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. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jan 30, 2015 as substantially equivalent to K124058 (Globus Medical, Inc., 2013) after a 39-day review. Its family tree reaches back 15 generations to 1985. 2 of the 343 devices in its family, counting itself, have a Class I recall. 158 later devices descend from it.
- Decided
- Jan 30, 2015
- Review
- 39 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K853033 (1985). 184 ancestors in all, the oldest K781443 (1978). 158 later devices descend from it, 6 citing it directly. 2 of the 343 devices in this family, counting this one, have a Class I recall.
- Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 11 generations between
- 3 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- 2 generations backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- 1 generation backK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
- This deviceK143633 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 · cites it directly · 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
- Descendant · 4 generations on · 59 of its ownK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
Show all 15 generations
- Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 14 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 13 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 12 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 11 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 10 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 9 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 8 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 7 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 6 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 5 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 4 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 3 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- 2 generations backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- 1 generation backK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
- This deviceK143633 CREO Stabilization SystemGlobus Medical, Inc. · 2015
Showing 5 of 158 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 158 · See all- K180210CREO® Stabilization SystemGlobus Medical, Inc. · 2018 · cites it directly88descendants
- K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019 · 2 generations on69descendants
- K171651Excelsius GPSGlobus Medical, Inc. · 2017 · cites it directly69descendants
- K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · 3 generations on61descendants
- K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021 · 4 generations on59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −14 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −13 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −12 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −11 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −10 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −9 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −8 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −7 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −6 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −5 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −4 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −3 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
| −2 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
| −1 | K124058 | Creo Stabilization System | Globus Medical, Inc. | 2013 | — |
| 0 (this device) | 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 | — |
| +1 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
| +3 | K203056 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| +4 | K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 8 | 0 |
| 2020 | 9 | 0 |
| 2021 | 9 | 1 |
| 2022 | 17 | 0 |
| 2023 | 22 | 0 |
| 2024 | 29 | 0 |
| 2025 | 30 | 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.
Top candidate predicates for a new NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 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 |
|---|---|---|---|
| * | K124058 | Creo Stabilization SystemSummary page 4…B*, OSH, MNH, MNI, KWQ, KWP Regulatory Class III* and II, Panel Code 87. *Primary Primary Predicate: CREO® Stabilization System (K124058) Purpose: The purpose of this submission is to request clearance for additional cobalt chrome implants for the CREO® Stabilizati… | 2013 |
What descends from it? (158)
See all 1586 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180210 | CREO® Stabilization System | 2018 | 88 |
| K171651 | Excelsius GPS | 2017 | 69 |
| K151196 | Nautilus Spinal System | 2015 | 12 |
| K181139 | OLYMPIC Posterior Spinal Fixation System | 2018 | 8 |
| K203153 | CREO Stabilization System, Navigation Instruments, ExcelsiusGPS | 2021 | 1 |
| K253739 | SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5… | 2026 | 0 |
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 30 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 16 of the 184 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K180210 (Globus Medical, Inc., 2018) has gone furthest, with 88 descendants of its own.
- 14 other devices also cite its predicate K124058.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
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/K143633 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143633: CREO Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143633
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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