(210 days)
Not Found
No
The summary describes a mechanical bone plate and screw system with no mention of software, image processing, or AI/ML terms.
No.
The plates are used for bone fixation after fractures, fusions, or osteotomies. While they help in the healing process, they do not directly provide therapy.
No
Explanation: The "Intended Use" section states the device is for "internal bone fixation," indicating it is a treatment device, not a diagnostic one. It does not mention identifying or characterizing a disease or condition.
No
The device description explicitly states the device is made of stainless steel plates, indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "internal bone fixation for bone fractures, fusions, or osteotomies." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical implantable device (plates made of stainless steel) used for structural support within the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological samples.
The information provided describes a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Arthrex Compression Plates are intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle, foot, hand, and wrist, such as opening wedge osteotomies of Hallux Valgus.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Arthrex Compression Plates are a family of low profile plates available in various design configurations. The plates are made of stainless steel and are available in lengths of 20mm, 25mm and 30mm (interaxis lengths).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, foot, hand, and wrist
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 and compression distraction of the proposed devices is substantially equivalent to that of the predicate devices Arthrex Low Profile Plates and Arthrex Compression Staple.
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
Arthrex 8 Traditional 510(K): ARTHREX COMPRESSION PLATES
510(k) Summary of Safety and Effectiveness 2
| Date Summary Prepared | February 22, 2013 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Ivette Galmez |
| Regulatory Affairs Associate | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA. | |
| Telephone: 239/643.5333, ext. 1263 | |
| Fax: 239/598.5508 | |
| Email: ivette.galmez@arthrex.com | |
| SEP 2 5 2013 | |
| Trade Name | Arthrex Compression Plates |
| Common Name | Plate, fixation, bone |
| Product Code -Classification | |
| Name | |
| CFR | HRS, HWC |
| 21 CFR 888.8030: Single/multiple component metallic bone fixation | |
| appliances and accessories | |
| Predicate Device | K052614: Arthrex Low Profile Plate and Screw System |
| K040907: Arthrex Small Fragment Plates and Screws | |
| K080111: Arthrex Compression Staple | |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to obtain |
| clearance for the Arthrex Compression Plates. | |
| Device Description and Intended | |
| Use | The Arthrex Compression Plates are a family of low profile plates available |
| in various design configurations. The plates are made of stainless steel and | |
| are available in lengths of 20mm, 25mm and 30mm (interaxis lengths). | |
| The Arthrex Compression Plates are intended to be used for internal bone | |
| fixation for bone fractures, fusions, or osteotomies in the ankle, foot, hand, | |
| and wrist, such as opening wedge osteotomies of Hallux Valgus. | |
| Substantial Equivalence | |
| Summary | The Arthrex Compression Plates are substantially equivalent to the |
| predicates Arthrex Low Profile Plates and Screws System in which the | |
| basic features and intended uses are the same. The Arthrex Compression | |
| Plates are substantially equivalent to the predicates Arthrex Low Profile | |
| Plates and Arthrex Compression Staple in which the material, | |
| technological characteristics and performance of the devices are similar. |
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Arthrex 8 TRADITIONAL 510(K): ARTHREX COMPRESSON PLATES
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| Substantial Equivalence Summary (continue) | Any differences between the Arthrex Compression Plates and the predicates are considered minor and do not raise questions concerning safety and effectiveness. |
|---|---|
| The submitted mechanical testing data demonstrated that the bending and compression distraction of the proposed devices is substantially equivalent to that of the predicate devices Arthrex Low Profile Plates and Arthrex Compression Staple. | |
| Based on the indication for use, technological characteristics, and the comparison to the predicate devices, Arthrex, Inc. has determined that the Arthrex Compression Plates is substantially equivalent to currently marketed predicate devices. |
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing health, services, and people. The logo is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 25, 2013
Arthrex, Incorporated Ms. Ivette Galmez Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108
Re: K130510
Trade/Device Name: Arthrex Compression 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: August 6, 2013 Received: August 7, 2013
Dear Ms. Galmez:
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 Fournal 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 may or subject to additions, 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 that i Dr Had Intatutes and regulations administered by other Federal agencies. You must of any I edital stiners and 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. Ivette Galmez
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.
Sincercly yours,
Erin I: Keith
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Arthrex TRADITIONAL 510(K): ARTHREX COMPRESSION PLATES
Indications for Use
510(k) Number (if known): K130510
Device Name: Arthrex Compression Plates
Indications For Use:
The Arthrex Compression Plates are intended to be used for internal bone fixation for bonc fractures, fusions, or osteotomies in the ankle, foot, hand, and wrist, such as opening wedge osteotomies of Hallux Valgus.
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 (ODF:) PAGE I of I
Elizabeth L. Frank -S
Division of Orthopedic Devices