510(k) · Cleared
ClearedPalladian Lumbar Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurostructures, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Feb 25, 2015 as substantially equivalent to K000236 (Interpore Cross Intl., 2000) and 8 other predicates after a 107-day review. Its family tree reaches back 11 generations to 1990.
- Decided
- Feb 25, 2015
- Review
- 107 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 11 generations to K901587 (1990). 85 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 7 generations between
- 3 generations backK062670 Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated · 2007
- 2 generations backK073245 Extended Vertiflex Spinal Screw SystemVertiflex, Inc. · 2008
- 1 generation backK102870 Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc. · 2011
- This deviceK143230 Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc. · 2015
Show all 11 generations
- Root · 11 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 10 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 9 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 8 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- 7 generations backK993503 Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc. · 2000
- 6 generations backK021623 Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsIame, Inc. · 2002
- 5 generations backK032739 Ucr Spinal SystemSeaspine · 2003
- 4 generations backK043232 Ucr Spinal SystemSeaspine · 2004 · Recalled
- 3 generations backK062670 Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated · 2007
- 2 generations backK073245 Extended Vertiflex Spinal Screw SystemVertiflex, Inc. · 2008
- 1 generation backK102870 Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc. · 2011
- This deviceK143230 Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −10 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −9 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −8 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| −7 | K993503 | Haider-Ucr Spinal System | International Advanced Medical Enterprises, Inc. | 2000 | — |
| −6 | K021623 | Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments | Iame, Inc. | 2002 | — |
| −5 | K032739 | Ucr Spinal System | Seaspine | 2003 | — |
| −4 | K043232 | Ucr Spinal System | Seaspine | 2004 | 1 |
| −3 | K062670 | Vertiflex Spinal Screw System | Vertiflex (Tm), Incorporated | 2007 | — |
| −2 | K073245 | Extended Vertiflex Spinal Screw System | Vertiflex, Inc. | 2008 | — |
| −1 | K102870 | Exactech Proliant Polyaxial Pedicle Screw System | Exactech, Inc. | 2011 | — |
| 0 (this device) | K143230 | Palladian Lumbar Pedicle Screw System | Neurostructures, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 10 | 0 |
| 2001 | 3 | 0 |
| 2002 | 7 | 0 |
| 2003 | 9 | 0 |
| 2004 | 12 | 0 |
| 2005 | 8 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 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? (9)
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 |
|---|---|---|---|
| * | K000236 | Synergy VLS Cap Nut Models 2206, 6102Summary page 5…is submission is the Interpore Synergy VLS Open. Table 5-1 Predicate Devices 510k Number Trade or Proprietary or Model Name Manufacturer K000236 Synergy VLS Open Interpore K103490, K033901, K955348 Moss Miami Titan… | 2000 |
| * | K103490 | Expedium Spine System, Moss Miami Spine SystemSummary page 5…er Trade or Proprietary or Model Name Manufacturer K000236 Synergy VLS Open Interpore K103490, K033901, K955348 Moss Miami Titanium DePuy Spine Inc. K081080 TSRH… | 2011 |
| * | K033901 | Merlin Spine SystemSummary page 5…Trade or Proprietary or Model Name Manufacturer K000236 Synergy VLS Open Interpore K103490, K033901, K955348 Moss Miami Titanium DePuy Spine Inc. K081080 TSRH… | 2004 |
| * | K955348 | Titanium Moss Miami Spinal SystemSummary page 5…Trade or Proprietary or Model Name Manufacturer K000236 Synergy VLS Open Interpore K103490, K033901, K955348 Moss Miami Titanium DePuy Spine Inc. K081080 TSRH… | 1996 |
| * | K081080 | TSRH Spinal SystemSummary page 5…Synergy VLS Open Interpore K103490, K033901, K955348 Moss Miami Titanium DePuy Spine Inc. K081080 TSRH Medtronic K020279, K051971, K024096 OPTIMA™… | 2008 |
| * | K020279 | Forex Corporation, Optima, Spinal SystemSummary page 5…901, K955348 Moss Miami Titanium DePuy Spine Inc. K081080 TSRH Medtronic K020279, K051971, K024096 OPTIMA™ U&I Corporation K102870 Spine Prol… | 2002 |
| * | K051971 | Optima Spinal SystemSummary page 5…348 Moss Miami Titanium DePuy Spine Inc. K081080 TSRH Medtronic K020279, K051971, K024096 OPTIMA™ U&I Corporation K102870 Spine Proliant Scre… | 2005 |
| * | K024096 | Optima, Spinal SystemSummary page 5…Moss Miami Titanium DePuy Spine Inc. K081080 TSRH Medtronic K020279, K051971, K024096 OPTIMA™ U&I Corporation K102870 Spine Proliant Screw System… | 2003 |
| * | K102870 | Exactech Proliant Polyaxial Pedicle Screw SystemSummary page 5…TSRH Medtronic K020279, K051971, K024096 OPTIMA™ U&I Corporation K102870 Spine Proliant Screw System Exactech PERFORMANCE DATA The Palladian™ Lumbar Pedicle Sc… | 2011 |
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 25 years and passes through 10 companies; a new generation was cleared every 2.1 years on median.
- 14 of the 85 ancestors have a recall of any class.
- 11 other devices also cite its predicate K000236.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 use of the Palladian™ Lumbar Pedicle Screw System is indicated as an adjunct to fusion of the L5-S1 vertebra for the treatment of; degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformity, or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudoarthrosis, and previous failed fusion.
The Palladian™ Lumbar Pedicle Screw System is a non-cervical spinal fixation system, and intended for use with autograft and/or allograft. Pedicle screw fixation is limited to skeletally mature patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143230 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143230: Palladian Lumbar Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143230
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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