IFS PROFILE PLATES, SCREWS, AND WASHERS

K110086 · Internal Fixation Systems, Inc. · HRS · Sep 9, 2011 · Orthopedic

Device Facts

• Record ID: K110086
• Device Name: IFS PROFILE PLATES, SCREWS, AND WASHERS
• Applicant: Internal Fixation Systems, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Sep 9, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

IFS bone plates and screws, provided non-sterile, are intended to treat fractures and osteotomies of various bones including the clavicle, pelvis, scapula, humerus, radius, ulna, femur, tibia, calcaneus, and fibula. The IFS washers, provided non-sterile, are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over an area when used for fracture fixation of small bones and bone fragments.

Device Story

IFS Bone Plates, Screws, and Washers are metallic orthopedic implants used for fracture fixation and osteotomies. Plates and screws stabilize bone segments; washers distribute load to prevent screw head penetration through bone cortex. Devices are manufactured from Titanium 6Al-4V ELI or stainless steel. Intended for use by surgeons in clinical/OR settings. Implants are distributed non-sterile and require end-user steam sterilization. Clinical benefit includes structural support for bone healing and prevention of hardware-related cortical damage.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of design, material, and functional specifications to predicate devices.

Technological Characteristics

Materials: Titanium 6Al-4V ELI or stainless steel. Form factor: Bone plates, screws, and washers. Sterilization: Non-sterile, intended for end-user steam sterilization per AAMI/ANSI/ISO 11737 guidelines to achieve SAL 10^-6.

Indications for Use

Indicated for patients requiring fracture fixation or osteotomy treatment of the clavicle, pelvis, scapula, humerus, radius, ulna, femur, tibia, calcaneus, and fibula. Washers indicated for use with screws to prevent cortical breakthrough in small bone/fragment fixation.

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

• Arthrex Low Profile Plate and Screw System (K052614)
• Synthes Calcaneal Plate (K020401)
• GPC Medical Bone Plates and Screws (K092493)
• Synthes USA Modular Mini Fragment LCP System (K063049)
• Synthes USA 1.5 Mini Fragment LCP System (K090047)
• Synthes USA 2.4/2.7 Locking Foot Module (K071264)
• Depuy Orthopaedics Small Fragment Locking Plating System (K072083)
• Depuy Orthopaedics Small Bone Locking Plate System (K081546)
• Zimmer Inc. Universal Locking System 3.5mm Plates and Screws (K082527)
• Synthes Spherical Washers (K052483)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Internal Fixation Systems (IFS). The logo consists of a circle with a stylized design inside, followed by the letters "IFS" in bold, sans-serif font. Below the circle and letters, the words "Internal Fixation Systems" are written in a smaller, sans-serif font.

Image /page/0/Picture/1 description: The image contains handwritten text that reads "K110086 # 1/2". The text appears to be a combination of alphanumeric characters and symbols. The number sign is present, followed by a fraction of one-half.

SEP - 9 2011

## Internal Fixation Systems, Inc. 510(k) Summary

.

