510(k) · Cleared
ClearedProtex Stabilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on May 20, 2004 as substantially equivalent to K992739 (Synthes Spine, 2000) and 2 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1999. 1 of the 556 devices in its family, counting itself, has a Class I recall. 551 later devices descend from it.
- Decided
- May 20, 2004
- Review
- 90 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K990745 (1999). 4 ancestors in all. 551 later devices descend from it, 4 citing it directly. 1 of the 556 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 1 generation backK992739 Click'xSynthes Spine · 2000 · Recalled
- This deviceK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- Descendant · cites it directly · 549 of its ownK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- Descendant · cites it directly · 547 of its ownK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- Descendant · 2 generations on · 405 of its ownK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- Descendant · 2 generations on · 404 of its ownK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- Descendant · 2 generations on · 376 of its ownK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
Showing 5 of 551 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 551 · See all- K052069Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005 · cites it directly549descendants
- K061202Revere Stabilization SystemGlobus Medical, Inc. · 2006 · cites it directly547descendants
- K081195Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008 · 2 generations on405descendants
- K091782Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009 · 2 generations on404descendants
- K093294Revere Stabilization SystemGlobus Medical, Inc. · 2010 · 2 generations on376descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −1 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| 0 (this device) | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| +1 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| +1 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| +2 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| +2 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| +2 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 6 | 0 |
| 2010 | 4 | 0 |
| 2011 | 7 | 0 |
| 2012 | 10 | 0 |
| 2013 | 16 | 0 |
| 2014 | 21 | 0 |
| 2015 | 25 | 0 |
| 2016 | 19 | 0 |
| 2017 | 32 | 0 |
| 2018 | 37 | 0 |
| 2019 | 29 | 0 |
| 2020 | 36 | 0 |
| 2021 | 30 | 1 |
| 2022 | 42 | 0 |
| 2023 | 63 | 0 |
| 2024 | 59 | 0 |
| 2025 | 52 | 0 |
| 2026 | 52 | 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? (3)
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 |
|---|---|---|---|
| * | K992739 | Click'xSummary page 1…888.3070 Spondylolisthesis Spinal Fixation Device System Product Codes MNH, MNI, KWQ, KWP, NKB. Regulatory Class II. Panel code 87. PREDICATE DEVICES: Synthes Click'X: K992739, SE date February 8, 2000 Synthes USS: K022949, SE date March 24, 2003 Synthes Click'X Monoaxial System: K031175, SE date Nov 14,… | 2000 |
| * | K022949 | Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature UssSummary page 1…ce System Product Codes MNH, MNI, KWQ, KWP, NKB. Regulatory Class II. Panel code 87. PREDICATE DEVICES: Synthes Click'X: K992739, SE date February 8, 2000 Synthes USS: K022949, SE date March 24, 2003 Synthes Click'X Monoaxial System: K031175, SE date Nov 14, 2003 Product codes are MNH, MNI, KWQ, KWP, NKB… | 2003 |
| * | K031175 | Click'x Monoaxial Screws and HooksSummary page 1…II. Panel code 87. PREDICATE DEVICES: Synthes Click'X: K992739, SE date February 8, 2000 Synthes USS: K022949, SE date March 24, 2003 Synthes Click'X Monoaxial System: K031175, SE date Nov 14, 2003 Product codes are MNH, MNI, KWQ, KWP, NKB. DEVICE DESCRIPTION: The PROTEX TM Stabilization System consist… | 2003 |
What descends from it? (551)
See all 5514 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K052069 (Globus Medical, Inc., 2005) has gone furthest, with 549 descendants of its own.
- 20 other devices also cite its predicate K992739.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PROTEXTM Stabilization System, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and…
Read the full statement (287 words)
The PROTEXTM Stabilization System, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
In addition, the PROTEXTM 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 as a posterior non-pedicle screw fixation system, the PROTEXTM Stabilization System is intended for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's disease), fracture, pseudarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are Tl-sacrum/ilium.
When used as an anterolateral thoracolumbar system, the PROTEXTM Stabilization System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040442: Protex 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/K040442
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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