510(k) · Cleared
ClearedACURA Stabilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Indius Medical Technologies Pvt., Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 26, 2020 as substantially equivalent to K142381 (Stryker Corp., 2014) and 6 other predicates after a 201-day review. Its family tree reaches back 18 generations to 2004. 1 of the 355 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 26, 2020
- Review
- 201 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 18 generations to K040583 (2004). 354 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 355 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations between
- 3 generations backK152968 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
- 2 generations backK161363 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2016
- 1 generation backK180458 FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC · 2018
- This deviceK200937 ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd. · 2020
Show all 18 generations
- Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 17 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 15 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 14 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 13 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 12 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 11 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 10 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 9 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 8 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 7 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 6 generations backK130646 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 5 generations backK133221 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2014 · Recalled
- 4 generations backK143149 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
- 3 generations backK152968 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
- 2 generations backK161363 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2016
- 1 generation backK180458 FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC · 2018
- This deviceK200937 ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd. · 2020
Class I recalls in this family
- K100952 Modification to Synthes Matrix System3 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −17 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −16 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −15 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −14 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −13 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −12 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −11 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −10 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −9 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −8 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −7 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −6 | K130646 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −5 | K133221 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2014 | 2 |
| −4 | K143149 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2015 | — |
| −3 | K152968 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2015 | — |
| −2 | K161363 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2016 | — |
| −1 | K180458 | FOCUS Pedicle Screw System | Nvision Biomedical Technologies, LLC | 2018 | — |
| 0 (this device) | K200937 | ACURA Stabilization System | Indius Medical Technologies Pvt., Ltd. | 2020 | — |
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 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 9 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 15 | 0 |
| 1999 | 13 | 0 |
| 2000 | 20 | 0 |
| 2001 | 26 | 0 |
| 2002 | 17 | 0 |
| 2003 | 21 | 0 |
| 2004 | 27 | 0 |
| 2005 | 24 | 0 |
| 2006 | 20 | 0 |
| 2007 | 23 | 0 |
| 2008 | 19 | 0 |
| 2009 | 16 | 0 |
| 2010 | 18 | 1 |
| 2011 | 12 | 0 |
| 2012 | 7 | 0 |
| 2013 | 8 | 0 |
| 2014 | 6 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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? (7)
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 |
|---|---|---|---|
| * | K142381 | Xia 3 Spinal SystemSummary page 5…Trade or Proprietary or Manufacturer Predicate Model Name Type K142381 Xia® 3 Spinal System Stryker Spine Primary K110280 REVLOK™ Fenestra… | 2014 |
| * | K110280 | Revlok Fenestrated Screw SystemSummary page 5…Model Name Type K142381 Xia® 3 Spinal System Stryker Spine Primary K110280 REVLOK™ Fenestrated Globus Medical Inc. Additional Screw System… | 2011 |
| * | K193365 | M.U.S.T. Pedicle Screw SystemSummary page 5…yker Spine Primary K110280 REVLOK™ Fenestrated Globus Medical Inc. Additional Screw System K193365 M.U.S.T. Pedicle Screw Medacta International Additional System… | 2020 |
| * | K180458 | FOCUS Pedicle Screw SystemSummary page 6…K200937 Page 3 of 3 K180458 FOCUS Pedicle Screw Nvision Biomedical Additional System… | 2018 |
| * | K131802 | Expedium, Viper. Viper 2 Spine SystemSummary page 6…0458 FOCUS Pedicle Screw Nvision Biomedical Additional System Technologies, LLC K131802 EXPEDIUM® Spine System DePuy Spine, Inc. Additional K180210 CREO® Stabilizat… | 2013 |
| * | K180210 | CREO® Stabilization SystemSummary page 6…System Technologies, LLC K131802 EXPEDIUM® Spine System DePuy Spine, Inc. Additional K180210 CREO® Stabilization Globus Medical Inc. Additional System K133350… | 2018 |
| * | K133350 | Revere Stabilization SystemSummary page 6…DePuy Spine, Inc. Additional K180210 CREO® Stabilization Globus Medical Inc. Additional System K133350 REVERE® Stabilization Globus Medical Inc. Additional System PERFORMA… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 38 of the 354 ancestors have a recall of any class; 1 has a Class I recall.
- 11 other devices also cite its predicate K142381.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
ACURA Stabilization System is intended to help provide immobilization and stabilization of spinal segments in skeletally mature patients (including small stature) and for pediatric patients as an adjunct to fusion using posterior pedicle screw fixation (T1-S2/Ilium), posterior hook fixation (T1-L5), or anterolateral fixation. These devices are indicated as an adjunct to fusion for the treatment of the following acute and chronic spinal instabilities or…
Read the full statement (170 words)
ACURA Stabilization System is intended to help provide immobilization and stabilization of spinal segments in skeletally mature patients (including small stature) and for pediatric patients as an adjunct to fusion using posterior pedicle screw fixation (T1-S2/Ilium), posterior hook fixation (T1-L5), or anterolateral fixation. These devices are indicated as an adjunct to fusion for the treatment of the following acute and chronic spinal instabilities or deformities:
1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
2. Degenerative spondylolisthesis
3. Trauma (fracture or dislocation)
4. Curvatures (Scoliosis, Kyphosis and /or Lordosis, Scheuermann’s disease)
5. Spinal tumours
6. Spinal Stenosis
7. Pseudarthrosis
8. Previous Failed Fusions
When used as an adjunct to fusion, ACURA Stabilization System is intended to be used with autograft and/or allograft.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the ACURA Stabilization System is intended as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200937 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200937: ACURA Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200937
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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