Trident All Poly Cup
by Howmedica Osteonics Corp. 2 variants
510(k) K001956
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK001956 | Date11 Dec 2000 | 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- Withdrawn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
- JDI
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3350
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Trident All Poly Cup is a polyethylene acetabular component designed for primary or revision total hip arthroplasty. It is intended for cemented fixation within the acetabulum and is paired with femoral heads for hip joint reconstruction. Constructed from Crossfire™ Ultra High Molecular Weight Polyethylene (UHMWPE), this component features a radiographic marker made of tantalum, replacing the original cobalt chromium alloy.
This device is supplied as a single-use orthopedic implant and is regulated under FDA 510(k) clearance (K001956) with a traditional review pathway. It is intended for use in sterile surgical settings and must be handled according to standard orthopedic implant protocols. The component is categorized under product code JDI and is part of the Orthopedic advisory committee’s review process. No additional regulatory status beyond the stated FDA clearance is implied.
Other devices from Howmedica Osteonics Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Trident All Poly Cup used for?
The Trident All Poly Cup is designed specifically for primary or revision total hip arthroplasty. It serves as the acetabular component, which is cemented into the pelvis to provide a stable socket for the femoral head during hip joint reconstruction. Its polyethylene construction and design make it suitable for these surgical procedures where durable, long-lasting acetabular fixation is required.
Is the Trident All Poly Cup single-use or reusable?
The Trident All Poly Cup is intended for single-use only. As an orthopedic implant, it is not designed to be sterilized or reused after a single surgical procedure. This aligns with standard medical device practices to ensure patient safety and sterility in sterile surgical settings.
What material is the Trident All Poly Cup made from?
The Trident All Poly Cup is constructed from Crossfire™ Ultra High Molecular Weight Polyethylene (UHMWPE). This material is chosen for its durability and biocompatibility in orthopedic applications. Additionally, it features a radiographic marker made of tantalum, which replaces the original cobalt chromium alloy, improving visibility during postoperative imaging.
How is the Trident All Poly Cup supplied and handled?
The Trident All Poly Cup is supplied as a sterile orthopedic implant, intended for use in sterile surgical environments. It must be handled according to standard orthopedic implant protocols to maintain sterility and ensure proper surgical technique. The component is not meant to be reprocessed or reused, reinforcing the importance of adhering to single-use guidelines.
What regulatory pathway does the Trident All Poly Cup follow?
The Trident All Poly Cup is regulated under the FDA 510(k) clearance pathway with a traditional review process. It was cleared under the product code JDI and falls under the Orthopedic advisory committee’s review process. The clearance number assigned is K001956, and it is classified as substantially equivalent to a predicate device.