510(k) · Cleared
ClearedDiplomat® Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signus Medizintechnik GmbH · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Apr 13, 2016 as substantially equivalent to K000236 (Interpore Cross Intl., 2000) and 12 other predicates after a 294-day review. Its family tree reaches back 11 generations to 1990. 1 of the 258 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Apr 13, 2016
- Review
- 294 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 13
Its longest line of descent runs back 11 generations to K901587 (1990). 253 ancestors in all, the oldest K781443 (1978). 4 later devices descend from it, 2 citing it directly. 1 of the 258 devices in this family, counting this one, has a Class I recall.
- 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 deviceK151704 Diplomat® Spinal SystemSignus Medizintechnik GmbH · 2016
- Descendant · cites it directly · 2 of its ownK191932 Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA · 2019
- Descendant · 2 generations on · 1 of its ownK231809 Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone…Ulrich Medical USA · 2023
- Descendant · 2 generations on · 0 of its ownK251719 Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK243281 LOCK-IN Spinal Fixation SystemLock-In USA Corp · 2024
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 deviceK151704 Diplomat® Spinal SystemSignus Medizintechnik GmbH · 2016
Class I recalls in this family
- K100952 Modification to Synthes Matrix System2 generations back · 2010
Most influential descendants
Showing 4 of 4 · See all- K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA · 2019 · cites it directly2descendants
- K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA · 2023 · 2 generations on1descendant
- K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc. · 2025 · 2 generations on0descendants
- K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp · 2024 · cites it directly0descendants
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) | K151704 | Diplomat® Spinal System | Signus Medizintechnik GmbH | 2016 | — |
| +1 | K191932 | Momentum™ Posterior Spinal Fixation System | Ulrich Medical USA | 2019 | — |
| +2 | K231809 | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement… | Ulrich Medical USA | 2023 | — |
| +2 | K251719 | Momentum® Posterior Spinal Fixation System | Ulrich Medical USA, Inc. | 2025 | — |
| +1 | K243281 | LOCK-IN Spinal Fixation System | Lock-In USA Corp | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 6 | 0 |
| 1998 | 10 | 0 |
| 1999 | 10 | 0 |
| 2000 | 18 | 0 |
| 2001 | 14 | 0 |
| 2002 | 17 | 0 |
| 2003 | 19 | 0 |
| 2004 | 27 | 0 |
| 2005 | 24 | 0 |
| 2006 | 13 | 0 |
| 2007 | 11 | 0 |
| 2008 | 12 | 0 |
| 2009 | 12 | 0 |
| 2010 | 7 | 1 |
| 2011 | 9 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (13)
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 6…on Table 5-1 Predicate Devices 510k Number Trade or Proprietary or Manufacturer Type Model Name K000236 Synergy VLS Open Interpore Primary K131820, K103490, K033901, Moss Miami… | 2000 |
| * | K131820 | Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon System, 10G, Avamax…Summary page 6…Manufacturer Type Model Name K000236 Synergy VLS Open Interpore Primary K131820, K103490, K033901, Moss Miami Titanium DePuy Spine Inc. Additional K955348 K081080… | 2013 |
| * | K103490 | Expedium Spine System, Moss Miami Spine SystemSummary page 6…acturer Type Model Name K000236 Synergy VLS Open Interpore Primary K131820, K103490, K033901, Moss Miami Titanium DePuy Spine Inc. Additional K955348 K081080 TSRH… | 2011 |
| * | K033901 | Merlin Spine SystemSummary page 6…Type Model Name K000236 Synergy VLS Open Interpore Primary K131820, K103490, K033901, Moss Miami Titanium DePuy Spine Inc. Additional K955348 K081080 TSRH… | 2004 |
| * | K955348 | Titanium Moss Miami Spinal SystemSummary page 6…Synergy VLS Open Interpore Primary K131820, K103490, K033901, Moss Miami Titanium DePuy Spine Inc. Additional K955348 K081080 TSRH Medtronic Additional K020279, K051971, K024096… | 1996 |
| * | K081080 | TSRH Spinal SystemSummary page 6…Synergy VLS Open Interpore Primary K131820, K103490, K033901, Moss Miami Titanium DePuy Spine Inc. Additional K955348 K081080 TSRH Medtronic Additional K020279, K051971, K024096 OPTIMA™… | 2008 |
| * | K020279 | Forex Corporation, Optima, Spinal SystemSummary page 6…Moss Miami Titanium DePuy Spine Inc. Additional K955348 K081080 TSRH Medtronic Additional K020279, K051971, K024096 OPTIMA™ U&I Corporation Additional K102870 Spine P… | 2002 |
| * | K051971 | Optima Spinal SystemSummary page 6…iami Titanium DePuy Spine Inc. Additional K955348 K081080 TSRH Medtronic Additional K020279, K051971, K024096 OPTIMA™ U&I Corporation Additional K102870 Spine Proliant S… | 2005 |
| * | K024096 | Optima, Spinal SystemSummary page 6…nium DePuy Spine Inc. Additional K955348 K081080 TSRH Medtronic Additional K020279, K051971, K024096 OPTIMA™ U&I Corporation Additional K102870 Spine Proliant Screw… | 2003 |
| * | K102870 | Exactech Proliant Polyaxial Pedicle Screw SystemSummary page 6…TSRH Medtronic Additional K020279, K051971, K024096 OPTIMA™ U&I Corporation Additional K102870 Spine Proliant Screw Exactech Additional System… | 2011 |
| * | K120838 | Synthes Matrix SystemSummary page 6…&I Corporation Additional K102870 Spine Proliant Screw Exactech Additional System K120838 Matrix System Synthes Additional K110280 Revlok… | 2012 |
| * | K110280 | Revlok Fenestrated Screw SystemSummary page 6…xactech Additional System K120838 Matrix System Synthes Additional K110280 Revlok Globus Additional K123717 UCentum… | 2011 |
| * | K123717 | UcentumSummary page 6…Matrix System Synthes Additional K110280 Revlok Globus Additional K123717 UCentum Ulrich Additional… | 2013 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 10 companies; a new generation was cleared every 2.1 years on median.
- 40 of the 253 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K191932 (Ulrich Medical USA, 2019) has gone furthest, with 2 descendants of its own.
- 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. 2016, 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 DIPLOMAT® Spinal 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…
Read the full statement (166 words)
The DIPLOMAT® Spinal 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)
- Spondylolisthesis
- Spinal stenosis
- Fracture
- Dislocation
- Scoliosis
- Kyphosis
- Spinal tumor
- Pseudoarthrosis
- Failed previous fusion
In addition, the DIPLOMAT® Spinal 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.
The DIPLOMAT® Spinal System is intended to be used with autograft and/or allograft.
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/K151704 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151704: Diplomat® Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151704
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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