(32 days)
The Synthes 1.0mm Ti. Cortex, Self-drilling screws are intended for fracture fixation in hand surgery and neurosurgery.
The 1.0mm Ti. Cortex Screws are self-drilling, have a flat head profile with rounded edges with a cruciform recess, and are available in lengths from 2 -- 4 mm.
This document is a 510(k) Summary and FDA clearance letter for a medical device, the Synthes 1.0mm Ti. Cortex, Self-drilling Screws. It does NOT contain information about acceptance criteria or a study proving that the device meets acceptance criteria.
The 510(k) process for medical devices like this typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a de novo study with acceptance criteria in the same way one might for a novel AI/software device.
Therefore, I cannot provide the requested information based on the provided text. The document focuses on:
- Sponsor and Device Information: Synthes (USA), 1.0mm Ti. Cortex, Self-drilling Screws.
- Intended Use: Fracture fixation in hand surgery and neurosurgery.
- Classification: 21 CFR 888.3040 (Smooth or Threaded Metallic Bone Fixation Fastener), Class II.
- Predicate Devices: Synthes 1.0 / 1.2 mm Plusdrive Screws and KLS Martin 1.0mm System Center-Drive Screw System.
- Substantial Equivalence: The primary claim is that the device is substantially equivalent to existing legally marketed devices, meaning it has the same intended use, technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness.
There are no details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone performance studies.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
These kinds of details are typically pertinent to the evaluation of software as a medical device (SaMD) or AI-based devices, which are not applicable to the physical bone screw described here.
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KOSO607
| 510(k) Summary | Page 1 of 1 |
|---|---|
| Sponsor: | Synthes (USA)1302 Wrights Lane EastWest Chester, PA 19380(610) 719-5000 |
| Device Name: | Synthes 1.0mm Ti. Cortex, Self-drilling Screws (Hand & Neuro) |
| Classification: | 21 CFR 888.3040: Smooth or Threaded Metallic Bone FixationFastener |
| Predicate Device: | Synthes 1.0 / 1.2 mm Plusdrive ScrewsKLS Martin 1.0mm System Center-Drive Screw System |
| Device Description: | The 1.0mm Ti. Cortex Screws are self-drilling, have a flat headprofile with rounded edges with a cruciform recess, and areavailable in lengths from 2 -- 4 mm. |
| Intended Use: | The Synthes 1.0mm Ti. Cortex, Self-drilling screws are intendedfor fracture fixation in hand surgery and neurosurgery. |
| SubstantialEquivalence: | Documentation is provided which demonstrates that the Synthes1.0mm Ti. Cortex Screws are substantially equivalent to otherlegally marketed devices.The term "substantial equivalence" as used in this 510(k)notification is limited to the definition of substantial equivalencefound in the Federal Food, Drug and Cosmetic Act, as amendedand as applied under 21CFR 807, Subpart E under which a devicecan be marketed without premarket approval or reclassification. Adetermination of substantial equivalency under this notification isnot intended to have any bearing whatsoever on the resolution ofpatent infringement suits or any other patent matters. Nostatements related to, or in support of substantial equivalenceherein shall be construed as an admission against interest under theUS Patent Laws or their application by the courts. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings. The eagle is enclosed in a circle with the text "U.S. Department of Health and Human Services" written around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 1 2005
Ms. Kathy Anderson Regulatory Affairs Manager Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania
Re: K050607
Trade/Device Name: Synthes (USA) 1.0mm Ti Cortex, Self-drilling Screws Regulation Numbers: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HRS Dated: March 09, 2005 Received: March 10, 2005
Dear Ms. Anderson:
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 - Ms. Kathy Anderson
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 (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/industry/support/index.html.
Sincerely yours.
Stypk Plurde
Image /page/2/Picture/5 description: The image shows a close-up, hand-drawn illustration of what appears to be a plant stem or branch. The stem is depicted with a slightly curved shape and has a few small, pointed leaves or buds emerging from its sides. The drawing style is simple, with clear lines and minimal shading, giving it a somewhat technical or botanical illustration feel.
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.0
Indications for Use
510(k) Number (if known):
Device Name: Synthes (USA) 1.0mm Ti. Cortex, Self-drilling Screws
Indications for Use:
The Synthes 1.0mm Ti. Cortex, Self-drilling screws are intended for fracture fixation in hand surgery and neurosurgery.
X Prescription Use (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hypt. Elurke
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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.