(41 days)
Not Found
Not Found
No
The device description focuses on the mechanical design of a bone screw and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are also marked as "Not Found".
Yes
The device is intended for the treatment of fractures and arthrodesis, which falls under the definition of a therapeutic device.
No
The Normed Compression Bone Screw System is described as a headless screw designed for internal fixation of bone fractures and osteotomies, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical bone screw system with different sizes and placement methods, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The Normed Compression Bone Screw System is a surgical implant designed to fix fractures and perform arthrodesis (joint fusion) in bones. It is physically inserted into the body.
- Intended Use: The intended use clearly describes the device's purpose in treating bone fractures and performing surgical procedures on bones. It does not involve the analysis of biological specimens.
Therefore, based on the provided information, the Normed Compression Bone Screw System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Normed Compression Bone Screw System intended for use for fractures or arthrodesis of carpals and metacarpals, radial head and radial stolid fractures, metatarsal fractures and osteotomies of the forefoot and intra- artcular arthrodesis in the wrist, pseudo-arthrosis, degenerative alteration and corrective osteotomies aiming to functionally stable osteosynthesis such as, but not limited to scaphoid fractures, fractures of other carpal bones, scaphoid pseudo-arthrosis, intercarpal arthrodesis of finger eng and metacarpal joints and fractures of ulna head and radius head.
Product codes
HRS, JDS
Device Description
The Normed Compression Bone Screw System is a headless screw with double self-tapping cancellous bone thread that is designed for dynamic adjustable intarfragmentary compression purposes. The pitch of the thread in the proximal segment is smaller than the thread pitch at the distal end. The compression force is produced due to the difference in pitch between the distal and proximal segments. The Normed Compression Bone Screw System consists of three systems. Mini System 1.5. Standard System 2.0 and High Compression System 2.0. The Mini System 1.5 may be placed using an open approach with the use of a target bow device for placement of the screw. The Standard System 2.0 and High Compression System 2.0 are cannulated and may be placed through percutaneous screw placement using K-wire as a guide in minimize the incision. All three systems are available in10 through 30 mm length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carpals and metacarpals, radial head and radial stolid, metatarsal, forefoot, wrist, scaphoid, finger eng and metacarpal joints, ulna head and radius head
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
Not Found
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.
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OCT - 6 2003
032634
page 1 of 1
510 (k) Summary
a. Device Classification Name: Plate, Fixation, Bone
b. Regulation Class / Number: Class II, Section 888.3000
c. Device Name: Normed Compression Bone Screw System
d. Product.Code: HRS e. Classification / Review Advisory Committee: Orthopedic
The Normed Compression Bone Screw System is a headless screw with double self-tapping cancellous bone thread that is designed for dynamic adjustable intarfragmentary compression purposes. The pitch of the thread in the proximal segment is smaller than the thread pitch at the distal end. The compression force is produced due to the difference in pitch between the distal and proximal segments. The Normed Compression Bone Screw System consists of three systems. Mini System 1.5. Standard System 2.0 and High Compression System 2.0. The Mini System 1.5 may be placed using an open approach with the use of a target bow device for placement of the screw. The Standard System 2.0 and High Compression System 2.0 are cannulated and may be placed through percutaneous screw placement using K-wire as a guide in minimize the incision. All three systems are available in10 through 30 mm length.
The Normed Compression Bone Screw System intended for use for fractures or arthrodesis of carpals and metacarpals, radial head and radial stolid fractures, metatarsal fractures and osteotomies of the forefoot and intra- artcular arthrodesis in the wrist, pseudo-arthrosis, degenerative alteration and corrective osteotomies aiming to functionally stable osteosynthesis such as, but not limited to scaphoid fractures of other carpal bones, scaphoid pseudo-arthrosis, intercarpal arthrodesis of finger eng and metacarpal joints and fractures of ulna head and radius head.
Official Contact Person:
Albert Enayati President Noviace™ Corporation 809 Carter Lane Paramus, NJ 07652 Tel: (201) 444-7306 Fax: (201) 444-7395 E-mail: noviace@aol.com
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Image /page/1/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized eagle symbol. The eagle is depicted with three lines forming its body and wings, giving it a modern and abstract appearance.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 6 2003
Mr. Albert Enayati President Noviace Corporation 809 Carter Lane Paramus, NJ 07652
Re: K032634
Trade/Device Name: Normed Compression Bone Screw System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDS Dated: August 22, 2003 Received: September 12, 2003
Dear Mr. Enayati:
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 contrôls 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 such 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.
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Page 2 - Mr. Albert Enayati
This letter will allow you to begin 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 (301) 594-4659. 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,
Mark A. Milkus
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
. .
Enclosure
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Indications for use
510 (k) Number (if known): K032634
Device Name: Normed Compression Bone Screw System
Indications for use:
The Normed Compression Bone Screw System intended for use for fractures or arthrodesis of carpals and metacarpals, radial head and radial stolid fractures, metatarsal fractures and osteotomies of the forefoot and intra- artcular arthrodesis in the wrist, pseudo-arthrosis, degenerative alteration and corrective osteotomies aiming to functionally stable osteosynthesis such as, but not limited to scaphoid fractures, fractures of other carpal bones, scaphoid pseudo-arthrosis, intercarpal arthrodesis of finger eng and metacarpal joints and fractures of ulna head and radius head.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Prescription use
OVER - THE - COUNTER USE
(Per 21 CFR 801.109)
Mark A Millman
Jivision Sion-Off . Restorative
14 Site(k) Number K032634
(Optional Format 1-2-96)