510(k) · Cleared
ClearedGoblin and Goblin LS Pedicle Screw Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medynus, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Apr 19, 2021 as substantially equivalent to K061202 (Globus Medical, Inc., 2006) and 4 other predicates after a 67-day review. Its family tree reaches back 10 generations to 1999. 1 later device descends from it.
- Decided
- Apr 19, 2021
- Review
- 67 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K990745 (1999). 60 ancestors in all, the oldest K933881 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 6 generations between
- 3 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 2 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 1 generation backK173131 Rexious Spinal Fixation SystemHuvexel Co., Ltd. · 2017
- This deviceK210420 Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK260362 QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal…MANTIZ Co., Ltd. · 2026
Show all 10 generations
- Root · 10 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 9 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 8 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 7 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 6 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 5 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 4 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 3 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 2 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 1 generation backK173131 Rexious Spinal Fixation SystemHuvexel Co., Ltd. · 2017
- This deviceK210420 Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −9 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −8 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −7 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −6 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −5 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −4 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −3 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −2 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| −1 | K173131 | Rexious Spinal Fixation System | Huvexel Co., Ltd. | 2017 | — |
| 0 (this device) | K210420 | Goblin and Goblin LS Pedicle Screw Systems | Medynus, Inc. | 2021 | — |
| +1 | K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS… | MANTIZ Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 8 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 7 | 0 |
| 2004 | 7 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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? (5)
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 |
|---|---|---|---|
| * | K061202 | Revere Stabilization SystemSummary page 5…s or better than the legally marketed predicate devices. Predicate Device: Primary predicate: Globus Medical - REVERE Stabilization System (K061202 and K093294) Additional predicates: Huvexel - Rexious Spinal Fixation System (K11… | 2006 |
| * | K093294 | Revere Stabilization SystemSummary page 5…than the legally marketed predicate devices. Predicate Device: Primary predicate: Globus Medical - REVERE Stabilization System (K061202 and K093294) Additional predicates: Huvexel - Rexious Spinal Fixation System (K111362 and K17… | 2010 |
| * | K111362 | Rexious Spinal Fixation SystemSummary page 5…ical - REVERE Stabilization System (K061202 and K093294) Additional predicates: Huvexel - Rexious Spinal Fixation System (K111362 and K173131) and CG Bio. Co. Ltd.- LumFix Spinal Fixation System (K160731). Refer… | 2011 |
| * | K173131 | Rexious Spinal Fixation SystemSummary page 5…K061202 and K093294) Additional predicates: Huvexel - Rexious Spinal Fixation System (K111362 and K173131) and CG Bio. Co. Ltd.- LumFix Spinal Fixation System (K160731). Reference Devices: K171808 - TDM Sma… | 2017 |
| * | K160731 | LumFix Spinal Fixation SytemSummary page 5…ates: Huvexel - Rexious Spinal Fixation System (K111362 and K173131) and CG Bio. Co. Ltd.- LumFix Spinal Fixation System (K160731). Reference Devices: K171808 - TDM Small Locking Plate and Screw System K190830 - TDM Screw System T… | 2016 |
| † | K171808 | TDM Plate and Screw System | 2018 |
| † | K190830 | TDM Screw Systems | 2019 |
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 |
|---|---|---|---|
| K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS… | 2026 | 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 22 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 8 of the 60 ancestors have a recall of any class.
- Of its descendants, K260362 (MANTIZ Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 29 other devices also cite its predicate K061202.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Goblin and Goblin LS Pedicle Screw Systems are intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion 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 and pseudarthrosis
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/K210420 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210420: Goblin and Goblin LS Pedicle Screw Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210420
Report an extraction error
Are you the manufacturer?
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