(90 days)
Not Found
No
The device description and performance studies focus on the mechanical properties of the plates and screws, with no mention of AI or ML technology. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended for the stabilization of fractures and reconstruction of bones, which are therapeutic interventions.
No
The device is a plate system used for stabilization of fractures and other bone procedures, which are therapeutic interventions rather than diagnostic processes.
No
The device description clearly states it is comprised of physical components like plates and screws made of titanium, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the stabilization of fractures, osteotomies, joint fusion, and reconstruction of bones. This is a surgical implant used directly on the patient's body.
- Device Description: The description details plates and screws made of titanium, which are physical components for surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a therapeutic device used to repair or stabilize bone structures.
N/A
Intended Use / Indications for Use
The Arthrex Distal Extremity Plate System 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.
Product codes
HWC, HRS
Device Description
The Arthrex Distal Extremity Plate System is comprised of a variety of flat and pre-contoured plate geometries. The plates are manufactured from titanium and feature both locking and non-locking holes. The screw ranges from 2.0 mm to 4.0 mm in diameter and in length from 8 mm to 80 mm. The screws are solid and may be either locking or non-locking.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand/wrist, foot/ankle
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 strength of the plates and the torque and pull-out force of the screws are substantially equivalent to that of the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K090692, K063049, K050110, K103705
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Traditional 510(k): Arthrex Distal Extremity Plate System, May 2, 2011
Arthrex 510(K): ARTHREX DISTAL EXTREMITY PLATE SYSTEM
AUG - 2 2011
Summary of Safety and Effectiveness April 22, 2011 Date Summary Prepared Manufacturer/Distributor/Sponsor Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108-1945 USA Courtney Smith 510(k) Contact Regulatory Affairs Project Manager Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108-1945 USA Telephone: 239/643.5553, ext. 1720 Fax: 239/598.5508 Email: courtney.smith(@arthrex.com Trade Name Distal Extremity Plate System Common Name Plate, fixation, bone Screw, fixation, bone HWC, HRS Product Code -Classification Name 21 CFR 888.3030: Single/multiple component metallic bone CFR fixation appliances and accessories. 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener. K090692: Wright Ortholoc 2.0/2.4 Plate System Predicate Device K063049: Synthes Modular Mini Fragment LCP System K050110: Synthes Modular Foot System K103705: Arthrex Low Profile Screws Purpose of Submission This traditional 510(k) premarket notification is submitted to obtain clearance for the Distal Extremity Plate System. Device Description and Intended The Arthrex Distal Extremity Plate System is comprised of a Use variety of flat and pre-contoured plate geometries. The plates are manufactured from titanium and feature both locking and non-locking holes. The screw ranges from 2.0 mm to 4.0 mm in diameter and in length from 8 mm to 80 mm. The screws are solid and may be either locking or non-locking. The Arthrex Distal Extremity Plate System 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 Distal Extremity Plate System is substantially equivalent Substantial Equivalence
1
K111253 (pg 2/2)
Traditional 510(k): Arthrex Distal Extremity Plate System, May 2, 2011
| Arthrex 510/KV ARTHREX DISTAL EXTREMITY PLATE SYSTE* |
|---|
| Summary | to the predicate devices, in which the basic features and
intended uses are the same. Any differences between the
Distal Extremity Plate System and the predicates are
considered minor and do not raise questions concerning safety
and effectiveness. |
|---------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The proposed devices are composed of titanium that is
substantially equivalent to the predicate devices. |
| | The submitted mechanical testing data demonstrated that the
bending strength of the plates and the torque and pull-out
force of the screws are substantially equivalent to that 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 Distal Extremity Plate System is
substantially equivalent to currently marketed predicate
devices. |
.
:
.
:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Arthrex, Inc. % Ms. Courtney Smith Regulatory Affairs Project Manager 1370 Creekside Blvd. Naples. FL 34108-1945
AUG - 2 2011
Re: K111253
Trade/Device Name: Arthrex Distal Extremity Plate System Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: May 2, 2011 Received: May 4, 2011
Dear Ms. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have deternined 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
3
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 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 Parl 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark McMillan
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Arthrex 510(K): ARTHREX DISTAL EXTREMITY PLATE SYSTEM
Indications for Use Form
Indications for Use
510(k) Number (if known): KU1253 (pa 1/1
Device Name: Arthrex Distal Extremity Plate System
Indications For Use:
The Arthrex Distal Extremity Plate System 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.
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
for M. Melkerson
(Division/Sign-Off) (Division/Sign-on/Surgical, Orthopedic,
Division of Surgical, Orthopedic, Divisionative Devices
510(k) Number K111253