(267 days)
No
The summary describes a mechanical implant (bone plate) and its intended use and mechanical testing. There is no mention of software, algorithms, image processing, AI, ML, or data sets, which are typically associated with AI/ML medical devices.
Yes
The device is described as being used for the "treatment of: Unicompartmental medial or lateral gonarthrosis with malalignment of the proximal tibia Idiopathic or posttraumatic varus or valgus deformity of the proximal tibia" and for "fixation of fractures." These uses indicate a therapeutic purpose.
No
The device is a bone plate intended for internal fixation in osteotomies and fractures of the tibia, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical implant (plate and screws) made of titanium, not software.
Based on the provided information, the TOMOFIX™ Medial High Tibia Plates are not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The TOMOFIX™ Medial High Tibia Plates are surgical implants designed to fix fractures and correct malalignment of the tibia. They are used in the body during surgery, not to test samples from the body.
The description clearly indicates a medical device used for surgical intervention, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The TOMOFIX™ Medial High Tibia Plates are indicated for open- and closed-wedge osteotomies, fixation of fractures, and malalignment caused by injury or disease of the medial proximal tibia for the treatment of:
- Unicompartmental medial or lateral gonarthrosis with malalignment of the proximal tibia
- Idiopathic or posttraumatic varus or valgus deformity of the proximal tibia
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The subject Titanium TomoFix™ Medial High Tibia Plate Anatomical is anatomically precontoured to fit the medial side of the proximal tibia (also referred to as high tibia) and is provided in a 'left' and 'right' version to accommodate the anatomy of the tibia in the left and right knee, respectively. The plate features seven round, threaded locking holes to provide a locked, fixed-angle construct and one combination locking / dynamic compression hole to allow temporary compression during the surgery. The subject plate is designed to accept existing, previously cleared 5.0 mm Locking Screws, 4.5 mm Cortex Screws and 5.0 mm Spacers
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
medial proximal tibia
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing demonstrates that the proposed Titanium TomoFix™ Medial High Tibia Plate Anatomical is substantially equivalent in mechanical properties to the predicate device. The subject device was tested under static and dynamic loading conditions to demonstrate mechanical equivalence compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of a human figure, and the text on the right is in blue.
Synthes (USA) Products, LLC Stephan Jepards Sr. Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
October 24, 2018
Re: K180213
Trade/Device Name: Titanium TomoFix Medial High Tibia Plate Anatomical 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: September 18, 2018 Received: September 19, 2018
Dear Stephan Jepards:
This letter corrects our substantially equivalent letter of October 19, 2018
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jesse Muir -S 2018.10.24 09:33:50 -04'00'
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K180213
Device Name
Titanium TomoFix™ Medial High Tibia Plate Anatomical (line extension to the existing Synthes TomoFix Osteotomy System)
Indications for Use (Describe)
The TOMOFIX™ Medial High Tibia Plates are indicated for open- and closed-wedge osteotomies, fixation of fractures, and malalignment caused by injury or disease of the medial proximal tibia for the treatment of:
- Unicompartmental medial or lateral gonarthrosis with malalignment of the proximal tibia
- Idiopathic or posttraumatic varus or valgus deformity of the proximal tibia
| Type of Use (Select one or both, as applicable) | |
|---|---|
|X | Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Date Prepared: September 17, 2018
| Sponsor: | DePuy Synthes
Stephan Jepards
1301 Goshen Parkway
West Chester, PA 19380
Office: +41 32 720 41 59 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary
Name: | Titanium TomoFix™ Medial High Tibia Plate Anatomical (to be included within the
Synthes TomoFix™ Osteotomy System) |
| Device
common name | Bone plate |
| Classification: | Classification: Class II
Regulation Number: 21 CRF §888.3030
Product Code: HRS |
| Classification
Name | Single/multiple component metallic bone fixation appliances and accessories. |
| Predicate
Device | Titanium TomoFix™ Medial High Tibia Plate
initially cleared via K023941 |
| Reference
device | TomoFix™ Medial High Tibia Plate, Small,
initially cleared via K100676 |
| Device
Description: | The subject Titanium TomoFix™ Medial High Tibia Plate Anatomical is anatomically
precontoured to fit the medial side of the proximal tibia (also referred to as high tibia)
and is provided in a 'left' and 'right' version to accommodate the anatomy of the tibia
in the left and right knee, respectively. The plate features seven round, threaded
locking holes to provide a locked, fixed-angle construct and one combination locking
/ dynamic compression hole to allow temporary compression during the surgery.
The subject plate is designed to accept existing, previously cleared 5.0 mm Locking
Screws, 4.5 mm Cortex Screws and 5.0 mm Spacers |
| Indications for
Use: | The TOMOFIX™ Medial High Tibia Plates are indicated for open- and closed-wedge
osteotomies, fixation of fractures, and malalignment caused by injury or disease of the
medial proximal tibia for the treatment of:
Unicompartmental medial or lateral gonarthrosis with
malalignment of the proximal tibia Idiopathic or posttraumatic varus or valgus deformity of the
proximal tibia |
| Comparison to
Predicate | The subject device and the predicate are identical with respect to indications and
intended use.
The subject Titanium TomoFix™ Medial High Tibia Plate Anatomical feature
equivalent characteristics as the predicate devices. Specifically, identical
technological characteristics are as follows: Plates are compatible with 5.0 mm Locking Screws for angular, stable fixation Plates are compatible with 4.5 mm Cortex Screws to allow temporary compression of the lateral hinge Plates are offered sterile and non-sterile The differences in design features between the subject plates and the predicate and reference devices are listed below. The subject plates are available in a pre-shaped left and right version to accommodate the anatomy of the left and right tibia, respectively. The subject plates only feature one LCP combination-hole, where the predicate and reference devices each feature three LCP combination-hole in total. |
| Substantial
Equivalence: | The subject Titanium TomoFix™ Medial High Tibia Plate Anatomical has identical
indications compared to the predicate device. The features of the subject device are
substantially equivalent to the predicate device based on the similarities in intended
use and design. Mechanical testing demonstrates substantial equivalence of the
subject device to the predicate device.
In addition, the intended use, packaging, and sterilization of the predicates compared to the subject devices are identical. The subject and predicate devices are both made from commercially pure titanium grade 4 (TiCP4) in accordance with ASTM F67,
UNS R50700.
Mechanical testing demonstrates that the proposed Titanium TomoFix™ Medial High Tibia Plate Anatomical is substantially equivalent in mechanical properties to the predicate device. The subject device was tested under static and dynamic loading conditions to demonstrate mechanical equivalence compared to the predicate device.
In conclusion, the indications, technological characteristics, and performance testing demonstrate substantial equivalence of the subject Titanium TomoFix™ Medial High Tibia Plate Anatomical. |
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