(29 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and equivalence to predicate devices, with no mention of AI or ML.
Yes
The device is a bone fixation system intended for internal fixation of bones, which is a therapeutic intervention to treat conditions like fractures and nonunions.
No
Explanation: The Omni Foot and Ankle Plating System is described as a bone fixation system intended for internal fixation of arthrodeses, osteotomies, fractures, and nonunions. Its components are plates and screws. There is no mention of it being used to identify, detect, or monitor a disease or condition.
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 of bones in the foot and ankle. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of plates, screws, and instruments for surgical implantation. These are physical implants and surgical tools.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on analysis of biological samples.
Therefore, the Omni Foot and Ankle Plating System is a surgical implant system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Omni Foot and Ankle Plating System is internal fixation of arthrodesis, osteotomies, fractures and nonunions of the small bones of the foot & ankle including the fore-, mid-, and hind foot and ankle applications.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Omni Foot and Ankle 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 and 4.0mm solid screws in various lengths to be used as adjunctive fixation. The 3.5mm cannulated screw can also be used with a specialized locking screw ("Post") 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
foot & ankle including the fore-, mid-, and hind foot and ankle
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 new geometries of the Omni Foot and Ankle plates were compared to the Omni Foot System plates and ARIX System plates by engineering analysis. The 4.0mm solid screws were compared to the predicate Omni 3.5mm cannulated screws and 4.0mm AlignX solid screws by engineering analysis. The results of this analysis indicate that the Omi Foot and Ankle Plating System is equivalent to predicate devices.
Clinical Testing: No clinical testing was performed.
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.
K180808, K170780, K163044, K181067
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
August 20, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Extremity Medical, LLC. Brian Smekal Sr. VP, QA/RA and Compliance 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054
Re: K212297
Trade/Device Name: Omni Foot and Ankle 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: July 21, 2021 Received: July 22, 2021
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For: Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212297
Device Name
Omni Foot and Ankle Plating System
Indications for Use (Describe)
The Omni Foot and Ankle Plating System is internal fixation of arthrodesis, 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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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
Sr. VP, Quality Assurance, Regulatory Affairs and Compliance
Phone: (973) 588-8988
Email: bsmekal@extremitymedical.com |
| Date Prepared | July 21, 2021 |
| Trade Name | Omni Foot and Ankle Plating System |
| Classification
Name and
Number | 21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances and
accessories (Primary)
21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener |
| Product Code | HRS (plate, fixation, bone) (Primary)
HWC (screw, fixation, bone) |
| Primary
Predicate | K180808 – Omni Foot Plating System |
| Additional
Predicates | K170780 - ARIX Foot System (2.3/2.8)
K163044 - ORTHOLOC® 3Di Ankle Fracture Plating System
K181067 – AlignX Ankle Fusion System |
| Device
Description | The Omni Foot and Ankle 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 and 4.0mm solid screws in various lengths to be used as adjunctive fixation. The
3.5mm cannulated screw can also be used with a specialized locking screw ("Post") which
contains a locking feature at the distal end for compression/stabilization. |
| Indications for
use | The Omni Foot and Ankle Plating System is intended for use in 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. |
| Statement of
Technological
Comparison | The Omni Foot and Ankle Plating System and predicate devices are equivalent in terms of
design, material, mechanical properties and indications for use.
The subject and predicate are based on the following same technological elements:
Implants are used temporarily to generate compression across the joint/bone that is
being repaired/reconstructed. Devices are made of the same material (Unalloyed Titanium per ASTM F67 and Ti-
6Al-4V ELI per F136). |
| Non-clinical
Testing | The new geometries of the Omni Foot and Ankle plates were compared to the Omni Foot
System plates and ARIX System plates by engineering analysis. The 4.0mm solid screws
were compared to the predicate Omni 3.5mm cannulated screws and 4.0mm AlignX solid
screws by engineering analysis. The results of this analysis indicate that the Omi Foot and
Ankle Plating System is equivalent to predicate devices. |
| Clinical Testing | No clinical testing was performed. |
| Conclusion | The Omni Foot and Ankle Plating System is substantially equivalent to its predicate devices.
This conclusion is based upon indications for use, principles of operation, design, and
engineering analysis. |
Omni Foot and Ankle Plating System
4