Buttress Washer System
by Reliance Medical Systems, LLC
510(k) K073349
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK073349 | Date13 Feb 2008 | 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- Withdrawn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
- Full name
- Reliance Buttress Washer System
- 510(k) Number
- FDA Product Code
- KWQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3060
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Buttress Washer System is a spinal fixation device classified as an orthopedic implant under product code KWQ. It is designed to stabilize bone grafts at a single vertebral level (T1–S1) during spinal fusion procedures, providing temporary structural support while facilitating the formation of a solid fusion mass. Constructed from compatible materials, it may be used independently or in conjunction with other anterior, anterolateral, or posterior spinal systems.
This system is supplied in a non-sterile configuration and is intended for single-use. It is regulated under FDA 510(k) clearance (K073349) and is not intended for load-bearing applications. The device is available in specific model versions, such as 8-01-020, and must be handled and stored according to manufacturer guidelines to maintain integrity prior to surgical use.
Other devices from Reliance Medical Systems, LLC
Questions
AI-generated answers, 1 Oct 2026
What is the Reliance Buttress Washer System used for?
This device is designed to stabilize bone grafts at a single vertebral level (ranging from T1 to S1) during spinal fusion surgeries. It offers temporary structural support to help form a solid fusion mass while the bone heals, but it is not intended for load-bearing applications. It can be used independently or alongside other spinal fixation systems.
How is the Buttress Washer System supplied and prepared for use?
The system is supplied in a non-sterile configuration, meaning it requires sterilization by the surgical facility prior to use. It is intended for single-use only, so each unit must be sterilized separately for one surgical procedure. Follow the manufacturer’s guidelines for proper handling and sterilization to ensure device integrity.
What models are available for the Reliance Buttress Washer System?
The system is available in specific model versions, such as the 8-01-020. These models are designed to fit different anatomical requirements during spinal fusion procedures. Always verify the correct model for your surgical plan and confirm compatibility with your existing spinal fixation systems.
How should the Buttress Washer System be stored before use?
The device must be stored according to the manufacturer’s guidelines to maintain its integrity before surgical use. Since it is non-sterile and single-use, it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Ensure packaging remains intact until sterilization.
Is the Reliance Buttress Washer System reusable?
No, the Buttress Washer System is explicitly intended for single-use only. Reusing the device could compromise its structural integrity and compromise patient safety. Each unit must be discarded after one surgical procedure, even if it appears unused.