(64 days)
The Synthes Combination Clamp with Dynamization Clip is generally intended to be used in the construction of an external fixation frame to treat long bone and pelvic fractures. Specifically, the Synthes Combination Clamp with Dynamization Clip is intended for: - stabilization of soft tissue injuries and open or closed fractures; . - polytrauma; . - vertically stable pelvic fractures or as a treatment adjunct for vertically unstable pelvic . fractures: - arthrodesis and osteotomies with soft tissue problems; . - failures of total joints; ● - neutralization of fractures stabilized with limited internal fixation; ● - . non-unions/septic non-unions; - intraoperative reduction/stabilization tool to assist with indirect reduction; . - unilateral rectilinear bone segment transport or leg lengthening; ●
The Synthes Combination Clamp and Dynamization Clip attaches the Schanz screws (pins) to an 11 mm rod or tube, or two rod/tubes together. It consists of two spring compressed opposing vise plates that are interlocked to a one piece self contained clamp. The Dynamization clip is inserted into the clamp to allow dynamization. The device is manufactured from a Titanium Alloy and Stainless Steel.
This document is a 510(k) summary for a medical device called the "Synthes Combination Clamp and Dynamization Clip." It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.
Medical device summaries of this type (510(k) Pre-Market Notifications) are primarily focused on demonstrating substantial equivalence to a predicate device already on the market, rather than presenting detailed performance studies with acceptance criteria, sample sizes, or ground truth establishment.
Therefore, I cannot extract the requested information from the provided text because it is not present in this type of regulatory submission.
{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 logo that appears to be a stylized image of a person inside of a circle. To the right of the word is a small circle with an R inside, indicating a registered trademark.
OCT 16 1997
Attachment VII: Summary of Safety and Effectiveness Information [510(k) Summary]
SUBMITTER:
Synthes (USA) 1690 Russell Road Paoli. PA 19301 (610) 647-9700
Contact: Kevin J. O'Connell
COMMON OR USUAL NAME:
Traction, Component, Invasive
CLASSIFICATION CODE: 21 CFR, Section: 888.3040
Synthes Adjustable Clamp PREDICATE DEVICE:
DESCRIPTION:
The Synthes Combination Clamp and Dynamization Clip attaches the Schanz screws (pins) to an 11 mm rod or tube, or two rod/tubes together. It consists of two spring compressed opposing vise plates that are interlocked to a one piece self contained clamp. The Dynamization clip is inserted into the clamp to allow dynamization. The device is manufactured from a Titanium Alloy and Stainless Steel.
Generally intended to be used in the construction of an external INTENDED USE: fixation frame to treat long bone and pelvic fractures. Specifically for:
- stabilization of soft tissue injuries and open or closed . fractures:
- polytrauma; .
- vertically stable pelvic fractures or as a treatment adjunct for . vertically unstable pelvic fractures;
- arthrodesis and osteotomies with soft tissue problems; .
- failures of total joints; ●
- . neutralization of fractures stabilized with limited internal fixation;
- non-unions/septic non-unions; .
- intraoperative reduction/stabilization tool to assist with . indirect reduction;
- . unilateral rectilinear bone segment transport or leg lengthening.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human figures connected by flowing lines, resembling a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 1997
Mr. Kevin J. O'Connell Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 1766
Re: K973017 Synthes (USA) Combination Clamp and Dynamization Clip Regulatory Class: II Product Code: KTT Dated: August 12, 1997 Received: August 13, 1997
Dear Mr. O'Connell:
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 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 (Premarket Approval), 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 895. ದ 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 regulation 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 regulations.
{2}------------------------------------------------
Page 2 - Mr. Kevin J. O'Connell
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 diaqnostic 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,
L. Celia M. Witten, Ph.D.
ia M. Witteh, Ph.D., M.D. 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 circular logo with a design inside. A small registered trademark symbol is located to the right of the word.
Page l _______ of ____________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for use:
The Synthes Combination Clamp with Dynamization Clip is generally intended to be used in the construction of an external fixation frame to treat long bone and pelvic fractures. Specifically, the Synthes Combination Clamp with Dynamization Clip is intended for:
- stabilization of soft tissue injuries and open or closed fractures; .
- polytrauma; .
- vertically stable pelvic fractures or as a treatment adjunct for vertically unstable pelvic . fractures:
- arthrodesis and osteotomies with soft tissue problems; .
- failures of total joints; ●
- neutralization of fractures stabilized with limited internal fixation; ●
- . non-unions/septic non-unions;
- intraoperative reduction/stabilization tool to assist with indirect reduction; .
- unilateral rectilinear bone segment transport or leg lengthening; ●
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number.
1<973017
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
§ 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.