# K220888: MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: May 24, 2022 after 57 days
- Product code: QSR (Sacroiliac Screw Placement Guide)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K040583 (2004). 152 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 154 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203673: MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides), Medacta International S.A. (2021) Summary page 4.
- K200792: MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides, Medacta Inernational SA (2020) Summary page 4.

## Most influential descendants
- K231483: MySpine Unilateral Guides (2023), 0 descendants of its own

## Indications for use
MySpine S2-Alar/Alar-Iliac and MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides are intended to be used with any 510(k) cleared, legally marketed, pedicle screw system (for its approved indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures intended for fusion. The SI trajectory of the MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guide is only intended to be used with M.U.S.T. SI Headless Screw System and its cleared indications for use. The MySpine S2-Alar/Alar-Iliac and MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides (hereinafter referred to as “MySpine guides”) are intended to be used as anatomical perforating guides, specific to a patient’s anatomy, to assist intraoperatively in the preparation of the screw trajectory in S1, S2 and in the Ilium. The guides are created using a surgical planning software which pre-operatively plans the positions of the components based upon radiological images of the patients’ anatomical landmarks and the selected surgical equipment. The MySpine guides are intended for single use only. Please see MySpine guides labelling for compatibility requirements between the MySpine guides and the 510(k) cleared pedicle screw system intended to be used.

Source page: https://510kreport.com/device/K220888
Methodology: https://510kreport.com/methodology