(29 days)
Not Found
No
The summary describes a mechanical osteotomy system and plate, with no mention of software, algorithms, or AI/ML capabilities. The performance studies focus on mechanical testing.
Yes
The device is described as being used for the treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease, which directly pertains to therapy.
No
The device description clearly states its purpose is for "stable fixation close to the knee," indicating it is a surgical implant designed for treatment, not diagnosis. The "Intended Use" also describes its use in surgical procedures like osteotomies and fracture treatment, not for identifying or characterizing diseases.
No
The device description explicitly states it is a system consisting 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (titanium plates) used for fixing bones during osteotomies and treating bone deformities and fractures. This is a device used in vivo (within the living body) for structural support and fixation, not for analyzing biological samples in vitro.
The description focuses on the mechanical properties and surgical application of the device, which is characteristic of a medical device used in surgery, not an IVD.
N/A
Intended Use / Indications for Use
The Synthes TomoFix™ 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 (USA) TomoFix™ Medial High Tibia Plate is a part of the Synthes TomoFix™ Osteotomy System which is a system consisting of titanium plates with locking and combination holes designed to provide stable fixation close to the knee.
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
Prescription Use (Per 21 CFR 801.109)
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
preclinical testing - including dynamic fatigue and static 3-point bend testing was performed comparing the proposed plate to the predicate plate and the results support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Synthes (USA) TomoFixTM Osteotomy System
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.
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 circular logo with a design inside. A small circle with an R inside is located to the right of the word.
K100676(pg 1/1)
3.0 510(k) Summary Page Synthes (USA) Sponsor: 1301 Goshen Parkway West Chester, PA 19380 APR - 8 2010 (610) 719-6604 Karl J. Nittinger Contact: Synthes (USA) 1301 Goshen Parkway West Chester, PA 19380 (610) 719-6941 Synthes (USA) TomoFix™ Medial High Tibia Plate, Small Device Name: Classification: Class II, §888.3030 - Single / multiple component metallic bone fixation appliance and accessories. HRS (Plate, Fixation, Bone) Classification Product Code: Synthes (USA) TomoFixTM Osteotomy System Predicate Devices: The Synthes (USA) TomoFix™ Medial High Tibia Plate is a part of Device the Synthes TomoFix™ Osteotomy System which is a system Description: consisting of titanium plates with locking and combination holes designed to provide stable fixation close to the knee. The Synthes (USA) TomoFix™ Osteotomy System is intended for Indications for open and closed wedge osteotomies of the medial proximal tibia, Use: 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. . Information presented supports the substantial equivalence of the Substantial TomoFix Medial High Tibia Plate, Small to the predicate device. The Equivalence: proposed plate has the same indications for use, is similar in shape/design, incorporates the same fundamental product technology and is composed of the same materials. Additionally, preclinical testing - including dynamic fatigue and static 3-point bend testing was performed comparing the proposed plate to the predicate plate and the results support substantial equivalence.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is composed of three thick, curved lines, and below it are three wavy lines that suggest water or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
APR - 8 2010
Synthes (USA) % Karl J. Nittinger 1301 Goshen Parkway West Chester, PA 19380
Re: K100676
Trade/Device Name: Synthes (USA) TomoFix™ Medial High Tibia Plate, Small Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS Dated: February 18, 2010 Received: March 10, 2010
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 marked in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Dr to 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, inst a of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract and warranties. We remind you, however, that device labeling must be truthful and not midler
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your devine 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 not 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
2
Page 2 – Mr. Karl J. Nittinger
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark M. Mulkerner
Mark N. Melkerson Director Division of Surgical, Orthopedic 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. The logo and the word "SYNTHES" are the main focus of the image. The overall impression is of a company logo or brand name.
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:
2.0
Synthes (USA) TomoFix™ Medial High Tibia Plate, Small
Indications for Use:
The Synthes TomoFix™ 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)
Soutte for mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100676