(170 days)
Not Found
No
The device description and intended use clearly describe mechanical implants (plates and screws) for bone fixation. There is no mention of software, algorithms, or any functionality that would suggest the use of AI or ML. The performance studies focus on mechanical properties.
Yes.
The device is used for internal bone fixation for fractures, fusions, osteotomies, and non-unions, which are all therapeutic interventions.
No
Explanation: The device, consisting of plates and screws, is intended for "internal bone fixation" for various bone conditions. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is a family of titanium and stainless steel plates and screws, which are hardware components, not software.
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 Fracture Plates and Low Profile Screws are for "internal bone fixation for bone fractures, fusions, osteotomies and non-unions." This describes a surgical implant used directly within the body to treat musculoskeletal conditions.
- Device Description: The device description details physical implants made of titanium and stainless steel (plates and screws) with specific dimensions.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs typically involve reagents, analyzers, or test kits.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Arthrex Fracture Plates are 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, fibula.
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, and Distal Extremity 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 (2.5mm 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, 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, 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)
HWC, HTN, HRS
Device Description
The Arthrex Fracture Plates are a family of titanium and stainless steel plates and screws. The plates are flat and contoured, ranging from 50 mm to 244 mm in length. The accompanying screws are 2.5mm to 6.7mm in diameter.
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)
The submitted mechanical testing data demonstrated that the bending, pull-out and torque strength of the proposed devices are substantially equivalent to the bending, pull-out and 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.
K011335, K102998, K103705, K111253, K112437
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.
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K123241 (Page 1 of 2)
APR 0 5 2013
510(k) Summary of Safety and Effectiveness
| Date Summary Prepared | September 12, 2012 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Courtney Smith |
| Manager, Regulatory Affairs | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5333, ext. 1720 | |
| Fax: 239/598.5508 | |
| Email: courtney.smith@arthrex.com | |
| Trade Name | Fracture Plates |
| Common Name | Plate, fixation, bone |
| Product Code -Classification | HWC, HTN, HRS |
| Name | |
| CFR | 21 CFR 888.8030: Single/multiple component metallic bone |
| fixation appliances and accessories | |
| 21 CFR 888.3040: Smooth or threaded metallic bone fixation | |
| fastener | |
| Predicate Device | K011335: Synthes On-third Tubular Plates |
| K102998: Acumed Congruent Bone Plate System | |
| K103705 / K111253 / K112437: Low Profile Screw | |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to |
| obtain clearance for the Arthrex Fracture Plates and the | |
| accompanying screws. | |
| Device Description and Intended | |
| Use | The Arthrex Fracture Plates are a family of titanium and |
| stainless steel plates and screws. The plates are flat and | |
| contoured, ranging from 50 mm to 244 mm in length. The | |
| accompanying screws are 2.5mm to 6.7mm in diameter. | |
| Intended Use | The Arthrex Fracture Plates are 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, calcaneus, | |
| and fibula. | |
| 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, and Distal Extremity 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 (2.5mm 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, 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, 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 | Fracture Plates are substantially equivalent to the predicate Synthes One-Third Tubular Plates (K011335), Acumed Congruent Bone Plate (K102998), and the cleared Low Profile Screws (K103705, K111253, and K112437) in which the basic features and intended uses are the same. Any differences between the Fracture Plates and the predicates are considered minor and do not raise questions concerning safety and effectiveness. |
| The proposed devices are composed of Titanium or Stainless Steel, which is substantially equivalent to the predicate devices. | |
| The submitted mechanical testing data demonstrated that the bending, pull-out and torque strength of the proposed devices are substantially equivalent to the bending, pull-out and torque strength of the predicate devices. | |
| Based on the indication for use, technological characteristics, and the comparison to the predicate devices, Arthrex, Inc. has determined that the Fracture Plates is substantially equivalent to currently marketed predicate devices. |
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered on the image and is the only element present. The words are arranged on a single line.
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the left side and top of the emblem.
Public Health Service
Letter dated: April 5, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Arthrex, Incorporated % Ms. Courtney Smith Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108
Re: K123241
Trade/Device Name: Arthrex Fracture Plates 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 13, 2013 Received: February 25, 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. Iisting 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
3
Page 2 - Ms. Courtnev 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/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 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.
Mark NMelkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Form
Indications for Use
510(k) Number (if known): K123241
Device Name: Arthrex Fracture Plates
Indications For Use:
The Arthrex Fracture Plates are 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, fibula.
Prescription Use _ V __ (Per 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
AND/OR Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PAGE 1 of 1
Elizabeth L. Frank -S
Division of Orthopedic Devices
5
Indications for Use Form
Indications for Use
510(k) Number (if known): K123241
Arthrex Low Profile Screws Device Name:
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, and Distal Extremity 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 (2.5mm 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, 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, 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 _ 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)
PAGE 1 of 1
Elizabeth | 読版ank -S
Division of Orthopedic Devices