U2 Tibial Baseplate CMA Type, Tibial Insert and Augment
by United Orthopedic Corporation
510(k) K131864
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK131864 | Date15 Jan 2014 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JWH
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3560
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The U2 Tibial Baseplate CMA Type is a modular orthopedic implant designed for total knee arthroplasty, featuring a cemented or augmentable tibial component with a cruciate-retaining (CMA) insert. It is intended for use in primary or revision knee procedures to restore joint function and stability, accommodating varying degrees of tibial bone defects through optional augments. The system includes a fixed baseplate with a curved anterior post to minimize impingement and wear-related complications.
This device is supplied as a sterile, single-use implant and is regulated under FDA 510(k) clearance (K131864) as substantially equivalent to a predicate device. It is available in cemented or augmentable configurations, with augments addressing tibial bone defects, and is intended for use in orthopedic surgical settings. Storage and handling must comply with sterile medical device protocols, and compatibility with MRI is not specified in the regulatory submission.
From the manufacturer
A universal baseplate design allows for augments and a 30 mm extension stem to address tibial bone defects. Cemented tibial baseplate Augmentable tibial baseplate The curved anterior post and cam is designed to reduce potential for impingement, component failure and poly wear.
The U2 Knee™ System, designed by the UNITED ORTHOPEDIC CORPORATION (UOC), is a complete range of 1 st line treatment PTGs: Fixed and mobile CR, fixed and mobile PS and PSA revision with constrained insert. The fixed tibial baseplate is commonly used in fixed cruciate-retaining (U2 CMA™) and posterior stabilised (U2 PS™) fixed inserts.
PDF Une e U2 Knee -. The tibial baseplate is available for varying levels of bony defects and fixation preferences in the following options - cemented type, augmentable type and TPS PLUS type.
Other devices from United Orthopedic Corporation
Questions
AI-generated answers, 18 Sep 2026
What types of knee procedures is the U2 Tibial Baseplate CMA Type intended for, and how does it accommodate different bone conditions?
The U2 Tibial Baseplate CMA Type is designed for both primary and revision total knee arthroplasty procedures. It includes a cemented or augmentable tibial component with optional augments to address varying degrees of tibial bone defects, ensuring stability and proper joint function regardless of bone loss or structural compromise.
Is this device reusable, or is it meant for single-use only? How should it be stored to maintain sterility?
The U2 Tibial Baseplate CMA Type is sterile and intended for single-use only. To preserve sterility, it must be stored and handled according to standard sterile medical device protocols, as outlined in the manufacturer’s instructions. Improper storage could compromise its integrity.
What configurations are available for the tibial component, and how do they differ?
The device is available in two primary configurations: a cemented tibial baseplate for standard bone fixation and an augmentable version that includes optional augments to address tibial bone defects. The augmentable option allows surgeons to customize the implant to fit patients with varying bone loss or structural deficiencies.
Does this device have any specific compatibility considerations, such as MRI safety?
The regulatory submission for the U2 Tibial Baseplate CMA Type does not specify MRI compatibility. Clinicians should verify compatibility with their MRI equipment and protocols before use, as metal implants can interfere with imaging. Always follow the manufacturer’s guidelines for safe postoperative imaging.