(42 days)
Not Found
No
The device description and intended use clearly describe a system of plates and screws for bone fixation, with no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML. The performance studies focus on mechanical properties.
Yes.
The device is used for internal fixation for fractures and reconstruction of bones, which is a therapeutic intervention.
No
Explanation: The device is described as an internal fixation system (plates and screws) for fractures and reconstruction of bones, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "family of plates offered in various widths, thicknesses and lengths and locking screws in various diameters and lengths," which are physical hardware components. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Arthrex Distal Radius Plate System and its associated screws are for "internal fixation for fractures and reconstruction of the small bones." This describes a surgical implant used to physically stabilize bone.
- Device Description: The device is described as a "family of plates offered in various widths, thicknesses and lengths and locking screws in various diameters and lengths." This further confirms it's a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Distal Radius Plate System is intended for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius and distal ulna. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and malunions.
This system can be used for palmar, dorsal or orthogonal application.
The Arthrex Low Profile Screws (2.0-2.4mm 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. When used with a plate, the screw may be used with the Arthrex Low Profile, Small Fragment Plates, Distal Extremity Plates, and Distal Radius Plates.
The Arthrex Low Profile Screws (2.0-3.0mm cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist.
The Arthrex Low Profile Screws (2.7mm 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, 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, Distal Radius Plates, Humeral Fracture Plates, and Osteotomy Plates.
The Arthrex Low Profile Screws (3.5mm and larger, cannulated) are intended to be used as stand-alone bone screws 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, femur and fibula.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Arthrex Distal Radius Plate System is a family of plates offered in various widths, thicknesses and lengths and locking screws in various diameters and lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius, distal ulna, ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, fibula
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 and the fatigue strength of the proposed devices are comparable to that of the predicate device for the desired indications.
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.
K040022 / K100271, K123875, K103705 / 111253
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
K131474 page 1 of 3
2 . 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
' « .
JUL 0 3 2013
| Date Summary Prepared | May 15, 2013 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Courtney Smith |
| Regulatory Affairs Manager | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 1720 | |
| Fax: 239/598.5508 | |
| Email: csmith@arthrex.com | |
| Trade Name | Arthrex Distal Radius Plate System |
| Common Name | Plate, fixation, bone |
| Screw, fixation, bone | |
| Product Code -Classification Name | HRS |
| CFR | Single/multiple component metallic bone fixation |
| appliances and accessories | |
| 21 CFR 888.3030 | |
| HWC | |
| Smooth or threaded metallic bone fixation fastener | |
| 21 CFR 888.3040 | |
| Predicate Device | K040022 / K100271: Stryker VariAx Distal Radius Locking |
| Plate System | |
| K123875: aap Radius Set | |
| K103705 / 111253: Low Profile Screws | |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted |
| to obtain clearance for the Arthrex Distal Radius Plate | |
| System. | |
| Device Description | The Arthrex Distal Radius Plate System is a family of plates |
| offered in various widths, thicknesses and lengths and | |
| locking screws in various diameters and lengths. | |
| Intended Use | The Distal Radius Plate System is intended for internal |
| fixation for fractures and reconstruction of the small | |
| bones, primarily including the distal radius and distal | |
| ulna. Examples of these internal fixations and | |
| reconstructions include compression fractures, intra- | |
| articular and extra-articular fractures, displaced | |
| fractures, osteotomies, non-unions and malunions. | |
| This system can be used for palmar, dorsal or orthogonal | |
| application. | |
| The Arthrex Low Profile Screws (2.0-2.4mm 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. When used with a plate, the screw | |
| may be used with the Arthrex Low Profile, Small Fragment | |
| Plates, Distal Extremity Plates, and Distal Radius Plates. | |
| The Arthrex Low Profile Screws (2.0-3.0mm cannulated) | |
| are intended to be used as stand-alone bone screws for | |
| internal bone fixation for bone fractures, fusions, | |
| osteotomies and non-unions in the ankle, foot, hand, and | |
| wrist. | |
| The Arthrex Low Profile Screws (2.7mm 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, 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, Distal Radius Plates, | |
| Humeral Fracture Plates, and Osteotomy Plates. | |
| The Arthrex Low Profile Screws (3.5mm and larger, | |
| cannulated) are intended to be used as stand-alone bone | |
| screws 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, femur and fibula. | |
| Substantial Equivalence Summary | The Arthrex Distal Radius Plate 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 Plate | |
| System and the predicates are considered minor and do | |
| not raise questions concerning safety and effectiveness. |
1
K131474 page 2 of 3
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K131474 page 3 of 3
The proposed devices are comprised of titanium. This material is substantially equivalent to the materials found in the predicate devices.
The submitted mechanical testing data demonstrates that the bending strength and the fatigue strength of the proposed devices are comparable to that of the predicate device for the desired indications.
Based on the indication for use, technological characteristics, and the summary of data submitted, Arthrex, Inc. has determined that the Distal Radius Plate System is substantially equivalent to currently marketed predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hamnshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 3, 2013
Arthrex, Incorporated % Ms. Courtney Smith Regulatory Affairs Manager 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K131474
Trade/Device Name: Arthrex Distal Radius Plate 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: May 31, 2013 Received: June 3, 2013
Dear Ms. Smith:
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
4
Page 2 - Ms. Courtney Smith
device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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,
Erin Keith
For
· Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and י Radiological Health •
Enclosure
5
K131474 - Arthrex Distal Radius Plate, Supplement 001 - May 31, 2013
Appendix 1
2.1 INDICATIONS FOR USE :::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: ...
Indications for Use
510(k) Number (if known): K131474
page 1 of 2 -
Arthrex Distal Radius Plate System Device Name:
Indications For Use:
The Arthrex Distal Radius Plate System is intended for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius and distal ulna. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, nonunions and malunions.
This system can be used for palmar, dorsal or orthogonal application.
Prescription Use _ V_ AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) (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)
Elizabet阿莎·ank -
Division of Orthopedic Devices
4 of 13
6
K131474 - Arthrex Distal Radius Plate, Supplement 001 - May 31, 2013
Appendix 1
Indications for Use
510(k) Number (if known):
page 2 of 2
Device Name: Arthrex Low Profile Screws
Indications For Use:
The Arthrex Low Profile Screws (2.0-2.4mm 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. When used with a plate, the screw may be used with the Arthrex Low Profile, Small Fragment Plates, Distal Extremity Plates, and Distal Radius Plates.
The Arthrex Low Profile Screws (2.0-3.0mm cannulated) are intended to be used as standalone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and nonunions in the ankle, foot, hand, and wrist.
The Arthrex Low Profile Screws (2.7mm and larger, solid) are intended to be used as standalone 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, 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, Distal Radius Plates, Humeral Fracture Plates, and Osteotomy Plates.
The Arthrex Low Profile Screws (3.5mm and larger, cannulated) are intended to be used as stand-alone bone screws 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, femur and fibula.
Prescription Use _ AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ElizabeFDAFrank-S
Division of Orthopedic Devices
ર of 13