Ultracongruent Insert
by United Orthopedic Corporation
510(k) K132752
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK132752 | Date13 Mar 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- Withdrawn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 Ultracongruent Insert is a semi-constrained, cemented knee prosthesis designed for patellofemoral articulation. Constructed from a polymer/metal/polymer combination, it is intended for use in total knee replacement procedures to restore joint function and congruency.
This device is supplied sterile and intended for single-use. It is classified under FDA product code JWH and has received FDA 510(k) clearance as substantially equivalent. The insert is compatible for use in standard knee arthroplasty settings and adheres to regulatory standards for orthopedic implants.
Other devices from United Orthopedic Corporation
Questions
AI-generated answers, 18 Sep 2026
What type of knee replacement procedure is the Ultracongruent Insert designed for, and how does its semi-constrained design benefit the patient?
The Ultracongruent Insert is specifically designed for total knee replacement procedures, focusing on restoring patellofemoral articulation—the connection between the kneecap and the thigh bone. Its semi-constrained design provides stability by limiting excessive movement while still allowing natural joint motion, which can help reduce wear on the implant and improve long-term durability compared to fully constrained options.
Is the Ultracongruent Insert reusable, or is it meant for single-use only? How does this affect its clinical use?
The Ultracongruent Insert is explicitly intended for single-use only, as stated in the manufacturer’s specifications. This design choice aligns with modern orthopedic best practices to minimize infection risks and ensure sterility, as each insert is supplied sterile and not intended for reprocessing or reuse in multiple procedures.
What materials is the Ultracongruent Insert made from, and how does this combination influence its performance in knee arthroplasty?
The Ultracongruent Insert is constructed from a polymer/metal/polymer combination, which balances durability and articulation. The outer polymer layer reduces friction against the femoral component, while the metal core provides structural integrity, and the inner polymer layer ensures smooth patellofemoral contact—critical for restoring natural knee movement and longevity in total knee replacements.
How should the Ultracongruent Insert be stored, and are there any specific handling instructions to maintain its sterility?
Since the Ultracongruent Insert is supplied sterile, it should be stored in its original, sealed packaging until ready for use. The manufacturer recommends keeping it in a clean, dry environment away from direct sunlight or extreme temperatures to preserve sterility and integrity. Always follow the included sterile barrier packaging instructions to avoid contamination before implantation.