Procotyl L-O Acetabular System
510(k) K142119
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK142119 | Date27 Feb 2015 | 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- Withdrawn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 L-O Acetabular System is a two-piece acetabular cup designed for total hip arthroplasty, providing modularity for shell fixation and bearing material options. It addresses contemporary challenges in acetabular reconstruction, including primary and revision procedures, with multiple liner configurations to accommodate diverse surgical needs.
This system is supplied as a sterile, single-use orthopedic implant intended for use in controlled surgical environments. It is regulated under FDA 510(k) clearance (K142119) and is classified under the traditional review pathway for orthopedic devices. The system includes various sizes and configurations to ensure compatibility with different patient anatomies and surgical approaches, adhering to strict manufacturing and sterility standards.
From the manufacturer
The intrinsic design features that address contemporary two-piece acetabular cup issues, coupled with multiple liner configurations, make the Procotyl® L acetabular cup system the choice for surgeons requiring a wide range of primary, revision and bearing material options. Not all products and options are available in all countries.
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.
Other devices from MicroPort Orthopedics Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of hip surgeries is the Procotyl L-O Acetabular System designed for, and how does its modularity help in those procedures?
The Procotyl L-O Acetabular System is specifically designed for total hip arthroplasty, including both primary and revision surgeries. Its modular two-piece design allows surgeons to select different shell fixation options and bearing materials, which helps address the varied anatomical challenges encountered in these procedures. This flexibility ensures better customization to patient-specific needs, improving outcomes in complex reconstructions.
Is the Procotyl L-O Acetabular System intended for reuse, or is it meant to be used only once per patient?
The Procotyl L-O Acetabular System is explicitly supplied as a single-use orthopedic implant. It is sterilized for surgical use in controlled environments and is not designed for reuse, adhering to standard orthopedic implant practices to ensure patient safety and sterility.
How many sizes and configurations are available for the Procotyl L-O Acetabular System, and why does this matter for surgeons?
While the exact number of sizes and configurations isn’t detailed here, the system is engineered to offer multiple sizes and liner options to match diverse patient anatomies and surgical approaches. This variety is critical for surgeons because it allows them to select the best-fit components for each patient, optimizing stability, fit, and long-term performance during hip replacement procedures.
What kind of sterility assurance does the Procotyl L-O Acetabular System provide, and how should it be stored before use?
The Procotyl L-O Acetabular System is sterile as supplied, meeting strict manufacturing standards for orthopedic implants. It should be stored in its original packaging under clean, dry conditions to maintain sterility until use. Proper storage ensures the device remains uncontaminated and ready for surgical application.
How was the FDA clearance for the Procotyl L-O Acetabular System determined, and what does the ‘traditional review pathway’ mean for this device?
The Procotyl L-O Acetabular System received FDA clearance under the traditional 510(k) review pathway, with a decision code of SESE (Substantially Equivalent in Safety and Effectiveness). This means the FDA determined it is comparable to a legally marketed predicate device in terms of technology and performance. The ‘traditional review’ indicates a thorough evaluation by the Orthopedic (OR) Advisory Committee before clearance.