All Poly Tibial Component
by United Orthopedic Corporation
510(k) K152430
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK152430 | Date12 Apr 2016 | 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- Withdrawn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, 20 Sep 2026
The All Poly Tibial Component UC is a semi-constrained cemented knee prosthesis designed for total knee arthroplasty. It features a polyethylene tibial component intended to articulate with femoral components, providing stability and load-bearing support in the patellofemoral and tibiofemoral joints. Constructed from polymer/metal/polymer materials, it is classified under the Orthopedic Prosthesis, Knee category with a semi-constrained design. The component is engineered for cemented fixation, ensuring secure integration with the tibia.
This device is supplied as a single-use, sterile implant intended for use in orthopedic surgical settings. It is available in multiple articular selections, including CR (congruent), PS (posterior-stabilized), and UC (uncemented femoral options, though the tibial component itself is cemented). The tibial baseplate includes size pairing options ('one up/one down') to accommodate varying anatomical requirements. Regulated under FDA 510(k) clearance (K152430), it adheres to traditional review pathways and is distributed for use in total knee replacement procedures.
From the manufacturer
Tibial baseplate "one up / one down" size pairing for UC insert ... APT All Poly Tibial Component Durable, lower cost, elimination of backside wear, and designed for easier removal if necessary[2,3]. Multiple articular selections: CR, PS, UC.
United Orthopedic Corporation is a leading international designer, manufacturer, and distributor of orthopedic implant solutions that have made life better for hundreds of thousands of people needing total hip and knee replacements.
Other devices from United Orthopedic Corporation
Questions
AI-generated answers, 20 Sep 2026
What types of knee replacement surgeries is the All Poly Tibial Component designed to support, and how does its design accommodate different patient anatomies?
The All Poly Tibial Component is designed for total knee arthroplasty, specifically to provide stability and load-bearing support in both the patellofemoral and tibiofemoral joints. Its semi-constrained design ensures secure articulation with femoral components, while the tibial baseplate includes size pairing options labeled 'one up/one down' to adapt to varying anatomical requirements. This flexibility allows surgeons to select the appropriate fit for individual patients during surgery.
Is this device reusable, or is it intended for single-use only? How does this affect its sterility and surgical workflow?
The All Poly Tibial Component is explicitly supplied as a single-use, sterile implant. This design ensures sterility is maintained for each surgical procedure, reducing the risk of cross-contamination and simplifying surgical workflows by eliminating the need for sterilization between uses. Single-use also aligns with best practices for orthopedic implants to minimize infection risks.
What articular selections are available for the All Poly Tibial Component, and how do they differ in function?
The All Poly Tibial Component is available in three articular selections: CR (congruent), PS (posterior-stabilized), and UC (though the tibial component itself remains cemented). The CR selection provides a natural rolling-gliding motion, while the PS selection includes an integrated posterior stabilizer to enhance stability for patients with ligament insufficiency. These options allow surgeons to tailor the implant to the specific biomechanical needs of the patient’s knee.
How is the All Poly Tibial Component fixed to the tibia, and what materials does it use to ensure durability?
The All Poly Tibial Component is designed for cemented fixation, meaning it is secured to the tibia using orthopedic cement during surgery. This method ensures a stable and long-lasting bond. The component itself is constructed from polymer/metal/polymer materials, combining durability with the necessary articulation properties for knee function.
What regulatory pathway was followed for FDA clearance of this device, and how does this affect its distribution?
The All Poly Tibial Component received FDA clearance through the 510(k) pathway, specifically under the Traditional review process with a decision code of SESE (Substantially Equivalent). This means the manufacturer demonstrated that the device is substantially equivalent to a legally marketed predicate device. The clearance was granted on April 12, 2016, and the device is distributed for use in total knee replacement procedures as part of orthopedic surgical settings.