(85 days)
The Synthes Peri-Prosthetic Screws are intended for fixation of various long bones, such as the humerus, femur and tibia, in conjunction with Synthes locking plates that accept 4.0/5.0 mm locking screws. They are also for use in fixation of periprosthetic fractures, osteopenic bone, and fixation of non-unions or malunions.
The new Synthes 4.0/5.0mm Peri-prosthetic Locking Screws feature a self-tapping blunt tip, stardrive mechanism, and have a flat head profile with rounded edges. They are available in lengths ranging from 8mm to 12mm. The threads on the head of each locking screw are designed to engage with the threaded holes of currently marketed Synthes LCP® plating systems.
I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) summary and FDA clearance letter for the "Synthes Peri-Prosthetic Screws," which details the device description, intended use, classification, and substantial equivalence to predicate devices, but does not include the specifics of performance testing or clinical studies to meet acceptance criteria.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A horizontal line is present below the word. There is a registered trademark symbol to the right of the word.
SEP = 1 2004
Ko4/533
510(k) Summary 3.0
Page _________ of ___
| Sponsor: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700 |
|---|---|
| Device Name: | Synthes Peri-Prosthetic Screws |
| Classification: | 21 CFR 888.3040: Smooth or Threaded Metallic Bone FixationFastener. |
| Predicate Devices: | Synthes 4.0/5.0 mm Locking Screws |
| Device Description: | The new Synthes 4.0/5.0mm Peri-prosthetic Locking Screwsfeature a self-tapping blunt tip, stardrive mechanism, and have aflat head profile with rounded edges. They are available in lengthsranging from 8mm to 12mm. The threads on the head of eachlocking screw are designed to engage with the threaded holes ofcurrently marketed Synthes LCP® plating systems. |
| Intended Use: | The Synthes Peri-prosthetic Locking Screws are intended forfixation of various long bones, such as the humerus, femur andtibia, in conjunction with Synthes locking plates that accept 4.0/5.0mm locking screws. They are also for use in fixation ofperiprosthetic fractures, osteopenic bone, and fixation of non-unions or malunions. |
| SubstantialEquivalence: | Information presented supports substantial equivalence. |
{1}------------------------------------------------
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 stylized eagle or bird symbol, with three curved lines representing its body and wings. The bird is facing to the right. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 1 2004
Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Paoli, Pensylvania 19301
Re: K041533
Device Name: Synthes (USA) Peri-Prosthetic Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: June 7, 2004 Received: June 8, 2004
Dear Ms. Boyle:
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.
{2}------------------------------------------------
Page 2 - Lisa M. Boyle
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow yourse organ and inding 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 If you desire specific at noliance 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 other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark A. Milken
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
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A horizontal line runs beneath the word "SYNTHES". The logo and text appear to be a company or brand name.
of l Page 1
Indications for Use
510(k) Number (if known):
K04/1533
Device Name:
2.0
Synthes (USA) Peri-Prosthetic Screws
Indications for Use:
The Synthes Peri-Prosthetic Screws are intended for fixation of various long bones, such as the The Synthes Perfel Tostical Serows are meith Synthes locking plates that accept 4.0/5.0 mm
humerus, femur and tibia, in conjunction with Synthes locking plates actespense beg humerus, temur and tibla, in confulience with officition fractures, osteopenic bone, and fixation of non-unions or malunions.
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)
NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number: K041533
§ 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.