510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K220888Substantially Equivalent

MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides

Medacta International SA, Castel San Pietro (Ch), CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K220888 is the FDA 510(k) clearance record for MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides, a class II device, cleared for Medacta International S.A. on under FDA product code QSR (Sacroiliac Screw Placement Guide). FDA's definition for product code QSR reads: "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...". FDA records list 205 510(k) clearances for Medacta International S.A., from to . As of , FDA records show no recalls naming K220888.

Clearance record

Decision date
Received
(57 days to decision)
Product code
QSR Sacroiliac Screw Placement Guide
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Medacta International S.A. Strada Regina, Castel San Pietro (Ch), CH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QSR

Trailing 12 months

FDA records hold no clearances under product code QSR in the trailing twelve months.

FDA records show no clearances under product code QSR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QSR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260