(70 days)
Synthes TomoFix TM Osteotomy System, Synthes Large Fragment Dynamic Compression Locking System, Synthes LCP Distal Femur Plates
Not Found
No
The summary describes a system of titanium plates for bone fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a system for stable fixation of osteotomies and treatment of deformities, fractures, and malalignment caused by injury or disease, indicating its use in managing a medical condition.
No
The device description indicates it is a system of plates used for fixation of osteotomies and treatment of fractures and malalignment, which are surgical and treatment-oriented functions rather than diagnostic ones.
No
The device description explicitly states it consists of titanium plates, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The Synthes TomoFixTM Osteotomy System is a system of titanium plates and instruments used for surgical procedures (osteotomies) on bones. It is implanted into the body to provide stable fixation.
- Intended Use: The intended use clearly describes a surgical procedure to correct bone deformities and fractures.
This device is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / 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.
Product codes
HRS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
medial proximal tibia, lateral proximal tibia, medial and lateral distal femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
Synthes TomoFix TM Osteotomy System, Synthes Large Fragment Dynamic Compression Locking System, Synthes LCP Distal Femur Plates
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in a bold, sans-serif font. There is a registered trademark symbol to the right of the word. To the left of the word is a logo that appears to be a stylized representation of a person. There is a horizontal line underneath the word.
3.0
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| 510(k) Summary | Page | 1 | of | 1 | |
|---|---|---|---|---|---|
| Sponsor: | Synthes (USA) | ||||
| Karl J. Nittinger | |||||
| 1301 Goshen Parkway | |||||
| West 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 bone | ||||
| fixation appliance and accessories. | |||||
| Predicate Device: | Synthes TomoFix TM Osteotomy System | ||||
| Synthes Large Fragment Dynamic Compression Locking System | |||||
| Synthes LCP Distal Femur Plates | |||||
| Device Description: | 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. | |||||
| Intended Use: | Synthes TomoFix TM 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. | |||||
| Substantial | |||||
| Equivalence: | 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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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 registered trademark symbol is located to the right of the word.
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