Reflection Acetabular Component
by Smith & Nephew Richards, Inc. 510(k)
Active
510(k) K932755
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK932755 | Date6 May 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LPH
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3358
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Reflection Acetabular Component is an orthopedic device used in hip joint replacement procedures. It is designed to replace the acetabular socket in the pelvis during primary or revision hip arthroplasty.
This device is supplied as a single-use implant and is indicated for use in patients undergoing hip surgery where prior treatments have failed due to trauma or degenerative joint disease. It is authorized under FDA 510(k) clearance K932755 and is intended for use with compatible femoral stems such as the Synergy or Spectron EF systems.
Other devices from Smith & Nephew Richards, Inc.
Questions
AI-generated answers, 21 Sep 2026
What is the Reflection Acetabular Component used for?
The Reflection Acetabular Component is used to replace the acetabular socket in the pelvis during hip joint replacement procedures, indicated for patients undergoing primary or revision hip arthroplasty when prior treatments have failed due to trauma or degenerative joint disease.
Is the Reflection Acetabular Component supplied as a single-use or reusable device?
The Reflection Acetabular Component is supplied as a single-use implant, meaning it is intended for one-time use during surgery and should not be reprocessed or reused after implantation to ensure patient safety and device integrity.
Which femoral stem systems is the Reflection Acetabular Component compatible with?
The Reflection Acetabular Component is intended for use with compatible femoral stems such as the Synergy or Spectron EF systems, as specified in its labeling, to ensure proper articulation and biomechanical function in hip replacement procedures.