510(k) · Cleared
ClearedBlack Diamond Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osseus Fusion Systems · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 29, 2019 as substantially equivalent to K090984 (Nexxt Spine, LLC, 2009) and 10 other predicates after an 84-day review. Its family tree reaches back 19 generations to 2001. 1 of the 536 devices in its family, counting itself, has a Class I recall. 13 later devices descend from it.
- Decided
- Oct 29, 2019
- Review
- 84 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 19 generations to K003155 (2001). 522 ancestors in all, the oldest K781443 (1978). 13 later devices descend from it, 1 citing it directly. 1 of the 536 devices in this family, counting this one, has a Class I recall.
- Root · 19 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 15 generations between
- 3 generations backK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
- 2 generations backK150896 Vitality Spinal Fixation SystemZimmer Spine, Inc. · 2015 · Recalled
- 1 generation backK171907 Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc. · 2017 · Recalled
- This deviceK192121 Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019
- Descendant · cites it directly · 12 of its ownK213935 PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022
- Descendant · 2 generations on · 5 of its ownK231199 Solar Lumbar Interbody Fusion SystemDegen Medical · 2023
- Descendant · 2 generations on · 4 of its ownK240326 Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc. · 2024
- Descendant · 2 generations on · 3 of its ownK223413 Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems · 2023
- Descendant · 3 generations on · 2 of its ownK241077 DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical · 2024
Show all 19 generations
- Root · 19 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 18 generations backK012254 VBROsteotech, Inc. · 2001
- 17 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 16 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 15 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 14 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 10 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
- 9 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 8 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- 7 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 6 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
- 5 generations backK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
- 4 generations backK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
- 3 generations backK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
- 2 generations backK150896 Vitality Spinal Fixation SystemZimmer Spine, Inc. · 2015 · Recalled
- 1 generation backK171907 Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc. · 2017 · Recalled
- This deviceK192121 Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K100952 Modification to Synthes Matrix System4 generations back · 2010
Most influential descendants
Showing 5 of 13 · See all- K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022 · cites it directly12descendants
- K231199Solar Lumbar Interbody Fusion SystemDegen Medical · 2023 · 2 generations on5descendants
- K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc. · 2024 · 2 generations on4descendants
- K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems · 2023 · 2 generations on3descendants
- K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical · 2024 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −18 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −17 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −16 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −15 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −14 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −12 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −11 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −10 | K061938 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| −9 | K062427 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −8 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| −7 | K110522 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −6 | K113593 | Nextgen Altius Oct System | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
| −5 | K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement System | Biomet Spine (Aka Ebi, LLC) | 2013 | 2 |
| −4 | K131615 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2013 | — |
| −3 | K133746 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2014 | 1 |
| −2 | K150896 | Vitality Spinal Fixation System | Zimmer Spine, Inc. | 2015 | 3 |
| −1 | K171907 | Vitality® Spinal Fixation System | Zimmer Biomet Spine, Inc. | 2017 | 2 |
| 0 (this device) | K192121 | Black Diamond Pedicle Screw System | Osseus Fusion Systems | 2019 | — |
| +1 | K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems | 2022 | — |
| +2 | K231199 | Solar Lumbar Interbody Fusion System | Degen Medical | 2023 | — |
| +2 | K240326 | Solar™ Lumbar Interbody Fusion System | Degen Medical, Inc. | 2024 | — |
| +2 | K223413 | Pisces™-SA STANDALONE ALIF Interbody System | Osseus Fusion Systems | 2023 | — |
| +3 | K241077 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | 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 | 6 | 0 |
| 1993 | 4 | 0 |
| 1994 | 3 | 0 |
| 1995 | 11 | 0 |
| 1996 | 12 | 0 |
| 1997 | 13 | 0 |
| 1998 | 23 | 0 |
