510(k) · Cleared
ClearedMySpine Unilateral Guides
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · PQC Pedicle Screw Placement Guide
Cleared on Jul 21, 2023 as substantially equivalent to K203673 (Medacta International S.A., 2021) and 3 other predicates after a 59-day review. Its family tree reaches back 19 generations to 2004. 1 of the 154 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 21, 2023
- Review
- 59 days
- Class
- Class II
- Product code
- PQC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 19 generations to K040583 (2004). 153 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 154 devices in this family, counting this one, has a Class I recall.
- Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations between
- 3 generations backK181399 FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2018
- 2 generations backK203673 MySpine Pedicle Screw Placement Guides Extension (MySpine Low…Medacta International S.A. · 2021
- 1 generation backK220888 MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A. · 2022
- This deviceK231483 MySpine Unilateral GuidesMedacta International S.A. · 2023
Show all 19 generations
- Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 18 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 17 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 16 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 15 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 14 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 13 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 12 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 11 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 10 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 9 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 8 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 7 generations backK121115 M.U.S.T Pedicle Screw SystemMedacta International · 2012 · Recalled
- 6 generations backK132788 Myspine Pedicle Screw Placement GuidesMedacta International · 2014
- 5 generations backK143222 FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2015
- 4 generations backK162419 FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2016
- 3 generations backK181399 FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2018
- 2 generations backK203673 MySpine Pedicle Screw Placement Guides Extension (MySpine Low…Medacta International S.A. · 2021
- 1 generation backK220888 MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A. · 2022
- This deviceK231483 MySpine Unilateral 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 |
|---|---|---|---|---|---|
| −19 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −18 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −17 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −16 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −15 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −14 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −13 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −12 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −11 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −10 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −9 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −8 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −7 | K121115 | M.U.S.T Pedicle Screw System | Medacta International | 2012 | 1 |
| −6 | K132788 | Myspine Pedicle Screw Placement Guides | Medacta International | 2014 | — |
| −5 | K143222 | FIREFLY Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2015 | — |
| −4 | K162419 | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2016 | — |
| −3 | K181399 | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2018 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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? (4)
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 5…II III. Predicate Device Substantial equivalence is claimed to the following primary predicate device: MySpine Pedicle Screw Placement Guides Extension, K203673, Medacta International SA Additionally, the following predicate devices are used within the submission: MySpine S2-SI P… | 2021 |
| * | K220888 | MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesSummary page 5…ta International SA Additionally, the following predicate devices are used within the submission: MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides, K220888, Medacta International SA MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides, K200792, Medacta Internati… | 2022 |
| * | K200792 | MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesSummary page 5…pine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides, K220888, Medacta International SA MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides, K200792, Medacta International SA MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments, K173472, Med… | 2020 |
| * | K173472 | MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsSummary page 5…r/Alar-Iliac Pedicle Screw Placement Guides, K200792, Medacta International SA MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments, K173472, Medacta Interational SA K23… | 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 153 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K203673.
How does its category compare?
All PQC devicesPQC Pedicle 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 · 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 MC and Drill Pilot MySpine is intended to be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its approved indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures intended for fusion. MySpine Drill Pilot is intended as a thoracic and lumbar posterior pedicle targeting guides for patients requiring spinal fusion between the levels of T1 to L5. The…
Read the full statement (458 words)
MySpine MC and Drill Pilot
MySpine is intended to be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its approved indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures intended for fusion. MySpine Drill Pilot is intended as a thoracic and lumbar posterior pedicle targeting guides for patients requiring spinal fusion between the levels of T1 to L5. The device is intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body.
MySpine MC is intended as a lumbar and sacral posterior pedicle targeting guide for patients requiring spinal fusion between the levels of L1 to S1.
The device is provided with two options:
• Drill based
• K-wire based
MySpine MC drill based are intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body. MySpine MC K-wire based are intended for the placement of K-wires to assist in the positioning of pedicle screws in the vertebral body.
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 on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. MySpine MC and Drill Pilot 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.
MySpine S2-Alar/Alar-Iliac and MySpine Anchor guides
MySpine S2-Alar/Alar-Iliac and MySpine Anchor 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 Anchor guide is only intended to be used with M.U.S.T. SI Headless Screw System and its cleared indications for use.
MySpine S2-Alar/Alar-Iliac and MySpine Anchor 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 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. 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 posterior fixation screw system intended to be used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231483 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231483: MySpine Unilateral Guides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231483
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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