Prosthesis, Double Cup (K780052)
by Depuy, Inc.
510(k) K780052
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK780052 | Date20 Jan 1978 | 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- Withdrawn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
- Full name
- Prosthesis, Double Cup
- 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
This device is a Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, as classified under FDA product code JDI. It is designed as an orthopedic implant intended for hip replacement surgery, featuring a dual-cup configuration to provide stability and articulation within the hip joint. Constructed from metal and polymer materials, it is cemented into place for secure fixation during implantation. The semi-constrained design allows for controlled movement while maintaining joint stability.
The Prosthesis, Double Cup (K780052) is supplied as a sterile, single-use implant intended for surgical use in orthopedic procedures. It is regulated under FDA 510(k) clearance (K780052) with a Substantially Equivalent (SESE) determination, classified as a Class II device under special controls. Storage and handling must comply with sterile medical device protocols to ensure integrity prior to surgical implantation. No additional regulatory markings beyond the FDA clearance appear in the device specifications.
Other devices from Depuy, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Prosthesis, Double Cup (K780052) used for?
This device is designed as a semi-constrained hip prosthesis for use in total hip arthroplasty (replacement surgery). The dual-cup configuration provides enhanced stability while allowing controlled movement, making it suitable for patients requiring secure articulation within the hip joint. The metal/polymer construction and cemented fixation ensure durable placement during implantation.
How is the Prosthesis, Double Cup (K780052) supplied and prepared for use?
The prosthesis is supplied as a sterile, single-use implant, meaning it is intended for one surgical procedure only. It must be handled according to sterile medical device protocols to maintain its integrity before implantation. The sterile packaging ensures readiness for surgical use without additional preparation beyond standard orthopedic sterilization procedures.
Is the Prosthesis, Double Cup (K780052) reusable or single-use?
This device is explicitly classified as single-use. Due to its sterile packaging and design for cemented fixation, reuse is not recommended or supported by the manufacturer. Single-use ensures patient safety and compliance with medical device regulations, preventing cross-contamination or degradation of material integrity.
What materials are used in the construction of the Prosthesis, Double Cup (K780052)?
The prosthesis combines metal and polymer materials for its construction. The specific combination is tailored to provide durability, stability, and biocompatibility within the hip joint. The metal components offer structural integrity, while the polymer components contribute to smooth articulation and load distribution during movement.
How should the Prosthesis, Double Cup (K780052) be stored before use?
Storage must adhere to sterile medical device protocols to preserve the device’s integrity. The packaging should remain unopened until immediately before use, and the prosthesis should be stored in a clean, dry environment protected from physical damage or contamination. Follow manufacturer guidelines for temperature and humidity control if applicable, though no specific storage conditions are detailed beyond standard sterile device handling.