510(k) · Cleared
ClearedPitkar Spinal Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
S.H.Pitkar Orthotools Pvt., Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Sep 9, 2024 as substantially equivalent to K043578 (Solco Biomedical Co., Ltd., 2005) and 5 other predicates after a 224-day review. Its family tree reaches back 17 generations to 1999.
- Decided
- Sep 9, 2024
- Review
- 224 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 17 generations to K990745 (1999). 208 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.
- Root · 17 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 13 generations between
- 3 generations backK162995 Ibis® Pedicle Screw SystemOrtho Development Corporation · 2017
- 2 generations backK161225 Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd. · 2017
- 1 generation backK180226 TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd. · 2018
- This deviceK240233 Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd. · 2024
Show all 17 generations
- Root · 17 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 16 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 15 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 14 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 13 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 12 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 11 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 10 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 9 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 8 generations backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- 7 generations backK110906 Apex Spine SystemSpinecraft, LLC · 2011
- 6 generations backK113058 Tiger Spine SystemCorelink, LLC · 2012
- 5 generations backK131785 Pagoda Pedicle Screw SystemOrtho Development Corp. · 2013
- 4 generations backK142146 Ibis Pedicle Screw SystemOrtho Development Corp. · 2014
- 3 generations backK162995 Ibis® Pedicle Screw SystemOrtho Development Corporation · 2017
- 2 generations backK161225 Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd. · 2017
- 1 generation backK180226 TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd. · 2018
- This deviceK240233 Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −16 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −15 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −14 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −13 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −12 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −11 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −10 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −9 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| −8 | K102488 | Apex Spine System W/ Cocr Rods | Spinecraft, LLC | 2010 | — |
| −7 | K110906 | Apex Spine System | Spinecraft, LLC | 2011 | — |
| −6 | K113058 | Tiger Spine System | Corelink, LLC | 2012 | — |
| −5 | K131785 | Pagoda Pedicle Screw System | Ortho Development Corp. | 2013 | — |
| −4 | K142146 | Ibis Pedicle Screw System | Ortho Development Corp. | 2014 | — |
| −3 | K162995 | Ibis® Pedicle Screw System | Ortho Development Corporation | 2017 | — |
| −2 | K161225 | Paonan Armstrong Posterior Spinal Fixation System | Paonan Biotech Co., Ltd. | 2017 | — |
| −1 | K180226 | TREND II Spinal Fixation System- STEP Series | Paonan Biotech Co., Ltd. | 2018 | — |
| 0 (this device) | K240233 | Pitkar Spinal Pedicle Screw System | S.H.Pitkar Orthotools Pvt., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 8 | 0 |
| 1996 | 8 | 0 |
| 1997 | 8 | 0 |
| 1998 | 15 | 0 |
| 1999 | 9 | 0 |
| 2000 | 15 | 0 |
| 2001 | 16 | 0 |
| 2002 | 7 | 0 |
| 2003 | 10 | 0 |
| 2004 | 21 | 0 |
| 2005 | 17 | 0 |
| 2006 | 12 | 0 |
| 2007 | 6 | 0 |
| 2008 | 7 | 0 |
| 2009 | 7 | 0 |
| 2010 | 6 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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? (6)
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 |
|---|---|---|---|
| * | K043578 | The 4CIS Spinal System and 4CIS Low Back SystemSummary page 5…(21 CFR 888.3060) Classification Name: Regulatory Class: II 3. Predicate Device(s): • Primary Predicate Device: K043578 (4CIS Spinal System and 4CIS Low Back System) • Additional Predicates: K082572(Synthes USS Polyaxial System,… | 2005 |
| * | K082572 | Uss Iliosacral, Uss PolyaxialSummary page 5…I 3. Predicate Device(s): • Primary Predicate Device: K043578 (4CIS Spinal System and 4CIS Low Back System) • Additional Predicates: K082572(Synthes USS Polyaxial System, Synthes USS Iliosacral System), K090648 (VIPER II Syste… | 2008 |
| * | K090648 | Viper 2 SystemSummary page 5…ck System) • Additional Predicates: K082572(Synthes USS Polyaxial System, Synthes USS Iliosacral System), K090648 (VIPER II System), K190471 (4CIS Chiron Spinal Fixation System), K180226 (TREND II… | 2009 |
| * | K190471 | 4CIS® Chiron Spinal Fixation SystemSummary page 5…nal Predicates: K082572(Synthes USS Polyaxial System, Synthes USS Iliosacral System), K090648 (VIPER II System), K190471 (4CIS Chiron Spinal Fixation System), K180226 (TREND II… | 2019 |
| * | K180226 | TREND II Spinal Fixation System- STEP SeriesSummary page 5…Iliosacral System), K090648 (VIPER II System), K190471 (4CIS Chiron Spinal Fixation System), K180226 (TREND II Spinal Fixation System- STEP Series), K201457 (Auxein… | 2018 |
| * | K201457 | Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemSummary page 5…(4CIS Chiron Spinal Fixation System), K180226 (TREND II Spinal Fixation System- STEP Series), K201457 (Auxein Brand Vertaux 5.5 mm Pedicle Screw System) • Reference Device… | 2021 |
| † | K192619 | Pitkar Locked Plating System | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 14 of the 208 ancestors have a recall of any class.
- 1 other device also cites its predicate K043578.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Pitkar Spinal Pedicle Screw System is intended for non-cervical posterior and anterolateral fixation of the spine 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/or sacral spine: 1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc…
Read the full statement (101 words)
The Pitkar Spinal Pedicle Screw System is intended for non-cervical posterior and anterolateral fixation of the spine 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/or sacral spine:
1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies);
2. Spondylolisthesis;
3. Trauma (i.e., fracture or dislocation);
4. Spinal Stenosis;
5. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
6. Tumor;
7. Pseudoarthrosis and/or failed previous fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240233: Pitkar Spinal 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/K240233
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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