S.A.F. Acetabular Cup
by Synergy Orthopaedics Intl., Inc.
510(k) K895157
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK895157 | Date1 Dec 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KWA
- Device Class
- Class III
- Regulation
- 21 CFR Part 888.3330
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The S.A.F. Acetabular Cup is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component). It is designed as a metal acetabular component intended for use in total hip arthroplasty, providing a stable, uncemented fixation within the pelvic bone to restore hip function and mobility.
This device is supplied as a reusable surgical implant and is intended for use in orthopedic procedures. It is not sterilized for single-use and must be handled under sterile conditions during surgery. The device is classified as Class III under FDA regulations and has received FDA 510(k) clearance for substantial equivalence. Multiple model references are listed, ensuring compatibility with various surgical applications.
Other devices from Synergy Orthopaedics Intl., Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of hip procedures is the S.A.F. Acetabular Cup designed for, and how does it differ from cemented alternatives?
The S.A.F. Acetabular Cup is specifically designed for total hip arthroplasty procedures where a semi-constrained metal uncemented acetabular component is required. Unlike cemented alternatives, this device is intended for uncemented fixation, meaning it relies on bone ingrowth or osseointegration to stabilize within the pelvic bone over time. This approach eliminates the need for bone cement while providing a durable, stable foundation for hip function and mobility.
Is the S.A.F. Acetabular Cup reusable or single-use, and what precautions must be taken during surgery?
The S.A.F. Acetabular Cup is reusable and intended for surgical reuse under sterile conditions. Since it is not sterilized for single-use, it must be handled as a sterile implant during the procedure to prevent contamination. Proper sterilization protocols must be followed between uses, and the device should only be used in a controlled, sterile environment to maintain its integrity and safety.
How many model references are available for the S.A.F. Acetabular Cup, and why does this matter for surgeons?
The S.A.F. Acetabular Cup comes in multiple model references (listed under the provided FEI numbers), ensuring compatibility with a wide range of patient anatomies and surgical preferences. This variety allows surgeons to select the appropriate size, orientation, or design features to optimize fit, stability, and long-term outcomes for individual patients during total hip replacement procedures.
What regulatory pathway was followed for FDA clearance of the S.A.F. Acetabular Cup, and what does this mean for its use?
The S.A.F. Acetabular Cup received FDA 510(k) clearance through a Traditional review pathway, with a decision of Substantial Equivalence (SESE) by the Orthopedic (OR) Advisory Committee. This means the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for use as a metal uncemented acetabular component in total hip arthroplasty. The clearance confirms its compliance with Class III regulatory requirements.