(85 days)
No
The device description focuses on mechanical components (plates and screws) and mechanical testing, with no mention of software, algorithms, or AI/ML terms.
Yes
The device is described as an "Elbow System Plate Line Extension" intended for "fracture fixation of long bones," specifically "distal humerus and proximal ulna." This function directly addresses and treats a medical condition (fractures), classifying it as a therapeutic device.
No
Explanation: The device is intended for "fracture fixation" and acts as a "plate" and "screws", which are interventional and therapeutic functions, not diagnostic.
No
The device description explicitly states it is comprised of plates and screws, which are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fracture fixation of long bones," specifically the distal humerus and proximal ulna. This is a surgical procedure involving the implantation of a device to stabilize broken bones.
- Device Description: The device is comprised of "plates and screws" made of titanium. These are physical implants used in surgery.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function. It is a surgical implant.
The information provided clearly describes a surgical implant used for fracture fixation, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
The Variax Elbow System Plate Line Extension is intended for fracture fixation of long bones. Indications include distal humerus and proximal ulna.
Product codes
HRS
Device Description
The subject VariAx Elbow System is comprised of plates and screws, manufactured from Titanium alloy and Commercially Pure Titanium. The subject system was determined substantially quivalent in K073527. This Special 510(k) submission is intended to address the shortening of the Distal Posterior Medial Humeral Plates, left and right. Two process changes, which have been documented internally and affect the entire Distal Posterior Medial humeral Plate family, are also discussed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal humerus and proximal ulna.
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
Mechanical testing demonstrates substantial equivalence of the subject components to the predicate devise in regards to mechanical strength. Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject Variax Elbow System Plate Line Extension to the predicate device VariAx Elbow System K073527.
Key Metrics
Not Found
Predicate Device(s)
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
VARIAX ELBOW SYSTEM PLATE LINE EXTENSION
Special 510(k)
093433
510(k) Summary of Safety and Effectiveness: Variax Elbow System Plate Line Extension
Nov 2, 2009
JAN 2 8 2010
Submission Information
Name and Address of the Sponsor of the 510(k) Submission:
Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
For Information contact:
Melissa A. Matarese, Regulatory Affairs Associate Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-5116 Fax: (201) 831-4116
Date Summary Prepared:
Device Identification Proprietary Name:
Variax Elbow System Plate Line Extension
Common Name: Classification Name and Reference:
Device Product Code:
Bone plates and screws Single/multiple component metallic bone fixation appliances and accessories, 21 CFR §888.3030
HRS: Plate, Fixation, Bone
Description:
The subject VariAx Elbow System is comprised of plates and screws, manufactured from Titanium alloy and Commercially Pure Titanium. The subject system was determined substantially quivalent in K073527. This Special 510(k) submission is intended to address the shortening of the Distal Posterior Medial Humeral Plates, left and right. Two process changes, which have been documented internally and affect the entire Distal Posterior Medial humeral Plate family, are also discussed.
Intended Use:
The Variax Elbow System Plate Line Extension does not alter the intended use of the predicate systems as cleared in their respective premarket notifications. The indications for use for the subject plates are provided below.
Indications for Use:
The Variax Elbow System Plate Line Extension is intended for fracture fixation of long bones. Indications include distal humerus and proximal ulna.
1
VARIAX ELBOW SYSTEM PLATE LINE EXTENSION
Statement of Technological Comparison:
The features of the subject components are substantially equivalent to the predicate devices based on similarities in intended use and design. Mechanical testing demonstrates substantial equivalence of the subject components to the predicate devise in regards to mechanical strength. In addition, the intended use, manufacturing methods, packaging, and sterilization of the predicate and subject components are identical.
The subject and predicate devices are made from Titanium alloy (Ti-6Al-4V) and Commercially Pure Titanium. Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject Variax Elbow System Plate Line Extension to the predicate device VariAx Elbow System K073527.
ู้จัก
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. The symbol on the right is a stylized representation of a bird or abstract human figure, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corp. % Ms. Melissa A. Matarese Regulatory Affairs Associate 325 Corporate Drive Mahwah, New Jersey 07430
JAN 2 8 2010
Re: K093433
Trade/Device Name: VariAx Elbow System Plate Line Extension Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and
accessories
Regulatory Class: II Product Code: HRS Dated: January 14, 2010 Received: January 19, 2010
Dear Ms. Matarese: ·
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have deterniined 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. Ilsting 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 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.
3
Page 2 - Ms. Melissa A. Matarese
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/CDRHQffices/ucm11.5809.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 vours.
Aoubara buekn
Mark N. Melkerson . Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K ○93イタミ
Device Name: VariAx Elbow System Plate Line Extension
Indications For Use:
. .
The Variax Elbow System Plate Line Extension is intended for fracture fixation of long bones. Indications include distal humerus and proximal ulna.
Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Smuta for Nixon
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093433
22