Prosthesis, Total Hip-Test Cup

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

510(k) Number

K760108 ↗

FDA Product Code

JDG

Device Class

Class II

Regulation

21 CFR Part 888.3360

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Wheelchair Muff

  Class I

  FDA 510(k) K780195 Active Cleared 9 Mar 1978

• Strap, Legrest

  Class I

  FDA 510(k) K780191 Active Cleared 14 Feb 1978

• Threaded Rod Clamp

  Class I

  FDA 510(k) K781447 Active Cleared 27 Sep 1978

• Wheelchair Accessories

  Class I

  FDA 510(k) K780184 Active Cleared 13 Feb 1978

• Cup, Acetabular, Long Posterior Wall

  Class II

  FDA 510(k) K780398 Active Cleared 21 Mar 1978

• Flat Wrench

  Class I

  FDA 510(k) K781451 Active Cleared 27 Sep 1978

See all devices from Orthopedic Equipment Co., Inc. →

• What is the primary purpose of the Prosthesis, Total Hip-Test Cup in surgical procedures?

  The Prosthesis, Total Hip-Test Cup is designed as a trial implant to evaluate the fit, stability, and function of a total hip replacement before permanent fixation. It allows surgeons to assess how the implant interacts with the patient’s anatomy during the procedure, ensuring optimal placement before committing to a permanent component.

• Is this device intended for single-use or can it be reused in multiple surgeries?

  The Prosthesis, Total Hip-Test Cup is explicitly described as a reusable orthopedic implant, meaning it is engineered for use in multiple surgical procedures within controlled environments. Reusability is common for test implants to reduce costs and waste while maintaining sterility protocols.

• What regulatory pathway was followed for FDA clearance of this device?

  This device received FDA 510(k) clearance (K760108) under the Traditional 510(k) review pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. It falls under Class II classification (FDA regulation 888.3360) and was reviewed by the Orthopedic (OR) Advisory Committee.

• Are there any specific storage requirements mentioned for this test cup?

  The provided data does not explicitly detail storage conditions (e.g., temperature, humidity, or packaging). However, as a reusable medical device, it should be stored in a clean, sterile, or sterilizable environment to prevent contamination before and after use. Standard orthopedic implant storage guidelines should be followed.

• How does this test cup differ from a permanent hip prosthesis?

  Unlike permanent hip prostheses, which are intended for long-term fixation, the Prosthesis, Total Hip-Test Cup is a temporary trial implant used intraoperatively to verify fit, stability, and function. Once the surgeon confirms optimal placement, it is typically removed, and a permanent component is implanted in its place.