510(k) · Cleared
ClearedChoice Spine Starfire Pedicle Screw System
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 Nov 15, 2010 as substantially equivalent to K024096 (U&I Corp., America, 2003) and 4 other predicates after a 102-day review. Its family tree reaches back 9 generations to 1985. 88 later devices descend from it.
- Decided
- Nov 15, 2010
- Review
- 102 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K853033 (1985). 62 ancestors in all. 88 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 5 generations between
- 3 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 2 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- This deviceK102204 Choice Spine Starfire Pedicle Screw SystemChoicespine, LP · 2010
- Descendant · cites it directly · 82 of its ownK132049 Thunderbolt and Lancer Pedicle Screw SystemsChoicespine · 2014
- Descendant · 2 generations on · 73 of its ownK160775 Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP · 2016
- Descendant · 3 generations on · 70 of its ownK181677 Kodiak Spinal Fixation SystemAlphatec Spine, Inc. · 2018
- Descendant · 4 generations on · 69 of its ownK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
- Descendant · 4 generations on · 61 of its ownK203056 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020
Show all 9 generations
- Root · 9 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 8 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 7 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 6 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 5 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 4 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 3 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 2 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- This deviceK102204 Choice Spine Starfire Pedicle Screw SystemChoicespine, LP · 2010
Showing 5 of 88 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 88 · See all- K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine · 2014 · cites it directly82descendants
- K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP · 2016 · 2 generations on73descendants
- K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc. · 2018 · 3 generations on70descendants
- K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019 · 4 generations on69descendants
- K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · 4 generations on61descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −8 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −7 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −6 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −5 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −4 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −3 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −2 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −1 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| 0 (this device) | K102204 | Choice Spine Starfire Pedicle Screw System | Choicespine, LP | 2010 | — |
| +1 | K132049 | Thunderbolt and Lancer Pedicle Screw Systems | Choicespine | 2014 | — |
| +2 | K160775 | Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems | Choicespine, LP | 2016 | — |
| +3 | K181677 | Kodiak Spinal Fixation System | Alphatec Spine, Inc. | 2018 | — |
| +4 | K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019 | — |
| +4 | K203056 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 6 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 4 | 0 |
| 2002 | 9 | 0 |
| 2003 | 7 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 8 | 0 |
| 2023 | 14 | 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? (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 |
|---|---|---|---|
| * | K024096 | Optima, Spinal SystemSummary page 1…Orthosis, Spondylolisthesis Spinal Fixation NKB - Orthosis, Spinal Pedlicle Fixation, For Degenerative Disc Disease Predicate Devices OPTIMATm Spinal System (K024096, K(031585) Firebird TM Spinal Fixation System (K(081684) CoralI TM Spinal Fixation System (1(041592) Exped ium TM 6.35 S… | 2003 |
| * | K031585 | U&I, Optima, Spinal SystemSummary page 1…pondylolisthesis Spinal Fixation NKB - Orthosis, Spinal Pedlicle Fixation, For Degenerative Disc Disease Predicate Devices OPTIMATm Spinal System (K024096, K(031585) Firebird TM Spinal Fixation System (K(081684) CoralI TM Spinal Fixation System (1(041592) Exped ium TM 6.35 Spinal Fixa… | 2003 |
| * | K081684 | Blackstone Pedicle Screw SystemSummary page 1…sis, Spinal Pedlicle Fixation, For Degenerative Disc Disease Predicate Devices OPTIMATm Spinal System (K024096, K(031585) Firebird TM Spinal Fixation System (K(081684) CoralI TM Spinal Fixation System (1(041592) Exped ium TM 6.35 Spinal Fixation System (K(062174) Device Description… | 2008 |
| * | K041592 | Coral Spinal SystemSummary page 1…Disc Disease Predicate Devices OPTIMATm Spinal System (K024096, K(031585) Firebird TM Spinal Fixation System (K(081684) CoralI TM Spinal Fixation System (1(041592) Exped ium TM 6.35 Spinal Fixation System (K(062174) Device Description The Choice Spine STARFIRE TM Pedicle Screw Syst… | 2004 |
| * | K062174 | Modification to Expedium Spine SystemSummary page 1…System (K024096, K(031585) Firebird TM Spinal Fixation System (K(081684) CoralI TM Spinal Fixation System (1(041592) Exped ium TM 6.35 Spinal Fixation System (K(062174) Device Description The Choice Spine STARFIRE TM Pedicle Screw System is a top-loading, polyaxial screw spinal fixation… | 2006 |
What descends from it? (88)
See all 882 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 companies; a new generation was cleared every 1.3 years on median.
- 8 of the 62 ancestors have a recall of any class.
- Of its descendants, K132049 (Choicespine, 2014) has gone furthest, with 82 descendants of its own.
- 29 other devices also cite its predicate K024096.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 STARFIRETM Pedicle Screw System is 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 (DOD; 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 lordlosis);
tumor;
pseudloarthrosis; and
failed previous fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102204: Choice Spine Starfire 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/K102204
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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