(53 days)
Not Found
No
The device description focuses on the mechanical components and materials of a surgical plating system, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
Yes
The device is intended for the fixation of fractures and osteotomy, which are therapeutic interventions.
No
The device, a Distal Radius Locking Plating System, is described as being "intended for the fixation of intra and extra-articular fractures as well as distal radius osteotomy." This indicates it is a therapeutic device (for fixing fractures) rather than a diagnostic one (for identifying or diagnosing conditions).
No
The device description clearly states it consists of physical components like plates, screws, and pegs made of titanium alloy, 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 is for the "fixation of intra and extra-articular fractures as well as distal radius osteotomy." This describes a surgical procedure performed directly on the patient's body to treat a physical condition (fractures and osteotomy).
- Device Description: The device consists of "plates designed for various fracture modes of the radius" and associated screws and pegs. These are physical implants used in surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose conditions, or monitor treatment. The provided description does not mention any such use or interaction with biological specimens.
Therefore, the Distal Radius Locking Plating System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Distal Radius Locking Plating System is intended for the fixation of intra and extra-articular fractures as well as distal radius osteotomy.
Product codes
HRS, HWC
Device Description
The Distal Radius Locking Plating System consists of plates designed for various fracture modes of the radius. The system is used with locking screws, locking pegs, locking threaded pegs and cortical screws. Each device is manufactured from titanium alloy (Ti-6Al-V4 ELI - ASTM F 136-02a) and can be supplied color anodized or notanodized.
The Distal Radius Locking Plating System will be provided non-sterile for steam sterilization by health care professionals prior to use.
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 professionals
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
K061917 (pg. 1 of 2)
Image /page/0/Picture/1 description: The image shows the logo for NewClip. The logo features the word "NEWCLIP" in bold, sans-serif font. Below the word is a smaller line of text that appears to say "Technologies". Above the word is a curved line that resembles a satellite dish.
SUMMARY OF SAFETY AND EFFECTIVENESS
A. Submitter's Name and adress
AUG 2 8 2006
NEWCLIP TECHNICS Z.A du Pâtis Rue de la fontaine grillée F-44 690 La Haye-Fouassiere France Telephone : (33) 2 28 21 37 12 Fax : (33) 2 40 63 68 37
Summary preparation date: February 15, 2011
B. Official Correspondent
J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 Tele/Fax - 512-388-0199 Email - ortho.medix@sbcglobal.net
C. Establishment registration number : 3007143290
D. Device name
Distal Radius Locking Plating System
E. Device Classification Name
Plate, fixation, bone (21 CFR 888.3030) Screw, fixation, bone (21 CFR 888.3040)
F. Proposed regulatory Class
Class II
G. Device Product Code
HRS HWC
H. Panel Code
Orthopedic
1
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K061917 (pg. 2 of 2)
I. Device Description
The Distal Radius Locking Plating System consists of plates designed for various fracture modes of the radius. The system is used with locking screws, locking pegs, locking threaded pegs and cortical screws. Each device is manufactured from titanium alloy (Ti-6Al-V4 ELI - ASTM F 136-02a) and can be supplied color anodized or notanodized.
The Distal Radius Locking Plating System will be provided non-sterile for steam sterilization by health care professionals prior to use.
J. Intended use:
The Distal Radius Locking Plating System is intended for the fixation of intra and extra-articular fractures as well as distal radius osteotomy.
K. Predicate device:
- Volar Radius Plate System of HAND INNOVATIONS (K030198) ●
- Synthes Locking Distal Radius Plating System of SYNTHES (K012114) ●
- Ace Humerus and Radius Plates of ACE MEDICAL COMPANY (K955472) ●
2
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
MAR - 4 2011
NewClip Technics % The Orthomedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K061917
Trade/Device Name: Radius Locking Plating 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: June 29, 2006 Received: July 6, 2006
Dear Mr. Webb:
This letter corrects our substantially equivalent letter of August 28, 2006. 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 (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.
3
Page 2 - Mr. J.D. Webb
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.
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,
Atiz vs. nh
for
Mark N. Melkerson Director Division of Surgical, Restorative and Orthopedic Devices Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Radius Locking Plating System
Indications for Use:
The Distal Radius Locking Plating System is intended for the fixation of intra and extra-articular fractures as well as distal radius osteotomy.
Prescription Use 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
for Mark Mellemson
(Divisio annedic.
Erie Insurance Group
510(k) Number K061917