510(k) · Cleared
ClearedMySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta Inernational SA · PQC Pedicle Screw Placement Guide
Cleared on Oct 5, 2020 as substantially equivalent to K173472 (Medacta International S.A., 2018) after a 193-day review. Its family tree reaches back 16 generations to 2004. 1 of the 151 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Oct 5, 2020
- Review
- 193 days
- Class
- Class II
- Product code
- PQC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K040583 (2004). 146 ancestors in all, the oldest K781443 (1978). 4 later devices descend from it, 3 citing it directly. 1 of the 151 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations between
- 3 generations backK132788 Myspine Pedicle Screw Placement GuidesMedacta International · 2014
- 2 generations backK153273 MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016
- 1 generation backK173472 MySpine Pedicle Screw Placement Guides – MC and Drill Pilot…Medacta International S.A. · 2018
- This deviceK200792 MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA · 2020
- Descendant · cites it directly · 3 of its ownK203673 MySpine Pedicle Screw Placement Guides Extension (MySpine Low…Medacta International S.A. · 2021
- Descendant · cites it directly · 1 of its ownK220888 MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A. · 2022
- Descendant · 2 generations on · 0 of its ownK231515 MySpine Cervical GuidesMedacta International S.A. · 2023
- Descendant · cites it directly · 0 of its ownK231483 MySpine Unilateral GuidesMedacta International S.A. · 2023
Show all 16 generations
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 13 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 12 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 11 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 10 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 9 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 8 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 7 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 6 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 5 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 4 generations backK121115 M.U.S.T Pedicle Screw SystemMedacta International · 2012 · Recalled
- 3 generations backK132788 Myspine Pedicle Screw Placement GuidesMedacta International · 2014
- 2 generations backK153273 MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016
- 1 generation backK173472 MySpine Pedicle Screw Placement Guides – MC and Drill Pilot…Medacta International S.A. · 2018
- This deviceK200792 MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA · 2020
Class I recalls in this family
- K100952 Modification to Synthes Matrix System4 generations back · 2010
Most influential descendants
Showing 4 of 4 · See all- 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 · cites it directly1descendant
- K231515MySpine Cervical GuidesMedacta International S.A. · 2023 · 2 generations on0descendants
- K231483MySpine Unilateral GuidesMedacta International S.A. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −13 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −12 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −11 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −10 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −9 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −8 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −7 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −6 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −5 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −4 | K121115 | M.U.S.T Pedicle Screw System | Medacta International | 2012 | 1 |
| −3 | K132788 | Myspine Pedicle Screw Placement Guides | Medacta International | 2014 | — |
| −2 | K153273 | MySpine Pedicle Screw Placement Guides - LP | Medacta International S.A. | 2016 | — |
| −1 | K173472 | MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments | Medacta International S.A. | 2018 | — |
| 0 (this device) | K200792 | MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides | Medacta Inernational SA | 2020 | — |
| +1 | K203673 | MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides… | Medacta International S.A. | 2021 | — |
| +1 | K220888 | MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides | Medacta International S.A. | 2022 | — |
| +2 | K231515 | MySpine Cervical Guides | Medacta International S.A. | 2023 | — |
| +1 | K231483 | MySpine Unilateral 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 | 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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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 PQC device
- #1 K253472 FIREFLY® Pedicle Screw Navigation Guidescore 15.7 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K173472 | MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsSummary page 4…II. Predicate Device Substantial equivalence is claimed to the following device: ¾ MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments, K173472, Medacta Interational SA (Primary Predicate) IV. Device Description The MySpine S2-Alar/Alar-Iliac Pedicle Screw… | 2018 |
What descends from it? (4)
3 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 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 8 months on median.
- 22 of the 146 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K203673 (Medacta International S.A., 2021) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K173472.
How does its category compare?
All PQC devicesPQC Pedicle Screw Placement Guide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · PQC
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PQC
82in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PQC
No recall names PQC since 2007.
Adverse event reports per year · PQC
1in 2025
MAUDE reports naming product code PQC, 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 | 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 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 3 | 82 | 0 | 3 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
MySpine S2-Alar/Alar-Iliac is intended for use with M.U.S.T. Pedicle Screw System and its cleared indications for use.
MySpine S2-Alar/Alar-Iliac guides (referred to from this point on as, MySpine guides) are intended to be used as anatomical perforating guides, specific to a patient’s anatomy, to assist intra-operatively in the preparation of the screw trajectory in S1, S2 and in the Ilium. The guides are created using a surgical planning software which pre-operatively plans the positions of the components based upon radiological images of the patients’ anatomical landmarks and the surgical equipment selected. MySpine 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/K200792 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200792: MySpine S2-Alar/Alar-Iliac 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/K200792
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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