(90 days)
The Synthes MatrixRIB Fixation System is indicated for the fixation and stabilization of rib fractures, fusions and osteotomies of normal and osteoporotic bone.
The Synthes MatrixRIB Fixation System consists of bone plates, intramedullary (IM) splints and screws. All plates, IM splints and screws are manufactured from titanium alloy. The devices are provided sterile and non-sterile.
The provided text is a 510(k) summary for the Synthes MatrixRIB Fixation System, a medical device for fixing rib fractures. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
Instead, it focuses on demonstrating substantial equivalence to predicate devices through mechanical tests and engineering analyses. This is a common pathway for medical devices seeking FDA clearance, where the focus is on showing the new device is as safe and effective as existing legally marketed devices, rather than conducting new clinical trials with acceptance criteria.
Therefore, I cannot fulfill your request for the specific details outlined (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details, training set details) because this information is not present in the provided document.
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K0816623
Page _ 1 of _ of _ 1
SEP 0 8 2008
3.0 510(k) Summary
Sponsor: Synthes (USA) 1301 Goshen Parkway West Chester, PA 19380 (610) 719-6604 Contact: Amnon Talmor Synthes (USA) 1301 Goshen Parkway West Chester, PA 19380 (610) 719-6604 Device Name: Synthes MatrixRIB Fixation System Class II per 21 CFR §888.3030; Plate, Fixation, Bone Classification: Class II per 21 CFR §888.3040; Screw, Fixation, Bone Predicate Device: Acumed Rib Congruent Bone Plate System Synthes Sternal Fixation System MatrixMANDIBLE Plate and Screw System OrthoPro Steinman Pins And Kirschner Wires Device The Synthes MatrixRIB Fixation System consists of bone Description: plates, intramedullary (IM) splints and screws. All plates, IM splints and screws are manufactured from titanium alloy. The devices are provided sterile and non-sterile. Intended Use: The Synthes MatrixRIB Fixation System is indicated for the fixation and stabilization of rib fractures, fusions and osteotomies of normal and osteoporotic bone. Substantial Mechanical tests and engineering analyses were conducted to demonstrate the safety and effectiveness of the Synthes Equivalence: MatrixRIB Fixation System and support substantial equivalence to the predicates listed above.
DM
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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 image of an eagle with its wings spread.
SEP - 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes (USA) % Mr. Amnon Talmor Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K081623
Trade/Device Name: Synthes MatrixRIB Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: HRS, HWC Dated: June 6, 2008 Received: June 10, 2008
Dear Mr. Talmor:
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. Ilsting 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.
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Page 2 - Mr. Amnon Talmor
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M Millman
Mark N. Melkerson 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
KO81623 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Synthes MatrixRIB Fixation System
Indications for Use:
The Synthes MatrixRIB Fixation System is indicated for the fixation and stabilization of rib fractures, fusions and osteotomies of normal and osteoporotic bone.
X Over-The-Counter Use Prescription Use (21 CFR 807 Subpart C) (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millman
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K 081623
§ 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.