510(k) · Cleared
ClearedGREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Greens Surgicals Pvt., Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 10, 2024 as substantially equivalent to K121342 (Stryker Corp., 2012) and 2 other predicates after a 612-day review. Its family tree reaches back 18 generations to 2001. 1 of the 329 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 10, 2024
- Review
- 612 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 18 generations to K003155 (2001). 328 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 329 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 14 generations between
- 3 generations backK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
- 2 generations backK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
- 1 generation backK150896 Vitality Spinal Fixation SystemZimmer Spine, Inc. · 2015 · Recalled
- This deviceK230325 GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd. · 2024
Show all 18 generations
- Root · 18 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 17 generations backK012254 VBROsteotech, Inc. · 2001
- 16 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 15 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 14 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 13 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 9 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
- 8 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 7 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- 6 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 5 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
- 4 generations backK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
- 3 generations backK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
- 2 generations backK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
- 1 generation backK150896 Vitality Spinal Fixation SystemZimmer Spine, Inc. · 2015 · Recalled
- This deviceK230325 GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd. · 2024
Class I recalls in this family
- K100952 Modification to Synthes Matrix System4 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −17 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −16 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −15 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −14 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −13 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −12 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −11 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −10 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −9 | K061938 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| −8 | K062427 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −7 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| −6 | K110522 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −5 | K113593 | Nextgen Altius Oct System | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
| −4 | K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement System | Biomet Spine (Aka Ebi, LLC) | 2013 | 2 |
| −3 | K131615 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2013 | — |
| −2 | K133746 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2014 | 1 |
| −1 | K150896 | Vitality Spinal Fixation System | Zimmer Spine, Inc. | 2015 | 3 |
| 0 (this device) | K230325 | GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System | Greens Surgicals Pvt., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 6 | 0 |
| 1996 | 6 | 0 |
| 1997 | 7 | 0 |
| 1998 | 12 | 0 |
| 1999 | 9 | 0 |
| 2000 | 21 | 0 |
| 2001 | 22 | 0 |
| 2002 | 16 | 0 |
| 2003 | 18 | 0 |
| 2004 | 36 | 0 |
| 2005 | 31 | 0 |
| 2006 | 23 | 0 |
| 2007 | 12 | 0 |
| 2008 | 19 | 0 |
| 2009 | 20 | 0 |
| 2010 | 16 | 1 |
| 2011 | 11 | 0 |
| 2012 | 5 | 0 |
| 2014 | 3 | 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.
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? (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 |
|---|---|---|---|
| * | K121342 | Xia 4.5 Spinal SystemSummary page 6…Following are the predicate devices with which we are declaring substantial equivalence : Primary predicate device: Stryker Xia 4.5mm Evolution Polyaxial Screw (K121342) Additional predicate devices: CD HORIZON® Multi- Axial Screw (K152457) Zimmer Vital Polyaxial Screw (K150896) === Page 7… | 2012 |
| * | K152457 | CD HORIZON Spinal SystemSummary page 6…ial equivalence : Primary predicate device: Stryker Xia 4.5mm Evolution Polyaxial Screw (K121342) Additional predicate devices: CD HORIZON® Multi- Axial Screw (K152457) Zimmer Vital Polyaxial Screw (K150896)… | 2015 |
| * | K150896 | Vitality Spinal Fixation SystemSummary page 6…evice: Stryker Xia 4.5mm Evolution Polyaxial Screw (K121342) Additional predicate devices: CD HORIZON® Multi- Axial Screw (K152457) Zimmer Vital Polyaxial Screw (K150896) K230325… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 34 of the 328 ancestors have a recall of any class; 1 has a Class I recall.
- 4 other devices also cite its predicate K121342.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 GREENS BRAND Posterior, Non‐cervical Pedicle Screw Spinal System is a pedicle screw fixation system intended for 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…
Read the full statement (176 words)
The GREENS BRAND Posterior, Non‐cervical Pedicle Screw Spinal System is a pedicle screw fixation system intended for 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)
• Spondylolisthesis
• Trauma (e.g., fracture or dislocation)
• Deformity or curvature (e.g., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Spinal stenosis
• Pseudarthrosis
• Failed previous fusion
Paediatric Use:
When used for posterior non‐cervical screw fixation in paediatric patients, the GREENS BRAND Posterior, Non‐cervical Pedicle Screw Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, it is intended to treat paediatric patients diagnosed with the following conditions:
• Spondylolisthesis
• Spondylolysis
• Fracture caused by tumor and/or trauma.
Paediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230325 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230325: GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230325
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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