Axis Charcot Fixation System

K211261 · Extremity Medical, LLC · HWC · May 28, 2021 · Orthopedic

Device Facts

• Record ID: K211261
• Device Name: Axis Charcot Fixation System
• Applicant: Extremity Medical, LLC
• Product Code: HWC · Orthopedic
• Decision Date: May 28, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Axis Charcot Fixation System in diameters of 4.5 to 8.5mm is indicated for reconstruction procedures, non-unions 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).

Device Story

Axis Charcot Fixation System comprises cannulated titanium alloy fixation beams and accessories; used for midfoot reconstruction, non-unions, and fusions. Device provides mechanical fixation for bones in foot and ankle; specifically medial and lateral column fusion for Charcot neuroarthropathy. System includes range of diameters (4.5mm to 8.5mm) to accommodate patient anatomy. Operated by orthopedic surgeons in clinical/surgical settings. Surgeon selects appropriate beam size based on patient anatomy to achieve bone fixation; output is physical stabilization of bone segments. Benefits include restoration of structural integrity and fusion in complex foot/ankle pathologies.

Clinical Evidence

No clinical data. Substantial equivalence supported by engineering analyses of mechanical and pullout strength.

Technological Characteristics

Cannulated bone fixation beams; material: titanium alloy; diameters: 4.5mm to 8.5mm. Mechanical fixation principle. Standalone device.

Indications for Use

Indicated for patients requiring foot and ankle bone reconstruction, non-union repair, or fusion (arthrodesis), including neuropathic osteoarthropathy (Charcot) affecting metatarsals, cuneiforms, cuboid, navicular, calcaneus, and talus.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Axis Charcot Fixation System/ 4.5 to 8.5 Screw System (K171018)
• Paragon 28 Monster Screw System (K190586)
• Stryker T2 ICF System (K193366)
• Wright Medical Salvation Beams and Bolts System (K140741)

Submission Summary (Full Text)

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May 28, 2021

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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Medical, LLC. Mary Hoffman Manager, Quality Assurance and Regulatory Affairs 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054

Re: K211261

Trade/Device Name: Axis Charcot Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC. HTN Dated: April 23, 2021 Received: April 26, 2021

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

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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 ([e-mail]) or phone [phone] 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) K211261

Device Name Axis Charcot Fixation System

#### Indications for Use (Describe)

The Axis Charcot Fixation System in diameters of 4.5 to 8.5mm is indicated for reconstruction procedures, non-unions 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).

| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# Special 510(k) Summary of Safety and Effectiveness:

| Submitter | Extremity Medical, LLC<br>300 Interpace Parkway, Suite 410<br>Parsippany, NJ 07054 |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Mary Hoffman, MS<br>Manager, Quality Assurance and Regulatory Affairs<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared | May 27, 2021 |
| Trade Name | Axis Charcot Fixation System |
| Classification<br>Name and<br>Number | 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener (Primary)<br>21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances and<br>accessories |
| Product Code | HWC (screw, fixation, bone) (Primary)<br>HTN (washer, bolt, nut) |
| Primary<br>Predicates | K171018 - Axis Charcot Fixation System/ 4.5 to 8.5 Screw System |
| Additional<br>Predicates | K190586 – Paragon 28 Monster Screw System<br>K193366 – Stryker T2 ICF System<br>K140741 - Wright Medical Salvation Beams and Bolts System |
| Device<br>Description | The Axis Charcot Fixation System consists of 5.5, 6.5 and 7.5mm cannulated, titanium alloy<br>fixation beams and accessories used for midfoot reconstruction. The modified device adds<br>additional sizes, 4.5 and 8.5mm cannulated, titanium alloy fixation beams, previously<br>cleared under Extremity Medical's 4.5 to 8.5 Screw System (K171018). The additional sizes<br>offer the surgeon options for placement based on patient anatomy. |
| Indications for<br>use | The Axis Charcot Fixation System in diameters of 4.5 to 8.5mm is indicated for<br>reconstruction procedures, non-unions and fusions of bones in the foot and ankle including<br>the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples<br>include: medial and lateral column fusion resulting from neuropathic osteoarthropathy<br>(Charcot). |
| Statement of<br>Technological<br>Comparison | The Axis Charcot Fixation System consists of bone screws used for fixation in the foot for<br>arthrodesis procedures. The sizes of screws offered in the Axis System (4.5 to 8.5mm) are<br>equivalent to the predicate devices in terms of design and material mechanical properties,<br>and in indications for use. |
| Non-clinical<br>Testing | Engineering analyses evaluating mechanical strength of the smallest beam diameter (4.5mm) and pullout strength of the shortest, smallest beam diameter demonstrated that the modified device is substantially equivalent to the predicate devices for the intended use.<br>Additionally, the largest beam diameter (8.5mm) is no worst case than the predicates therefore no additional safety and effectiveness concerns are presented for the subject device in relation to the implant's size for the patient anatomy. |
| Clinical Testing | No clinical testing was performed. |
| Conclusion | The Axis Charcot Fixation System is substantially equivalent to its predicate device. This conclusion is based upon indications for use, principles of operation, design, engineering and mechanical test evaluation. |

## Axis Charcot Fixation System

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