S-ROM Poly-Dial Constrained Acetabular Liner
by Depuy, A Johnson & Johnson Co.
PMA P960054
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP960054 | Date19 Jun 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- S-Rom Poly-Dial Constrained Liner
- Generic Name
- Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
- PMA Number
- FDA Product Code
- KWZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3310
- Advisory Committee
- Orthopedic
- FDA Decision
- APRL
Overview
AI-generated summary, 18 Sep 2026
The S-ROM Poly-Dial Constrained Acetabular Liner is a Prosthesis, hip, constrained, cemented or uncemented, metal/polymer, designed to reduce dislocation risk in total hip arthroplasty. It functions as a high-fixation component within a constrained acetabular system, providing stability for patients at elevated risk of instability due to prior dislocation, bone loss, or neuromuscular conditions.
This device is supplied as a single-use component for use in primary or revision total hip replacement procedures. It is intended for intraoperative placement as part of a constrained acetabular assembly and requires sterile handling. Approved under FDA_PMA (P960054), it adheres to orthopedic regulatory standards for hip prostheses and is categorized under Product Code KWZ for administrative classification.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the S-ROM Poly-Dial Constrained Acetabular Liner in total hip replacement procedures?
The S-ROM Poly-Dial Constrained Acetabular Liner is designed specifically to reduce the risk of hip dislocation in patients undergoing total hip arthroplasty. It is intended for use in high-risk patients, such as those with a history of prior dislocations, bone loss, joint laxity, neuromuscular conditions, or intraoperative instability. By functioning as a high-fixation component within a constrained acetabular system, it provides enhanced stability to the hip joint.
Is the S-ROM Poly-Dial Constrained Acetabular Liner meant for use in both primary and revision surgeries?
Yes, the device is approved for use in both primary and revision total hip replacement procedures. Its design addresses instability concerns common in these cases, particularly for patients at elevated risk of dislocation due to factors like bone loss or neuromuscular conditions.
How is the S-ROM Poly-Dial Constrained Acetabular Liner supplied, and what are the handling requirements?
The S-ROM Poly-Dial Constrained Acetabular Liner is supplied as a single-use component, meaning it is intended for one-time intraoperative use only. Due to its sterile nature, it requires careful sterile handling during surgery to maintain integrity and prevent contamination.
What materials are used in the construction of the S-ROM Poly-Dial Constrained Acetabular Liner?
The device is constructed from metal and polymer materials, combining both for durability and stability in constrained hip arthroplasty. This composition is typical for acetabular liners designed to withstand the mechanical demands of the hip joint while reducing dislocation risk.
How is the regulatory approval status of this device determined, and what does it cover?
The S-ROM Poly-Dial Constrained Acetabular Liner received FDA approval through a Premarket Approval (PMA) application, specifically under PMA number P960054. This approval covers its use as a component of a total hip prosthesis in patients at high risk of dislocation due to specific clinical factors like prior dislocations, bone loss, or neuromuscular conditions. The approval process ensures the device meets stringent safety and effectiveness standards for orthopedic implants.