Techmedica Mueller Type Polyethylene Acetabular Cup

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

Full name

Techmedica Mueller Type Polyethylene Acetbul Cup

510(k) Number

K925181 ↗

FDA Product Code

JDL

Device Class

Class III

Regulation

21 CFR Part 888.3320

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Techmedica Standard Cemented Hip System

  Class II

  FDA 510(k) K926387 Active Cleared 1 Feb 1994

• Continuum Knee System (Cks)

  Class II

  FDA 510(k) K914072 Active Cleared 18 Feb 1992

• Cks Oscillating Saw Blade

  Class I

  FDA 510(k) K921131 Active Cleared 8 Jun 1992

• Techmedia Bone Staple

  Class II

  FDA 510(k) K813567 Active Cleared 12 Jan 1982

• Patella Prosthesis

  Class II

  FDA 510(k) K840100 Active Cleared 9 Feb 1984

• Continuum Knee System

  Class II

  FDA 510(k) K920080 Active Cleared 1 Sep 1992

See all devices from Techmedica, Inc. →

• What types of surgical procedures is the Mueller Type Polyethylene Acetabular Cup designed for?

  The Mueller Type Polyethylene Acetabular Cup is specifically designed for use in total hip arthroplasty procedures. It is intended to replace the natural hip joint in patients suffering from degenerative joint disease or trauma, providing stability and mobility through articulation with femoral components. It is a semi-constrained, metal-cemented acetabular component.

• Is the Mueller Type Polyethylene Acetabular Cup intended for single-use or can it be reused?

  The Mueller Type Polyethylene Acetabular Cup is explicitly described as a reusable surgical implant. It is intended for use in sterile operating environments, meaning it can be sterilized and reused for multiple procedures, provided proper sterilization protocols are followed.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its safety and equivalence?

  The Mueller Type Polyethylene Acetabular Cup received FDA clearance through a 510(k) Traditional Review process, classified under product code JDL as a Class III device. The clearance was granted as substantially equivalent (SESE) to predicate devices, meaning the FDA determined that it has the same intended use and technological characteristics as legally marketed devices. This pathway ensures that the device meets safety and effectiveness standards comparable to existing, cleared alternatives.

• Are there any specific sizes or models available for this acetabular cup, and how would I identify them?

  The provided data lists multiple FEI numbers (e.g., 3020282716, 1000577893, etc.) associated with this device, which likely correspond to different sizes or variants of the Mueller Type Polyethylene Acetabular Cup. These identifiers are used in regulatory filings and may help distinguish specific models or configurations. For precise sizing details, you would need to consult the manufacturer’s catalog or technical documentation, as the data does not specify exact dimensions or model names.

• Does this device have any special considerations regarding MRI safety or compatibility?

  The regulatory data for the Mueller Type Polyethylene Acetabular Cup does not explicitly mention MRI safety or compatibility. If MRI imaging is required for patients with this implant, you would need to verify with the manufacturer or consult clinical guidelines, as metal components in hip prostheses can pose risks in magnetic fields. Always confirm compatibility before scheduling MRI procedures.