# K200792: MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides

- Pathway: 510(k) (Traditional)
- Applicant: Medacta Inernational SA
- Decided: Oct 5, 2020 after 193 days
- Product code: PQC (Pedicle Screw Placement Guide)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K040583 (2004). 146 ancestors in all.
4 later devices descend from it; 3 cite it directly.
1 of 151 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173472: MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments, Medacta International S.A. (2018) Summary page 4.

## Most influential descendants
- K203673: MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides) (2021), 3 descendants of its own
- K220888: MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides (2022), 1 descendant of its own
- K231515: MySpine Cervical Guides (2023), 0 descendants of its own
- K231483: MySpine Unilateral Guides (2023), 0 descendants of its own

## Indications for use
MySpine S2-Alar/Alar-Iliac is intended for use with M.U.S.T. Pedicle Screw System and its cleared indications for use. MySpine S2-Alar/Alar-Iliac guides (referred to from this point on as, MySpine guides) are intended to be used as anatomical perforating guides, specific to a patient’s anatomy, to assist intra-operatively 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 surgical equipment selected. MySpine guides are intended for single use only.

Source page: https://510kreport.com/device/K200792
Methodology: https://510kreport.com/methodology