S-ROM ZTT Acetabular Cup-Apical Hole Plug

No FDA recalls on record, checked 22 Oct 2026.

Full name

S-Rom(R) Ztt(Tm) Acetabular Cup-Apical Hole Plug

510(k) Number

K931676 ↗

FDA Product Code

JDL

Device Class

Class III

Regulation

21 CFR Part 888.3320

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• S-ROM Total Hip Replacement System

  Class II

  FDA 510(k) K920739 Active Cleared 24 Nov 1992

• S-Rom Femoral Hip Stem - Size 14 X 8

  Class II

  FDA 510(k) K954935 Active Cleared 22 Jan 1996

• Knee Prothesis

  Class II

  FDA 510(k) K941769 Active Cleared 1 Feb 1995

• Src Total Knee

  Not classified

  FDA 510(k) K841022 Active Cleared 25 Jun 1984

• S-Rom Opc (One-Piece Cemented) II Femoral Hip Prosthesis

  Class II

  FDA 510(k) K951084 Active Cleared 31 May 1995

• S-Rom 135 Femoral Stem & Collar(Part of S-Rom Hip

  Class II

  FDA 510(k) K851422 Active Cleared 18 Sep 1985

See all devices from Joint Medical Products Corp. →

• What is the primary purpose of the S-ROM ZTT Acetabular Cup-Apical Hole Plug in a hip replacement procedure?

  The S-ROM ZTT Acetabular Cup-Apical Hole Plug is designed as a component of a two-part hip replacement system. It is implanted within the acetabulum (hip socket) to restore hip joint function, providing structural support and stability when secured with bone cement. It is part of a semi-constrained metal hip prosthesis, ensuring compatibility with other system components.

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

  The S-ROM ZTT Acetabular Cup-Apical Hole Plug is explicitly described as a reusable medical implant. However, like all reusable implants, it must be sterilized and handled according to strict sterile medical device protocols before each use to prevent contamination and ensure patient safety.

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

  Since this device is implanted directly into the body, it must be stored and handled as a sterile medical implant. Proper sterile packaging and adherence to sterile medical device protocols are required to maintain its integrity before use. The manufacturer’s instructions for sterilization and storage should be followed to ensure safety and functionality.

• Are there multiple sizes or models available for this device?

  The provided data lists multiple FEI numbers (e.g., 3020282716, 1047843, etc.), which typically correspond to different sizes, models, or variants of the device. While the exact dimensions or specifications are not detailed here, these identifiers suggest that the S-ROM ZTT Acetabular Cup-Apical Hole Plug may be available in various configurations to accommodate different patient anatomies or surgical needs.

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

  No, the S-ROM ZTT Acetabular Cup-Apical Hole Plug is explicitly not intended for MRI use. Patients implanted with this device should avoid MRI procedures, as metal components may pose risks such as heating, artifacts, or injury during scanning.