510(k) · Cleared
ClearedMySpine Cervical Guides
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · QSD Posterior Cervical Screw Placement Guide
Cleared on Dec 7, 2023 as substantially equivalent to K220132 (Mighty Oak Medical, Inc., 2022) and 2 other predicates after a 196-day review. Its family tree reaches back 18 generations to 2004. 1 of the 160 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 7, 2023
- Review
- 196 days
- Class
- Class II
- Product code
- QSD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 18 generations to K040583 (2004). 159 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 160 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations between
- 3 generations backK162419 FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2016
- 2 generations backK181399 FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2018
- 1 generation backK203673 MySpine Pedicle Screw Placement Guides Extension (MySpine Low…Medacta International S.A. · 2021
- This deviceK231515 MySpine Cervical GuidesMedacta International S.A. · 2023
Show all 18 generations
- Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 17 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 15 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 14 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 13 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 12 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 11 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 10 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 9 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 8 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 7 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 6 generations backK121115 M.U.S.T Pedicle Screw SystemMedacta International · 2012 · Recalled
- 5 generations backK132788 Myspine Pedicle Screw Placement GuidesMedacta International · 2014
- 4 generations backK143222 FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2015
- 3 generations backK162419 FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2016
- 2 generations backK181399 FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2018
- 1 generation backK203673 MySpine Pedicle Screw Placement Guides Extension (MySpine Low…Medacta International S.A. · 2021
- This deviceK231515 MySpine Cervical GuidesMedacta International S.A. · 2023
Class I recalls in this family
- K100952 Modification to Synthes Matrix System4 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −17 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −16 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −15 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −14 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −13 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −12 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −11 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −10 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −9 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −8 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −7 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −6 | K121115 | M.U.S.T Pedicle Screw System | Medacta International | 2012 | 1 |
| −5 | K132788 | Myspine Pedicle Screw Placement Guides | Medacta International | 2014 | — |
| −4 | K143222 | FIREFLY Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2015 | — |
| −3 | K162419 | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2016 | — |
| −2 | K181399 | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2018 | — |
| −1 | K203673 | MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides… | Medacta International S.A. | 2021 | — |
| 0 (this device) | K231515 | MySpine Cervical Guides | Medacta International S.A. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 13 | 0 |
| 2001 | 11 | 0 |
| 2002 | 8 | 0 |
| 2003 | 13 | 0 |
| 2004 | 17 | 0 |
| 2005 | 13 | 0 |
| 2006 | 8 | 0 |
| 2007 | 6 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 1 |
| 2011 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QSD device
- #1 K220132 FIREFLY® Cervical Navigation Guidescore 8.4 · 5 generations · no Class I recall
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K220132 | FIREFLY® Cervical Navigation GuideSummary page 4…ication II III. Predicate Device Substantial equivalence is claimed to the following primary predicate device: FIREFLY Cervical Navigation Guide, K220132, Mighty Oak Medical Inc. Additionally, the following predicate devices are used within the submission: MySpine Pedicle… | 2022 |
| * | K203673 | MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Summary page 4…220132, Mighty Oak Medical Inc. Additionally, the following predicate devices are used within the submission: MySpine Pedicle Screw Placement Guides Extension, K203673, Medacta International SA MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments, K173472, Medacta… | 2021 |
| * | K173472 | MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsSummary page 4… MySpine Pedicle Screw Placement Guides Extension, K203673, Medacta International SA MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments, K173472, Medacta Interational SA IV. Device Description MySpine Cervical guides are patient specific devices intended to be… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 22 of the 159 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All QSD devicesQSD Posterior Cervical Screw Placement Guide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QSD
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QSD
Too few QSD 510(k)s in any year since 2007 to give a median.
Recalls per year · QSD
No recall names QSD since 2007.
Adverse event reports per year · QSD
No MAUDE report names QSD since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (174 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K231515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231515: MySpine Cervical Guides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231515
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026