U2 Total Knee System Additional Sizes
by United Orthopedic Corporation
510(k) K150829
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK150829 | Date25 Sep 2015 | 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- Withdrawn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 Total Knee System Additional Sizes is a Total Knee Prosthesis (FDA Product Code: JWH), designed as an extension to a previously cleared knee replacement system. It features modular femoral and tibial components with consistent condylar curvature and intercondylar width, enabling full interchangeability between components. This system is intended for use in primary and revision total knee arthroplasty procedures, offering multiple fixed-bearing insert options to accommodate varying patient anatomy.
The device is supplied as a sterile, single-use orthopedic implant system, intended for use in controlled surgical environments. It includes additional sizing options to expand the range of available implants, ensuring compatibility with a broader range of patient morphologies. Regulatory clearance was granted under the FDA’s 510(k) pathway (K150829) as substantially equivalent to a predicate device, with no third-party review involved. Storage and handling must adhere to standard orthopedic implant protocols to maintain sterility and functionality.
From the manufacturer
The U2 Knee is a comprehensive Total Knee Replacement (TKR) system offering a full range of interchangeable primary and revision options. With time tested implant design and award-winning instrument solutions, the U2 Knee offers a complete TKR platform.
PDF Comprehensive Total Knee System -. Consistency in U2 Knee System Consistent condylar curvature and intercondylar width allows full interchangeability between femoral and tibial components.
PDF Une e U2 Knee -. The U2 Knee system provides full interchangeability and multiple fixed-bearing insert options. In addition to the commonly used CR and PS type inserts, U2 Knee system offers ultracongruent insert options, in order to offer more extensive choices for broader patient morphological demands.
Manufacturer's product page: Total Knee Replacement
Other devices from United Orthopedic Corporation
Questions
AI-generated answers, 18 Sep 2026
What types of knee replacement surgeries is the U2 Total Knee System- Additional Sizes intended for?
The U2 Total Knee System- Additional Sizes is designed for both primary and revision total knee arthroplasty procedures. Its modular components and expanded sizing options help accommodate a wider range of patient anatomies, ensuring flexibility for surgeons during complex or standard knee replacements.
How is the U2 Total Knee System- Additional Sizes supplied, and is it reusable?
The system is supplied as a sterile, single-use orthopedic implant. It is intended for one-time surgical use only, adhering to standard orthopedic implant protocols to preserve sterility and functionality. Reuse is not recommended or supported by the manufacturer.
What makes the modular design of this knee system beneficial for surgeons?
The modular femoral and tibial components feature consistent condylar curvature and intercondylar width, allowing full interchangeability between parts. This design flexibility enables surgeons to tailor the implant to the patient’s anatomy more precisely, improving fit and outcomes for a broader range of patients.
Are there multiple bearing options available with this system, and why does that matter?
Yes, the U2 Total Knee System- Additional Sizes offers multiple fixed-bearing insert options. This variety accommodates varying patient anatomies and surgical preferences, allowing clinicians to select the most appropriate bearing surface for stability, durability, and long-term joint function.
How should the U2 Total Knee System- Additional Sizes be stored to maintain its integrity?
Storage must follow standard orthopedic implant protocols to ensure sterility and functionality. Since it is sterile upon packaging, it should remain unopened until use and protected from contamination, moisture, or physical damage in a controlled surgical environment.