(62 days)
No
The 510(k) summary describes a standard bone fixation system with plates and screws and does not mention any AI or ML components or capabilities.
No
The device is a bone fixation system used for surgical intervention (plates, screws). It's not a device that itself delivers therapy to a patient.
No
The device is a bone fixation system (implants like plates and screws) used for treating fractures and fusions, not for diagnosing medical conditions.
No
The device description explicitly states it consists of Titanium Alloy plates, screws, and instruments, which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Axis Plating System is for the "indication and fixation of fractures or osteotomies, reconstruction procedures, nonunions and fusions of bones in the foot and ankle". This describes a surgical implant used to physically stabilize and repair bone structures within the body.
- Device Description: The description details plates, screws, and instruments used for implanting these components into bone. This is consistent with a surgical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Axis Plating System is a surgical implant used for structural support and fixation within the body.
N/A
Intended Use / Indications for Use
The Axis Plating System is indication and fixation of fractures or osteotomies, reconstruction procedures, nonunions and fusions of bones in the foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include: medial and lateral column fusion resulting from neuropathy (Charcot).
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC, HTN
Device Description
The Axis Plating System is a bone fixation system consisting of Titanium Alloy (Ti-6AL-4V) plates, locking and non-locking plate screws, which meet ASTM F136, and a set of instruments used for implant site preparation and delivery. The plates are available in various configurations, essentially differing by geometry and number of holes. The plate screws are provided in diameters of 3.5mm and 4.5mm in lengths from 8mm to 50mm. The System offers 4.0mm cannulated screws and beams in various lengths to be used as adjunctive fixation. The 4.0mm cannulated screws and beams 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 and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Specific testing performed on the Axis system include:
• Plate Engineering Analysis
• Screw Engineering Analysis for:
o Pullout
o Torsion/bending
o Torque to failure
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.
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.
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November 21, 2019
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: on the left, there is a seal with an abstract image of human faces, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and most prominent.
Extremity Medical, LLC. Brian Smekal VP, Regulatory Affairs and Quality Assurance 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054
Re: K192592
Trade/Device Name: Axis 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, HTN Dated: September 19, 2019 Received: September 20, 2019
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
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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) 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,
Shumaya Ali, M.P.H. 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) K192592
Device Name Axis Plating System
Indications for Use (Describe)
The Axis Plating System is indication and fixation of fractures or osteotomies, reconstruction procedures, nonunions and fusions of bones in the foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include: medial and lateral column fusion resulting from neuropathy (Charcot).
| 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
Axis Plating System
| Date Prepared | November 20, 2019 |
|---|---|
| 510(k) Number | K192592 |
| Submitter | Extremity Medical, LLC. |
| 300 Interpace Parkway, Suite 410 | |
| Parsippany, NJ 07054 | |
| Phone: (973) 588-8980 | |
| Contact Person | Brian Smekal, MS, RAC |
| VP, Regulatory Affairs and Quality Assurance | |
| Trade Name | Axis Plating System |
| Regulation, | |
| Product Code, | |
| Classification, and | |
| Common Name | 888.3030, HRS, Plate, Fixation, Bone |
| 888.3040, HWC, Screw, Fixation, Bone | |
| 888.3030, HTN, Washer, Nut Bolt | |
| Primary Predicate | K190365 - Baby Gorilla/Gorilla Plating System |
| Reference Devices | K180808 - Omni Foot Plating System |
| K140792 - Salvation 3di Plating System | |
| Device Description | The Axis Plating System is a bone fixation system consisting of Titanium Alloy (Ti- |
| 6AL-4V) plates, locking and non-locking plate screws, which meet ASTM F136, and a | |
| set of instruments used for implant site preparation and delivery. The plates are available | |
| in various configurations, essentially differing by geometry and number of holes. The | |
| plate screws are provided in diameters of 3.5mm and 4.5mm in lengths from 8mm to | |
| 50mm. The System offers 4.0mm cannulated screws and beams in various lengths to be | |
| used as adjunctive fixation. The 4.0mm cannulated screws and beams 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 Axis Plating System is indicated for stabilization and fixation of fractures or |
| osteotomies, reconstruction procedures, nonunions and fusions of bones in the | |
| foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, | |
| calcaneus and talus; specific examples include: medial and lateral column fusion | |
| resulting from neuropathic osteoarthropathy (Charcot). | |
| Statement of | |
| Technological | |
| Comparison | The Axis Plating System is equivalent to predicate device Baby Gorilla/Gorilla Plating |
| System in terms of indications for use, design, and material mechanical properties. The | |
| Axis Plating System is equivalent to the predicate device Omni Foot Plating System in | |
| design of the Compression Post, materials, mechanical properties and indications for | |
| use. The reference device Salvation 3di Plating System (K140792) is used to further | |
| support equivalence in terms of plate screw sizes and indications for use. | |
| Non-clinical | |
| Testing | Specific testing performed on the Axis system include: |
| • Plate Engineering Analysis | |
| • Screw Engineering Analysis for: | |
| o Pullout | |
| o Torsion/bending | |
| o Torque to failure | |
| Clinical Testing | No clinical testing was performed. |
| Conclusion | The Axis Plating System is substantially equivalent to its predicate devices. This |
| conclusion is based upon indications for use, principles of operation, design, and | |
| mechanical test data. |
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