Mercury Spinal System
510(k) K172967
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK172967 | Date10 Apr 2018 | 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- Withdrawn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
- NKB
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Mercury Spinal System is a posterior thoracolumbar spinal fixation device classified under the FDA’s orthopedic product code NKB. It consists of a 5.5mm titanium rod-based system with cannulated and non-cannulated multi-axial pedicle screws designed to stabilize and correct spinal deformities in the thoracolumbar and sacral regions.
This system is intended for use in skeletally mature patients as an adjunct to spinal fusion procedures. It is supplied as a reusable surgical instrument set paired with sterile implants, with no specific MRI safety restrictions noted. The system’s modular design allows for integration with other Spinal Elements fixation systems, such as the Overwatch or Lotus connectors, to extend fixation levels. Authorized under FDA 510(k) clearance (K172967), it adheres to traditional review standards for orthopedic spinal devices.
Other devices from Spinal Elements, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of spinal conditions is the Mercury® Spinal System designed to address in the operating room?
The Mercury® Spinal System is intended for use as an adjunct to spinal fusion procedures in skeletally mature patients to stabilize and correct spinal deformities specifically in the thoracolumbar and sacral regions. It is not designed for primary treatment of spinal conditions but rather to provide additional fixation support during surgery.
Is the Mercury® Spinal System reusable or single-use, and how is it supplied to the operating room?
The Mercury® Spinal System is supplied as a reusable surgical instrument set paired with sterile implants. This means the instruments can be reused after proper cleaning and sterilization, while the implants themselves are sterile and intended for single-use during surgery.
What materials is the Mercury® Spinal System made of, and does it have any special considerations for imaging?
The Mercury® Spinal System is made primarily of titanium, specifically a 5.5mm titanium rod-based system. There are no specific MRI safety restrictions mentioned, so it can be used in patients who require MRI imaging post-surgery, though standard MRI safety protocols should still be followed.
Can the Mercury® Spinal System be combined with other Spinal Elements fixation systems, and if so, how?
Yes, the Mercury® Spinal System features a modular design that allows it to integrate with other Spinal Elements fixation systems, such as the Overwatch or Lotus connectors. This modularity enables surgeons to extend fixation levels and customize the system to meet specific patient needs during spinal fusion procedures.
What is the regulatory pathway for the Mercury® Spinal System, and who should a buyer contact for more information?
The Mercury® Spinal System has received FDA clearance through a 510(k) submission (K172967) under traditional review standards for orthopedic spinal devices. For inquiries, buyers or clinicians can contact Spinal Elements, Inc. at the address provided: 3115 Melrose Dr. Suite 200, Carlsbad, CA 92010, or reach out to Julie Lamothe for further details.