(119 days)
Not Found
No
The device description and intended use clearly define a system of mechanical implants (plates, screws, buttons) for bone fixation. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies focus on mechanical properties.
Yes
The device is intended for internal bone fixation for fractures, fusions, non-unions, osteotomies, and ligament repair, which are all therapeutic interventions for medical conditions.
No
The device is described as a system for internal bone fixation (plates, screws, and buttons) used to treat fractures and non-unions, not to diagnose them.
No
The device description explicitly states it is a family of stainless steel plates, screws, and buttons, which are physical hardware components.
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 and Intended Use: The provided information clearly describes the Arthrex Fracture System as a collection of stainless steel plates, screws, and buttons intended for the internal fixation of bone fractures, fusions, osteotomies, and non-unions. This is a surgical implant used directly on the bone within the body.
- Lack of In Vitro Testing: There is no mention of this device being used to test samples outside of the body. The performance studies described are mechanical tests (bending and pull-out strength), not diagnostic tests on biological samples.
Therefore, based on the provided information, the Arthrex Fracture System is a surgical implant for bone fixation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Arthrex Fracture System is 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, femur and fibula. The Arthrex Fracture Plates are to be used with the 2.7mm-4.0mm Arthrex Low Profile Screws.
The Clavicle Plate Button is intended for use with the clavicle plates for clavicle indications such as for the treatment of syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruption, and this button may not be used alone. The button is intended to be used with #5 Fiber Wire or FiberTape.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HRS, HTN
Device Description
The Arthrex Fracture System is a family of stainless steel plates, screws, and buttons. The plates may be contoured or straight and may be available in left and right configurations. The plates are to be used with the 2.7mm-4.0mm Low Profile Screws. The screws are solid and fully threaded and may be locking or non-locking. The button is stainless steel and designed to fit securely in the holes of the fracture plates. The button is intended to be used with the previously cleared suture, which is provided separately.
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, femur and 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 demonstrated that the bending and pull-out strength of the proposed devices are substantially equivalent to the bending and pull-out 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, K043248, K052776, K103705, K111253
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
2 510(k) Summary of Safety and Effectiveness
K112437 (pg.1 of 2)
| Date Summary Prepared | November 29, 2011 |
|---|---|
| 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: | |
| 239/643.5553, ext. 1720 | |
| Fax: 239/598.5508 | |
| Email: csmith@arthrex.com | |
| Trade Name | Arthrex Fracture System |
| Common Name | Plate, fixation, bone |
| Product Code -Classification Name | HWC, HRS, HTN |
| 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 | K011335: Synthes One-Third Tubular Plates |
| K102998: Acumed Congruent Bone Plate System | |
| K043248 / K052776: Arthrex TightRope Syndesmosis and | |
| Acromioclavicular (AC) Devices | |
| K103705 / K111253: Arthrex Low Profile Screws | |
| Device Description and | |
| Intended Use | The Arthrex Fracture System is a family of stainless steel plates, |
| screws, and buttons. The plates may be contoured or straight and | |
| may be available in left and right configurations. The plates are to | |
| be used with the 2.7mm-4.0mm Low Profile Screws. The screws | |
| are solid and fully threaded and may be locking or non-locking. | |
| The button is stainless steel and designed to fit securely in the | |
| holes of the fracture plates. The button is intended to be used with | |
| the previously cleared suture, which is provided separately. | |
| The Arthrex Fracture System is 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, femur and fibula. The | |
| Arthrex Fracture Plates are to be used with the 2.7mm-4.0mm | |
| Arthrex Low Profile Screws. | |
| plates for clavicle indications such as for the treatment of | |
| syndesmotic trauma, such as fixation of acromioclavicular | |
| separations due to coracoclavicular ligament disruption, and this | |
| button may not be used alone. The button is intended to be used | |
| with #5 FiberWire or FiberTape. | |
| Substantial Equivalence | |
| Summary | The Arthrex Fracture System is substantially equivalent to the |
| predicate Synthes One-Third Tubular Plates (K011335), Acumed | |
| Congruent Bone Plate System (K102998), Arthrex TightRope | |
| Syndesmosis and Acromioclavicular (AC) Devices (K043248 / | |
| K052776), and the cleared Arthrex Low Profile Screws | |
| (K103705, K111253) in which the basic features and intended | |
| uses are the same. Any differences between the Fracture System | |
| and the predicates are considered minor and do not raise questions | |
| concerning safety and effectiveness. | |
| The proposed devices are composed of Stainless Steel which is | |
| substantially equivalent to the predicate devices. | |
| The submitted mechanical testing data demonstrated that the | |
| bending and pull-out strength of the proposed devices are | |
| substantially equivalent to the bending and pull-out 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 System is substantially equivalent to | |
| currently marketed predicate devices. |
1
KI12437 (pg. 2 of z)
・・
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Arthrex, Incorporated % Ms. Courtney Smith Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108
DEC 2 1 2011
Re: K112437
Trade/Device Name: Arthrex Fracture System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN, HWC, HRS Dated: December 12, 2011 Received: December 14, 2011
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.
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
3
Page 2 – Ms. Courtney Smith
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 N. Melleman
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
1 Indications for Use Form
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Arthrex Fracture System
Indications For Use:
The Arthrex Fracture System is 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, femur and fibula. The Arthrex Fracture Plates are to be used with the 2.7mm-4.0mm Arthrex Low Profile Screws.
The Clavicle Plate Button is intended for use with the clavicle plates for clavicle indications such as for the treatment of syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruption, and this button may not be used alone. The button is intended to be used with #5 Fiber Wire or FiberTape.
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
Muthal Mheen
(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic, DIVIsion of Suices
510(k) Number K112437