510(k) Report

510(k) · Cleared

Cleared

MySpine Pedicle Screw Placement Guides - LP

K153273510(k) TraditionalCleared Jun 29, 2016230-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medacta International S.A. · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Jun 29, 2016 as substantially equivalent to K132788 (Medacta International, 2014) after a 230-day review. Its family tree reaches back 14 generations to 2004. 1 of the 151 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.

Decided
Jun 29, 2016
Review
230 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
1

Its longest line of descent runs back 14 generations to K040583 (2004). 144 ancestors in all, the oldest K781443 (1978). 6 later devices descend from it, 2 citing it directly. 1 of the 151 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2010: 5 other ancestors, 1 with a Class I recall12009: 3 other ancestors2007: 6 other ancestors2004: 17 other ancestors2003: 13 other ancestors2011: 1 other ancestor2008: 4 other ancestors2006: 8 other ancestors2005: 13 other ancestors2002: 7 other ancestors2001: 11 other ancestors2000: 13 other ancestors1999: 4 other ancestors1998: 4 other ancestors1997: 3 other ancestors1995: 3 other ancestors1996: 3 other ancestors1994: 1 other ancestor1978: 1 other ancestor1993: 2 other ancestors1992: 5 other ancestors1990: 2 other ancestors1984: 1 other ancestor2021: 1 descendant cleared2018: 1 descendant cleared2020: 1 descendant cleared2023: 2 descendants cleared2022: 1 descendant cleared×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) K121115 · M.U.S.T Pedicle Screw System · Medacta International · 2012 · recalledK132788 · Myspine Pedicle Screw Placement Guides · Medacta International · 201419801990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 9 other ancestors, 1 with a Class I recall14 generations back: 31 other ancestors5 generations back: 42 other ancestors6 generations back: 26 other ancestors7 generations back: 12 other ancestors8 generations back: 10 other ancestors 1 generation forward: 2 descendants2 generations forward: 4 descendants K132788 · Myspine Pedicle Screw Placement Guides · Medacta International · 2014K121115 · M.U.S.T Pedicle Screw System · Medacta International · 2012 · recalledK113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−10−50
  1. Root · 14 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 10 generations between
  3. 3 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  4. 2 generations backK121115 M.U.S.T Pedicle Screw SystemMedacta International · 2012 · Recalled
  5. 1 generation backK132788 Myspine Pedicle Screw Placement GuidesMedacta International · 2014
  6. This deviceK153273 MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016
  7. Descendant · cites it directly · 5 of its ownK173472 MySpine Pedicle Screw Placement Guides – MC and Drill Pilot…Medacta International S.A. · 2018
  8. Descendant · 2 generations on · 4 of its ownK200792 MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA · 2020
  9. Descendant · cites it directly · 3 of its ownK203673 MySpine Pedicle Screw Placement Guides Extension (MySpine Low…Medacta International S.A. · 2021
  10. Descendant · 2 generations on · 1 of its ownK220888 MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A. · 2022
  11. Descendant · 2 generations on · 0 of its ownK231515 MySpine Cervical GuidesMedacta International S.A. · 2023
Show all 14 generations
  1. Root · 14 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 13 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 12 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 11 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 10 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 9 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 8 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 7 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 6 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 5 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 4 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 3 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 2 generations backK121115 M.U.S.T Pedicle Screw SystemMedacta International · 2012 · Recalled
  14. 1 generation backK132788 Myspine Pedicle Screw Placement GuidesMedacta International · 2014
  15. This deviceK153273 MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2018: 12020: 12021: 12022: 12023: 2
2018high 2 (2023) · low 0 (2019)2026

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System3 generations back · 2010

Most influential descendants

Showing 5 of 6 · See all
  • K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A. · 2018 · cites it directly5descendants
  • K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA · 2020 · 2 generations on4descendants
  • K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A. · 2021 · cites it directly3descendants
  • K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A. · 2022 · 2 generations on1descendant
  • K231515MySpine Cervical GuidesMedacta International S.A. · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−13K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−12K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−11K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−10K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−9K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−8K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−7K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−6K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−5K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−4K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−3K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−2K121115M.U.S.T Pedicle Screw SystemMedacta International20121
−1K132788Myspine Pedicle Screw Placement GuidesMedacta International2014—
0 (this device)K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.2016—
+1K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.2018—
+2K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA2020—
+1K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides…Medacta International S.A.2021—
+2K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.2022—
+2K231515MySpine Cervical GuidesMedacta International S.A.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
199020
199250
199320
199410
199530
199630
199730
199840
199940
2000130
2001110
200270
2003130
2004170
2005130
200680
200760
200840
200930
201051
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
202010
202110
202210
202320
FIG. 1 — Lineage of K153273, 2004–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K132788Myspine Pedicle Screw Placement Guides
Summary page 4
…ct Code: MNI Regulation Number: 21 CFR 888.3070 Device Class: II PREDICATE DEVICE INFORMATION MySpine Pedicle Screw Placement Guides, K132788, Medacta International SA DEVICE DESCRIPTION MySpine Pedicle Screw Placement Guides - LP are a design modification to MySpine P…
Medacta International2014—

Also cleared against K132788: 2 other devices →

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185
K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213

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 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 5 months on median.
  • 22 of the 144 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K173472 (Medacta International S.A., 2018) has gone furthest, with 5 descendants of its own.
  • 2 other devices also cite its predicate K132788.

How does its category compare?

All MNI devices

MNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · MNI

1in 2017

2007: 202008: 232009: 182010: 162011: 172012: 192013: 142014: 62015: 122016: 72017: 1
2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007: 82 days median2008: 64 days median2009: 86 days median2010: 74 days median2011: 111 days median2012: 75 days median2013: 77 days median2014: 104 days median2015: 54 days median2016: 168 days median
2007high 168 (2016) · low 54 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MNI

1in 2018

2007: 262008: 82009: 32010: 12012: 12013: 42015: 12018: 1
2007high 26 (2007) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MNI

80in 2025

2007: 832008: 1082009: 1382010: 1262011: 1462012: 2002013: 8242014: 3012015: 2602016: 1172017: 2472018: 1342019: 1882020: 1152021: 2702022: 2142023: 1222024: 1142025: 80
2007high 824 (2013) · low 80 (2025)2025

MAUDE reports naming product code MNI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200720822683
200823648108
200918863138
201016741126
2011171110146
201219751200
201314774824
201461040301
201512541260
201671680117
20171—0247
20180—1134
20190—0188
20200—0115
20210—0270
20220—0214
20230—0122
20240—0114
20250—080
20260—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 (164 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.

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K132788

2 other devices cite the same predicate.

  • K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A. · 2018
  • K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2015

More from Medacta International S.A.

167 FDA decisions under this applicant name. See the company

  • K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254202MectaLIF 3D Metal AnteriorMedacta International S.A. · 2026
  • K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2026
  • K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A. · 2026

Recent decisions in MNI

The MNI category page

  • K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017
  • K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016
  • K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc. · 2016
  • K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2016
  • K160320PremierShandong Weigao Orthopaedic Device Co., Ltd. · 2016

https://510kreport.com/device/K153273 · printed Nov 6, 2026

Cite this page

510(k) Report. “K153273: MySpine Pedicle Screw Placement Guides - LP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153273

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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