(99 days)
No
The 510(k) summary describes a system of titanium alloy fixation beams and screws for bone reconstruction and fixation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are bench tests, not studies involving data analysis or model training.
Yes
The device is indicated for reconstruction procedures, non-unions, and fusions of bones, and arthrodesis, which are therapeutic interventions.
No
This device is a fixation system (screws, beams) used for surgical reconstruction, non-unions, and fusions of bones in the foot and ankle, not for diagnosing conditions.
No
The device description explicitly states it consists of "cannulated, titanium alloy fixation beams and accessories" and "cannulated, titanium alloy fixation screws," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes the Axis Charcot Fixation System and the 4.5 to 8.5 Screw System as implants used for fixation, reconstruction, and fusion of bones in the foot and ankle. These are surgical devices used directly on the patient's body, not for testing samples outside the body.
The information provided aligns with a surgical implant device, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
HWC, HTN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot and ankle, metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus, metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid joints
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Bench testing including pull-out and static and dynamic bending and engineering analysis were performed on the Axis Charcot Fixation System and compared to the predicate device. No clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with a focus on the shape of the face and neck. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profiles.
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 410
Parsippany, NJ 07054 |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Brian Smekal, MS, RAC
VP, Regulatory Affairs and Quality Assurance
Phone: (973) 588-8980; Email: bsmekal@extremitymedical.com |
| Date Prepared | July 11, 2017 |
| Trade Names | Axis Charcot Fixation System
4.5 to 8.5 Screw System |
| Common Name | Screw, Fixation, Bone
Washer, Bolt Nut |
| Classification Name
and Number | 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener
21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances and accessories |
| Product Code | HWC, HTN |
| Predicate Devices | Axis Charcot Fixation System
K140741 - Salvation Beams and Bolts System
K060736 - Smith & Nephew 6.5 and 8.0mm Cannulated Screws (Reference Device)
K151418 – Paragon 28 Monster Screw System
K121349 - Extremity Medical Screw and Washer System (Reference Device) |
| | 4.5 to 8.5 Screw System
K082934 – Extremity Medical Midfoot Screw System
K151418 – Paragon 28 Monster Screw System
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
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. |
| Indications for 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, 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. |
| Statement of
Technological
Comparison | Axis Charcot Fixation System
The 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 the
predicate devices WMT Salvation Beams and Bolts and Smith & Nephew 6.5 and 8.0mm
Cannulated Screws in terms of screw size offering and material of manufacture (Ti-6Al-4V). The
optional accessory washer/nut enables retention of the screw in bone and help generate and
maintain compression across a joint. The differences in design of the clip as compared to
predicate washers/nuts do not introduce new issues of safety or effectiveness.
4.5 to 8.5 Screw System
The sizes of screws offered in the 4.5 to 8.5 Screw System are equivalent to the predicate devices
Extremity Medical Screw and Washer System and Paragon28 Monster Screw System in terms to
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
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
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 analysis
and mechanical test evaluation.
4.5 to 8.5 Screw System
The 4.5 to 8.5 Screw System is substantially equivalent to its predicate devices. This conclusion
is based upon indications for use, principles of operation, design, engineering analysis and
mechanical test testing. |
Axis Charcot Fixation System/4.5 to 8.5 Screw System
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