Device Information:
The Trigon HA Stand-Alone Wedge Fixation System consists of PEEK Optima HA Enhanced wedges with tantalum markers. The wedges are designed to provide angular correction of small bones in the foot and include two screw-receiving holes, surface teeth, and an area for grafting material. Available in various shapes (rectangular, kidney, circular, oval, and teardrop) and sizes, the wedges come with 2.5mm diameter titanium screws that range in length from 10 to 30mm. Ancillary fixation is required for some applications.
Indications:
The device is intended for internal bone fixation for bone fractures or osteotomies in the foot and ankle, such as:
- Cotton (opening wedge) Osteotomies of the Medial Cuneiform
- Evans Lengthening Osteotomies
- Subtalar Fusion
- First Metatarsal-Cuneiform Lengthening Arthrodesis
- Calcaneocuboid Arthrodesis
- Z-Calcaneal Lengthening Osteotomies
- MTP Lengthening Arthrodesis
Intended Use:
The device is intended for use by orthopedic surgeons to stabilize fractures or perform osteotomies in the foot and ankle. It is not designed for use in the spine.
Availability:
Prescription use only.
Contraindications:
None mentioned in the 510k document.
Limitations:
None mentioned in the 510k document.
Study Results:
- Clinical Testing: No clinical testing results are provided in the 510k document.
- Nonclinical and Safety Testing: This system underwent engineering analysis, comparing materials, processes (including cleaning and sterilization), and intended use. The comparison demonstrated safety and substantial equivalence to the predicate devices.
Regulatory Information:
- Regulation Number: 21 CFR 888.3030
- Regulatory Class: Class II
- Product Codes: PLF, HWC, HRS
- 510(k) Number: K234116
The device is subject to the Quality System (QS) regulations, which include design controls, corrective and preventive actions, and compliance with labeling and adverse event reporting regulations.
Manufacturer Information:
- Name: Nvision Biomedical Technologies, Inc.
- Address: 4590 Lockhill Selma, San Antonio, TX 78249, USA
- Contact Person: Analaura Villarreal-Berain (Engineering Project Manager)
Predicate Device Information:
- Primary Predicate Device: Trigon HA Stand-Alone Wedge Fixation System (K220197)
- Additional Predicate Device: Trigon HA Stand-Alone Wedge Fixation System (K193414)
- Reference Predicate Device: Nvision’s nva, nvp, nvt (K193645)
The current device maintains the same intended use and performance as the predicate devices, with configuration modifications for different foot procedures. Compared to the predicate devices, no new safety or efficacy concerns were raised.
Implications:
This System offers surgeons flexibility in treating bone fractures and performing osteotomies in the foot and ankle. It supports stable fixation and allows for angular correction with ancillary fixation, which may improve patient outcomes.
References:
- Trigon HA Stand-Alone Wedge Fixation System. 510(k) Number K234116. FDA Summary: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K234116
- https://nvisionbiomed.com/
Medevx 