510(k) · Decided
DecidedTransition Stabilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · NQP Posterior Metal/Polymer Spinal System, Fusion
Cleared on Feb 20, 2009 as substantially equivalent to K061202 (Globus Medical, Inc., 2006) and 1 other predicate after a 441-day review. Its family tree reaches back 5 generations to 1999. 2 later devices descend from it.
- Decided
- Feb 20, 2009
- Review
- 441 days
- Class
- Class II
- Product code
- NQP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K990745 (1999). 14 ancestors in all, the oldest K962628 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 4 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 3 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 2 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 1 generation backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- This deviceK073439 Transition Stabilization SystemGlobus Medical, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK133153 Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK143377 PedFuse Pedicle Screw SystemSpinefrontier, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −4 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −3 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −2 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −1 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| 0 (this device) | K073439 | Transition Stabilization System | Globus Medical, Inc. | 2009 | — |
| +1 | K133153 | Spinefrontier Pedfuse Pedicle Screw System | Spinefrontier, Inc. | 2014 | — |
| +2 | K143377 | PedFuse Pedicle Screw System | Spinefrontier, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 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.
Planning a device in NQP? 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 NQP device
- #1 K203678 CD HORIZON™ Spinal Systemscore 10.9 · 15 generations · no Class I recall
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 |
|---|---|---|---|
| * | K061202 | Revere Stabilization SystemSummary page 1…me: TRANSITION TM Stabilization System Classification: Product Code NQP. Class II. 21 CFR §888.3070 Pedicle Screw Spinal System Predicate(s): REVERE (K061202), Dynesys (K031511) Device Description: The TRANSITION TM Stabilization System implants include pedicle screws and implant assem… | 2006 |
| * | K031511 | Dynesys Spinal SystemSummary page 1…tabilization System Classification: Product Code NQP. Class II. 21 CFR §888.3070 Pedicle Screw Spinal System Predicate(s): REVERE (K061202), Dynesys (K031511) Device Description: The TRANSITION TM Stabilization System implants include pedicle screws and implant assemblies which are pro… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133153 | Spinefrontier Pedfuse Pedicle Screw System | 2014 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K133153 (Spinefrontier, Inc., 2014) has gone furthest, with 1 descendant of its own.
- 29 other devices also cite its predicate K061202.
How does its category compare?
All NQP devicesNQP Posterior Metal/Polymer Spinal System, Fusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NQP
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · NQP
70in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQP
6in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQP
8in 2025
MAUDE reports naming product code NQP, 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 | 2 | — | 34 | 45 |
| 2008 | 6 | 156 | 4 | 101 |
| 2009 | 3 | 70 | 6 | 109 |
| 2010 | 2 | — | 0 | 119 |
| 2011 | 0 | — | 0 | 60 |
| 2012 | 0 | — | 6 | 66 |
| 2013 | 0 | — | 0 | 58 |
| 2014 | 1 | — | 0 | 46 |
| 2015 | 0 | — | 0 | 38 |
| 2016 | 0 | — | 0 | 79 |
| 2017 | 0 | — | 0 | 28 |
| 2018 | 0 | — | 0 | 29 |
| 2019 | 2 | — | 0 | 8 |
| 2020 | 0 | — | 0 | 15 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 12 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The TRANSITION TM Stabilization System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine in skeletally mature patients: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudoarthrosis). In addition, the TRANSITION TM…
Read the full statement (127 words)
The TRANSITION TM Stabilization System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine in skeletally mature patients: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudoarthrosis).
In addition, the TRANSITION TM Stabilization System is indicated for use in patients: who are receiving fusions with autogenous graft only; who are having the device fixed or attached to the lumbar or sacral spine; and who are having the device removed after the development of a solid fusion mass.
TRANSITION TM is only indicated for use when fusion with autogenous bone graft is being performed at all instrumented levels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073439 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073439: Transition Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073439
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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