Tibial Baseplate, Tibial Insert
by United Orthopedic Corporation
510(k) K222700
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK222700 | Date6 Oct 2022 | 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- Withdrawn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 Tibial Baseplate and Tibial Insert are orthopedic components designed for total knee arthroplasty, providing a stable platform for the tibial side of the knee joint. The baseplate is engineered to accommodate augments and extension stems (20 mm, 45 mm, 70 mm, and 95 mm) to address tibial bone defects, ensuring proper alignment and load distribution during knee replacement procedures.
These components are supplied as part of a modular knee system, intended for surgical use in orthopedic settings. The tibial baseplate features a highly mirror-polished surface beneath the insert to minimize backside wear and enable rotational movement of the insert in internal-external directions. The device is classified under FDA product code JWH (Regulation 888.3560) and holds a Special 510(k) clearance for substantial equivalence in orthopedic applications.
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.
Augmentable baseplate design allows for augments and 20, 45, 70, 95 mm extension stems to address tibial bone defects. A highly mirror-polished tibial baseplate surface underneath the tibial insert is designed to reduce backside wear and allow the insert to rotate in an internal-external direction.
Other devices from United Orthopedic Corporation
Questions
AI-generated answers, 18 Sep 2026
What types of knee bone defects can the Tibial Baseplate from United Orthopedic Corporation address during a total knee replacement?
The Tibial Baseplate is designed to accommodate tibial bone defects through modular augments and extension stems in lengths of 20 mm, 45 mm, 70 mm, and 95 mm. These components help restore proper alignment and distribute load evenly across the knee joint, ensuring stability during knee arthroplasty.
How is the Tibial Insert from United Orthopedic Corporation intended to function within the knee joint, and what benefits does its design provide?
The Tibial Insert is engineered to sit atop the Tibial Baseplate, which has a highly mirror-polished surface beneath it. This design minimizes backside wear and allows the insert to rotate internally and externally, improving flexibility and reducing friction in the knee joint during movement.
Are the Tibial Baseplate and Tibial Insert components part of a larger system, and how are they supplied for surgical use?
Yes, these components are supplied as part of a modular knee system designed specifically for total knee arthroplasty. They are intended for surgical use in orthopedic settings, where surgeons can customize the fit based on patient anatomy and bone defects.
What regulatory pathway was followed for the Tibial Baseplate and Tibial Insert, and what does this mean for its use in clinical settings?
The Tibial Baseplate and Tibial Insert received a Special 510(k) clearance under the FDA’s substantial equivalence determination (decision code SESE) for orthopedic applications. This means the device was reviewed by the Orthopedic (OR) Advisory Committee and deemed substantially equivalent to a legally marketed predicate device, allowing its use in clinical settings for total knee arthroplasty.