510(k) · Cleared
ClearedH-Link Integrated Rod
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 3, 2008 as substantially equivalent to K061202 (Globus Medical, Inc., 2006) and 2 other predicates after a 20-day review. Its family tree reaches back 5 generations to 1999.
- Decided
- Jan 3, 2008
- Review
- 20 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K990745 (1999). 12 ancestors in all, the oldest K962628 (1997). No later device cites it as a predicate yet.
- 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 deviceK073517 H-Link Integrated RodGlobus Medical, Inc. · 2008
View 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) | K073517 | H-Link Integrated Rod | Globus Medical, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 3 | 0 |
| 2005 | 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 NKB? 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? (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 |
|---|---|---|---|
| * | K061202 | Revere Stabilization SystemSummary page 1…Product Codes MNH, MNI, NKB. Regulatory Class IIand1ctitfanel Code 87. Predicate(s): Globus Medical REVERE TM Stabilization System K061202, SE date July 20, 2006 Globus Medical PROTEX® Stabilization System K040442, SE date May 20, 2… | 2006 |
| * | K040442 | Protex Stabilization SystemSummary page 1…s Medical REVERE TM Stabilization System K061202, SE date July 20, 2006 Globus Medical PROTEX® Stabilization System K040442, SE date May 20, 2004 K052069, SE date August 17, 2005 Product Codes MNH, MNI, NKB included… | 2004 |
| * | K052069 | Protex Stabilization System with Additional ComponentesSummary page 1…K061202, SE date July 20, 2006 Globus Medical PROTEX® Stabilization System K040442, SE date May 20, 2004 K052069, SE date August 17, 2005 Product Codes MNH, MNI, NKB included Regulatory Class IIand III, Pan… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 9 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 29 other devices also cite its predicate K061202.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 H-LINKTM Integrated Rod, when used with 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…
Read the full statement (149 words)
The H-LINKTM Integrated Rod, when used with 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 H-LINKTM Integrated Rod 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073517 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073517: H-Link Integrated Rod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073517
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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