510(k) · Cleared
ClearedModification to Vertebron PSS Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vertebron, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jun 13, 2007 as substantially equivalent to K033352 (Vertebron, Inc., 2004) and 2 other predicates after a 27-day review. Its family tree reaches back 7 generations to 1995. 49 later devices descend from it.
- Decided
- Jun 13, 2007
- Review
- 27 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K951116 (1995). 26 ancestors in all, the oldest K933881 (1994). 49 later devices descend from it, 6 citing it directly.
- Root · 7 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
- 6 generations backK963639 Acromed Pedicle ScrewAcromed Corp. · 1996
- 5 generations backK982511 Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
- 4 generations backK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
- 3 generations backK033352 Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2004
- 2 generations backK043152 Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2005
- 1 generation backK051716 Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2005
- This deviceK071376 Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2007
- Descendant · cites it directly · 24 of its ownK073430 Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2008
- Descendant · cites it directly · 22 of its ownK081597 Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2008
- Descendant · 2 generations on · 21 of its ownK080767 Conquest Spinal SystemLife Spine · 2008
- Descendant · 3 generations on · 17 of its ownK123373 Nautilus Spinal SystemLife Spine · 2013
- Descendant · 4 generations on · 14 of its ownK132760 Nautilus Spinal SystemLife Spine, Inc. · 2013
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K073430Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2008 · cites it directly24descendants
- K081597Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc. · 2008 · cites it directly22descendants
- K080767Conquest Spinal SystemLife Spine · 2008 · 2 generations on21descendants
- K123373Nautilus Spinal SystemLife Spine · 2013 · 3 generations on17descendants
- K132760Nautilus Spinal SystemLife Spine, Inc. · 2013 · 4 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K951116 | Acromed Pedicle Screw | Acromed Corp. | 1995 | — |
| −6 | K963639 | Acromed Pedicle Screw | Acromed Corp. | 1996 | — |
| −5 | K982511 | Depuy Motech Moss Miami Spinal Systems | Depuy, Inc. | 1998 | — |
| −4 | K030383 | Modification to Moss Miami Spinal System Polyaxial Screws | Depuyacromed | 2003 | — |
| −3 | K033352 | Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2004 | — |
| −2 | K043152 | Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2005 | — |
| −1 | K051716 | Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2005 | — |
| 0 (this device) | K071376 | Modification to Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2007 | — |
| +1 | K073430 | Valeo Pedicle Screw Spinal System | Amedica Corp. | 2008 | — |
| +1 | K081597 | Modification to Vertebron PSS Pedicle Screw System | Vertebron, Inc. | 2008 | — |
| +2 | K080767 | Conquest Spinal System | Life Spine | 2008 | — |
| +3 | K123373 | Nautilus Spinal System | Life Spine | 2013 | — |
| +4 | K132760 | Nautilus Spinal System | Life Spine, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 7 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K033352 | Vertebron PSS Pedicle Screw SystemSummary page 1…le Screw Spinal System PROPRIETARY NAME: VERTEBRON T M PSS Pedicle Screw System PREDICATE DEVICES: VERTEBRON' T M PSS Pedicle Screw System - K033352, K043152 & K051716 DEVICE DESCRIPTION: The VERTEBRON PSS Pedicle Screw System is… | 2004 |
| * | K043152 | Vertebron PSS Pedicle Screw SystemSummary page 1…VERTEBRON T M PSS Pedicle Screw System PREDICATE DEVICES: VERTEBRON' T M PSS Pedicle Screw System - K033352, K043152 & K051716 DEVICE DESCRIPTION: The VERTEBRON PSS Pedicle Screw System is comprised… | 2005 |
| * | K051716 | Vertebron PSS Pedicle Screw SystemSummary page 1…VERTEBRON T M PSS Pedicle Screw System PREDICATE DEVICES: VERTEBRON' T M PSS Pedicle Screw System - K033352, K043152 & K051716 DEVICE DESCRIPTION: The VERTEBRON PSS Pedicle Screw System is comprised of non-ste… | 2005 |
What descends from it? (49)
See all 496 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073430 | Valeo Pedicle Screw Spinal System | 2008 | 24 |
| K081597 | Modification to Vertebron PSS Pedicle Screw System | 2008 | 22 |
| K131810 | Osseus Black Diamond Pedicle Screw System | 2013 | 14 |
| K132280 | Altus Spine Pedicle Screw System | 2013 | 6 |
| K151648 | Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle… | 2015 | 5 |
| K073531 | Accin Pedicle Screw System | 2008 | 0 |
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 12 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 26 ancestors have a recall of any class.
- Of its descendants, K073430 (Amedica Corp., 2008) has gone furthest, with 24 descendants of its own.
- 8 other devices also cite its predicate K033352.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 VERTEBRON PSST Pedicle Screw System is intended for noncervical, nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fision in…
Read the full statement (117 words)
The VERTEBRON PSST Pedicle Screw System is intended for noncervical, nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fision in skeletally mature patients. The VERTEBRON PSSM Pedicle Screw System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis (Grade 3 and 4 at L5-SI or degenerative spondylolisthesis with objective evidence of neurologic impairment); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071376 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071376: Modification to Vertebron PSS Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071376
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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