(99 days)
Axis Charcot Fixation System:
The Axis Charcot Fixation System in diameters of 5.5, 6.5 and 7.5mm 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 osteoarthopathy (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, navicular-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid joints.
Axis Charcot Fixation System
The Axis Charcot Fixation System consists of 5.5, 6.5 and 7.5mm cannulated, titanium alloy 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 bone reconstruction, osteotomy, arthrodesis and fracture repair and fixation in the foot.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
This document is a 510(k) premarket notification for the "Axis Charcot Fixation System, 4.5 to 8.5mm Screw System." It's important to note that 510(k) submissions typically demonstrate substantial equivalence to a predicate device, rather than de novo approval requiring extensive clinical efficacy studies. Therefore, the "acceptance criteria" here are framed around demonstrating comparable performance to existing, legally marketed devices.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance (vs. Predicate) |
|---|---|---|
| Material Equivalence | Material of manufacture | Ti-6Al-4V (equivalent to predicate devices) |
| Screw Size Offering | Diameters (5.5, 6.5, 7.5mm for Axis Charcot; 4.5 to 8.5mm for Screw System) | Equivalent to predicate devices (WMT Salvation Beams and Bolts, Smith & Nephew 6.5 and 8.0mm Cannulated Screws; Extremity Medical Screw and Washer System, Paragon28 Monster Screw System) |
| Mechanical Performance | Pull-out strength | Bench testing performed and compared to predicate device |
| Static bending | Bench testing performed and compared to predicate device | |
| Dynamic bending | Bench testing performed and compared to predicate device | |
| Design Characteristics | Optional accessory washer/nut | Design differences in the clip of the washer/nut do not introduce new issues of safety or effectiveness compared to predicate washers/nuts. |
| Intended Use Equivalence | Indications for Use | "substantially equivalent" to predicate devices based on indications for use. |
| Principle of Operation | (Implicitly assessed) | "substantially equivalent" to predicate devices based on principles of operation. |
2. Sample size used for the test set and the data provenance
The document explicitly states: "No clinical testing was performed." Therefore, there is no "test set" in the sense of patient data.
- Sample Size for Mechanical Testing: Not explicitly stated in the summary, but typical for bench testing, multiple samples of each device configuration would be tested.
- Data Provenance: Not applicable as no clinical data was collected. The bench testing would have been conducted by Extremity Medical, LLC or a contracted lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no clinical testing was performed, there was no ground truth to establish from patient data using expert review. The "ground truth" for the mechanical testing would be the raw data collected from the testing equipment, and the comparison point would be the performance of the predicate device (likely from published data or internal testing).
4. Adjudication method for the test set
Not applicable. No expert adjudication of clinical data was performed.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a bone fixation system (screws), not an AI-powered diagnostic tool. MRMC studies are used for evaluating diagnostic performance in image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing:
- Ground Truth: The physical properties and performance measurements (e.g., pull-out force, bending stiffness, fatigue life) derived directly from the bench tests.
- Comparison Basis: The performance characteristics of the identified predicate devices, likely obtained through literature, publicly available predicate device information, or internal testing for comparison purposes.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device. The design and manufacturing processes are informed by engineering principles, material science, and the performance characteristics of existing devices, rather than a "training set" in the context of data-driven models.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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510(k) Summary of Safety and Effectiveness:
| Submitter | Extremity Medical, LLC.300 Interpace Parkway, Suite 410Parsippany, NJ 07054 |
|---|---|
| Contact Person | Brian Smekal, MS, RACVP, Regulatory Affairs and Quality AssurancePhone: (973) 588-8980; Email: bsmekal@extremitymedical.com |
| Date Prepared | July 11, 2017 |
| Trade Names | Axis Charcot Fixation System4.5 to 8.5 Screw System |
| Common Name | Screw, Fixation, BoneWasher, Bolt Nut |
| Classification Nameand Number | 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances and accessories |
| Product Code | HWC, HTN |
| Predicate Devices | Axis Charcot Fixation SystemK140741 - Salvation Beams and Bolts SystemK060736 - Smith & Nephew 6.5 and 8.0mm Cannulated Screws (Reference Device)K151418 – Paragon 28 Monster Screw SystemK121349 - Extremity Medical Screw and Washer System (Reference Device) |
| 4.5 to 8.5 Screw SystemK082934 – Extremity Medical Midfoot Screw SystemK151418 – Paragon 28 Monster Screw SystemK121349 - 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 alloyfixation 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 inbone reconstruction, osteotomy, arthrodesis and fracture repair and fixation in the foot. | |
| Indications for use | Axis Charcot Fixation SystemThe Axis Charcot Fixation System in diameters of 5.5, 6.5 and 7.5mm is indicated forreconstruction procedures, non-unions and fusions of bones in the foot and ankle including themetatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include:medial and lateral column fusion resulting from neuropathic osteoarthopathy (Charcot).4.5 to 8.5 Screw SystemThe 4.5 to 8.5mm Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform,navicular-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid joints. |
| Statement ofTechnologicalComparison | Axis Charcot Fixation SystemThe Axis System consists of bone screws used for fixation in the foot for arthrodesis procedures.The sizes of screws offered in the Axis System (5.5, 6.5 and 7.5mm) are equivalent to thepredicate devices WMT Salvation Beams and Bolts and Smith & Nephew 6.5 and 8.0mmCannulated Screws in terms of screw size offering and material of manufacture (Ti-6Al-4V). Theoptional accessory washer/nut enables retention of the screw in bone and help generate andmaintain compression across a joint. The differences in design of the clip as compared topredicate washers/nuts do not introduce new issues of safety or effectiveness.4.5 to 8.5 Screw SystemThe sizes of screws offered in the 4.5 to 8.5 Screw System are equivalent to the predicate devicesExtremity Medical Screw and Washer System and Paragon28 Monster Screw System in terms toscrew 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 wereperformed on the Axis Charcot Fixation System and compared to the predicate device. |
| Clinical Testing | No clinical testing was performed. |
| Conclusion | Axis Charcot Fixation SystemThe Axis Charcot Fixation System is substantially equivalent to its predicate device. Thisconclusion is based upon indications for use, principles of operation, design, engineering analysisand mechanical test evaluation.4.5 to 8.5 Screw SystemThe 4.5 to 8.5 Screw System is substantially equivalent to its predicate devices. This conclusionis based upon indications for use, principles of operation, design, engineering analysis andmechanical test testing. |
Axis Charcot Fixation System/4.5 to 8.5 Screw System
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§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
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.(b)
Classification. Class II.