510(k) · Cleared
ClearedThunderbolt and Lancer Pedicle Screw Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Choicespine · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Aug 15, 2014 as substantially equivalent to K102204 (Choicespine, LP, 2010) and 3 other predicates after a 409-day review. Its family tree reaches back 10 generations to 1985. 82 later devices descend from it.
- Decided
- Aug 15, 2014
- Review
- 409 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K853033 (1985). 100 ancestors in all. 82 later devices descend from it, 5 citing it directly.
- Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 6 generations between
- 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 1 generation backK102204 Choice Spine Starfire Pedicle Screw SystemChoicespine, LP · 2010
- This deviceK132049 Thunderbolt and Lancer Pedicle Screw SystemsChoicespine · 2014
- Descendant · cites it directly · 73 of its ownK160775 Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP · 2016
- Descendant · 2 generations on · 70 of its ownK181677 Kodiak Spinal Fixation SystemAlphatec Spine, Inc. · 2018
- Descendant · 3 generations on · 69 of its ownK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
- Descendant · 3 generations on · 61 of its ownK203056 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- Descendant · 4 generations on · 59 of its ownK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
Show all 10 generations
- Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 9 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 8 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 7 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 6 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 5 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 4 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 1 generation backK102204 Choice Spine Starfire Pedicle Screw SystemChoicespine, LP · 2010
- This deviceK132049 Thunderbolt and Lancer Pedicle Screw SystemsChoicespine · 2014
Showing 5 of 82 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 82 · See all- K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP · 2016 · cites it directly73descendants
- K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc. · 2018 · 2 generations on70descendants
- K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019 · 3 generations on69descendants
- K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · 3 generations on61descendants
- K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021 · 4 generations on59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −9 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −8 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −7 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −6 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −5 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −4 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −3 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −2 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −1 | K102204 | Choice Spine Starfire Pedicle Screw System | Choicespine, LP | 2010 | — |
| 0 (this device) | K132049 | Thunderbolt and Lancer Pedicle Screw Systems | Choicespine | 2014 | — |
| +1 | K160775 | Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems | Choicespine, LP | 2016 | — |
| +2 | K181677 | Kodiak Spinal Fixation System | Alphatec Spine, Inc. | 2018 | — |
| +3 | K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019 | — |
| +3 | K203056 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| +4 | K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 8 | 0 |
| 1999 | 7 | 0 |
| 2000 | 11 | 0 |
| 2001 | 4 | 0 |
| 2002 | 11 | 0 |
| 2003 | 10 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 8 | 0 |
| 2023 | 12 | 0 |
| 2024 | 15 | 0 |
| 2025 | 16 | 0 |
| 2026 | 15 | 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? (4)
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 |
|---|---|---|---|
| * | K102204 | Choice Spine Starfire Pedicle Screw SystemSummary page 5…d implant construct. Predicate Device(s): The THUNDERBOLT™ and LANCER™ Pedicle Screw System is substantially equivalent to the previously cleared Choice Spine Starfire (K102204), Pioneer Surgical Streamline (K111502), DePuy Moss Miami (K983583) and U&I Optima (K031585). Performance Standards: Performance… | 2010 |
| * | K111502 | Streamline TL Spinal SystemSummary page 5…s): The THUNDERBOLT™ and LANCER™ Pedicle Screw System is substantially equivalent to the previously cleared Choice Spine Starfire (K102204), Pioneer Surgical Streamline (K111502), DePuy Moss Miami (K983583) and U&I Optima (K031585). Performance Standards: Performance testing was completed by an independen… | 2011 |
| * | K983583 | Depuy Acromed Moss and Moss Miami Spinal SystemsSummary page 5…CER™ Pedicle Screw System is substantially equivalent to the previously cleared Choice Spine Starfire (K102204), Pioneer Surgical Streamline (K111502), DePuy Moss Miami (K983583) and U&I Optima (K031585). Performance Standards: Performance testing was completed by an independent laboratory following ASTM… | 1998 |
| * | K031585 | U&I, Optima, Spinal SystemSummary page 5…is substantially equivalent to the previously cleared Choice Spine Starfire (K102204), Pioneer Surgical Streamline (K111502), DePuy Moss Miami (K983583) and U&I Optima (K031585). Performance Standards: Performance testing was completed by an independent laboratory following ASTM F1717 and ASTM F1798. The… | 2003 |
What descends from it? (82)
See all 825 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160775 | Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems | 2016 | 73 |
| K150380 | ProMIS Fixation System | 2015 | 4 |
| K182721 | Choice Spine Navigation System | 2019 | 2 |
| K171456 | Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems | 2017 | 0 |
| K170942 | The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems | 2017 | 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 29 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 9 of the 100 ancestors have a recall of any class.
- Of its descendants, K160775 (Choicespine, LP, 2016) has gone furthest, with 73 descendants of its own.
- 1 other device also cites its predicate K102204.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 THUNDERBOLT™ Minimally Invasive and LANCER™ Open Pedicle Screw Systems are 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 disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and…
Read the full statement (157 words)
The THUNDERBOLT™ Minimally Invasive and LANCER™ Open Pedicle Screw Systems are 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 disc disease (DDD; 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; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
When used in a posterior percutaneous approach with MIS instrumentation, the THUNDERBOLT™ System is intended for noncervical pedicle fixation 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; deformities; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132049 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132049: Thunderbolt and Lancer Pedicle Screw Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132049
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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