# K203673: MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)

- Pathway: 510(k) (Special)
- Applicant: Medacta International S.A.
- Decided: Apr 6, 2021 after 111 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: 17 generations back to K040583 (2004). 151 ancestors in all.
3 later devices descend from it; 3 cite it directly.
1 of 155 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200792: MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides, Medacta Inernational SA (2020) Summary page 6.
- K173472: MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments, Medacta International S.A. (2018) Summary page 6.
- K153273: MySpine Pedicle Screw Placement Guides - LP, Medacta International S.A. (2016) Summary page 6.
- K181883: FIREFLY® Midline Navigation Guide, Mighty Oak Medical, Inc. (2018) Summary page 6.
- K181399: FIREFLY® Pedicle Screw Navigation Guide, Mighty Oak Medical, Inc. (2018) Summary page 6.

## Most influential descendants
- 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 as a thoracic and lumbar posterior pedicle targeting guide for patients requiring spinal fusion between the levels of TI to L5. MySpine Screw Placement Guides are intended to be used as anatomical perforating guides specific for a single patient anatomy to assist intraoperatively in the positioning of pedicle screws in the vertebral body. MySpine is intended to be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its approved indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures intended for fusion. MySpine Low Profile screw placement guides are intended for the placement of K-wires to assist in the positioning of pedicle screws. Use of the guides involves 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 Screw placement guides are intended for single use only. Please see MySpine guides labeling for compatibility requirements between the MySpine guides and the 510(k) cleared pedicle screw system intended to be used. MySpine is intended to be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its approved indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures intended for fusion. MySpine Drill Pilot is intended as a thoracic and lumbar posterior pedicle targeting guide for patients requiring spinal fusion between the levels of TI to L5. 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 LI to Si. The device is provided with two options: o Drill based o 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. Please see MySpine guides labeling for compatibility requirements between the MySpine guides and the 510(k) cleared pedicle screw system intended to be used. MySpine S2-Alar/Alar-Iliac is intended to be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its approved indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures intended for fusion. 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 Si, 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. Please see MySpine S2-Alar/Alar-Iliac guides labeling 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/K203673
Methodology: https://510kreport.com/methodology