(54 days)
The Normed Titanium Osteotomy Plating System intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes skeleton.
The Normed Titanium Osteotomy Plating System consists of titanium plates in two configurations, wedge and step, which are attached to the bone using screw fixation. The wedge plates are available in six lengths, namely, 3,4,5,6,7and 8 mm with 2.3 mm diameter screws extends from 10 to 28 mm long. The step plates are available in four lengths, namely, 3,4,5 and 6 mm with 3.5 mm diameter screws extends from 10 to 28 mm long. The plates screw holes are threaded and can accept locking screws with threaded and non-threaded screw head.
The provided text is a 510(k) summary for the Normed Titanium Osteotomy Plating System, which is a medical device for bone fixation. It describes the device, its intended use, and states that the FDA found it substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria.
Specifically, the following information, as requested in the prompt, is not present in the provided text:
- A table of acceptance criteria and the reported device performance: This information is not included. The document only describes the device and its intended use.
- Sample size used for the test set and the data provenance: No test studies or data are mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
- Adjudication method: Not applicable as no test set or ground truth is discussed.
- Multi reader multi case (MRMC) comparative effectiveness study: No such study is mentioned. This device is a bone plating system, not an AI or imaging diagnostic device where MRMC studies are typically performed.
- Standalone (i.e. algorithm only without human-in-the loop performance) study: Not applicable as this is a physical medical device, not an algorithm.
- The type of ground truth used: Not applicable as no studies or ground truth establishment are discussed.
- The sample size for the training set: Not applicable as no training sets or algorithms are discussed.
- How the ground truth for the training set was established: Not applicable.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, often through bench testing and often does not require new clinical studies for Class II devices like this one. The document indicates that the device was deemed "substantially equivalent" to predicate devices, which means its safety and effectiveness are established by its similarity to already-approved devices, rather than through new, extensive clinical studies detailed in this summary.
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9 2002 SEP
Kodd 325
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510 (k) Summary
Device Name: Normed Titanium Osteotomy Plating System
Device Identification: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Class II
Product Code: 87 HRS (21 CFR - 888.3030)
The Normed Titanium Osteotomy Plating System consists of titanium plates in two configurations, wedge and step, which are attached to the bone using screw fixation. The wedge plates are available in six lengths, namely, 3,4,5,6,7and 8 mm with 2.3 mm diameter screws extends from 10 to 28 mm long. The step plates are available in four lengths, namely, 3,4,5 and 6 mm with 3.5 mm diameter screws extends from 10 to 28 mm long. The plates screw holes are threaded and can accept locking screws with threaded and non-threaded screw head.
The Normed Titanium Osteotomy Plating System intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes skeleton. The system can be used in both adult and pediatric patients.
Official Contact Person: Albert Enayati President Osteomedics Inc. 809 Carter Lane Paramus, NJ 07652 Tel: (201) 444-7306 Fax: (201) 444-7395 E-mail: osteomedics@aol.com
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
9 2002 SEP
Albert Enayati President Osteomedics, Inc. 809 Carter Lane Paramus, New Jersey 07652
Re: K022325
Trade/Device Name: Normed Titanium Osteotomy Plating System Regulation Number: 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: July 7, 2002 Received: July 17, 2002
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 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 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.
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): k02035
Device Name: Normed Titanium Osteotomy Plating System
Indications for use:
The Normed Titanium Osteotomy Plating System intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes skeleton. The system can be used in both adult and pediatric patients.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Prescription use X
(Per 21 CFR 801.109)
OR OVER – THE – COUNTER USE
Styp Purdy
(Division Sign-Off) Division of General. Restorative and Neurological Devices
510(k) Number K022325
(Optional Format 1-2-96)
§ 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.