Implex Modular Elliptical Porous Acetabular Cup, Model XX-2YY-ZZZZ

No FDA recalls found in the data synced 22 Oct 2026.

Full name

The Implex Modular Elliptical Porous Acetabular Cup, Model Xx-2YY-Zzzz

510(k) Number

K992409 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Implex Corp. →

• What is the Implex Modular Elliptical Porous Acetabular Cup XX-2YY-ZZZZ used for?

  This device is designed for total hip arthroplasty in cases of severe hip joint degeneration, trauma, or other pathologies requiring joint replacement. Its elliptical shape and porous surface enhance osseointegration, allowing it to bond with surrounding bone for stable fixation. It is suitable for cemented, cementless, or hybrid fixation methods, depending on clinical needs.

• Is the Implex Modular Elliptical Porous Acetabular Cup XX-2YY-ZZZZ sterile upon receipt?

  No, the device is not sterile at the time of shipment. It must be sterilized prior to use in accordance with the manufacturer’s instructions to ensure safety and efficacy in the operating room.

• How is the Implex Modular Elliptical Porous Acetabular Cup XX-2YY-ZZZZ supplied and what sizes are available?

  The device is supplied as a reusable surgical implant for orthopedic use. Sizes are determined by the model-specific reference code XX-2YY-ZZZZ, which indicates the exact dimensions and configuration available for clinical application.

• Can the Implex Modular Elliptical Porous Acetabular Cup XX-2YY-ZZZZ be used with MRI?

  No, this device is MRI unsafe. Careful handling and proper imaging protocols must be followed to avoid interference or damage to the implant during or after surgery.

• What regulatory clearance does the Implex Modular Elliptical Porous Acetabular Cup XX-2YY-ZZZZ hold?

  The device holds FDA 510(k) clearance under the Orthopedic Advisory Committee, with clearance number K992409. This classification confirms it is substantially equivalent to a legally marketed predicate device for its intended use in total hip arthroplasty.