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510(k) K220888

MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides by Medacta International S.A. — Product Code QSR

K220888 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides". The FDA issued a decision of Substantially Equivalent on May 24, 2022. The device falls under product code QSR (Sacroiliac Screw Placement Guide), a Class II device regulated under 21 CFR 888.3040. Medacta International S.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2022
Date Received
March 28, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sacroiliac Screw Placement Guide
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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.

Other clearances by Medacta International S.A.

  • K261016 — MSS - Humeral reverse liners extension (June 10, 2026)
  • K254202 — MectaLIF 3D Metal Anterior (May 5, 2026)
  • K253940 — M.U.S.T. Pedicle Screw System - Extension (April 28, 2026)
  • K253328 — GMK 3D Metal Tibial Tray Extension (February 26, 2026)
  • K250644 — MSS - Monobloc stem (February 3, 2026)
  • K251043 — Mpact 3D Metal Implants Extension – DMLS Technology (January 28, 2026)
  • K252847 — NextAR Hip Platform (January 9, 2026)
  • K242603 — MyPAO SA guides (November 19, 2025)
  • K250338 — MSS - Humeral reverse liners extension (October 31, 2025)
  • K250450 — Coated hip implants (September 19, 2025)

FDA data resources