resections where bone strength has not been compromised.

- · Iliac crest harvest sites.
Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use I (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)

Muriam C. Provost

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

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**510(k) Number** K03196/