| 1999 | 22 | 0 |
| 2000 | 29 | 0 |
| 2001 | 35 | 0 |
| 2002 | 27 | 0 |
| 2003 | 28 | 0 |
| 2004 | 51 | 0 |
| 2005 | 45 | 0 |
| 2006 | 31 | 0 |
| 2007 | 25 | 0 |
| 2008 | 31 | 0 |
| 2009 | 26 | 0 |
| 2010 | 28 | 1 |
| 2011 | 17 | 0 |
| 2012 | 11 | 0 |
| 2013 | 9 | 0 |
| 2014 | 8 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 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? (11)
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 |
|---|---|---|---|
| * | K090984 | Inertia Pedicle Screw SystemSummary page 4…Product Code CFR Section 21 CFR section 888.3070 Device Panel Orthopedic Primary Predicate INERTIA Pedicle Screw System, NEXXT Spine (K090984/ K101278/ K132412/ Device K153453) Black Diamond Pedicle Screw System, Osseus Fusion… | 2009 |
| * | K101278 | Inertia Pedicle Screw SystemSummary page 4…ode CFR Section 21 CFR section 888.3070 Device Panel Orthopedic Primary Predicate INERTIA Pedicle Screw System, NEXXT Spine (K090984/ K101278/ K132412/ Device K153453) Black Diamond Pedicle Screw System, Osseus Fusion Systems (… | 2010 |
| * | K132412 | Inertia Mis Pedicle Screw SystemSummary page 4…Section 21 CFR section 888.3070 Device Panel Orthopedic Primary Predicate INERTIA Pedicle Screw System, NEXXT Spine (K090984/ K101278/ K132412/ Device K153453) Black Diamond Pedicle Screw System, Osseus Fusion Systems (K131810)… | 2013 |
| * | K153453 | Inertia Pedicle Screw and Deformity Correxxion SystemSummary page 4…on 888.3070 Device Panel Orthopedic Primary Predicate INERTIA Pedicle Screw System, NEXXT Spine (K090984/ K101278/ K132412/ Device K153453) Black Diamond Pedicle Screw System, Osseus Fusion Systems (K131810) Secondary Predicate Vitality… | 2016 |
| * | K131810 | Osseus Black Diamond Pedicle Screw SystemSummary page 4…ew System, NEXXT Spine (K090984/ K101278/ K132412/ Device K153453) Black Diamond Pedicle Screw System, Osseus Fusion Systems (K131810) Secondary Predicate Vitality® Spinal Fixation System, Zimmer Spine, Inc. (K150896 / K1719007) Devices Xia… | 2013 |
| * | K150896 | Vitality Spinal Fixation SystemSummary page 4…Black Diamond Pedicle Screw System, Osseus Fusion Systems (K131810) Secondary Predicate Vitality® Spinal Fixation System, Zimmer Spine, Inc. (K150896 / K1719007) Devices Xia® 3 Spinal System, Stryker Spine (K091291 / K113666 / K142381) S… | 2015 |
| * | K171907 | Vitality® Spinal Fixation System Our reading of the summary gave K171900, FDA’s number for Acclarix AX4 Diagnostic Ultrasound System (Edan Instruments, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Vitality® Spinal Fixation System, Zimmer Spine, Inc.”. | 2017 |
| * | K091291 | Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodSummary page 4…131810) Secondary Predicate Vitality® Spinal Fixation System, Zimmer Spine, Inc. (K150896 / K1719007) Devices Xia® 3 Spinal System, Stryker Spine (K091291 / K113666 / K142381) Savannah-T Dual Fix, Amendia (K132925) Synergy VLS – open… | 2009 |
| * | K113666 | Xia 3 Spinal SystemSummary page 4…econdary Predicate Vitality® Spinal Fixation System, Zimmer Spine, Inc. (K150896 / K1719007) Devices Xia® 3 Spinal System, Stryker Spine (K091291 / K113666 / K142381) Savannah-T Dual Fix, Amendia (K132925) Synergy VLS – open, Cross Me… | 2012 |
| * | K142381 | Xia 3 Spinal SystemSummary page 4…redicate Vitality® Spinal Fixation System, Zimmer Spine, Inc. (K150896 / K1719007) Devices Xia® 3 Spinal System, Stryker Spine (K091291 / K113666 / K142381) Savannah-T Dual Fix, Amendia (K132925) Synergy VLS – open, Cross Medical Prod… | 2014 |
| * | K132925 | Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T…Summary page 4…c. (K150896 / K1719007) Devices Xia® 3 Spinal System, Stryker Spine (K091291 / K113666 / K142381) Savannah-T Dual Fix, Amendia (K132925) Synergy VLS – open, Cross Medical Products (K940631 / K950099) Reference Predicate Moss Miami SS,… | 2014 |
| † | K940631 | Cross Medical - Synergy (TM) Spine System | 1995 |
| † | K950099 | Synergy (TM) TI Posterior Spinal System | 1997 |
| † | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | 1995 |
| † | K954696 | Rogozinski Thoracolumbar Spinal Rod | 1996 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213935 | PISCES-SA Standalone ALIF Interbody System | 2022 | 12 |
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 18 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 53 of the 522 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K213935 (Osseus Fusion Systems, 2022) has gone furthest, with 12 descendants of its own.
- 4 other devices also cite its predicate K090984.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Black Diamond Pedicle Screw System, with or without MIS instrumentation, 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 thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and…
Read the full statement (185 words)
The Black Diamond Pedicle Screw System, with or without MIS instrumentation, 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 thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Black Diamond Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Black Diamond Pedicle Screw System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
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/K192121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192121: Black Diamond 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/K192121
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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