ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K201259
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK201259 | Date8 Jan 2021 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HRS
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The OrthoLoc 2 with 3Di Technology Pilon Fracture Plating System is a bone fixation plate designed for the internal stabilization of complex intra- and extra-articular fractures, osteotomies, and non-unions. It features a polyaxial locking mechanism with titanium nitride-coated heads and a proprietary plate hole design, enabling off-axis screw placement up to 15° in any direction and allowing screws to be relocked up to three times.
This system is supplied as a reusable surgical implant and is intended for use in orthopedic procedures under sterile conditions. Available in 2.7 mm and 3.5 mm diameters, it adheres to FDA 510(k) clearance (K201259) under the classification of Plate, Fixation, Bone (Medical). The device is regulated under 888.3030 and is manufactured by Wright Medical Technology, Inc.
Other devices from Wrightmedicaltechnologyinc
Questions
AI-generated answers, 19 Sep 2026
What types of fractures and bone conditions is the OrthoLoc 2 with 3Di Technology system specifically designed to stabilize internally?
The OrthoLoc 2 with 3Di Technology Pilon Fracture Plating System is designed for internal stabilization of complex intra-articular and extra-articular fractures, osteotomies, and non-unions. Its polyaxial locking mechanism and proprietary plate design allow for flexible screw placement, making it suitable for challenging cases where precise alignment is critical.
Is the OrthoLoc 2 system reusable or single-use, and how should it be handled to maintain sterility?
The OrthoLoc 2 system is reusable and intended for use in sterile surgical conditions. Since it is not single-use, proper cleaning, sterilization, and handling protocols must be followed to ensure sterility between procedures, as it is designed for repeated orthopedic applications.
What screw diameters are available for the OrthoLoc 2 system, and how does the polyaxial locking feature benefit the surgeon?
The system is available with screws in 2.7 mm and 3.5 mm diameters, allowing surgeons to select the appropriate size for the patient’s anatomy. The polyaxial locking mechanism enables off-axis screw placement up to 15° in any direction, improving flexibility in fracture reduction and fixation while also allowing screws to be relocked up to three times for enhanced stability.
How is the OrthoLoc 2 system regulated in the U.S., and what does the FDA clearance indicate about its intended use?
The OrthoLoc 2 system holds FDA 510(k) clearance (K201259) under the classification of *Plate, Fixation, Bone (Medical)* (product code HRS). This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device, meaning it meets regulatory standards for bone fixation plates used in orthopedic procedures. The approval does not specify clinical indications but confirms compliance with safety and performance requirements for its intended surgical applications.