P.T.H. Metal-Backed Acetabular Cup

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

510(k) Number

K870234 ↗

FDA Product Code

JDL

Device Class

Class III

Regulation

21 CFR Part 888.3320

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Femoral Hemi-Hip Prostheses

  Class II

  FDA 510(k) K855228 Active Cleared 11 Feb 1986

• Femoral Hemi-Hip Prosthesis

  Class II

  FDA 510(k) K862460 Active Cleared 6 Oct 1986

• Superfixation(Tm)

  Class II

  FDA 510(k) K863343 Active Cleared 15 Sep 1986

• What is the primary purpose of the PTH Metal-Backed Acetabular Cup in hip replacement surgery?

  The PTH Metal-Backed Acetabular Cup is designed as a metal-backed acetabular component for total hip arthroplasty. It provides structural reinforcement and stability to the acetabular cup during hip joint replacement, helping to restore hip function and mobility in patients suffering from degenerative joint disease or trauma. Its semi-constrained design ensures compatibility with femoral components for improved joint stability.

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

  The PTH Metal-Backed Acetabular Cup is explicitly supplied as a reusable medical device. It is intended for use in orthopedic surgical settings and must be handled and stored according to standard orthopedic implant protocols to maintain sterility and integrity before surgical application.

• What storage and handling precautions should be taken for this device?

  Since this device is reusable, it must be stored and handled following standard orthopedic implant protocols to preserve sterility and structural integrity. The manufacturer does not indicate any special storage conditions beyond typical medical device care, but it is critical to follow these guidelines to ensure the device remains safe and effective for subsequent surgeries.

• Are there any specific size or model variations available for this acetabular cup?

  The provided data lists multiple registration numbers (e.g., 3020282716, 1047843, etc.) under the product code JDL, which suggests there may be multiple sizes or models available for the PTH Metal-Backed Acetabular Cup. For precise sizing options, refer to the manufacturer’s catalog or technical documentation, as these details are not explicitly described in the provided data.

• Can this device be used in patients who require MRI scans after surgery?

  No, the PTH Metal-Backed Acetabular Cup is explicitly stated as not indicated for MRI use. Patients who require MRI imaging post-surgery should consult their healthcare provider for alternative imaging modalities or devices that are MRI-compatible.