(18 days)
Synthes 5.0/7.3 mm Cannulated Locking screws are intended to be used with existing Synthes LCP® plating systems for the fixation of various long bones, such as the femur.
The Synthes 5.0/7.3 mm Cannulated Locking Screws feature self-drilling and self-tapping tips, have a flat head profile with rounded edges with a hex drive recess. They are available in additional lengths ranging from 100 - 145mm. The threads below the head of each locking screw are designed to engage with the threaded holes of currently marketed Synthes LCP® plating systems.
The provided text does not contain information about acceptance criteria or a study proving that the device meets such criteria. The document is a 510(k) summary for the Synthes 5.0/7.3 mm Cannulated Locking Screws, which primarily focuses on establishing substantial equivalence to a predicate device.
The content includes:
- Device Description: Synthes 5.0/7.3 mm Cannulated Locking Screws are self-drilling, self-tapping, have a flat head with rounded edges and a hex drive recessive, and are available in various lengths.
- Intended Use: For use with existing Synthes LCP® plating systems for the fixation of various long bones, such as the femur.
- Material: Stainless Steel.
- Classification: Class II, 21 CFR 888.3040: Smooth or Threaded Metallic Bone Fixation Fastener.
- Predicate Device: Synthes 5.0/7.3 mm Cannulated Locking Screws (the document states the predicate is the same as the new device, which is unusual for a typical 510(k) summary, often implying a modification or re-submission for the same device type).
- Substantial Equivalence: Stated as supported by comparative information.
It explicitly lacks details regarding:
- Specific acceptance criteria (e.g., performance thresholds for strength, fatigue, biocompatibility, etc.).
- Any study design, methodology, results, or data pertaining to the device's performance against such criteria.
- The elements related to AI/algorithm performance (test set, ground truth, experts, MRMC studies, standalone performance, training set) are entirely irrelevant as this is a physical medical device, not an AI or software-based diagnostic tool.
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APR 1 2 2004
040765
page 1 of 1
3.0 Summary of Safety and Effectiveness Information [510(k) Summary]
| SPONSOR: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700Contact: Lisa M. Boyle |
|---|---|
| DEVICE NAME: | Synthes 5.0/7.3 mm Cannulated Locking Screws |
| CLASSIFICATION: | Class II § 21 CFR 888.3040: Smooth or Threaded Metallic Bone FixationFastener. |
| PREDICATE DEVICE: | Synthes 5.0/7.3 mm Cannulated Locking Screws |
| DEVICE DESCRIPTION: | The Synthes 5.0/7.3 mm Cannulated Locking Screws feature self-drillingand self-tapping tips, have a flat head profile with rounded edges with a hexdrive recess. They are available in additional lengths ranging from 100 -145mm. The threads below the head of each locking screw are designed toengage with the threaded holes of currently marketed Synthes LCP®plating systems. |
| INTENDED USE: | Synthes 5.0/7.3 mm Cannulated Locking screws are intended to be usedwith existing Synthes LCP® plating systems for the fixation of various longbones, such as the femur. |
| SUBSTANTIALEQUIVALENCE: | Comparative information presented supports substantial equivalence. |
| MATERIAL | Stainless Steel |
.
Confidential
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized symbol consisting of three abstract human figures connected by flowing lines, representing the department's focus on people and their well-being.
Public Health Service
APR 1 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Rc: K040765
Trade/Device Name: Synthes (USA) 5.0/7.3 mm Cannulated Locking Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JDW Dated: March 24, 2004 Received: March 25, 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 adultcration.
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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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,
L. Mark A. Mulhausen
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 Statement 2.0
Page _ 1_ of _________________________________________________________________________________________________________________________________________________________________
K040765 510(k) Number (if known):
Synthes (USA) 5.0/7.3 mm Cannulated Locking Screw Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications: Synthes 5.0/7.3 mm Cannualted Locking Screws are intended to be used with existing Synthes LCP® plating systems for the fixation of various long bones, such as the femur.
X Prescription Use (Per 21 CFR 801.109)
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Over-The-Counter Usc
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Synthes (USA)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sig...)
Division of General, Restorative,
and Neurological Devices
Confidential 510(k) N: K040765
Confidential
Synthes (USA) 5.0/7/3 mm Cannulated Locking Screws
0004
§ 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.