S.A.F. Acetabular Cup with Porous Coating
by Synergy Orthopaedics Intl., Inc.
510(k) K896614
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK896614 | Date9 Jan 1990 | 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- Withdrawn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
- JDL
- Device Class
- Class III
- Regulation
- 21 CFR Part 888.3320
- Advisory Committee
- Orthopedic
- FDA Decision
- SN
Overview
AI-generated summary, 18 Sep 2026
The S.A.F. Acetabular Cup with Porous Coating is a Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component). It is designed as a metal acetabular cup intended for use in total hip arthroplasty, providing a stable, porous-coated surface to enhance osseointegration and long-term fixation with the femoral component.
This device is supplied sterile and intended for single-use in orthopedic surgical settings. It is classified as a Class III medical device under FDA regulations (regulation number 888.3320) and has received FDA 510(k) clearance (K896614) under the Traditional 510(k) review pathway. Multiple registration numbers (e.g., 8043792, 2242737) correspond to its various model variants, all of which adhere to orthopedic surgical standards for hip replacement procedures.
Other devices from Synergy Orthopaedics Intl., Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of hip replacement surgeries is the S.A.F. Acetabular Cup designed for, and how does its porous coating contribute to its function?
The S.A.F. Acetabular Cup is specifically designed for use in total hip arthroplasty procedures, serving as a metal acetabular component that pairs with a femoral prosthesis. Its porous coating enhances osseointegration—meaning it promotes the growth of bone into the cup’s surface—which improves stability and long-term fixation with the femoral component, reducing the risk of loosening over time.
Is the S.A.F. Acetabular Cup reusable or intended for single-use, and how should it be stored to maintain sterility?
The S.A.F. Acetabular Cup is supplied sterile and intended for single-use only in orthopedic surgical settings. To preserve sterility, it should be stored in its original packaging, away from direct sunlight, extreme temperatures, and moisture, following the manufacturer’s instructions for shelf life and handling.
What regulatory pathway was followed for FDA clearance of this device, and how does that affect its use in clinical practice?
The S.A.F. Acetabular Cup received FDA clearance through the Traditional 510(k) review pathway, which means it was determined to be *substantially equivalent* to a legally marketed predicate device. This clearance allows it to be legally marketed and used in clinical practice for its intended purpose—total hip arthroplasty—as long as it adheres to the approved specifications and labeling.
Does this device come in multiple sizes or models, and how would a surgeon determine the appropriate fit for a patient?
Yes, the S.A.F. Acetabular Cup is available in multiple sizes and models, as indicated by its various registration numbers (e.g., 8043792, 2242737). The correct size is determined preoperatively through imaging and measurements of the patient’s acetabulum, ensuring proper fit, stability, and alignment during total hip replacement surgery.