(67 days)
Synthes Cerclage Positioning Pin is intended for use with cerclage monofilament wire and multifilament cable to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants.
The Cerclage Positioning Pin is designed for use in dynamic compression screw holes that accept a 4.5 mm bone screw. The Cerclage Positioning Pin (and cerclage wire or cable) can be used with a variety of Synthes plates.
The design of the cerclage positioning pin is an oval body with a hole running perpendicular to the long axis (for use in compression holes), and has a stud protruding from the bottom. By placing the post through the top of the dynamic compression screw hole into a pre-drilled hole in cortical bone a stable structure is created for cerclage wire or cable fixation. The wire or cable is passed around the bone, through the Cerclage Positioning Pin hole above the outer plate surface, and then the wire is twisted or cable is crimped for final securement.
I am sorry, but based on the provided document, there is no information about acceptance criteria or a study that proves the device meets specific performance metrics.
The document is a 510(k) summary for the "Synthes Cerclage Positioning Pin" and primarily focuses on:
- Device identification and classification: Name, common name, classification, and predicate device.
- Description and intended use: How the device works and for what purpose.
- FDA's substantial equivalence determination: The FDA's letter stating that the device is substantially equivalent to a legally marketed predicate device.
- Indications for Use statement.
This type of submission to the FDA (510(k)) aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device. It typically relies on comparison to the predicate rather than on new, extensive performance studies with acceptance criteria as one might see for novel devices or PMAs.
Therefore, I cannot provide the requested table or details about a study, sample sizes, experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the information given.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized figure inside. A registered trademark symbol is present to the upper right of the word "SYNTHES".
NOV - 2 1999
| Attachment VI: | Summary of Safety and Effectiveness Information[510(k) Summary] |
|---|---|
| SUBMITTER | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700Contact: Sheri L. Musgnung |
| DEVICE NAME: | Synthes Cerclage Positioning Pin |
| COMMON OR USUALNAME | Smooth or thread metallic bone fixation fastener |
| DEVICECLASSIFICATION: | Class II, 21 CFR 888.3040 |
| PREDICATE DEVICE: | Synthes Wire Mount (K953777) |
| DESCRIPTION: | The design of the cerclage positioning pin is an oval body with ahole running perpendicular to the long axis (for use incompression holes), and has a stud protruding from the bottom.By placing the post through the top of the dynamic compressionscrew hole into a pre-drilled hole in cortical bone a stablestructure is created for cerclage wire or cable fixation. The wireor cable is passed around the bone, through the CerclagePositioning Pin hole above the outer plate surface, and then thewire is twisted or cable is crimped for final securement. |
| INTENDED USE: | Synthes Cerclage Positioning Pin is intended for use withcerclage monofilament wire and multifilament cable to augmentfracture stabilization with plates used in long bone fixation whenthe use of screws is contraindicated, as in the presence ofintramedullary implants. |
The Cerclage Positioning Pin is designed for use in dynamic compression screw holes that accept a 4.5 mm bone screw. The Cerclage Positioning Pin (and cerclage wire or cable) can be used with a variety of Synthes plates.
Synthes (USA) Cerclage Positioning Pin
.
CONFIDENTIAL
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three overlapping lines that resemble an abstract bird or wave pattern.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 2 1999
Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes USA 1690 Russell Road 19301 Paoli, Pennsylvania
Re: K992891 Synthes Cerclage Positioning Pin Trade Name: Requlatory Class: II Product Code: JDQ Dated: August 26, 1999 Received: August 27, 1999
Dear Ms. Musgnung:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
{2}------------------------------------------------
Page 2 - Ms. Sheri L. Musgnung
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M
Ph.D., M.D. Cella M. Witten, Director Division of General and Restorative 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 logo that appears to be a stylized image inside of a circle. To the right of the word is a registered trademark symbol.
Indications for Use Statement 2.0
| 1 | ||
|---|---|---|
| ---- |
510(k) Number (if known): ·
Synthes Cerclage Positioning Pin Device Name:
Indications For Use:
Synthes Cerclage Positioning Pin is intended for use with cerclage monofilament wire and multifilament cable to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants.
The Cerclage Positioning Pin is designed for use in dynamic compression screw holes that accept a 4.5 mm bone screw. The Cerclage Positioning Pin (and cerclage wire or cable) can be used with a variety of Synthes plates.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
X Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
DCOTE
(Division Sign-Off)
Division of General Restorative Devices K99282,
510(k) Number
Synthes (USA) Cerclage Positioning Pin CONFIDENTIAL
000004
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.