(70 days)
Synthes TomoFixTM Osteotomy System is intended for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis.
The Synthes TomoFix TM Medial Distal Femur Plates are part of the Synthes TomoFix TM Osteotomy System which is a system consisting of titanium plates with locking and combination holes designed to provide stable fixation of osteotomies close to the knee. The TomoFix TM Medial Distal Femur Plates consist of titanium plates anatomically contoured to fit the medial distal femur. The plates are available in right and left versions and feature locking holes in the head and combination locking/dynamic compression holes in the shaft.
The provided text is a 510(k) summary for the Synthes (USA) TomoFix™ Medial Distal Femur Plates. This document is related to a medical device's regulatory clearance and does not contain information about acceptance criteria or a study proving device performance using AI or human readers with AI assistance. It focuses on demonstrating "substantial equivalence" to predicate devices, which is a regulatory pathway for certain medical devices.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results or effect sizes of human readers with/without AI assistance.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
These elements are typically found in a clinical study report or a detailed technical report for an AI/CADe device, not in a 510(k) summary for a bone fixation plate. The 510(k) summary only describes the device, its intended use, classification, and predicate devices to demonstrate substantial equivalence to a legally marketed product.
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3.0
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| 510(k) Summary | Page | 1 | of | 1 | |
|---|---|---|---|---|---|
| Sponsor: | Synthes (USA)Karl J. Nittinger1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6941 | JUL 23 2008 | |||
| Device Name: | Synthes (USA) TomoFix TM Medial Distal Femur Plates | ||||
| Classification: | Class II; §888.3030 - Single / multiple component metallic bonefixation appliance and accessories. | ||||
| Predicate Device: | Synthes TomoFix TM Osteotomy SystemSynthes Large Fragment Dynamic Compression Locking SystemSynthes LCP Distal Femur Plates | ||||
| Device Description: | The Synthes TomoFix TM Medial Distal Femur Plates are part of theSynthes TomoFix TM Osteotomy System which is a systemconsisting of titanium plates with locking and combination holesdesigned to provide stable fixation of osteotomies close to the knee.The TomoFix TM Medial Distal Femur Plates consist of titaniumplates anatomically contoured to fit the medial distal femur. Theplates are available in right and left versions and feature lockingholes in the head and combination locking/dynamic compressionholes in the shaft. | ||||
| Intended Use: | Synthes TomoFix TM Osteotomy System is intended for open andclosed wedge osteotomies of the medial proximal tibia, lateralproximal tibia, medial and lateral distal femur, treatment of boneand joint deformities, fractures, and malalignment caused by injuryor disease such as osteoarthritis. | ||||
| SubstantialEquivalence: | Information presented supports substantial equivalence. |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its wing, symbolizing strength and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes (USA) % Mr. Karl J. Nittinger 1301 Goshen Pkwy. West Chester, PA 19380
JUL 2 3 2008
Re: K081353 Trade/Device Name: Synthes (USA) TomoFix™ Medial Distal Femur Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: May 12, 2008 Received: May 14, 2008
Dear Mr. Nittinger:
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.
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Page 2 - Mr. Karl J. Nittinger
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 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. 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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2.0 .
Indications for Use
K081353 (pg 1/1) 510(k) Number (if known):
Device Name: Synthes (USA) TomoFix™ Medial Distal Fernur Plates
Indications for Use:
Synthes TomoFixTM Osteotomy System is intended for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis.
Prescription Use X (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Re .. ... and Neurological Devices
510(k) Number 108313
§ 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.