Freeman Acetabular Cup

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

510(k) Number

K852699 ↗

FDA Product Code

KWA

Device Class

Class III

Regulation

21 CFR Part 888.3330

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Freeman Hip

  Class II

  FDA 510(k) K852839 Active Cleared 29 Oct 1985

• Total Hip Femoral Component

  Class II

  FDA 510(k) K840150 Active Cleared 27 Feb 1984

• Mark I Total Knee Sys. Arthroplasty

  Class II

  FDA 510(k) K832302 Active Cleared 16 Aug 1983

• Yasargil Fenestrated Aneurysm Clip &

  Class II

  FDA 510(k) K833652 Active Cleared 27 Jan 1984

• PM Cementless Screw-In Acetabular Cup

  Class III

  FDA 510(k) K850773 Active Cleared 2 May 1985

• Cls Hip Prosthesis

  Class II

  FDA 510(k) K852517 Active Cleared 18 Sep 1985

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• What types of hip surgeries is the Freeman Acetabular Cup designed for, and how does its semi-constrained design benefit patients?

  The Freeman Acetabular Cup is specifically designed for total hip arthroplasty (replacement surgery) to replace a damaged or diseased acetabulum. Its semi-constrained metal construction provides a stable bearing surface for the femoral head, which helps reduce dislocation risk while allowing some flexibility for natural hip movement. This design is particularly useful in cases where additional stability is needed without sacrificing full range of motion.

• Is the Freeman Acetabular Cup reusable or single-use, and what does that mean for surgical planning?

  The Freeman Acetabular Cup is supplied as a reusable surgical implant, meaning it is intended for multiple uses after proper sterilization and cleaning between procedures. This allows hospitals to optimize inventory while ensuring consistent performance across surgeries. However, reuse requires adherence to strict sterilization protocols to maintain safety and functionality.

• How many sizes and variants of the Freeman Acetabular Cup are available, and how do I determine the correct size for a patient?

  The Freeman Acetabular Cup comes in multiple sizes and variants, as indicated by the listed registration numbers (e.g., 8043792, 3020282716, etc.). The correct size is determined by preoperative imaging and measurements of the patient’s acetabulum, typically by an orthopedic surgeon or surgical planner. The manufacturer’s sizing guides or surgical planning software should be consulted to match the patient’s anatomy with the appropriate cup variant.

• What regulatory pathway was followed for FDA clearance of the Freeman Acetabular Cup, and what does that mean for clinicians?

  The Freeman Acetabular Cup received FDA 510(k) clearance under the Traditional pathway, with a decision of *Substantially Equivalent* (SESE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets safety and effectiveness standards. Clinicians can rely on this clearance as evidence of regulatory scrutiny, though individual surgical decisions should still follow evidence-based protocols.

• How should the Freeman Acetabular Cup be stored to maintain its integrity before use?

  Since the Freeman Acetabular Cup is a reusable implant, it must be stored in a clean, dry, and protected environment to prevent contamination or damage. Sterilization packaging (e.g., peel pouches or trays) should be used when not in active use, and storage should comply with hospital infection control protocols. Always follow the manufacturer’s instructions for cleaning, sterilization, and storage to ensure longevity and safety.