510(k) · Cleared
ClearedCreo Stabilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Cleared on May 13, 2013 as substantially equivalent to K122226 (Globus Medical, Inc., 2012) and 6 other predicates after a 133-day review. Its family tree reaches back 14 generations to 1985. 2 of the 356 devices in its family, counting itself, have a Class I recall. 172 later devices descend from it.
- Decided
- May 13, 2013
- Review
- 133 days
- Class
- Class II
- Product code
- OSH
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 14 generations to K853033 (1985). 183 ancestors in all, the oldest K781443 (1978). 172 later devices descend from it, 15 citing it directly. 2 of the 356 devices in this family, counting this one, have a Class I recall.
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 10 generations between
- 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- 1 generation backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- This deviceK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
- Descendant · cites it directly · 158 of its ownK143633 CREO Stabilization SystemGlobus Medical, Inc. · 2015
- Descendant · cites it directly · 88 of its ownK180210 CREO® Stabilization SystemGlobus Medical, Inc. · 2018
- Descendant · 2 generations on · 69 of its ownK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
- Descendant · 2 generations on · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 61 of its ownK203056 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020
Show all 14 generations
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 13 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 12 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 11 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 10 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 9 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 8 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 7 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 6 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 5 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 4 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- 1 generation backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- This deviceK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
Showing 5 of 172 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 172 · See all- K143633CREO Stabilization SystemGlobus Medical, Inc. · 2015 · cites it directly158descendants
- K180210CREO® Stabilization SystemGlobus Medical, Inc. · 2018 · cites it directly88descendants
- K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019 · 2 generations on69descendants
- K171651Excelsius GPSGlobus Medical, Inc. · 2017 · 2 generations on69descendants
- K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · 3 generations on61descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −13 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −12 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −11 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −10 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −9 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −8 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −7 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −6 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −5 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −4 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −3 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −2 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
| −1 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
| 0 (this device) | K124058 | Creo Stabilization System | Globus Medical, Inc. | 2013 | — |
| +1 | K143633 | CREO Stabilization System | Globus Medical, Inc. | 2015 | — |
| +1 | K180210 | CREO® Stabilization System | Globus Medical, Inc. | 2018 | — |
| +2 | K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019 | — |
| +2 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
| +3 | K203056 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 8 | 0 |
| 2000 | 11 | 0 |
| 2001 | 17 | 0 |
| 2002 | 7 | 0 |
| 2003 | 11 | 0 |
| 2004 | 21 | 0 |
| 2005 | 21 | 0 |
| 2006 | 9 | 0 |
| 2007 | 8 | 0 |
| 2008 | 9 | 0 |
| 2009 | 11 | 0 |
| 2010 | 6 | 1 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 10 | 0 |
| 2020 | 9 | 0 |
| 2021 | 10 | 1 |
| 2022 | 19 | 0 |
| 2023 | 23 | 0 |
| 2024 | 31 | 0 |
| 2025 | 31 | 0 |
| 2026 | 28 | 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.
2 devices in this family have 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? (7)
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 |
|---|---|---|---|
| * | K122226 | Revere Stabilization SystemSummary page 1…Product Codes MNH, MNI, KWQ, KWP, NKB, OSH Regulatory Class 11and Ill, Panel Code 87. Predicate(s): REVERE® Stabilization System K122226 REVERE® 4.5 Stabilization System K1 13395 Medtronic CD Horizon® Spinal System K102807… | 2012 |
| * | K113395 | Revere 4.5 Stabilization SystemSummary page 1…Regulatory Class 11and Ill, Panel Code 87. Predicate(s): REVERE® Stabilization System K122226 REVERE® 4.5 Stabilization System K1 13395 Medtronic CD Horizon® Spinal System K102807 Synthes UISS (including Matrix and Click'X) S… | 2012 |
| * | K102807 | CD Horizon Spinal SystemSummary page 1…cate(s): REVERE® Stabilization System K122226 REVERE® 4.5 Stabilization System K1 13395 Medtronic CD Horizon® Spinal System K102807 Synthes UISS (including Matrix and Click'X) Spinal System. K031175, K100952 & K1032… | 2010 |
| * | K031175 | Click'x Monoaxial Screws and HooksSummary page 1…Medtronic CD Horizon® Spinal System K102807 Synthes UISS (including Matrix and Click'X) Spinal System. K031175, K100952 & K103287 DePuy VI PER® 2 System Kil1136 Purpose: The purpose of this submission is to request clea… | 2003 |
| * | K100952 | Modification to Synthes Matrix SystemSummary page 1…Medtronic CD Horizon® Spinal System K102807 Synthes UISS (including Matrix and Click'X) Spinal System. K031175, K100952 & K103287 DePuy VI PER® 2 System Kil1136 Purpose: The purpose of this submission is to request clearance of… | 2010 |
| * | K103287 | Synthes 6.0 Cocr and CPT TI-3 RodsSummary page 1…Medtronic CD Horizon® Spinal System K102807 Synthes UISS (including Matrix and Click'X) Spinal System. K031175, K100952 & K103287 DePuy VI PER® 2 System Kil1136 Purpose: The purpose of this submission is to request clearance of the CREOTM… | 2011 |
| * | K111136 | Expedium Spine System, Viper System, Viper 2 System | 2012 |
What descends from it? (172)
See all 17215 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143633 | CREO Stabilization System | 2015 | 158 |
| K180210 | CREO® Stabilization System | 2018 | 88 |
| K181139 | OLYMPIC Posterior Spinal Fixation System | 2018 | 8 |
| K212066 | Adena-Zina System | 2021 | 3 |
| K231694 | MASADA Modular Spinal Fixation System | 2023 | 2 |
| K191835 | CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments | 2019 | 2 |
| K181068 | CREO® Stabilization System, REVERE® Stabilization System | 2018 | 2 |
| K133366 | Orthros Posterior Stabilization System | 2014 | 2 |
| K203153 | CREO Stabilization System, Navigation Instruments, ExcelsiusGPS | 2021 | 1 |
| K190376 | PASS LP Spinal System | 2019 | 1 |
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 28 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 16 of the 183 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K143633 (Globus Medical, Inc., 2015) has gone furthest, with 158 descendants of its own.
- 7 other devices also cite its predicate K122226.
How does its category compare?
All OSH devicesOSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OSH
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · OSH
82in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OSH
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OSH
3in 2025
MAUDE reports naming product code OSH, 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 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 3 | 76 | 0 | 1 |
| 2013 | 14 | 82 | 0 | 2 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 9 |
| 2017 | 0 | — | 1 | 4 |
| 2018 | 0 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CREO Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients (including small stature) and for pediatric patients (CREO 4.75 only). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc…
Read the full statement (325 words)
The CREO Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients (including small stature) and for pediatric patients (CREO 4.75 only). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis). When used as an adjunct to fusion, the CREO Stabilization System is intended to be used with autograft and/or allograft.
In addition, the CREO Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CREO 4.75 Stabilization System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The CREO 4.75 Stabilization System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
In order to achieve additional levels of fixation in skeletally mature patients, the CREO Stabilization System rods may be connected to the REVERE® Stabilization System (5.5mm or 6.35mm rod), REVERE® 4.5 Stabilization System (4.5mm rod) or ELLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. In order to achieve additional levels of fixation in pediatric patients, the CREO Stabilization System rods may be connected to the REVERE® 4.5 Stabilization System using corresponding connectors. Refer to the REVERE®, REVERE® 4.5, or ELLIPSE® system package insert for instructions and indications of use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K124058 · printed Nov 6, 2026
Cite this page
510(k) Report. “K124058: Creo Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K124058
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