VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW

K140876 · Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic · HRS · Jul 22, 2014 · Orthopedic

Device Facts

• Record ID: K140876
• Device Name: VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW
• Applicant: Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic
• Product Code: HRS · Orthopedic
• Decision Date: Jul 22, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

EDGE Orthopaedics' VIEW and REDUCE Plating Systems are intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The plates are available for use with EDGE Orthopaedics' locking and non-locking bone screws. Plates and screws are intended for single use only. Screws are not intended for use in the spine.

Device Story

Bone fixation system comprising titanium alloy plates and bone screws; designed for stabilization, fixation, and reconstruction of small bones in extremities (hand, feet, wrist, ankles, fingers, toes). VIEW plates feature window design for visual monitoring of healing. REDUCE plates include T, L, Y, and straight configurations. System includes instrumentation (depth gauges, screwdrivers, reamers, plate benders) for surgical insertion. Used by orthopedic surgeons in clinical settings. Provides mechanical stabilization of bone segments to facilitate healing.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing only, including torsional strength, driving/removal torque, axial pull-out strength, and single-cycle bend testing per ASTM standards.

Technological Characteristics

Titanium alloy plates and screws. Mechanical fixation via locking and non-locking screws. Bench testing per ASTM F543 (torsional strength, torque, pull-out) and ASTM F382 (bend testing). Sterile, single-use components.

Indications for Use

Indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, and toes. Contraindicated for use in the spine.

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

• DARCO Locking Plating System (K061808)
• ORTHOLOC® 2.0/2.4 Plate System (K090692)

Submission Summary (Full Text)

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Premarket Notification

EDGE Orthopaedics VIEW and REDUCE Plating Systems K140876

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# 5. 510(k) Summary

Date Prepared [21 CFR 807.92(a)(1)]

July 18, 2014

## Submitter's Information [21 CFR 807.92(a)(1)]

Jan Triani EDGE Orthopaedics 6 Mars Court, Unit 6-3 Boonton, NJ 07005 Phone: [phone] Fax: [phone]

Establishment Registration Number: 3010726797

## Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

| Trade Name: | EDGE Orthopaedics VIEW and REDUCE Plating Systems |
|----------------------|---------------------------------------------------------------------------------------------------|
| Common Name: | Bone Fixation Plate and Bone Screw |
| Classification Name: | Class II, 21 CFR 888.3030 Plate, Fixation Bone<br>Class II, 21 CFR 888.3040 Screw, Fixation, Bone |
| Product Code: | HRS/HWC |
| Panel Code: | Orthopedics |

Predicate Device [21 CFR 807.92(a)(3)] DARCO Locking Plating System ORTHOLOC® 2.0/2.4 Plate System

- K061808 (Darco International) - K090692 (Wright Medical Technology)

## Description of the Device [21 CFR 807.92(a)(4)]

The EDGE Orthopaedics' VIEW™ Plating System has been designed to support multiple indications within the mid-foot. The system includes titanium alloy, sterile packaged Lapidus, First Metatarsophalangeal (MTP), Calcaneal-Cuboid (CC), Evans and Talonavicular (TN) Plates along with sterile titanium alloy bone screws. The design creates a "window" offering a continuous view into the healing process.

The EDGE Orthopaedics' REDUCE® Fracture Plating System has been designed to support multiple indications within the forefoot and mid-foot. The system includes titanium alloy, sterile packaged T. L. Y. and Straight Plates along with sterile titanium alloy bone screws.

VIEW and REDUCE Plating Systems are offered in a variety of sizes for use with the nonlocking and locking bone screws. The screws are available in variety of diameters and lengths to help support the fixation, correction or stabilization of bones.

The corresponding instrumentation (depth gauges, screwdrivers, reamers, and plate benders) to facilitate insertion is found in EDGE's RIVAL Instrument Tray.

JUL 22 2011

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## EDGE Orthopaedics VIEW and REDUCE Plating Systems K140876

# Intended Use [21 CFR 807.92(a)(5)]

EDGE Orthopaedics' VIEW and REDUCE Plating Systems are intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The plates are available for use with EDGE Orthopaedics' locking and non-locking bone screws.

Plates and screws are intended for single use only. Screws are not intended for use in the spine.

## Technological Characteristics [21 CFR 807.92(a)(6)]

The subject device is similar in design, material and indications to the predicate devices.

#### Performance Data [21 CFR 807.92(b)(1)]

The safety and effectiveness of the EDGE Orthopaedics' VIEW and REDUCE Plating Systems are adequately supported by the substantial equivalence information, materials information and the following non-clinical testing provided within this Premarket Notification: torsional strength per ASTM F543, driving and removal torque per ASTM F543, axial pull out strength per ASTM F543, and Single Cycle Bend Testing per ASTM F382.

### Clinical Data [21 CFR 807.92(b)(2)]

Clinical data was not used to determine substantial equivalence.

#### Conclusion [21 CFR 807.92(b)(3)]

The analysis of the EDGE Orthopaedics' VIEW and REDUCE Plating Systems within this Premarket Notification supports the conclusion that the subject device is substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 22, 2014

Icon Orthopedic Concepts, LLC DBA EDGE Orthopaedics Ms. Jan Triani Director of Quality Assurance and Regulatory Affairs 6 Mars Court, Unit 6-3 Boonton, New Jersey 07005

Re: K140876

Trade/Device Name: EDGE Orthopaedics VIEW™ and REDUCE™ Plating Systems Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: April 24, 2014 Received: April 25, 2014

Dear Ms. Triani:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Jan Triani

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Lori A. Wiggins

- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification

EDGE Orthopaedics, Inc. VIEWTM and REDUCE™ Plating Systems

# 4. Indications for Use Statement

510(k) Number (if known): K140876

Device Name: EDGE Orthopaedics VIEW™ and REDUCE™ Plating Systems

Indications for Use:

EDGE Orthopaedics' VIEW™ and REDUCE™ Plating Systems are intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The plates are available for use with EDGE Orthopaedics locking and non-locking bone screws.

Plates and screws are intended for single use only. Screws are not intended for use in the spine.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

ElizabethFrank -S

Division of Orthopedic Devices