510(k) · Cleared
ClearedCocr Rods
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 May 14, 2010 as substantially equivalent to K061202 (Globus Medical, Inc., 2006) and 6 other predicates after a 53-day review. Its family tree reaches back 8 generations to 1999. 1 of the 411 devices in its family, counting itself, has a Class I recall. 374 later devices descend from it.
- Decided
- May 14, 2010
- Review
- 53 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 8 generations to K990745 (1999). 36 ancestors in all, the oldest K962628 (1997). 374 later devices descend from it, 11 citing it directly. 1 of the 411 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 7 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 6 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 5 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 4 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 3 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 2 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 1 generation backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- This deviceK100788 Cocr RodsGlobus Medical, Inc. · 2010
- Descendant · cites it directly · 260 of its ownK113395 Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012
- Descendant · cites it directly · 236 of its ownK111449 Revolve Additional ImplantsGlobus Medical, Inc. · 2011
- Descendant · cites it directly · 232 of its ownK111479 Revere CrosstopGlobus Medical, Inc. · 2011
- Descendant · cites it directly · 225 of its ownK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- Descendant · cites it directly · 177 of its ownK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
Showing 5 of 374 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub3 generations on · 2021
Most influential descendants
Showing 5 of 374 · See all- K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012 · cites it directly260descendants
- K111449Revolve Additional ImplantsGlobus Medical, Inc. · 2011 · cites it directly236descendants
- K111479Revere CrosstopGlobus Medical, Inc. · 2011 · cites it directly232descendants
- K122226Revere Stabilization SystemGlobus Medical, Inc. · 2012 · cites it directly225descendants
- K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010 · cites it directly177descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −7 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −6 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −5 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −4 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −3 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −2 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −1 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| 0 (this device) | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| +1 | K113395 | Revere 4.5 Stabilization System | Globus Medical, Inc. | 2012 | — |
| +1 | K111449 | Revolve Additional Implants | Globus Medical, Inc. | 2011 | — |
| +1 | K111479 | Revere Crosstop | Globus Medical, Inc. | 2011 | — |
| +1 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
| +1 | K102488 | Apex Spine System W/ Cocr Rods | Spinecraft, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 4 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 8 | 0 |
| 2013 | 11 | 0 |
| 2014 | 11 | 0 |
| 2015 | 19 | 0 |
| 2016 | 11 | 0 |
| 2017 | 25 | 0 |
| 2018 | 27 | 0 |
| 2019 | 18 | 0 |
| 2020 | 27 | 0 |
| 2021 | 19 | 1 |
| 2022 | 28 | 0 |
| 2023 | 41 | 0 |
| 2024 | 48 | 0 |
| 2025 | 39 | 0 |
| 2026 | 36 | 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.
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? (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 |
|---|---|---|---|
| * | K061202 | Revere Stabilization SystemSummary page 1…Device System Product Codes MNH, MNI, KWQ, KWP, NKB. Regulatory Class Ill, Panel Code 87. Predicate(s): REVERE® Stabilization System (K061 202, K081 195, K091 782, K093294), BEACONTM Stabilization System (K073172, K09261 0), and Medtronic S… | 2006 |
| * | K081195 | Revere Uniplanar ScrewsSummary page 1…stem Product Codes MNH, MNI, KWQ, KWP, NKB. Regulatory Class Ill, Panel Code 87. Predicate(s): REVERE® Stabilization System (K061 202, K081 195, K091 782, K093294), BEACONTM Stabilization System (K073172, K09261 0), and Medtronic Sofamor Dan… | 2008 |
| * | K091782 | Revere 6.35 Stabilization SystemSummary page 1…Product Codes MNH, MNI, KWQ, KWP, NKB. Regulatory Class Ill, Panel Code 87. Predicate(s): REVERE® Stabilization System (K061 202, K081 195, K091 782, K093294), BEACONTM Stabilization System (K073172, K09261 0), and Medtronic Sofamor Danek TSRH Sp… | 2009 |
| * | K093294 | Revere Stabilization SystemSummary page 1…NH, MNI, KWQ, KWP, NKB. Regulatory Class Ill, Panel Code 87. Predicate(s): REVERE® Stabilization System (K061 202, K081 195, K091 782, K093294), BEACONTM Stabilization System (K073172, K09261 0), and Medtronic Sofamor Danek TSRH Spinal System (K093058) Pu… | 2010 |
| * | K073172 | Beacon Stabilization SystemSummary page 1…egulatory Class Ill, Panel Code 87. Predicate(s): REVERE® Stabilization System (K061 202, K081 195, K091 782, K093294), BEACONTM Stabilization System (K073172, K09261 0), and Medtronic Sofamor Danek TSRH Spinal System (K093058) Purpose: The purpose of this submission is… | 2007 |
| * | K092610 | Modification to Beacon Stabilization SystemSummary page 1…Class Ill, Panel Code 87. Predicate(s): REVERE® Stabilization System (K061 202, K081 195, K091 782, K093294), BEACONTM Stabilization System (K073172, K09261 0), and Medtronic Sofamor Danek TSRH Spinal System (K093058) Purpose: The purpose of this submission is the additi… | 2009 |
| * | K093058 | TSRH Spinal SystemSummary page 1…061 202, K081 195, K091 782, K093294), BEACONTM Stabilization System (K073172, K09261 0), and Medtronic Sofamor Danek TSRH Spinal System (K093058) Purpose: The purpose of this submission is the addition of CoCr Rods to the BEACON TM and REVERE® Stabilization Systems. Devic… | 2009 |
What descends from it? (374)
See all 37411 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113395 | Revere 4.5 Stabilization System | 2012 | 260 |
| K111449 | Revolve Additional Implants | 2011 | 236 |
| K111479 | Revere Crosstop | 2011 | 232 |
| K122226 | Revere Stabilization System | 2012 | 225 |
| K102488 | Apex Spine System W/ Cocr Rods | 2010 | 177 |
| K110963 | Ellipse Occipito-Cervico-Thoracic Spinal System | 2011 | 98 |
| K121670 | Medyssey Cannulated Pedicle Screw | 2013 | 11 |
| K121922 | Beacon Stabilization System | 2012 | 9 |
| K103671 | Genesys Spine Tilock System | 2011 | 8 |
| K173131 | Rexious Spinal Fixation System | 2017 | 5 |
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 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 36 ancestors have a recall of any class.
- Of its descendants, K113395 (Globus Medical, Inc., 2012) has gone furthest, with 260 descendants of its own.
- 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. 2010, 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 BEACON T M Stabilization System, when used as a posterior pedlicle 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 (579 words)
The BEACON T M Stabilization System, when used as a posterior pedlicle 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 BEACON TM 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 pedlicle screw fixation for these patients are L3-sacrum/ilium.
When used as a posterior non-pedlicle screw fixation system, the BEACON TM 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 dlisease), fracture, pseudoarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are Ti-sacrum/ilium.
When used as an anterolateral thoracolumbar system, the BEACON TM 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 lordlosis), fracture or dislocation of the thoracolumbar spine, pseudloarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L-5.
The REVERE® 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, pseudloarthrosis and failed previous fusion.
In addition, the REVERE¶O 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 REVERE® 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 lordlosis, Scheuermann's disease), fracture, pseudoarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are Tl-sacrum/ilium.
When used as an anterolateral thoracolumbar system, the REVERE® 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, pseucloarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L-5.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100788: Cocr Rods.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100788
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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