(119 days)
Synthes 1.5mm Headless Compression Screws are indicated for fixation of intra-articular and extra-articular fractures, avulsions, non-unions, and osteotomies of small bones and small bone fragments; as well as arthrodeses of small joints.
The Synthes 1.5mm Headless Compression Screws are solid bone fixation screws featuring a partially threaded shaft and threaded head. The screws are available in stainless steel and titanium.
The provided text is a 510(k) summary for a medical device called "Synthes (USA) 1.5mm Headless Compression Screws." This document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a study for acceptance criteria of an AI/ML powered device.
Therefore, the information required to answer your questions regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement for an AI/ML device is not present in the provided text. The document is typical for a traditional medical device submission, which relies on engineering and material testing, and comparison to predicate devices, rather than clinical performance studies with AI components.
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3.0
K090949
| 510(k) Summary | Page | 1 | of 1 | |
|---|---|---|---|---|
| Sponsor: | Synthes (USA)Karl J. Nittinger1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6941 | JUL 31 2009 | ||
| Device Name: | Synthes (USA) 1.5mm Headless Compression Screws | |||
| Classification: | Class II, §888.3040 - Smooth or threaded metallic bone fixationfastener. | |||
| Predicate Device: | Synthes 3.0mm Headless Compression ScrewsSynthes Stainless Steel Modular Hand System | |||
| Device Description: | The Synthes 1.5mm Headless Compression Screws are solid bonefixation screws featuring a partially threaded shaft and threadedhead. The screws are available in stainless steel and titanium. | |||
| Intended Use: | Synthes 1.5mm Headless Compression Screws are indicated forfixation of intra-articular and extra-articular fractures, avulsions,non-unions, and osteotomies of small bones and small bonefragments; as well as arthrodeses of small joints. | |||
| SubstantialEquivalence: | Information presented supports substantial equivalence. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black.
Public Health Service
od and Drug Administration 200 Corporate Boulevard Rockville MD 20850
JUL 3 1 2009
Re: K090949
Synthes (USA)
% Mr. Karl J. Nittinger 1301 Goshen Parkway West Chester, PA 19380
Trade/Device Name: Synthes (USA) 1.5mm Headless Compression Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: July 10, 2009 Received: July 15, 2009
Dear Mr. Nittinger:
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 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); 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/cdrh/comp/ for the Center for Devices and Radiological Health's
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Page 2 -- Mr. Karl J. Nittinger
(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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely vours.
Clarbare Borchus
Mark N. Me rsön Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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THES
2.0
Indications for Use
510(k) Number (if known):
Device Name:
Synthes (USA) 1.5mm Headless Compression Screws
Indications for Use:
Synthes 1.5mm Headless Compression Screws are indicated for fixation of intra-articular and extra-articular fractures, avuisions, non-unions, and osteotomies of small bones and small bone fragments; as well as arthrodeses of small joints.
Prescription Use X (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)
Jonita
(Division Sign-Off) for mxn
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090949
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.