(267 days)
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
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
I am sorry, but the provided text does not contain information about the acceptance criteria and study proving a device meets those criteria, as typically found in a medical device submission beyond a 510(k) summary. The document appears to be a 510(k) clearance letter and summary for a bone plate, focusing on substantial equivalence to a predicate device.
The 510(k) Summary for the "Titanium TomoFix™ Medial High Tibia Plate Anatomical" primarily addresses the substantial equivalence documentation, which involves comparing a new device to a legally marketed predicate device rather than establishing performance against specific acceptance criteria for a novel or de novo device.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This document does not present quantitative performance metrics against predefined acceptance criteria for clinical or algorithmic performance. It discusses mechanical testing for equivalence.
- Sample size used for the test set and the data provenance: Not applicable to this type of submission, which relies on mechanical testing for equivalence, not a clinical test set of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not established in this document.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is for a physical orthopedic implant, not an AI/imaging device requiring reader studies.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable. The "ground truth" here is mechanical equivalence demonstrated through testing against the predicate.
- The sample size for the training set: Not applicable to a physical implant.
- How the ground truth for the training set was established: Not applicable.
What the document does state regarding performance and equivalence:
- Acceptance Criteria & Performance (Implied for Equivalence): The document states that "Mechanical testing demonstrates substantial equivalence of the subject device to the predicate device." And "The subject device was tested under static and dynamic loading conditions to demonstrate mechanical equivalence compared to the predicate device." While specific numerical acceptance criteria (e.g., "must withstand X N of force") and reported performance values are not tabulated, the implicit acceptance criterion is that its mechanical performance is demonstrably equivalent to the predicate.
- The product is a "Titanium TomoFix™ Medial High Tibia Plate Anatomical," a bone plate used for osteotomies and fracture fixation. This is a physical orthopedic implant, not an AI/software device.
- The study referenced is mechanical testing (static and dynamic loading conditions) to demonstrate equivalence to the predicate device, not a study involving human readers or clinical data interpretation.
- Predicate Device: Titanium TomoFix™ Medial High Tibia Plate (cleared via K023941).
- Reference Device: TomoFix™ Medial High Tibia Plate, Small (cleared via K100676).
Therefore, this document does not contain the information requested, as it pertains to a different type of device submission (a 510(k) for substantial equivalence of a physical implant) than what your query implies (likely a software or AI/ML medical device).
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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 SynthesStephan Jepards1301 Goshen ParkwayWest Chester, PA 19380Office: +41 32 720 41 59 |
|---|---|
| ProprietaryName: | Titanium TomoFix™ Medial High Tibia Plate Anatomical (to be included within theSynthes TomoFix™ Osteotomy System) |
| Devicecommon name | Bone plate |
| Classification: | Classification: Class IIRegulation Number: 21 CRF §888.3030Product Code: HRS |
| ClassificationName | Single/multiple component metallic bone fixation appliances and accessories. |
| PredicateDevice | Titanium TomoFix™ Medial High Tibia Plateinitially cleared via K023941 |
| Referencedevice | TomoFix™ Medial High Tibia Plate, Small,initially cleared via K100676 |
| DeviceDescription: | The subject Titanium TomoFix™ Medial High Tibia Plate Anatomical is anatomicallyprecontoured 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 tibiain the left and right knee, respectively. The plate features seven round, threadedlocking 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 LockingScrews, 4.5 mm Cortex Screws and 5.0 mm Spacers |
| Indications forUse: | The TOMOFIX™ Medial High Tibia Plates are indicated for open- and closed-wedgeosteotomies, fixation of fractures, and malalignment caused by injury or disease of themedial proximal tibia for the treatment of:Unicompartmental medial or lateral gonarthrosis withmalalignment of the proximal tibia Idiopathic or posttraumatic varus or valgus deformity of theproximal tibia |
| Comparison toPredicate | The subject device and the predicate are identical with respect to indications andintended use.The subject Titanium TomoFix™ Medial High Tibia Plate Anatomical featureequivalent characteristics as the predicate devices. Specifically, identicaltechnological 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. |
| SubstantialEquivalence: | The subject Titanium TomoFix™ Medial High Tibia Plate Anatomical has identicalindications compared to the predicate device. The features of the subject device aresubstantially equivalent to the predicate device based on the similarities in intendeduse and design. Mechanical testing demonstrates substantial equivalence of thesubject 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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§ 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.