S-ROM ZT HA Proximal Femoral Sleeve

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

510(k) Number

K912713 ↗

FDA Product Code

MEH

Device Class

Class II

Regulation

21 CFR Part 888.3353

Advisory Committee

Orthopedic

FDA Decision

SN

• S-ROM Total Hip Replacement System

  Class II

  FDA 510(k) K920739 Active Cleared 24 Nov 1992

• S-ROM ZTT Acetabular Cup-Apical Hole Plug

  Class III

  FDA 510(k) K931676 Active Cleared 18 May 1994

• 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

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• What is the S-ROM ZT HA Proximal Femoral Sleeve used for?

  The S-ROM ZT HA Proximal Femoral Sleeve is designed as a semi-constrained, uncemented hip prosthesis to provide structural support and stability to the proximal femur during hip arthroplasty. It interfaces with the femoral component to distribute load and improve joint function, particularly in orthopedic surgeries where uncemented fixation is preferred.

• Is the S-ROM ZT HA Proximal Femoral Sleeve sterile and single-use?

  Yes, the device is supplied sterile and intended for single-use only. This ensures patient safety by preventing cross-contamination and maintains the integrity of the prosthesis during surgical procedures.

• What material is the S-ROM ZT HA Proximal Femoral Sleeve made from?

  The sleeve is constructed from metal and polymer materials, specifically designed as a non-porous device. This combination provides the necessary strength and durability for load-bearing applications in hip arthroplasty.

• How should the S-ROM ZT HA Proximal Femoral Sleeve be stored?

  The sleeve must be stored according to sterile medical device protocols to preserve its sterility and functionality. Follow the manufacturer’s guidelines for handling and storage to ensure it remains uncontaminated and ready for surgical use.

• What regulatory clearance does the S-ROM ZT HA Proximal Femoral Sleeve have?

  The device holds FDA 510(k) clearance under the classification of Prosthesis, Hip, Semi-constrained, Uncemented, Metal/Polymer, Non-porous. The clearance number is K912713, and it was reviewed by the Orthopedic (OR) Advisory Committee.