Prime E-CLASS XLPE Liner
510(k) K181598
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK181598 | Date14 Sep 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- Withdrawn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
- LZO
- FDA applicant
- Microport Orthopedics, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3353
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Prime E-Class XLPE Liner is a hip joint prosthesis, semi-constrained, metal/ceramic/polymer, designed for cemented or non-porous uncemented fixation. It features a cross-linked polyethylene (XLPE) liner intended to articulate with a femoral component, providing stability and durability in total hip arthroplasty procedures. This device falls under the regulatory classification of 21 CFR 888.3353, ensuring compliance with orthopedic implant standards.
The Prime E-Class XLPE Liner is supplied sterile and intended for single-use in surgical settings. It is classified as Class II under FDA regulations and holds a 510(k) clearance (K181598) for substantial equivalence in orthopedic applications. Storage and handling must adhere to sterile medical device protocols, and its dimensions are standardized for compatibility with approved femoral components. No additional regulatory markings beyond the FDA clearance are specified.
Other devices from MicroPort Orthopedics Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of hip procedures is the Prime E-Class XLPE Liner intended for, and how is it fixed in place?
The Prime E-Class XLPE Liner is designed for total hip arthroplasty procedures, specifically to articulate with a femoral component. It is available in configurations for either cemented fixation or non-porous uncemented fixation, providing flexibility depending on the patient’s clinical needs and surgeon preference. The semi-constrained design enhances stability during articulation.
Is the Prime E-Class XLPE Liner reusable, or is it meant for single-use only?
The Prime E-Class XLPE Liner is explicitly intended for single-use in surgical settings only. This aligns with standard sterile medical device protocols to ensure patient safety and prevent cross-contamination. Reuse is not recommended or supported by the manufacturer.
How should the Prime E-Class XLPE Liner be stored, and what sterility guarantees does it provide?
The liner is supplied sterile and must be stored according to sterile medical device protocols to maintain its integrity. Since it is intended for single-use, it should be kept in its original packaging until immediately before use, following the manufacturer’s instructions to preserve sterility and prevent contamination.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for compatibility?
The Prime E-Class XLPE Liner received FDA 510(k) clearance (K181598) under the traditional review pathway, with a decision of substantial equivalence (SESE) to a predicate device in orthopedic applications. This means it meets FDA standards for safety and effectiveness and is classified under 21 CFR 888.3353, ensuring compatibility with approved femoral components for total hip arthroplasty.