# K231515: MySpine Cervical Guides

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Dec 7, 2023 after 196 days
- Product code: QSD (Posterior Cervical Screw Placement Guide)
- Device class: 2
- Regulation: 21 CFR 888.3075
- 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). 159 ancestors in all.
No later device cites it as a predicate yet.
1 of 160 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220132: FIREFLY® Cervical Navigation Guide, Mighty Oak Medical, Inc. (2022) Summary page 4.
- 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.
- K173472: MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments, Medacta International S.A. (2018) Summary page 4.

## Indications for use
MySpine Cervical is intended to be used with any 510(k) cleared, legally marketed, posterior cervical screw system (for its cleared indications for use) and its respective compatible components for cervical posterior spinal fixation procedures intended for fusion. MySpine Cervical guides are patient specific devices intended to be used as anatomical perforating guides, specific to a single patient’s anatomy, to assist intra-operatively in the positioning of screws during posterior cervical fixation surgery between the levels of C2 to C7. For pedicle diameters equal or less than ø4mm, Medacta provides the guides for the pilot hole preparation into the lateral mass without penetrating the pedicle. The use of the guides involves a surgical planning software, with which the surgeon preoperatively plans the surgical placement of the implants based upon the radiological images of the patients’ anatomical landmarks and the selected surgical equipment. These components include patient-specific guides fabricated based on the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. MySpine Cervical guides are intended for single use only.

Source page: https://510kreport.com/device/K231515
Methodology: https://510kreport.com/methodology