510(k) · Cleared
ClearedMySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · QSR Sacroiliac Screw Placement Guide
Cleared on May 24, 2022 as substantially equivalent to K203673 (Medacta International S.A., 2021) and 1 other predicate after a 57-day review. Its family tree reaches back 18 generations to 2004. 1 of the 154 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- May 24, 2022
- Review
- 57 days
- Class
- Class II
- Product code
- QSR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to K040583 (2004). 152 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly. 1 of the 154 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 deviceK220888 MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A. · 2022
- Descendant · cites it directly · 0 of its ownK231483 MySpine Unilateral 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 deviceK220888 MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A. · 2022
Class I recalls in this family
- K100952 Modification to Synthes Matrix System5 generations back · 2010
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −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) | K220888 | MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides | Medacta International S.A. | 2022 | — |
| +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 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K203673 | MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Summary page 4…II III. Predicate Device Substantial equivalence is claimed to the following primary predicate device: MySpine Pedicle Screw Placement Guides Extension, K203673, Medacta International SA In addition the following predicate device is referenced within the submission : MySpine S2-Alar… | 2021 |
| * | K200792 | MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesSummary page 4…dacta International SA In addition the following predicate device is referenced within the submission : MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides, K200792, Medacta International SA IV. Device Description The MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides ar… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231483 | MySpine Unilateral Guides | 2023 | 0 |
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 · 5 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 22 of the 152 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K231483 (Medacta International S.A., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K203673.
How does its category compare?
All QSR devicesQSR Sacroiliac Screw Placement Guide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QSR
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · QSR
Too few QSR 510(k)s in any year since 2007 to give a median.
Recalls per year · QSR
No recall names QSR since 2007.
Adverse event reports per year · QSR
1in 2023
MAUDE reports naming product code QSR, 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 | 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 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
MySpine S2-Alar/Alar-Iliac and MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides are intended to be used with any 510(k) cleared, legally marketed, pedicle screw system (for its approved indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures intended for fusion. The SI trajectory of the MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guide is only intended to be used with…
Read the full statement (189 words)
MySpine S2-Alar/Alar-Iliac and MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides are intended to be used with any 510(k) cleared, legally marketed, pedicle screw system (for its approved indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures intended for fusion. The SI trajectory of the MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guide is only intended to be used with M.U.S.T. SI Headless Screw System and its cleared indications for use. The MySpine S2-Alar/Alar-Iliac and MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides (hereinafter referred to as “MySpine guides”) are intended to be used as anatomical perforating guides, specific to a patient’s anatomy, to assist intraoperatively 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 selected surgical equipment. The MySpine guides are intended for single use only.
Please see MySpine guides labelling for compatibility requirements between the MySpine guides and the 510(k) cleared pedicle screw system intended to be used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220888 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220888: MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220888
Report an extraction error
Are you the manufacturer?
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