# K132788: Myspine Pedicle Screw Placement Guides

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International
- Decided: May 23, 2014 after 259 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- 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: 13 generations back to K040583 (2004). 143 ancestors in all.
12 later devices descend from it; 3 cite it directly.
1 of 156 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121115: M.U.S.T Pedicle Screw System, Medacta International (2012) Summary page 1.

## Most influential descendants
- K143222: FIREFLY Pedicle Screw Navigation Guide (2015), 8 descendants of its own
- K162419: FIREFLY® Pedicle Screw Navigation Guide (2016), 7 descendants of its own
- K153273: MySpine Pedicle Screw Placement Guides - LP (2016), 6 descendants of its own
- K181399: FIREFLY® Pedicle Screw Navigation Guide (2018), 5 descendants of its own
- K173472: MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments (2018), 5 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 T1 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 for use with M.U.S.T Pedicle Screw System and its cleared indications for use. 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.

Source page: https://510kreport.com/device/K132788
Methodology: https://510kreport.com/methodology