PROCOTYL PRIME Acetabular Cup System
510(k) K170444
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK170444 | Date26 Jun 2017 | 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- Withdrawn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, 18 Sep 2026
The Procotyl Prime Acetabular Cup System is a Hip Prosthesis, Acetabular Component (FDA LPH classification) designed for use in total hip arthroplasty. It features a highly cross-linked ultra-high molecular weight polyethylene bearing surface, providing durable articulation within the acetabular cavity to restore hip function and mobility.
This system is supplied as a sterile, single-use orthopedic implant intended for surgical use in accredited orthopedic facilities. It is available in various sizes to accommodate different patient anatomies and fixation methods, including press-fit and cemented options. The device holds FDA 510(k) clearance (K170444) and is regulated under the Orthopedic Advisory Committee (OR) for traditional 510(k) review.
From the manufacturer
MicroPort Orthopedics offers a variety of acetabular cup systems designed to meet the needs of any total hip arthroplasty approach or surgeon preference. Providing unsurpassed surgical flexibility for shell fixation and bearing material choices, our various acetabular cup systems have 25 years of market history.
The Prime acetabular cup system is the next step in the evolution of the successful Dynasty® acetabular cup system. The system is optimized for a highly cross-linked ultra-high molecular weight polyethylene bearing surface, eliminating the compromises associated with modularity to accommodate alternative bearing surfaces.
Other devices from MicroPort Orthopedics Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of fixation methods are included in the Procotyl Prime Acetabular Cup System, and how does this affect its versatility in surgery?
The Procotyl Prime Acetabular Cup System is designed with flexibility in mind, offering both press-fit and cemented fixation options. This dual-method approach allows surgeons to choose the most appropriate technique based on patient-specific factors like bone quality, anatomy, and clinical needs. Press-fit options rely on the natural seating of the cup within the acetabulum, while cemented options provide additional stability for cases where bone integrity may be compromised.
Is the Procotyl Prime Acetabular Cup System intended for reuse, or is it meant to be used only once per patient?
The Procotyl Prime Acetabular Cup System is explicitly labeled as sterile and single-use, meaning it is intended for one-time surgical use per patient. This design ensures patient safety by minimizing the risk of infection or contamination associated with reprocessing or reuse, which is critical in orthopedic implants.
How does the bearing surface of the Procotyl Prime Acetabular Cup System contribute to its long-term performance in total hip arthroplasty?
The system features a highly cross-linked ultra-high molecular weight polyethylene (UHMWPE) bearing surface, which is engineered to reduce wear and friction during articulation. This material choice is intended to enhance durability, lower the risk of particulate debris, and improve long-term joint function and mobility for patients undergoing total hip arthroplasty.
What sizes are available for the Procotyl Prime Acetabular Cup System, and how does this accommodate different patient anatomies?
While the exact sizing details are not specified in the provided data, the system is described as available in various sizes to match different patient anatomies. This modularity allows surgeons to select the appropriate cup size for optimal fit, stability, and alignment during total hip arthroplasty, ensuring better outcomes tailored to individual patients.