(91 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical fixation, with no mention of AI/ML terms or functionalities.
No.
The device is described as a system of plates and screws for fixation of fractures and osteotomy, which are surgical interventions, not therapeutic treatments in the sense of curing disease or health problem.
No
Explanation: The device is described as a system of plates and screws for fracture fixation and osteotomy, indicating it is a surgical implant rather than a diagnostic tool. Its intended use is to "fixation of intra and extraarticular fractures as well as distal radius osteotomy," which are treatment procedures, not diagnostic ones.
No
The device description explicitly states it consists of "a range of plates and screws for distal radius surgery" made from titanium, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of intra and extraarticular fractures as well as distal radius osteotomy." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of "plates and screws for distal radius surgery." These are implants used in surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
The Universal Distal Radius System is intended for the fixation of intra and extraarticular fractures as well as distal radius osteotomy.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Universal Distal Radius System consists of a range of plates and screws for distal radius surgery. Each device is manufactured from titanium and can be color anodized. The Universal Distal Radius System will be provided non-sterile for steam sterilization by health care professional's prior use, or provided sterile by gamma sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professional
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 following tests were conducted:
- Comparative compression and flexion test on plates.
No clinical studies were performed.
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.
K061917, K100944, K102694, K102998, K090053
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
JUN 1 9 2013
510 (k) Summary for Universal Distal Radius System 4.
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the Universal Distal Radius System.
Summary preparation date: February 11, 2013
1. Submitter:
Contact Person:
NEWCLIP TECHNICS P.A. de la Lande Saint Martin 45 rue des Garottières F-44115 Haute-Goulaine - France Telephone: (33) 2 28 21 37 12
J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 Telephone: 512-388-0199
- Trade name:
Class:
Product code:
Common Name:
Classification Name:
Universal Distal Radius System
II
HRS/HWC
Plates for distal radius Screws for distal radius
Plate, Fixation, Bone (21 CFR part. 888.3030) Screw, Fixation, Bone (21 CFR part. 888.3040)
Predicate or legally marketed devices which are substantially equivalent: 3.
- The Distal Radius Locking Plating System of Newclip Technics (K061917). .
- The Clavicle Locking Plating System of Newclip Technics (K100944). .
- Synthes Locking Distal Radius Plating System (K102694). .
- Acumed Congruent Bone Plate System (K102998). .
- Medartis AGAPTUS® 2.0 Radial Head System (K090053).
Section 4 Page 1 of 3
ોન્દ્રનો
1
4. Description of the device:
The Universal Distal Radius System consists of a range of plates and screws for distal radius surgery. Each device is manufactured from titanium and can be color anodized. The Universal Distal Radius System will be provided non-sterile for steam sterilization by health care professional's prior use, or provided sterile by gamma sterilization.
Titanium alloy Ti-6A1-4V ELI (conform to ASTM F 136-02a and/or ISO 5832-3).
The implants of Universal Distal Radius System are indicated for fixation of intra and extra-articular fractures as well as distal radius osteotomy.
This Special 510(k) is submitted in order to gain clearance for plates that are substantially equivalent to the predicate and additional screws.
5. Substantial equivalence claimed to predicate devices:
The Universal Distal Radius System is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performance.
6. Intended use:
The Universal Distal Radius System is intended for fixation of intra and extraarticular fractures as well as distal radius osteotomy
Section 4 Page 2 of 3
.
.
Materials:
Function:
Change from Predicate:
2
K130774
Image /page/2/Picture/2 description: The image shows a logo with the letters "nct" inside of a circle. Below the circle, the words "NEWCLIP-TECH CO" are written in a stylized font. The logo is black and white and appears to be scanned from a document.
·
7. Non-clinical Test Summary:
The following tests were conducted:
- Comparative compression and flexion test on plates. .
- Non-clinical Test Summary:
No clinical studies were performed.
9. Conclusions Nonclinical and Clinical:
The Universal Distal Radius System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.
Section 4 Page 3 of 3
3
Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three overlapping wings, symbolizing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
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.
June 19, 2013
NEWCLIP TECHNICS
% The OrthoMedix Group, Incorporated Mr. J.D. Webb Official Correspondent 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K130774
Trade/Device Name: Universal Distal Radius 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: May 22, 2013 Received: May 24, 2013
Dear Mr. Webb:
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
4
Page 2 - Mr. J.D. Webb
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.
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/Resourcesfor You/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/ReportalProblem/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.
For
Sincerely yours,
Erin DKeith
Mark N. Melkerson
-Director-Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows a logo with the letters "nct" inside of a circle. Below the circle, the words "NEWCLIP-TECHNICS" are written in all capital letters. The logo appears to be for a company or organization with the acronym NCT.
INDICATIONS FOR USE 3.
510(k) Number (if known): K130774
Device Name: Universal Distal Radius System
Indications for Use:
The Universal Distal Radius System is intended for the fixation of intra and extraarticular fractures as well as distal radius osteotomy. -
Prescription Use _ X AND/OR Part 21 CFR 801 Subpart D) : Over-The-Counter Use
(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
Image /page/5/Picture/12 description: The image shows the text "Casey L. Hanley, Ph.D." on the top line, followed by a horizontal line. The second line of text says "Division of Orthopedic Devices". There is a graphic to the right of the text on the top line.