(93 days)
Not Found
No
The 510(k) summary describes a system of physical implants (plates and screws) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a system of plates and screws intended for fixation of bones, which is a structural or supportive function, not a therapeutic one that would involve treating or curing a disease or condition through non-surgical means. It is used in surgical repair rather than therapy.
No
The device description clearly states its purpose is for "fixation of fractures, fusions, ostectomies and non-unions," and it consists of "implantable titanium plates and screws." This indicates a therapeutic or reconstructive function, not a diagnostic one.
No
The device description explicitly states it is a family of implantable titanium plates and screws, which are physical hardware components, not software.
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 Arthrex Distal Radius System is described as a family of implantable titanium plates and screws. These are physical implants used to fix fractures and other bone issues.
- Intended Use: The intended use is for "fixation of fractures, fusions, ostectomies and non-unions of the radius, ulna, olecranon, metacarpal, metatarsal, and malleolus." This is a surgical intervention, not a diagnostic test performed on a sample.
The description clearly indicates that this is a surgical implant used for structural support and fixation within the body, not a device used to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Arthrex Distal Radius System is intended for fixation of fractures, fusions, ostectomies and non-unions of the radius, ulna, olecranon, metacarpal, metatarsal, and malleolus.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Arthrex Distal Radius System is a family of implantable titanium plates and screws intended to be used for fixation of fractures, fusions, osteotomies and non-unions of the radius, ulna, olecranon, metacarpal, metatarsal, and malleolus.
The subject plates are contoured and may be available in left and right configurations, ranging in length from 25mm to 166mm and feature both locking and non-locking holes.
The accompanying screws are solid, fully or partially threaded, and may be locking or non-locking. The proposed screw offering subject of this application are 2.4mm to 3.5mm in diameter and 8mm to 34mm in length and include the Arthrex Low Profile Screws previously cleared under the auspices of K131474.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radius, ulna, olecranon, metacarpal, metatarsal, and malleolus
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)
The submitted mechanical testing data demonstrates that the bending strength of the plates is substantially equivalent to that 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.
K082300, K081546, K131474, K040907
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 seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a human face.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 3. 2015
Arthrex Inc. Ms. Laura Medlin Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K143749 Trade/Device Name: Arthrex Distal Radius 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: February 5, 2015 Received: February 11, 2015
Dear Ms. Laura 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 (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
1
Page 2 – Ms. Laura Medlin
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/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 vours.
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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Arthrex TRADITIONAL 510(K): ARTHREX DISTAL RADIUS SYSTEM
2.4 INDICATIONS FOR USE
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 | ||
|---|---|---|---|
| Food and Drug Administration | |||
| Indications for Use | Expiration Date: January 31, 2017 | ||
| See PRA Statement below. | |||
| 510(k) Number (if known) | K143749 | ||
| Device Name | |||
| Arthrex Distal Radius System | |||
| Indications for Use (Describe) | |||
| The Arthrex Distal Radius System is intended for fixation of fractures, fusions, ostectomies and non-unions of the radius, | |||
| ulna, olecranon, metacarpal, metatarsal, and malleolus. | |||
| 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
2.5 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Date Summary Prepared | February 5, 2015 |
|---|---|
| Manufacturer/ | |
| Distributor/ | |
| Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Laura Medlin |
| Regulatory Affairs | |
| 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 Distal Radius System |
| Common Name | Plate, fixation, bone |
| Screw, fixation, bone | |
| Product Code, | |
| Classification Name | HRS - Plate, Fixation, Bone |
| HWC - Screw, Fixation, Bone | |
| 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 | K082300: DePuy Orthopaedics Anatomic Locking Plating System |
| K081546: DePuy Orthopaedics Small Bone Locking Plating System | |
| K131474: Arthrex Distal Radius Plate System | |
| K040907: Arthrex Small Fragment Plates and Screws | |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to obtain clearance for |
| the Arthrex Distal Radius System. | |
| Device Description | The Arthrex Distal Radius System is a family of implantable titanium plates and |
| screws intended to be used for fixation of fractures, fusions, osteotomies and non- | |
| unions of the radius, ulna, olecranon, metacarpal, metatarsal, and malleolus. |
The subject plates are contoured and may be available in left and right
configurations, ranging in length from 25mm to 166mm and feature both locking
and non-locking holes.
The accompanying screws are solid, fully or partially threaded, and may be locking
or non-locking. The proposed screw offering subject of this application are 2.4mm
to 3.5mm in diameter and 8mm to 34mm in length and include the Arthrex Low
Profile Screws previously cleared under the auspices of K131474. |
| Intended Use | The Arthrex Distal Radius System is intended for fixation of fractures, fusions,
osteotomies and non-unions of the radius, ulna, olecranon, metacarpal,
metatarsal, and malleolus. |
| Substantial
Equivalence Summary | The Arthrex Distal Radius System is substantially equivalent to the predicate
devices, in which the basic design features and intended uses are the same. Any
differences between the Arthrex Distal Radius System and the predicates are
considered minor and do not raise questions concerning safety and effectiveness.
The submitted mechanical testing data demonstrates that the bending strength of
the plates is substantially equivalent to that of the predicate devices.
Based on the indication for use, technological characteristics, and the summary of
data submitted, Arthrex, Inc. has determined that the Arthrex Distal Radius
System is substantially equivalent to currently marketed predicate devices |