Axis Charcot Fixation System, 4.5 to 8.5mm Screw System

K171018 · Extremity Medical, LLC · HWC · Jul 13, 2017 · Orthopedic

Device Facts

• Record ID: K171018
• Device Name: Axis Charcot Fixation System, 4.5 to 8.5mm Screw System
• Applicant: Extremity Medical, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Jul 13, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Axis Charcot Fixation System: The Axis Charcot Fixation System in diameters of 5.5, 6.5 and 7.5mm is indicated for 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). 4.5 to 8.5 Screw System: The 4.5 to 8.5mm Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid joints.

Device Story

System comprises cannulated titanium alloy fixation beams/screws and accessories (washers/nuts); used for midfoot reconstruction, osteotomy, arthrodesis, and fracture repair in foot/ankle. Operated by surgeons in clinical/OR settings. Device provides mechanical fixation to stabilize bone segments; accessories facilitate retention and compression across joints. Benefits include stabilization of bone during healing process. No software or AI components.

Clinical Evidence

No clinical data. Bench testing performed, including pull-out, static bending, and dynamic bending tests, compared against predicate devices.

Technological Characteristics

Materials: Ti-6Al-4V titanium alloy. Form factor: Cannulated screws/beams (4.5mm to 8.5mm diameters). Principle: Mechanical bone fixation fastener. No energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring bone reconstruction, nonunion repair, or arthrodesis in the foot and ankle, including metatarsals, cuneiforms, cuboid, navicular, calcaneus, and talus, specifically for medial and lateral column fusion resulting from neuropathic osteoarthropathy (Charcot).

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

• Salvation Beams and Bolts System (K140741)
• Paragon 28 Monster Screw System (K151418)
• Extremity Medical Midfoot Screw System (K082934)

Reference Devices

• Smith & Nephew 6.5 and 8.0mm Cannulated Screws (K060736)
• Extremity Medical Screw and Washer System (K121349)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Extremity Medical, LLC. Brian Smekal VP, Regulatory Affairs and Ouality Assurance 300 Interpace Parkway Suite 410 Parsippany, New Jersey 07054

July 13, 2017

Re: K171018

Trade/Device Name: Axis Charcot Fixation System, 4.5 to 8.5mm Screw 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: May 24, 2017 Received: May 25, 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

#### K171018

### Device Name

Axis Charcot Fixation System, 4.5 to 8.5mm Screw System

Indications for Use (Describe)

Axis Charcot Fixation System:

The Axis Charcot Fixation System in diameters of 5.5, 6.5 and 7.5mm is indicated for 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).

4.5 to 8.5 Screw System:

The 4.5 to 8.5mm Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid joints.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) Summary of Safety and Effectiveness:

| Submitter | Extremity Medical, LLC.<br>300 Interpace Parkway, Suite 410<br>Parsippany, NJ 07054 |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Brian Smekal, MS, RAC<br>VP, Regulatory Affairs and Quality Assurance<br>Phone: [phone]; Email: [e-mail] |
| Date Prepared | July 11, 2017 |
| Trade Names | Axis Charcot Fixation System<br>4.5 to 8.5 Screw System |
| Common Name | Screw, Fixation, Bone<br>Washer, Bolt Nut |
| Classification Name<br>and Number | 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener<br>21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances and accessories |
| Product Code | HWC, HTN |
| Predicate Devices | Axis Charcot Fixation System<br>K140741 - Salvation Beams and Bolts System<br>K060736 - Smith & Nephew 6.5 and 8.0mm Cannulated Screws (Reference Device)<br>K151418 – Paragon 28 Monster Screw System<br>K121349 - Extremity Medical Screw and Washer System (Reference Device) |
| | 4.5 to 8.5 Screw System<br>K082934 – Extremity Medical Midfoot Screw System<br>K151418 – Paragon 28 Monster Screw System<br>K121349 - Extremity Medical Screw and Washer System (Reference Device) |
| Device Description | Axis Charcot Fixation System |
| | 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. |
| | 4.5 to 8.5 Screw System |
| | The 4.5 to 8.5 diameter screws consists of cannulated, titanium alloy fixation screws for use in<br>bone reconstruction, osteotomy, arthrodesis and fracture repair and fixation in the foot. |
| Indications for use | Axis Charcot Fixation System<br>The Axis Charcot Fixation System in diameters of 5.5, 6.5 and 7.5mm is indicated for<br>reconstruction procedures, non-unions and fusions of bones in the foot and ankle including the<br>metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include:<br>medial and lateral column fusion resulting from neuropathic osteoarthopathy (Charcot).<br>4.5 to 8.5 Screw System<br>The 4.5 to 8.5mm Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform,<br>navicular-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid joints. |
| Statement of<br>Technological<br>Comparison | Axis Charcot Fixation System<br>The Axis System consists of bone screws used for fixation in the foot for arthrodesis procedures.<br>The sizes of screws offered in the Axis System (5.5, 6.5 and 7.5mm) are equivalent to the<br>predicate devices WMT Salvation Beams and Bolts and Smith & Nephew 6.5 and 8.0mm<br>Cannulated Screws in terms of screw size offering and material of manufacture (Ti-6Al-4V). The<br>optional accessory washer/nut enables retention of the screw in bone and help generate and<br>maintain compression across a joint. The differences in design of the clip as compared to<br>predicate washers/nuts do not introduce new issues of safety or effectiveness.<br>4.5 to 8.5 Screw System<br>The sizes of screws offered in the 4.5 to 8.5 Screw System are equivalent to the predicate devices<br>Extremity Medical Screw and Washer System and Paragon28 Monster Screw System in terms to<br>screw size offering and material of manufacture (Ti-6Al-4V). |
| Non-clinical Testing | Bench testing including pull-out and static and dynamic bending and engineering analysis were<br>performed on the Axis Charcot Fixation System and compared to the predicate device. |
| Clinical Testing | No clinical testing was performed. |
| Conclusion | Axis Charcot Fixation System<br>The Axis Charcot Fixation System is substantially equivalent to its predicate device. This<br>conclusion is based upon indications for use, principles of operation, design, engineering analysis<br>and mechanical test evaluation.<br>4.5 to 8.5 Screw System<br>The 4.5 to 8.5 Screw System is substantially equivalent to its predicate devices. This conclusion<br>is based upon indications for use, principles of operation, design, engineering analysis and<br>mechanical test testing. |

## Axis Charcot Fixation System/4.5 to 8.5 Screw System

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