510(k) · Cleared
ClearedThe JASPER Spinal Fixation System II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gbs Commonwealth Co., Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jun 19, 2019 as substantially equivalent to K173645 (Gbs Commonwealth Co., Ltd., 2018) and 1 other predicate after an 86-day review. Its family tree reaches back 13 generations to 1999. 1 later device descends from it.
- Decided
- Jun 19, 2019
- Review
- 86 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K990745 (1999). 134 ancestors in all, the oldest K933881 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 9 generations between
- 3 generations backK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
- 2 generations backK173645 JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd. · 2018
- 1 generation backK182059 Prase MIS Spinal SystemGbs Commonwealth Co., Ltd. · 2018
- This deviceK190762 The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK232292 Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd. · 2023
Show all 13 generations
- Root · 13 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 12 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 11 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 10 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 9 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 8 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 7 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 6 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 5 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 4 generations backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- 3 generations backK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
- 2 generations backK173645 JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd. · 2018
- 1 generation backK182059 Prase MIS Spinal SystemGbs Commonwealth Co., Ltd. · 2018
- This deviceK190762 The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd. · 2019
Most influential descendants
Showing 1 of 1 · See all- K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −12 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −11 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −10 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −9 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −8 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −7 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −6 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −5 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| −4 | K102488 | Apex Spine System W/ Cocr Rods | Spinecraft, LLC | 2010 | — |
| −3 | K120270 | Venus Spinal Fixation System | L&K BIOMED Co., Ltd. | 2012 | — |
| −2 | K173645 | JASPER Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 2018 | — |
| −1 | K182059 | Prase MIS Spinal System | Gbs Commonwealth Co., Ltd. | 2018 | — |
| 0 (this device) | K190762 | The JASPER Spinal Fixation System II | Gbs Commonwealth Co., Ltd. | 2019 | — |
| +1 | K232292 | Peridot-EX Expandable Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 14 | 0 |
| 2001 | 10 | 0 |
| 2002 | 5 | 0 |
| 2003 | 10 | 0 |
| 2004 | 10 | 0 |
| 2005 | 13 | 0 |
| 2006 | 11 | 0 |
| 2007 | 6 | 0 |
| 2008 | 9 | 0 |
| 2009 | 6 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2016 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K173645 | JASPER Spinal Fixation SystemSummary page 4…uct Introduction of The JASPER Spinal Fixation System II. The Purpose of this 510(k) submission is to combine the existing 510(k) clearance system (K173645 and K182059). The JASPER Spinal Fixation System II has the same intended use and fundamental scientific technology as… | 2018 |
| * | K182059 | Prase MIS Spinal SystemSummary page 4…tion of The JASPER Spinal Fixation System II. The Purpose of this 510(k) submission is to combine the existing 510(k) clearance system (K173645 and K182059). The JASPER Spinal Fixation System II has the same intended use and fundamental scientific technology as the previous… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232292 | Peridot-EX Expandable Intervertebral Body Fusion System | 2023 | 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 20 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 13 of the 134 ancestors have a recall of any class.
- Of its descendants, K232292 (Gbs Commonwealth Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K173645.
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 JASPER Spinal Fixation System II is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: The JASPER Spinal Fixation System II is indicated for the…
Read the full statement (242 words)
The JASPER Spinal Fixation System II is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use:
The JASPER Spinal Fixation System II is indicated for the following:
- 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)
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- Tumor
- Stenosis
- Pseudoarthrosis
- Failed previous fusion
The JASPER Spinal Fixation System II is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the JASPER Spinal Fixation System II 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 spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190762: The JASPER Spinal Fixation System II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190762
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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