(77 days)
Not Found
Not Found
No
The summary describes a mechanical fixation system (plates and screws) and mentions mechanical testing, with no indication of software, image processing, or AI/ML terms.
Yes
The device is described as being used for the "temporary stabilization of long bone fractures" and consists of "locking plates and screws for the internal fixation of long bone fractures," which is a direct treatment (therapy) for a medical condition.
No
The device is described as an internal fixation system for stabilizing long bone fractures, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it consists of "locking plates and screws for the internal fixation of long bone fractures," which are physical hardware components.
Based on the provided information, the Numelock™ II System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "temporary stabilization of long bone fractures." This is a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device consists of "locking plates and screws for the internal fixation of long bone fractures." These are implants used to physically stabilize bones.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
IVDs are used to perform tests in vitro (outside the body) on samples to provide information about a patient's health status. The Numelock™ II System is a surgical implant used in vivo (inside the body) to treat a physical condition.
N/A
Intended Use / Indications for Use
The Numelock™ II System is intended for use in the temporary stabilization of long bone fractures.
Product codes
KTT
Device Description
The Numelock™ II System consists of a series of locking plates and screws for the internal fixation of long bone fractures. The plates are available in different styles and configurations to fit various anatomical sites. Each plate has holes for screw fixation and is pre-contoured to fit the anatomical profile of the different periarticular regions of long bones.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bone fractures
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 demonstrated comparable mechanical properties to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
Food and Drua Administration 9200 Corporate Boulevard Rockville MD 20850
Vivian Kelly Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Drive Mahwah. New Jersey 07430
MAR 3 0 2005
Re: K041709
Trade/Device Name: Numelock™ II System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: June 21,2004 Received: June 23,2004
This letter corrects our substantially equivalent letter of September 8,2004 regarding the incorrect received date of April 23,2004. The correct received date is shown above.
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.
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); 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.
1
Page 2- Vivian Kelly
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Hypt Rhodes
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K64 J78 Device Name: Numclock™ II System
Indications for Use :
The Numelock™ II System is intended for use in the temporary stabilization of long bone fractures.
Over-The-Counter Use Prescription Use × AND/OR (Pan 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 )
Mark A. Miller
Page 1 of 1
9
Division Sign (Division of General, Restorative, and Neurological Devices
510(k) Numbe
3
Numelock™ II System
SEP - 8 2004
510(k) Premarket Notification
510(k) Summary of Safety and Effectiveness for the Numelock™ II System
| Proprietary Name: | Numelock™ II System |
|---|---|
| Common Name: | |
| Classification Name and Reference | Single/multiple component metallic bone fixation |
| appliances and accessories, 87 KTT | |
| 21 CFR §888.3030 | |
| Regulatory Class: | Class II |
| Device Product Code: | |
| For Information contact: | Vivian Kelly, Regulatory Affairs Specialist |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-5581 | |
| Fax: (201) 831-6038 | |
| Date Summary Prepared: | June 21, 2004 |
Description:
The Numelock™ II System consists of a series of locking plates and screws for the internal fixation of long bone fractures. The plates are available in different styles and configurations to fit various anatomical sites. Each plate has holes for screw fixation and is pre-contoured to fit the anatomical profile of the different periarticular regions of long bones.
Intended Use:
The Numelock™ II System is intended for use in the temporary stabilization of long bone fractures.
Substantial Equivalence:
The design and function of the Numelock™ II System is substantially equivalent to that of the predicate devices. Both the subject and predicate systems offer different types of plates in varying configurations and lengths for use with the other accessories such as locking screws, shaft screws, and washers. This system is equivalent to other systems on the market in regards to design, materials, indications and operational principals. Mechanical testing demonstrated comparable mechanical properties to the predicate devices.