(30 days)
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.
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, thickness and number of holes. A locking compression slot is included in the plate to allow use of a locking screw for additional compression if desired by the surgeon. The locking and non-locking plate screws are provided in diameters of 2.3mm, 2.8mm and 3.5mm in lengths ranging from 6mm to 50mm. The System offers 3.5mm headed and headless cannulated screws and 4.0mm solid screws in various lengths to be used as adjunctive fixation. The 3.5mm cannulated screws can also be used with a specialized locking screw ("Post") which contains a locking feature at the distal end for compression/stabilization. The Omni Foot and Ankle Plating System includes general use and system-specific instrumentation, such as drill bits, drill sleeves and drill guides, depth gauges, targeting guide, drivers, guidewires, and rasps. The system also includes a system-specific sterilization tray.
This document describes the FDA's clearance of the Omni Foot and Ankle Plating System. It does not contain information about an AI/ML medical device, clinical performance studies with human readers, or the establishment of ground truth using experts. Instead, it focuses on the substantial equivalence of a traditional medical device (bone fixation system) to previously cleared predicate devices through engineering analysis and material comparisons.
Therefore, I cannot provide the requested information about acceptance criteria for an AI device, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these details are not present in the provided text.
The information relevant to the device's acceptance is found in the "Non-clinical Testing" section:
Non-clinical Testing Summary:
- Device Tested: Omni Foot and Ankle Plating System (new plate geometries and 3.5mm headless cannulated screws).
- Comparison:
- New plate geometries compared to existing Omni Foot and Ankle System plates and ARIX Foot System (2.3/2.8) plates.
- 3.5mm headless cannulated screws compared to predicate Omni 3.5mm cannulated screws and Extremity Medical Compression Screw.
- Methodology: Engineering analysis and compression testing for the locking compression slot.
- Conclusion: The analysis indicated that the Omni Foot and Ankle Plating System is equivalent to predicate devices and does not introduce new issues of safety or effectiveness.
Key takeaway from the document regarding "acceptance":
The acceptance of this device by the FDA is based on demonstrating substantial equivalence to legally marketed predicate devices through non-clinical performance data (engineering analysis and mechanical testing), rather than clinical studies or the type of AI/ML performance evaluation described in your prompt.
Specifically, for a non-AI/ML device like this, the "acceptance criteria" revolve around aspects such as:
- Material Equivalence: Meeting ASTM standards (F67 and F136) for unalloyed Titanium and Titanium Alloy (Ti-6AL-4V).
- Design Equivalence: Demonstrating that new geometries, dimensions, and features (like the locking compression slot) are comparable to predicate devices.
- Mechanical Performance Equivalence: Ensuring the device performs similarly to predicates in terms of strength, compression, and stability, as demonstrated through engineering analysis and testing (e.g., compression testing).
- Intended Use Equivalence: The indications for use must be substantially similar to the predicate devices.
Since the request is specific to an AI device and the provided text is for a traditional surgical implant, much of the requested information is not applicable. If you are looking for an example of an AI/ML device approval, this document is not suitable.
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June 10, 2022
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Exremity Medical, LLC. Mary Hoffman Manager, Ouality Assurance and Regulatory Affairs 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054
Re: K221362
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: May 10, 2022 Received: May 11, 2022
Dear Mary Hoffman:
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
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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) 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 (OS) 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 mediation-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,
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)
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 81 CFR 201.5 and D) |
|---|
| ☐ Over-The-Counter Use (81 CFR 201.6) |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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K221362 Special 510(k) Summary:
Omni Foot and Ankle Plating System
| Submitter | Extremity Medical, LLC300 Interpace Parkway, Suite 410Parsippany, NJ 07054 |
|---|---|
| Contact Person | Mary Hoffman, MSManager, Quality Assurance and Regulatory AffairsPhone: (973) 588-8980 ext. 502Email: mhoffman@extremitymedical.com |
| Date Prepared | June 10, 2022 |
| Trade Name | Omni Foot and Ankle Plating System |
| ClassificationName andNumber | 21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances andaccessories (Primary)21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener |
| Product Code | HRS (plate, fixation, bone) (Primary)HWC (screw, fixation, bone) |
| PrimaryPredicate | K212297- Omni Foot and Ankle Plating System |
| AdditionalPredicates | K170780 - ARIX Foot System (2.3/2.8)K081934 - Extremity Medical Compression Screw |
| DeviceDescription | The Omni Foot and Ankle Plating System is a bone fixation system consisting of unalloyedTitanium 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 sitepreparation and delivery. The plates are available in various configurations, essentiallydiffering by the lengths, thickness and number of holes. A locking compression slot isincluded in the plate to allow use of a locking screw for additional compression if desired bythe surgeon. The locking and non-locking plate screws are provided in diameters of 2.3mm,2.8mm and 3.5mm in lengths ranging from 6mm to 50mm. The System offers 3.5mmheaded and headless cannulated screws and 4.0mm solid screws in various lengths to beused as adjunctive fixation. The 3.5mm cannulated screws can also be used with aspecialized locking screw ("Post") which contains a locking feature at the distal end forcompression/stabilization. The Omni Foot and Ankle Plating System includes general useand system-specific instrumentation, such as drill bits, drill sleeves and drill guides, depthgauges, targeting guide, drivers, guidewires, and rasps. The system also includes a system-specific sterilization tray. |
| Indications for use | The Omni Foot and Ankle Plating System is intended for use in 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. |
| Statement ofTechnologicalComparison | The primary purpose of this Special 510(k) is to introduce additional plate geometries with locking compression slot, 3.5mm headless cannulated lag screws in lengths of 14-50mm, general and specific use instruments for joint preparation and targeting/insertion of the implants, and new implant and instrument tray configuration.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-clinicalTesting | The new geometries of the Omni plates were compared to the Omni Foot and Ankle System plates and ARIX Foot System (2.3/2.8) plates by engineering analysis. Compression testing was performed for the locking compression slot. The 3.5mm headless cannulated screws were compared to the predicate Omni 3.5mm cannulated screws and Extremity Medical Compression Screw by engineering analysis. The results of this analysis indicate that the Omni Foot and Ankle Plating System is equivalent to predicate devices and does not introduce new issues of safety or effectiveness. |
| 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. |
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§ 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.