# K173472: MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Apr 19, 2018 after 161 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: 15 generations back to K040583 (2004). 145 ancestors in all.
5 later devices descend from it; 4 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)
- K153273: MySpine Pedicle Screw Placement Guides - LP, Medacta International S.A. (2016) Summary page 4.
- K132788: Myspine Pedicle Screw Placement Guides, Medacta International (2014) Summary page 4.

## Most influential descendants
- K200792: MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides (2020), 4 descendants of its own
- 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 is intended for use with M.U.S.T Pedicle Screw System and its cleared indications for use. MySpine Drill Pilot is intended as a thoracic and lumbar posterior pedicle targeting guide for patients requiring spinal fusion between the levels of T1 to LS. The device is intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body. MySpine MC is intended as a lumbar and sacral posterior pedicle targeting guide for patients requiring spinal fusion between the levels of L1 to S1. The device is provided with two options: * Drill based * K-wire based MySpine MC drill based are intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body. MySpine MC k-wire based are intended for the placement of K-wires to assist in the positioning of pedicle screws in the vertebral body. Use of the guides involves a surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of patient radiological images with identifiable placement anatomical landmarks and surgical equipment components. These components include patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. MySpine MC and Drill Pilot guides are intended for single use only.

Source page: https://510kreport.com/device/K173472
Methodology: https://510kreport.com/methodology