PROCOTYL PRIME E-CLASS XLPE Liner

No FDA recalls found in the data synced 25 Oct 2026.

510(k) Number

K171181 ↗

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

• Procotyl® P Trial Shell 72

  Class IIa

  CE/MDR

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  Class IIa

  CE/MDR

• Anterior Single Offset Broach Handle

  Class I

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• Trial Liner Rim-Lock Standard Procotyl® L / O 32 Group E

  Class IIa

  CE/MDR

• Trial Acetabular Cup Procotyl® L / O Size 68 Gr G

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  CE/MDR

• Procotyl® P Add-on Trial Liner 15DG Lip 36 Group E

  Class IIa

  CE/MDR

See all devices from MicroPort Orthopedics Inc. →

• What types of fixation methods are compatible with the Procotyl Prime E-Class XLPE Liner, and how does this affect its use in surgery?

  The Procotyl Prime E-Class XLPE Liner is designed for use with either cemented or nonporous uncemented fixation in total hip arthroplasty. This flexibility allows surgeons to choose the fixation method that best suits the patient’s clinical needs, bone quality, and surgical approach. The liner’s semi-constrained design complements both techniques, ensuring stability and articulation within the hip joint.

• Is the Procotyl Prime E-Class XLPE Liner intended for reuse in the operating room, or is it meant to be used only once?

  The Procotyl Prime E-Class XLPE Liner is explicitly supplied as a sterile, single-use component for orthopedic surgeons. This design ensures patient safety and sterility standards are maintained, as reuse could compromise integrity and introduce infection risks. It is intended for one-time use per patient during surgery.

• What materials are used in the Procotyl Prime E-Class XLPE Liner, and how does the cross-linked polyethylene (XLPE) benefit the device?

  The liner features cross-linked polyethylene (XLPE), a high-performance polymer designed to improve articulation and durability within the hip joint. XLPE enhances wear resistance compared to conventional polyethylene, reducing friction and the risk of liner degradation over time. This contributes to longer-lasting performance in total hip arthroplasty systems.

• How should the Procotyl Prime E-Class XLPE Liner be stored before use in the operating room?

  While specific storage instructions aren’t detailed in the provided data, the liner is supplied as a sterile component for OR use. Standard practices for orthopedic implants—such as keeping it in its original packaging, protected from moisture, extreme temperatures, and physical damage—should be followed. Always refer to the manufacturer’s included instructions for storage to maintain sterility and functionality.

• What regulatory pathway was followed for FDA clearance of the Procotyl Prime E-Class XLPE Liner, and what does this mean for its use in clinical settings?

  The device received FDA 510(k) clearance (K171181) under the Traditional pathway, classified as a Class II medical device and reviewed by the Orthopedic (OR) Advisory Committee. This means the manufacturer demonstrated it is substantially equivalent to a legally marketed predicate device, meeting FDA standards for safety and effectiveness. Clinicians can rely on this clearance as evidence of regulatory scrutiny before clinical use.