| Company Name: | Internal Fixation Systems, Inc.<br>10100 N.W. 116th Way, Suite 18<br>Miami, Florida 33178 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Christopher Endara<br>10100 N.W. 116th Way, Suite 18<br>Miami, Florida 33178<br>[phone] |
| Date Prepared: | August 12, 2011 |
| Trade Name: | IFS Bone Plates, Screws, and Washers |
| Common Name: | Plate, Fixation, Bone<br>Screw, Fixation, Bone<br>Washer |
| Classification: | 21 CFR 888.3030: Single/multiple component metallic bone fixation<br>appliances and accessories (HRS and NDG)<br>21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener<br>(HWC) |
| Predicate Devices: | <ul><li>Arthrex Low Profile Plate and Screw System (K052614)</li><li>Synthes Calcaneal Plate (K020401)</li><li>GPC Medical Bone Plates and Screws (K092493)</li><li>Synthes USA Modular Mini Fragment LCP System (K063049)</li><li>Synthes USA 1.5 Mini Fragment LCP System (K090047)</li><li>Synthes USA 2.4/2.7 Locking Foot Module (K071264)</li><li>Depuy Orthopaedics Small Fragment Locking Plating System (K072083)</li><li>Depuy Orthopaedics Small Bone Locking Plate System (K081546)</li><li>Zimmer Inc. Universal Locking System 3.5mm Plates and Screws (K082527)</li><li>Synthes Spherical Washers (K052483)</li></ul> |
| Device Description: | IFS bone plates consists of various shapes as well as screws are intended to<br>treat fractures and osteotomies of various bones, including the clavicle,<br>pelvis, scapula, humerus, radius, ulna, femur, tibia, and fibula. The washers<br>are to function with screws to prevent the screw head from breaking<br>through the cortex of the bone by providing additional surface area during<br>screw placement. The plates, screws, and washers are a one-piece device<br>made of Titanium 6Al-4V ELI or stainless steel. |

{1}------------------------------------------------

K110086=2

Image /page/1/Picture/1 description: The image shows a logo with the letters "IFS" in bold, black font. To the left of the letters is a circular graphic with a black and white design. Below the letters is the text "Internal Fixation Systems" in a smaller font. The logo appears to be for a company or organization related to internal fixation systems.

Intended Use: IFS bone plates and screws, provided non-sterile, are intended to treat fractures and osteotomies of various bones including the clavicle, pelvis, scapula, humerus, radius, ulna, femur, tibia, calcaneus, and fibula. The IFS washers, provided non-sterile, are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over an area when used for fracture fixation of small bones and bone fragments. Substantial Equivalence: IFS bone plates, screws, and washers have the same intended use, same technological characteristics, and materials as the predicate devices. Based on the information submitted, it is determined that the bone plate and screw system is substantially equivalent to the currently marketed predicate devices. Technological Characteristics The IFS bone plates, screws, and washers are substantially equivalent to the Comparison: predicate devices with respect to the design, function, and material. The plates have the same number of holes, similar thickness, lengths, widths, and material composition. The screws have the same diameters, lengths, and material composition. The washers have the same outer diameter, inner diameter, thickness, and material composition. Sterilization Information: The IFS Bone Plates, Screws, and Washers will be distributed non-sterile. The devices are sterilized by the end user per the AAMI Guidelines "Good Hospital Practice: Steam Sterilization and Sterility Assurance" and ANSI/AAMI/ISO 11737 guidelines to achieve the Sterility Assurance Level (SAL) of 106. There are no significant differences between the IFS bone plates, screws, Conclusion: and washers and the other implants as listed in the Substantially Equivalent Devices. The IFS plates, screws, and washers and the predicate devices have similar design attributes, material, and intended use thus is considered substantially equivalent.

{2}------------------------------------------------

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 eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

Internal Fixation Systems, Inc. % Mr. Christopher Endara 10100 N.W. 116" Way. Suite 18 Miami, Florida 33178

2011

Re: K110086

Trade/Device Name: IFS Profile Plates, Screws, and Washers 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. NDG Dated: August 19, 2011 Received: August 30, 2011

Dear Mr. Endara:

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. Insting 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 (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

{3}------------------------------------------------

Page 2 – Mr. Christopher Endara

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.

ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/wcm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.

Sincerely vours

Mark A. Wilkinson

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

Enclosure

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known): K110086

Device Name: IFS Bone Plates, Screws, and Washers

Indications for Use: IFS bone plates and screws, provided non-sterile, are intended to treat fractures and osteotomies of various bones including the clavicle, pelvis, scapula, humerus, radius, ulna, femur, tibia, calcaneus, and fibula.

The IFS washers, provided non-sterile, are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over an area when used for fracture fixation of small bones and bone fragments.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ar M. Muker

(Division Sig (Division Sign-Oil, Orthopedic, Orthopedic, Division of Such and Restorative Devices

Page 1 of

(k) Number K110086

510(k) Number