EBI OPTILOCK PERIARTICULAR PLATING SYSTEM

K061098 · Ebi, L.P. · HRS · May 24, 2006 · Orthopedic

Device Facts

• Record ID: K061098
• Device Name: EBI OPTILOCK PERIARTICULAR PLATING SYSTEM
• Applicant: Ebi, L.P.
• Product Code: HRS · Orthopedic
• Decision Date: May 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EBI® OptiLock® Periarticular Plating System (The System) is indicated for fixation of fractures and osteotomies involving the femur or tibia. The System is intended for buttressing multifragment distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures in normal or osteopenic bone and non-unions and malunions. The System is intended for the treatment of non-unions, malunions and fractures of the proximal tibia, including simple, comminuted lateral wedge, depression, medial vecomes of bicondylar, combinations of lateral wedge and depression and fractures with associated shaft fractures. The System is intended to buttress Metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial tibial plateau, medial split fractures with associated depressions and split of depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibial shaft. The System is indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.

Device Story

Metallic bone fixation system; includes plates and fasteners for stabilization of femur and tibia fractures/osteotomies. Used by orthopedic surgeons in clinical/surgical settings. Device provides mechanical buttressing and fixation to facilitate bone healing in patients with fractures or non-unions. System components are implanted to provide structural support to bone segments; clinical benefit derived from stabilization of fracture sites to promote union.

Clinical Evidence

Bench testing only. Mechanical testing conducted to demonstrate conformance to design specifications. Engineering rationales provided for additional component sizes.

Technological Characteristics

Metallic bone fixation system (plates and fasteners). Class II device. Design conforms to internal specifications. No specific material standards or software/energy sources described.

Indications for Use

Indicated for fixation of femur or tibia fractures and osteotomies, including distal femur (supracondylar, intra/extra-articular condylar), proximal tibia (simple, comminuted, lateral wedge, depression, bicondylar), medial tibial plateau, and distal tibia (ankle, malleolar, distal fibular) fractures. Includes treatment of non-unions, malunions, and fractures in normal or osteopenic bone.

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

• EBI® Pertiarticular Plating System

Submission Summary (Full Text)

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Kolo1098

# 510(k) SUMMARY

MAY 2 4 2006

#### EBI, L.P.'s

# EBI® OptiLock® Periarticular Plating System

| SUBMITTER: | EBI, L.P. |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ADDRESS: | 100 Interpace Parkway<br>Parsippany, NJ 07054 |
| PHONE: | [phone] |
| FAX: | [phone] |
| CONTACT PERSON: | Jennifer P. Harakal |
| DATE PREPARED: | April 18, 2006 |
| TRADE NAME: | EBI® OptiLock® Periarticular Plating System |
| COMMON NAME: | Internal Fixation Device |
| CLASSIFICATION NAME: | Single/Multiple Component Metallic Bone Fixation<br>Appliances and Accessories, Smooth or threaded metallic<br>bone fixation fastener, 21 CFR 888.3030, 21 CFR 888.3040 |
| CLASSIFICATION #: | Class II |
| PREDICATE DEVICES: | EBI® Pertiarticular Plating System |

## INTENDED/INDICATIONS FOR USE:

The EBI® OptiLock® Periarticular Plating System (The System) is indicated for fixation of fractures and osteotomies involving the femur or tibia.

The System is intended for buttressing multifragment distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures in normal or osteopenic bone and non-unions and malunions.

The System is intended for the treatment of non-unions, malunions and fractures of the proximal tibia, including simple, comminuted lateral wedge, depression, medial vecomes of bicondylar, combinations of lateral wedge and depression and fractures with associated shaft fractures.

The System is intended to buttress Metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial tibial plateau, medial split fractures with associated depressions and split of depression fractures of the medial tibia plateau. Also, for use in the fixation

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of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibial shaft.

The System is indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.

## TECHNOLOGICAL CHARACTERISTICS:

#### Performance Data

Mechanical testing of the Modified System was conducted which demonstrates that the Modified System conforms to its design specifications. Additionally, Engineering Rationales were written to demonstrate why further testing on the additional sizes of the Modified System components was not required to establish substantial equivalence.

## Substantial Equivalence

The Modified System is as safe and effective as its predicate devices with respect to intended use, indications for use, technological characteristics and principles of operation. The technological differences between the Modified System and its predicate devices do not raise any new issues of safety or effectiveness. Performance data and Engineering Analyses demonstrate that the Modified System is as safe and effective as its predicate devices. As such, the Modified System is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a stylized eagle with three legs and the text "DEPARTMENT OF HEALTH AND" arranged in a semi-circle above the eagle. The text is in all caps and is black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 4 2006

EBI, L.P. % Ms. Jennifer P. Harakal 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K061098

Trade/Device Name: EBI® OptiLock® Periarticular 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, HWC Dated: April 18, 2006 Received: April 19, 2006

Dear Ms. Harakal:

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

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## Page 2 - Ms. Jennifer P. Harakal

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. 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" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours.

Herbert Lomarino

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 Statement

510(k) Number (if known): K001098

Device Name: EBI® OptiLock® Periarticular Plating System

Indications for Use:

The EBI® OptiLock® Periarticular Plating System (The System) is indicated for the fixation of fractures and osteotomies involving the femur or tibia.

The System is intended for buttressing multifragment distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures in normal or osteopenic bone, and nonunions and malunions.

The System is intended for the treatment of nonunions, malunions and fractures of the proximal tibia, including simple, comminuted lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression and fractures with associated shaft fractures.

The System is intended to buttress Metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial tibial plateau, medial split fractures with associated depressions and split of depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibial shaft.

The System is indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.

Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off Division of General. Restorative. and Neurological Devices

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510(k) Number

115