510(k) · Cleared
ClearedThe Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Choicespine, LP · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Apr 26, 2017 as substantially equivalent to K132049 (Choicespine, 2014) and 1 other predicate after a 27-day review. Its family tree reaches back 12 generations to 1985.
- Decided
- Apr 26, 2017
- Review
- 27 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K853033 (1985). 112 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 8 generations between
- 3 generations backK102204 Choice Spine Starfire Pedicle Screw SystemChoicespine, LP · 2010
- 2 generations backK132049 Thunderbolt and Lancer Pedicle Screw SystemsChoicespine · 2014
- 1 generation backK160775 Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP · 2016
- This deviceK170942 The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw…Choicespine, LP · 2017
Show all 12 generations
- Root · 12 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 11 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 10 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 9 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 8 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 7 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 6 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 5 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 4 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 3 generations backK102204 Choice Spine Starfire Pedicle Screw SystemChoicespine, LP · 2010
- 2 generations backK132049 Thunderbolt and Lancer Pedicle Screw SystemsChoicespine · 2014
- 1 generation backK160775 Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP · 2016
- This deviceK170942 The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw…Choicespine, LP · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −11 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −10 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −9 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −8 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −7 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −6 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −5 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −4 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −3 | K102204 | Choice Spine Starfire Pedicle Screw System | Choicespine, LP | 2010 | — |
| −2 | K132049 | Thunderbolt and Lancer Pedicle Screw Systems | Choicespine | 2014 | — |
| −1 | K160775 | Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems | Choicespine, LP | 2016 | — |
| 0 (this device) | K170942 | The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems | Choicespine, LP | 2017 | — |
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 | 2 | 0 |
| 1998 | 8 | 0 |
| 1999 | 7 | 0 |
| 2000 | 11 | 0 |
| 2001 | 6 | 0 |
| 2002 | 11 | 0 |
| 2003 | 12 | 0 |
| 2004 | 6 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 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 |
|---|---|---|---|
| * | K132049 | Thunderbolt and Lancer Pedicle Screw SystemsSummary page 5…pseudoarthrosis; and failed previous fusion. Predicate Devices: Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems K132049 and K160775 (Primary Predicate). Non-Clinical Evaluations: The subject implants were demonstrated to not represent a new worst… | 2014 |
| * | K160775 | Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsSummary page 5…eudoarthrosis; and failed previous fusion. Predicate Devices: Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems K132049 and K160775 (Primary Predicate). Non-Clinical Evaluations: The subject implants were demonstrated to not represent a new worst case… | 2016 |
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 32 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 10 of the 112 ancestors have a recall of any class.
- 4 other devices also cite its predicate K132049.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 (227 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™ Minimally Invasive
System is intended for non-cervical 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; curvatures (i.e., scoliosis, kyphosis, and/or
lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used for hook fixation, The Lancer™ Open Pedicle Screw System is intended for posterior, non-cervical pedicle
and non-pedicle fixation for the following indications: 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; 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/K170942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170942: The Thunderbolt™ Minimally Invasive and Lancer™ Open 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/K170942
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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