Prime Acetabular Cup System
510(k) K180798
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK180798 | Date9 Jul 2018 | 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- Withdrawn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
- LPH
- FDA applicant
- Microport Orthopedics, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3358
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Prime Acetabular Cup System is a medical device classified as an acetabular orthopedic prosthesis, designed for use in total hip arthroplasty. It provides a structural component for the acetabulum, facilitating the articulation of the femoral head within the hip joint. The system is engineered to support various surgical approaches and is optimized for a highly cross-linked ultra-high molecular weight polyethylene bearing surface.
This device is intended for surgical use in orthopedic procedures, supplied sterile for single-use. It is regulated under the FDA’s 510(k) pathway, with clearance under the Traditional review process and classified under product code LPH. The system is intended for use in orthopedic settings and requires adherence to standard surgical protocols for implantation, including proper sterilization and handling procedures.
From the manufacturer
The Prime acetabular cup system is designed with simple, versatile instrumentation to support a variety of surgical approaches, including the following modern, soft tissue-sparing MicroPort surgical philosophies.
The Prime acetabular cup system is the fifth generation of MicroPort Orthopedics' acetabular cup systems and is the next step in the evolution of the successful Dynasty® acetabular cup aystem.