(102 days)
Not Found
No
The device description focuses on the materials and mechanical components of a bone fixation system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a bone fixation system used for internal fixation, reconstruction, or arthrodesis, which are surgical procedures, not therapeutic treatments.
No
Explanation: The device is a bone fixation system intended for internal fixation, reconstruction, or arthrodesis. It does not analyze patient data or provide diagnostic information.
No
The device description explicitly states it consists of physical components like titanium plates, screws, and instruments, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "internal fixation, reconstruction, or arthrodesis of the 1st Metatarsalphalangeal joint." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of "bone fixation system consisting of unalloyed Titanium plates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws." These are implants used within the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
The Omni Foot Plating System is a surgical implant used for orthopedic procedures, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Omni Foot Plating System is intended for use in internal fixation, reconstruction, or arthrodesis of the 1st Metatarsalphalangeal joint.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Omni Foot Plating System is a bone fixation system consisting of unalloyed Titanium plates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws, which meet ASTM F67 and ASTM F136, and a set of instruments used for implant site preparation and delivery. The plates are available in various configurations, essentially differing by the lengths and number of holes. The plate screws are provided in diameters of 2.8mm and 3.5mm in lengths from 8mm to 50mm. The System offers 3.5mm cannulated screws in various lengths to be used as adjunctive fixation. The 3.5mm cannulated screw can also be used with a specialized locking screw ("Peg") which contains a locking feature at the distal end for compression/stabilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
1st Metatarsalphalangeal joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing: The Omni Foot plates were compared to the Arix Foot System plates (K161864) by engineering analysis. Bench tests including pullout, torque and static bend testing were conducted to verify that the proposed 3.5mm screw and Peg device met all design specifications. The results of this testing indicate that the Omni Foot Plating System is equivalent to predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.
0
November 6, 2017
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
Indications for Use
510(k) Number (if known)
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary of Safety and Effectiveness:
| Submitter | Extremity Medical, LLC.
300 Interpace Parkway, Suite 410
Parsippany, NJ 07054 |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Brian Smekal, MS, RAC
VP, Regulatory Affairs and Quality Assurance
Phone: (973) 588-8988
Email: bsmekal@extremitymedical.com |
| Date Prepared | October 13, 2017 |
| Trade Name | Omni Foot Plating System |
| Common Name | Bone plates and screws |
| Classification
Name and
Number | 21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances and
accessories; 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener |
| Product Code | HRS, HWC |
| Predicate
Devices | K161864 - Arix Foot System (Jeil Medical Corporation)
K140397 - ParaLock Plating System (Paragon 28)
K121349 - Extremity Medical Screw and Washer System |
| Device
Description | The Omni Foot Plating System is a bone fixation system consisting of unalloyed Titanium
plates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws, which meet
ASTM F67 and ASTM F136, and a set of instruments used for implant site preparation and
delivery. The plates are available in various configurations, essentially differing by the
lengths and number of holes. The plate screws are provided in diameters of 2.8mm and
3.5mm in lengths from 8mm to 50mm. The System offers 3.5mm cannulated screws in
various lengths to be used as adjunctive fixation. The 3.5mm cannulated screw can also be
used with a specialized locking screw ("Peg") which contains a locking feature at the distal
end for compression/stabilization. |
| Indications for
use | The Omni Foot Plating System is intended for use in internal fixation, reconstruction, or
arthrodesis of the 1st Metatarsalphalangeal joint. |
| Statement of
Technological
Comparison | Omni Foot System, Bone Plates: Based on a technical feature comparison, the subject
device was found to be similar to all predicate devices with regard to design and materials.
The subject plates also have a polyaxial locking feature, identical to the design used in the
predicate device (K161864).
Omni Foot System, Bone Screws: They are identical in design of the Arix Foot System
Screw (K161864).
Omni Foot System, Locking Peg: The Peg device of the Omni System acts like a locking
screw while also acting as a bone washer/nut to help produce compression at the MTP joint
much like the crossing screw construct of the predicate screw system IO FiX (K121349). In
addition, the 4.2mm diameter of the Peg is equivalent in major diameter to the Paragon 28
ParaLock Plating System (K140397). |
| Non-clinical
Testing | The Omni Foot plates were compared to the Arix Foot System plates (K161864) by
engineering analysis. Bench tests including pullout, torque and static bend testing were
conducted to verify that the proposed 3.5mm screw and Peg device met all design
specifications. The results of this testing indicate that 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
conclusion is based upon indications for use, principles of operation, design, engineering
analysis and mechanical testing. |
Omni Foot Plating System
4
T