(189 days)
No
The device description and intended use are purely mechanical in nature, describing plates and screws for bone fixation. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
No
The device is described as an internal bone fixation system (plates and screws) intended for stabilizing fractures, aiding fusions, and reconstructing bone fragments, which are structural and mechanical functions, not therapeutic.
No
Explanation: This device is described as an orthopedic implant system (plates and screws) used for stabilization and internal bone fixation of fractures, fusions, osteotomies, and non-unions. Its intended use is for treatment and reconstruction, not for diagnosing medical conditions.
No
The device description explicitly states that the system is comprised of physical plates and screws made from stainless steel and titanium, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the stabilization of bone fractures, fusions, and reconstructions within the body (hand/wrist, foot/ankle). This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details plates and screws made from stainless steel and titanium, which are materials used for surgical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide information about a physiological state, health, or disease.
Therefore, the Arthrex Mesh Plate System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Arthrex Mesh Plate is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bone fragments of the hand/wrist, foot/ankle, and osteopenic bone.
The Arthrex Low Profile Screws (3.0 mm, 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 Mesh Plates.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Arthrex Mesh Plate System is a family of plates and screws made from stainless steel and titanium. The system is comprised of the Arthrex Mesh Plates and accompanying Arthrex Low Profile Screws. The proposed plates in long and short versions are offered sterile and non-sterile.
The accompanying screws are 3.0 mm low profile screws with lengths ranging from 42 mm to 50 mm. The proposed screws are offered sterile and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand/wrist, foot/ankle, ankle, foot
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)
Bacterial endotoxin testing was performed in accordance to USP .
Mechanical testing data was performed in accordance to ASTM F 382-14 (Standard Specification and Test Method for Metallic Bone Plates).
The submitted data for the proposed Arthrex Mesh Plate System demonstrates that the bending strength and fatigue testing of the plates, and the torque and pull out testing of the accompanying screws are substantially equivalent to that of the predicate devices 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.
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.
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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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them, resembling a symbol or emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 1, 2017
Arthrex, Inc. Ivette Galmez Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108
Re: K170547
Trade/Device Name: Arthrex Mesh 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: July 25, 2017 Received: July 28, 2017
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 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education (DICE) 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (DICE) 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.
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K170547
Device Name
Arthrex Mesh Plate System
Indications for Use (Describe)
The Arthrex Mesh Plate is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bone fragments of the hand/wrist, foot/ankle, and osteopenic bone.
| 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K170547
Device Name
Arthrex Mesh Plate System
Indications for Use (Describe)
The Arthrex Low Profile Screws (3.0 mm, 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 Mesh Plates.
| 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."
4
2.1 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Date Summary Prepared | August 30, 2017 |
|---|---|
| Manufacturer/Distributor/ | |
| Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Ivette Galmez |
| Senior Regulatory Affairs Specialist | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 71263 | |
| Fax: 239/598.5508 | |
| Email: igalmez@arthrex.com | |
| Trade Name | Arthrex Mesh Plate System |
| Common Name | Plate, fixation, bone |
| Product Code - | HRS, HWC |
| 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 | K111253: Arthrex Distal Extremity Plate System |
| K143614: Arthrex Low Profile Screws | |
| Reference Predicate | K150456: Arthrex Plates, Screws, and Staples |
| Purpose of Submission | This 510(k) premarket notification is submitted to obtain |
| clearance for the Arthrex Mesh Plate System, a line extension to | |
| the Arthrex Distal Extremity Plate System in K111253 and | |
| K150456. | |
| Device Description | The Arthrex Mesh Plate System is a family of plates and screws |
| made from stainless steel and titanium. The system is | |
| comprised of the Arthrex Mesh Plates and accompanying | |
| Arthrex Low Profile Screws. The proposed plates in long and | |
| short versions are offered sterile and non-sterile. |
The accompanying screws are 3.0 mm low profile screws with
lengths ranging from 42 mm to 50 mm. The proposed screws
are offered sterile and non-sterile. |
| Intended Use | The Arthrex Mesh Plate is intended for use in stabilization of
fresh fractures, revision procedures, osteotomies, joint fusion
and reconstruction of small bones and bone fragments of the
hand/wrist, foot/ankle, and osteopenic bone.
The Arthrex Low Profile Screws (3.0 mm, 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
Mesh Plates. |
| Substantial Equivalence
Summary | The Arthrex Mesh Plate System is substantially equivalent to the
predicate devices, in which the scientific technology, and
intended uses are the same. Any differences between the
Arthrex Mesh Plate System and the predicates are considered
minor and do not raise questions concerning safety and
effectiveness.
Bacterial endotoxin testing was performed in accordance to
USP .
Mechanical testing data was performed in accordance to ASTM
F 382-14 (Standard Specification and Test Method for Metallic
Bone Plates).
The submitted data for the proposed Arthrex Mesh Plate
System demonstrates that the bending strength and fatigue
testing of the plates, and the torque and pull out testing of the
accompanying screws are substantially equivalent to that of the
predicate devices for the desired indications.
Based on the intended use, technological characteristics and the
summary of data submitted, Arthrex, Inc. has determined that
the Arthrex Mesh Plate System is substantially equivalent to the
predicate. |
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