Sacroiliac Screw Placement Guide
The Sacroiliac Screw Placement Guide is a surgical instrument designed to assist surgeons in the accurate intraoperative placement of sacroiliac screws across the sacroiliac joint, using anatomical landmarks identifiable on preoperative imaging to guide proper screw trajectory. It improves the precision and safety of sacroiliac fixation procedures. Classified as FDA Class 2 under regulation 888.3040, it requires 510(k) clearance in the Orthopedic specialty. The device is not an implant and not life-sustaining.
Basic Information
- Product Code
- QSR
- Device Class
- FDA class 2
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
Definition
A sacroiliac screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of sacroiliac screws across the sacroiliac joint. The device utilizes anatomical landmarks that are identifiable on pre-operative imaging scans.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K220888 | MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides | May 24, 2022 | Substantially Equivalent | Medacta International S.A. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.