(104 days)
Not Found
No
The device description and performance studies focus on mechanical properties and traditional engineering analysis (Finite Element Analysis), with no mention of AI/ML terms or functionalities.
Yes.
The device is indicated for "fixation of fractures, osteotomies, non-unions and fusions of small bones and small bone segments in the foot and ankle," which describes a therapeutic purpose.
No
Explanation: The device is a plate system indicated for fixation of fractures, osteotomies, non-unions, and fusions in the foot and ankle, which are treatment functions, not diagnostic ones.
No
The device description explicitly states it is a plate system made from Titanium alloy, including screws and surgical instruments, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The AXI+LINE™ Proximal Bunion Correction System is a surgical implant (plate and screws) used for the fixation of bones in the foot and ankle. It is used in vivo (within the body) during surgery, not in vitro (outside the body) for testing specimens.
- Lack of IVD Characteristics: The provided information does not mention any aspects related to specimen collection, analysis of biological samples, or providing diagnostic information based on such analysis.
Therefore, based on the provided description, the AXI+LINE™ Proximal Bunion Correction System is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The AXI+LINE™ Proximal Bunion Correction System is indicated for fixation of fractures, osteotomies, non-unions and fusions of small bones and small bone segments in the foot and ankle.
Product codes
HRS, HWC
Device Description
The AXI+LINE™ Proximal Bunion Correction System is a plate system made from Titanium alloy. The geometry of the plate is that of a modified semi-tubular bone plate with a correction angle between the proximal and distal plate segments. The system also includes non-locking cortical and locking screws also made from Titanium alloy and necessary surgical site preparation and insertion instruments as a procedure pack.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot and ankle
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
Finite Element Analysis was used to determine the worst-case plate configuration for the static and dynamic four-point bend testing. Mechanical testing was performed as described in relevant recognized standards, including static and dynamic 4 point bend testing of the AXI+LINE™ Proximal Bunion Correction System plate per ASTM F-382 and axial push-out, insertion torque, and torque to failure testing of the locking and non-locking bone screws per ASTM F-543. The product is made from the same material as the predicate Nextremity MSP Metatarsal Shortening System. The device components are comprised of standard medical Titanium alloy (ASTM F136) with a long history of successful use for the same and other orthopedic indications. Biocompatibility testing was, therefore, not performed in support of the proposed device.
Key Metrics
Not Found
Predicate Device(s)
K131061, K140724, K143365, K142581
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2015
Nextremity Solutions, Incorporated Mr. Rvan Schlotterback Director, Product Development 210 North Buffalo Street Warsaw, Indiana 46580
Re: K152548 Trade/Device Name: AXI+LINE™ Proximal Bunion Correction System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: November 20, 2015 Received: November 23, 2015
Dear Mr. Schlotterback:
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 Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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" (21CFR 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 yours,
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 Statement
510(k) Number (if known): K152548
Device Name: AXI+LINE™ Proximal Bunion Correction System
Indications for Use:
The AXI+LINE™ Proximal Bunion Correction System is indicated for fixation of fractures, osteotomies, non-unions and fusions of small bones and small bone segments in the foot and ankle.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary
(Prepared on September 1, 2015)
Pursuant to §513(i) (3) (A) of the Food, Drug, and Cosmetic Act, Nextremity Solutions, Inc. is submitting the following summary of information:
| Trade Name: | AXI+LINE™ Proximal Bunion Correction System |
|---|---|
| Sponsor: | Nextremity Solutions, Inc. |
| 210 North Buffalo Street | |
| Warsaw, IN 46580 | |
| Contact Person: | Ryan Schlotterback |
| Director, Product Development | |
| 210 North Buffalo Street | |
| Warsaw, IN 46580 | |
| Direct: 574.485.2867 | |
| Mobile: 574.265.5308 | |
| Fax: 574.966.1396 | |
| Device Classification | |
| Name: | Single/multiple Component Metallic Bone |
| Fixation Fastener Appliances and Accessories | |
| 21 CRF §888.3030 | |
| Product Code: HRS |
Smooth or Threaded Metallic Bone Fixation
Fastener and Accessories
21 CFR §888.3040
Product Code: HWC |
| Classification: | According to Section 13 of the Federal Food, Drug and
Cosmetic Act, the device classification is Class II,
Performance Standards. |
| Predicate Devices: | K131061 – Nextremity Solutions – Restore™ Bunion
Correction System
K140724 – Nextremity Solutions – MSP™ Metatarsal
Shortening System
K143365 - Empirical Testing Corp.- Eminent Foot Plate
System
K142581 - PaxMed International LLC – APTUS Foot
System |
| | The Nextremity Solutions AXI+LINE™ Proximal Bunion
Correction System possesses the same technological
characteristics as the predicate devices. These characteristics
include the intended use, basic design, material, size and
fundamental technology. |
| Device Description: | The AXI+LINE™ Proximal Bunion Correction System is a
plate system made from Titanium alloy. The geometry of
the plate is that of a modified semi-tubular bone plate with a
correction angle between the proximal and distal plate
segments. The system also includes non-locking cortical
and locking screws also made from Titanium alloy and
necessary surgical site preparation and insertion instruments
as a procedure pack. |
| Indications for Use: | The Nextremity Solutions AXI+LINE™ Proximal Bunion
Correction System is indicated for fixation of fractures,
osteotomies, non-unions and fusions of small bones and
small bone segments in the foot and ankle. |
| Safety and Performance: | Finite Element Analysis was used to determine the worst-
case plate configuration for the static and dynamic four-
point bend testing. |
| | Mechanical testing was performed as described in relevant
recognized standards, including static and dynamic 4 point
bend testing of the AXI+LINE™ Proximal Bunion
Correction System plate per ASTM F-382 and axial push-
out, insertion torque, and torque to failure testing of the
locking and non-locking bone screws per ASTM F-543. |
| | The product is made from the same material as the predicate
Nextremity MSP Metatarsal Shortening System. The device
components are comprised of standard medical Titanium
alloy (ASTM F136) with a long history of successful use for
the same and other orthopedic indications. Biocompatibility
testing was, therefore, not performed in support of the
proposed device. |
| Conclusion: | Based on comparisons of the indications for use,
technological characteristics, and the results of performance
testing described above, the AXI+LINE™ Proximal Bunion
Correction System has been shown to be substantially |
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equivalent to predicate devices used for the same clinical indications.