Omni Foot Plating System

K172260 · Extremity Medical, LLC · HRS · Nov 6, 2017 · Orthopedic

Device Facts

• Record ID: K172260
• Device Name: Omni Foot Plating System
• Applicant: Extremity Medical, LLC
• Product Code: HRS · Orthopedic
• Decision Date: Nov 6, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Omni Foot Plating System is intended for use in internal fixation, reconstruction, or arthrodesis of the 1st Metatarsalphalangeal joint.

Device Story

Omni Foot Plating System is a bone fixation system for 1st Metatarsalphalangeal joint procedures. Components include unalloyed titanium plates and titanium alloy (Ti-6AL-4V) locking/non-locking screws; system includes instruments for site preparation and delivery. Plates feature polyaxial locking; screws provided in 2.8mm and 3.5mm diameters. System includes 3.5mm cannulated screws for adjunctive fixation and a specialized locking 'Peg' screw with a distal locking feature for compression/stabilization. Used by orthopedic surgeons in clinical settings. Device provides mechanical stabilization and compression to facilitate bone healing/fusion.

Clinical Evidence

No clinical testing was performed. Substantial equivalence supported by engineering analysis and bench testing (pullout, torque, static bend) comparing subject device to predicate systems.

Technological Characteristics

Materials: Unalloyed Titanium (ASTM F67) and Titanium Alloy Ti-6AL-4V (ASTM F136). Components: Plates, locking/non-locking screws (2.8mm, 3.5mm), 3.5mm cannulated screws, and locking 'Peg' (4.2mm). Features: Polyaxial locking plates. Connectivity: None (mechanical implant). Sterilization: Not specified.

Indications for Use

Indicated for internal fixation, reconstruction, or arthrodesis of the 1st Metatarsalphalangeal joint.

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

• Arix Foot System (K161864)
• ParaLock Plating System (K140397)
• Extremity Medical Screw and Washer System (K121349)

Submission Summary (Full Text)

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November 6, 2017

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Extremity Medical, LLC. Brian Smekal Vice President, Regulatory Affairs and Quality Assurance 300 Interpace Parkwav, Suite 410 Parsippany, New Jersey 07054

## Re: K172260

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: September 19, 2017 Received: September 20, 2017

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 (OS) 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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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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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)

K172260

Device Name Omni Foot Plating System

Indications for Use (Describe)

The Omni Foot Plating System is intended for use in internal fixation, reconstruction, or arthrodesis of the 1st Metatarsalphalangeal joint.

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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# 510(k) Summary of Safety and Effectiveness:

| 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 | October 13, 2017 |
| 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 | K161864 - Arix Foot System (Jeil Medical Corporation)<br>K140397 - ParaLock Plating System (Paragon 28)<br>K121349 - Extremity Medical Screw and Washer 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 ("Peg") 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, reconstruction, or<br>arthrodesis of the 1st Metatarsalphalangeal joint. |
| 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).<br>Omni Foot System, Bone Screws: They are identical in design of the Arix Foot System<br>Screw (K161864).<br>Omni Foot System, Locking Peg: The Peg device of the Omni System acts like a locking<br>screw while also acting as a bone washer/nut to help produce compression at the MTP joint<br>much like the crossing screw construct of the predicate screw system IO FiX (K121349). In<br>addition, the 4.2mm diameter of the Peg is equivalent in major diameter to the Paragon 28<br>ParaLock Plating System (K140397). |
| Non-clinical<br>Testing | The Omni Foot plates were compared to the Arix Foot System plates (K161864) by<br>engineering analysis. Bench tests including pullout, torque and static bend testing were<br>conducted to verify that the proposed 3.5mm screw and Peg device met all design<br>specifications. The results of this testing indicate that the Omni Foot Plating System is<br>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, engineering<br>analysis and mechanical testing. |

# Omni Foot Plating System

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