Omni Foot Plating System

K180808 · Extremity Medical, LLC · HRS · May 22, 2018 · Orthopedic

Device Facts

• Record ID: K180808
• Device Name: Omni Foot Plating System
• Applicant: Extremity Medical, LLC
• Product Code: HRS · Orthopedic
• Decision Date: May 22, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Omni Foot Plaing System is internal fixation of arthrodeses, osteotomies, fractures and nonunions of the small bones of the foot & ankle including the fore-, mid-, and hind foot and ankle applications.

Device Story

Omni Foot Plating System; bone fixation system for small bones of foot and ankle. Components: unalloyed titanium plates; titanium alloy (Ti-6AL-4V) locking/non-locking screws; 3.5mm cannulated screws; specialized locking 'Post' screw for compression/stabilization. Used by surgeons for internal fixation of arthrodeses, osteotomies, fractures, and nonunions. Instruments provided for implant site preparation and delivery. System provides mechanical stabilization of bone segments to facilitate healing.

Clinical Evidence

No clinical testing was performed. Substantial equivalence supported by engineering analysis comparing new plate geometries to predicate devices.

Technological Characteristics

Materials: Unalloyed Titanium (ASTM F67) and Titanium Alloy Ti-6AL-4V (ASTM F136). Components: Plates (various configurations), 2.8mm/3.5mm locking/non-locking screws, 3.5mm cannulated screws, and specialized locking 'Post' screw. Features: Polyaxial locking mechanism. Mechanical fixation device.

Indications for Use

Indicated for internal fixation of arthrodeses, osteotomies, fractures, and nonunions of small bones in the foot and ankle (forefoot, midfoot, hindfoot).

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

• Omni Foot Plating System (K172260)
• Arix Foot System (2.3/2.8) (K170780)
• Arix Foot System (K161864)
• 3.0mm Biomet Cannulated Screw System (K143188)

Submission Summary (Full Text)

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May 22, 2018

Extremity Medical, LLC Brian Smekal VP, Regulatory Affairs and Quality Assurance 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054

Re: K180808

Trade/Device Name: Omni Foot Plating System 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: March 27, 2018 Received: March 28, 2018

Dear Brian Smekal:

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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

## Katherine D. Kavlock -S

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

Enclosure

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### Indications for Use

510(k) Number (if known)

K180808

Device Name Omni Foot Plating System

#### Indications for Use (Describe)

The Omni Foot Plaing System is internal fixation of arthrodeses, osteotomies, fractures and nonunions of the small bones of the foot & ankle including the fore-, mid-, and hind foot and ankle applications.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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K180808 Page 1 of 2

# 510(k) Summary

## Omni Foot Plating System

| Submitter | Extremity Medical, LLC.<br>300 Interpace Parkway, Suite 410<br>Parsippany, NJ 07054 |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Brian Smekal, MS, RAC<br>VP, Regulatory Affairs and Quality Assurance<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared | May 10, 2018 |
| Trade Name | Omni Foot Plating System |
| Common Name | Bone plates and screws |
| Classification<br>Name and<br>Number | 21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances and<br>accessories; 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener |
| Product Code | HRS, HWC |
| Predicate<br>Devices | K172260 - Omni Foot Plating System<br>K170780 - Arix Foot System (2.3/2.8)<br>K161864 – Arix Foot System<br>K143188 - 3.0mm Biomet Cannulated Screw System |
| Device<br>Description | The Omni Foot Plating System is a bone fixation system consisting of unalloyed Titanium<br>plates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws, which meet<br>ASTM F67 and ASTM F136, and a set of instruments used for implant site preparation and<br>delivery. The plates are available in various configurations, essentially differing by the<br>lengths and number of holes. The plate screws are provided in diameters of 2.8mm and<br>3.5mm in lengths from 8mm to 50mm. The System offers 3.5mm cannulated screws in<br>various lengths to be used as adjunctive fixation. The 3.5mm cannulated screw can also be<br>used with a specialized locking screw ("Post") which contains a locking feature at the distal<br>end for compression/stabilization. |
| Indications for<br>use | The Omni Foot Plating System is intended for use in internal fixation of arthrodeses,<br>osteotomies, fractures and nonunions of the small bones of the foot & ankle including the<br>fore-, mid-, and hind foot and ankle applications. |
| Statement of<br>Technological<br>Comparison | Omni Foot System, Bone Plates: Based on a technical feature comparison, the subject<br>device was found to be similar to all predicate devices with regard to design and materials.<br>The subject plates also have a polyaxial locking feature, identical to the design used in the<br>predicate device (K161864 and K170780).<br>Omni Foot System, Bone Screws: They are identical in design of the screws previously<br>cleared under K172260 – Omni Foot Plating System. |
| Non-clinical<br>Testing | The new geometries of the Omni Foot plates were compared to the Arix Foot System plates<br>(K161864 and K170780) by engineering analysis. The results of this analysis indicate that<br>the Omni Foot Plating System is equivalent to predicate device. |
| Clinical Testing | No clinical testing was performed. |
| Conclusion | The Omni Foot Plating System is substantially equivalent to its predicate devices. This<br>conclusion is based upon indications for use, principles of operation, design, and<br>engineering analysis. |

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