(49 days)
Not Found
No
The device description and intended use clearly define the device as a system of physical implants (plates and screws) for bone fixation. There is no mention of software, algorithms, or any computational components that would suggest the use of AI or ML. The performance studies focus on mechanical properties, not algorithmic performance.
Yes
The device is described as an "implantable titanium plates and screws intended to be used for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions," which directly treats a medical condition.
No
The device is used for internal bone fixation (plates and screws) for various orthopedic conditions, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a family of implantable titanium plates and screws, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Arthrex Ankle Fusion Plating System and Low Profile Screws are implantable devices used for internal bone fixation (fractures, fusions, osteotomies, non-unions). They are physically placed within the body to stabilize bones.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, diagnostic testing, or providing information based on in vitro analysis.
The device is a surgical implant used for orthopedic procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Arthrex Ankle Fusion Plating System is intended to be used for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, and fibula.
The Arthrex Low Profile Screws (2.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, and wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula. When used with a plate, the screws may be used with the Arthrex, Low Profile, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plating System.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC, HTN
Device Description
The Arthrex Ankle Fusion Plating System is a family of implantable titanium plates and screws intended to be used for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, and fibula.
The subject plates are contoured and may be available in left and right configurations, ranging in length from 91.9mm to 133.6mm. The accompanying screws are solid or cannulated, fully or partially threaded, and may be locking or non-locking. The proposed screw offering subject of this application are 4.5mm to 6.7mm in diameter and 16mm to 120mm in length and include the partially threaded cannulated lag screws and 13mm washer previously cleared in K123241.
The Arthrex Low Profile Screws (2.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, and wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula. When used with a plate, the screws may be used with the Arthrex, Low Profile, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plating System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, fibula, femur
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)
Mechanical Testing: The four-point bending, pull-out and insertion torque strength of the proposed Arthrex Ankle Fusion Plating System devices are substantially equivalent to or better than the four-point bending, pull-out and insertion torque strength of the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "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.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 15, 2014
Arthrex, Inc. Ms. Laura Medlin Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108
Re: K141735
Trade/Device Name: Arthrex Ankle Fusion Plating 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, HTN Dated: July 18, 2014 Received: July 22, 2014
Dear Ms. Medlin:
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
1
Page 2 – Ms. Laura Medlin
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/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,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Arthrex Ankle Fusion Plating System
Indications for Use (Describe)
The Arthrex Ankle Fusion Plating System is intended to be used for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, and fibula.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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
Indications for Use
Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Arthrex Ankle Fusion Plating System
Indications for Use (Describe)
The Arthrex Low Profile Screws (2.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Distal Extremity Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plating System.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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."
4
510(k) Summary of Safety and Effectiveness
| Date Summary Prepared | August 12, 2014 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Laura Medlin |
| Regulatory Affairs Associate | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 72005 | |
| Fax: 239/598.5508 | |
| Email: Laura.Medlin@Arthrex.com | |
| Trade Name | Arthrex Ankle Fusion Plating System |
| Common Name | Plate, fixation, bone |
| Screw, fixation, bone | |
| Product Code | HWC, HTN, HRS |
| Classification Name / CFR | 21 CFR 888.3030 – Single/multiple component metallic |
| bone fixation appliances and accessories | |
| 21 CFR 888.3040: Smooth or threaded metallic bone | |
| fixation fastener | |
| Predicate Device | K123241: Arthrex Fracture Plates |
| Purpose of Submission | This special 510(k) premarket notification is submitted to |
| obtain clearance for the Arthrex Ankle Fusion Plating | |
| System. | |
| Device Description and | |
| Intended Use | The Arthrex Ankle Fusion Plating System is a family of |
| implantable titanium plates and screws intended to be | |
| used for internal bone fixation for bone fractures, fusions, | |
| osteotomies, and non-unions in the ankle, foot, hand, | |
| wrist, clavicle, scapula, olecranon, humerus, radius, ulna, | |
| tibia, calcaneous, and fibula. | |
| The subject plates are contoured and may be available in | |
| left and right configurations, ranging in length from | |
| 91.9mm to 133.6mm. The accompanying screws are solid | |
| or cannulated, fully or partially threaded, and may be | |
| locking or non-locking. The proposed screw offering | |
| subject of this application are 4.5mm to 6.7mm in | |
| diameter and 16mm to 120mm in length and include the | |
| partially threaded cannulated lag screws and 13mm | |
| washer previously cleared in K123241. | |
| The Arthrex Low Profile Screws (2.5mm and larger, solid) | |
| are intended to be used as stand-alone bone screws, or in | |
| a plate-screw system for internal bone fixation for bone | |
| fractures, fusions, osteotomies, and non-unions in the | |
| ankle, foot, hand, and wrist, clavicle, scapula, olecranon, | |
| humerus, radius, ulna, tibia, calcaneous, femur, and | |
| fibula. When used with a plate, the screws may be used | |
| with the Arthrex, Low Profile, Small Fragment Plates, | |
| Fracture Plates, Distal Extremity Plates, Humeral Fracture | |
| Plates, Osteotomy Plates, and Ankle Fusion Plating | |
| System. | |
| Substantial Equivalence Summary | Based on the intended use, technological characteristics |
| and comparison to the predicate devices, Arthrex, Inc. | |
| has determined that the Arthrex Ankle Fusion Plating | |
| System is substantially equivalent to the currently | |
| marketed predicate devices, Arthrex Fracture Plates | |
| (K123241). | |
| The implant materials are the same as the predicate | |
| devices. Further, mechanical testing data demonstrates | |
| that the four-point bending, pull-out and insertion torque | |
| strength of the proposed Arthrex Ankle Fusion Plating | |
| System devices are substantially equivalent to or better | |
| than the four-point bending, pull-out and insertion | |
| torque strength of the predicate devices. Any differences | |
| between the Arthrex Ankle Fusion Plating System and | |
| the predicates are considered minor and do not raise | |
| questions concerning safety and effectiveness. |
5