510(k) · Cleared
ClearedMyspine Pedicle Screw Placement Guides
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International · MNI Orthosis, Spinal Pedicle Fixation
Cleared on May 23, 2014 as substantially equivalent to K121115 (Medacta International, 2012) after a 259-day review. Its family tree reaches back 13 generations to 2004. 1 of the 156 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it.
- Decided
- May 23, 2014
- Review
- 259 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K040583 (2004). 143 ancestors in all, the oldest K781443 (1978). 12 later devices descend from it, 3 citing it directly. 1 of the 156 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations between
- 3 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 2 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 1 generation backK121115 M.U.S.T Pedicle Screw SystemMedacta International · 2012 · Recalled
- This deviceK132788 Myspine Pedicle Screw Placement GuidesMedacta International · 2014
- Descendant · cites it directly · 8 of its ownK143222 FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2015
- Descendant · 2 generations on · 7 of its ownK162419 FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2016
- Descendant · cites it directly · 6 of its ownK153273 MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016
- Descendant · 3 generations on · 5 of its ownK181399 FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2018
- Descendant · cites it directly · 5 of its ownK173472 MySpine Pedicle Screw Placement Guides – MC and Drill Pilot…Medacta International S.A. · 2018
Show all 13 generations
- Root · 13 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 10 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 9 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 8 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 7 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 6 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 5 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 4 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 3 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 2 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 1 generation backK121115 M.U.S.T Pedicle Screw SystemMedacta International · 2012 · Recalled
- This deviceK132788 Myspine Pedicle Screw Placement GuidesMedacta International · 2014
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K100952 Modification to Synthes Matrix System2 generations back · 2010
Most influential descendants
Showing 5 of 12 · See all- K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2015 · cites it directly8descendants
- K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2016 · 2 generations on7descendants
- K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016 · cites it directly6descendants
- K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2018 · 3 generations on5descendants
- K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A. · 2018 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −12 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −11 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −10 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −9 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −8 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −7 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −6 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −5 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −4 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −3 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −2 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −1 | K121115 | M.U.S.T Pedicle Screw System | Medacta International | 2012 | 1 |
| 0 (this device) | K132788 | Myspine Pedicle Screw Placement Guides | Medacta International | 2014 | — |
| +1 | K143222 | FIREFLY Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2015 | — |
| +2 | K162419 | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2016 | — |
| +1 | K153273 | MySpine Pedicle Screw Placement Guides - LP | Medacta International S.A. | 2016 | — |
| +3 | K181399 | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2018 | — |
| +1 | K173472 | MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments | Medacta International S.A. | 2018 | — |
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 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 13 | 0 |
| 2001 | 11 | 0 |
| 2002 | 7 | 0 |
| 2003 | 13 | 0 |
| 2004 | 17 | 0 |
| 2005 | 13 | 0 |
| 2006 | 8 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 1 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2026 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K121115 | M.U.S.T Pedicle Screw SystemSummary page 1…t Guides Common Name: Pedicle Screw Placement Guide Classification Name: orthosis, spinal pedicie fixation 21 CFR 888.3070 Class 11 Product Code: MVNI Predicate Device: K121115 MU.ST pedicle screw system, Medacta International… | 2012 |
| † | K093806 | Myknee Cutting Blocks | 2010 |
What descends from it? (12)
See all 123 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 4 months on median.
- 22 of the 143 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K143222 (Mighty Oak Medical, Inc., 2015) has gone furthest, with 8 descendants of its own.
- 12 other devices also cite its predicate K121115.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (143 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132788: Myspine Pedicle Screw Placement Guides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132788
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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