Clx Acetabular Cup (Wagner) for Cementless Fixat.

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

510(k) Number

K870924 ↗

FDA Product Code

KWA

Device Class

Class III

Regulation

21 CFR Part 888.3330

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Samuelson Acetabular Cup

  Class III

  FDA 510(k) K872985 Active Cleared 1 Oct 1987

• Femoral Heads/Modular & Fixed W/ Titan Nitride Sur

  Class II

  FDA 510(k) K892059 Active Cleared 19 Jul 1989

• Day Staple

  Class II

  FDA 510(k) K853267 Active Cleared 6 Sep 1985

• New Jersey Femoral Hip Prosthesis for Cement Appli

  Class II

  FDA 510(k) K884789 Active Cleared 8 Feb 1989

• C.S.M. Hip

  Not classified

  FDA 510(k) K862752 Active Cleared 7 Aug 1986

• M.W.P. Wrist Prosthesis

  Class II

  FDA 510(k) K872502 Active Cleared 23 Jul 1987

See all devices from Protek, Inc. →

• What type of hip implant is the CLX Acetabular Cup (Wagner) designed for, and how does it differ from cemented alternatives?

  The CLX Acetabular Cup (Wagner) is a semi-constrained, metal uncemented acetabular component specifically designed for cementless hip arthroplasty. Unlike cemented alternatives, it is engineered to integrate directly with the host bone over time, eliminating the need for bone cement while providing a stable fixation interface in the pelvis. This design is intended to facilitate long-term bone integration, reducing the risk of loosening associated with cemented implants.

• Is the CLX Acetabular Cup reusable or single-use, and how should it be handled in the operating room?

  The CLX Acetabular Cup is reusable, meaning it is intended for multiple surgical uses under strict sterilization protocols. As a reusable orthopedic implant, it must be properly cleaned, inspected, and sterilized between cases to maintain safety and performance. This aligns with standard practices for high-value surgical implants in orthopedic procedures.

• What regulatory pathway was followed for FDA clearance of this device, and when was it originally approved?

  The CLX Acetabular Cup received FDA 510(k) clearance (K870924) under the Traditional 510(k) pathway in 1987, with a decision date of September 14, 1987. It was classified as Substantially Equivalent (SESE) to a predicate device and falls under FDA regulation 888.3330, which governs acetabular components for hip replacements. The device is categorized under the Orthopedic (OR) Advisory Committee and is listed as a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component).

• Are there multiple sizes or models available for the CLX Acetabular Cup, and how does this affect surgical planning?

  While the provided data does not specify exact sizes or models, the CLX Acetabular Cup is part of a registered product family with multiple FEI (Facility Establishment Identifier) and registration numbers, indicating variability in inventory or inventory tracking. Clinicians should confirm available sizes with the manufacturer or distributor during surgical planning to ensure compatibility with the patient’s anatomy and the intended procedure. This variability is typical for reusable orthopedic implants to accommodate different patient anatomies.