(32 days)
No
The description focuses on mechanical fixation devices and does not mention any software, algorithms, or data processing related to AI/ML.
Yes
The "Intended Use / Indications for Use" states that the device is indicated for "reconstruction procedures, non-unions and fusions of bones in the foot and ankle," which directly describes a therapeutic application to treat medical conditions.
No
This device is a fixation system used for reconstruction procedures, non-unions, and fusions of bones, primarily in the foot and ankle, which are therapeutic interventions rather than diagnostic ones.
No
The device description explicitly states it consists of "cannulated, titanium alloy fixation beams and accessories," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided description clearly states that the Axis Charcot Fixation System consists of "cannulated, titanium alloy fixation beams and accessories used for midfoot reconstruction." These are physical implants used in surgical procedures.
- Intended Use: The intended use is for "reconstruction procedures, non-unions and fusions of bones in the foot and ankle." This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant used to fix bones, not a tool for analyzing biological samples.
N/A
Intended Use / Indications for 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).
Product codes
HWC, HTN
Device Description
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. The modified device adds additional sizes, 4.5 and 8.5mm cannulated, titanium alloy fixation beams, previously cleared under Extremity Medical's 4.5 to 8.5 Screw System (K171018). The additional sizes offer the surgeon options for placement based on patient anatomy.
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
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
Non-clinical Testing: Engineering analyses evaluating mechanical strength of the smallest beam diameter (4.5mm) and pull-out strength of the shortest, smallest beam diameter demonstrated that the modified device is substantially equivalent to the predicate devices for the intended use. 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.
Key Metrics
Not Found
Predicate Device(s)
K171018, K190586, K193366, K140741
Reference Device(s)
Not Found
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.
0
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
1
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
2
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) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Special 510(k) Summary of Safety and Effectiveness:
| Submitter | Extremity Medical, LLC
300 Interpace Parkway, Suite 410
Parsippany, NJ 07054 |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Mary Hoffman, MS
Manager, Quality Assurance and Regulatory Affairs
Phone: (973) 588-8980
Email: mhoffman@extremitymedical.com |
| Date Prepared | May 27, 2021 |
| Trade Name | Axis Charcot Fixation System |
| Classification
Name and
Number | 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener (Primary)
21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances and
accessories |
| Product Code | HWC (screw, fixation, bone) (Primary)
HTN (washer, bolt, nut) |
| Primary
Predicates | K171018 - Axis Charcot Fixation System/ 4.5 to 8.5 Screw System |
| Additional
Predicates | K190586 – Paragon 28 Monster Screw System
K193366 – Stryker T2 ICF System
K140741 - Wright Medical Salvation Beams and Bolts System |
| Device
Description | 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. The modified device adds
additional sizes, 4.5 and 8.5mm cannulated, titanium alloy fixation beams, previously
cleared under Extremity Medical's 4.5 to 8.5 Screw System (K171018). The additional sizes
offer the surgeon options for placement based on patient anatomy. |
| Indications for
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). |
| Statement of
Technological
Comparison | The Axis Charcot Fixation System consists of bone screws used for fixation in the foot for
arthrodesis procedures. The sizes of screws offered in the Axis System (4.5 to 8.5mm) are
equivalent to the predicate devices in terms of design and material mechanical properties,
and in indications for use. |
| Non-clinical
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.
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
4