510(k) · Cleared
ClearedFirebird Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blackstone Medical, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jul 28, 2010 as substantially equivalent to K092624 (Blackstone Medical, Inc., 2009) and 7 other predicates after a 218-day review. Its family tree reaches back 8 generations to 1998. 88 later devices descend from it.
- Decided
- Jul 28, 2010
- Review
- 218 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 8 generations to K980447 (1998). 88 ancestors in all, the oldest K901587 (1990). 88 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK980447 Depuy Motech Moss Miami Spinal SystemDePuy Orthopaedics, Inc. · 1998
- 7 generations backK013558 Blackstone Spinal Fixation System 4.5MM Mono-Axial ScrewBlackstone Medical, Inc. · 2002
- 6 generations backK022399 Blackstone Spinal Fixation System SpacerBlackstone Medical, Inc. · 2002
- 5 generations backK030241 Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc. · 2003
- 4 generations backK080407 Blackstone SFS Parallel Rod ConnectorsBlackstone Medical, Inc. · 2008 · Recalled
- 3 generations backK081684 Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008 · Recalled
- 2 generations backK082797 Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008
- 1 generation backK092624 Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · Recalled
- This deviceK093926 Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2010
- Descendant · cites it directly · 81 of its ownK130932 Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 78 of its ownK151488 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 73 of its ownK153428 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 61 of its ownK171082 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System…Orthofix, Inc. · 2017 · Recalled
- Descendant · 4 generations on · 37 of its ownK180179 Firebird® Spinal Fixation Systems: Firebird System; Firebird…Orthofix, Inc. · 2018
Showing 5 of 88 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 88 · See all- K130932Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · cites it directly81descendants
- K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · 2 generations on78descendants
- K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016 · 2 generations on73descendants
- K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc. · 2017 · 3 generations on61descendants
- K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc. · 2018 · 4 generations on37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K980447 | Depuy Motech Moss Miami Spinal System | DePuy Orthopaedics, Inc. | 1998 | — |
| −7 | K013558 | Blackstone Spinal Fixation System 4.5MM Mono-Axial Screw | Blackstone Medical, Inc. | 2002 | — |
| −6 | K022399 | Blackstone Spinal Fixation System Spacer | Blackstone Medical, Inc. | 2002 | — |
| −5 | K030241 | Modification to Blackstone Spinal Fixation System | Blackstone Medical, Inc. | 2003 | — |
| −4 | K080407 | Blackstone SFS Parallel Rod Connectors | Blackstone Medical, Inc. | 2008 | 1 |
| −3 | K081684 | Blackstone Pedicle Screw System | Blackstone Medical, Inc. | 2008 | 3 |
| −2 | K082797 | Blackstone Pedicle Screw System | Blackstone Medical, Inc. | 2008 | — |
| −1 | K092624 | Firebird Spinal Fixation System | Blackstone Medical, Inc. | 2009 | 1 |
| 0 (this device) | K093926 | Firebird Spinal Fixation System | Blackstone Medical, Inc. | 2010 | — |
| +1 | K130932 | Firebird Spinal Fixation System | Orthofix, Inc. | 2013 | 1 |
| +2 | K151488 | Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System | Orthofix, Inc. | 2015 | 1 |
| +2 | K153428 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System | Orthofix, Inc. | 2016 | 1 |
| +3 | K171082 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS… | Orthofix, Inc. | 2017 | 1 |
| +4 | K180179 | Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System… | Orthofix, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 7 | 0 |
| 1996 | 7 | 0 |
| 1997 | 5 | 0 |
| 1998 | 11 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 6 | 0 |
| 2002 | 5 | 0 |
| 2003 | 8 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 7 | 0 |
| 2020 | 5 | 0 |
| 2021 | 7 | 0 |
| 2022 | 12 | 0 |
| 2023 | 14 | 0 |
| 2024 | 8 | 0 |
| 2025 | 10 | 0 |
| 2026 | 11 | 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? (8)
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 |
|---|---|---|---|
| * | K092624 | Firebird Spinal Fixation SystemSummary page 2…rthopedic Device Panel Predicate Devices: * Firebird Spinal Fixation System, Cobalt-Chrome Rods (K092624 SE 9-25-09) * Blackstone Pedicle Screw System, 4.0 mm Screws… | 2009 |
| * | K082797 | Blackstone Pedicle Screw SystemSummary page 2…(K092624 SE 9-25-09) * Blackstone Pedicle Screw System, 4.0 mm Screws (K082797 SE 10-17-08) * Blackstone Pedicle Screw System (K081684 SE 9-15-08)… | 2008 |
| * | K081684 | Blackstone Pedicle Screw SystemSummary page 2…ackstone Pedicle Screw System, 4.0 mm Screws (K082797 SE 10-17-08) * Blackstone Pedicle Screw System (K081684 SE 9-15-08) * Blackstone Medical, Inc. Spinal Fixation System (SFS),… | 2008 |
| * | K080407 | Blackstone SFS Parallel Rod ConnectorsSummary page 2…Inc. Spinal Fixation System (SFS), represented by that system's most recent premarket notification, K080407 SE 3-13-08 * Synthes Universal Spine System lliosacral/Polyaxial… | 2008 |
| * | K082572 | Uss Iliosacral, Uss PolyaxialSummary page 2…notification, K080407 SE 3-13-08 * Synthes Universal Spine System lliosacral/Polyaxial System (K082572 SE 11-24-08) * DePuy Acromned Moss Miami Spinal System (K030383… | 2008 |
| * | K030383 | Modification to Moss Miami Spinal System Polyaxial ScrewsSummary page 2…System lliosacral/Polyaxial System (K082572 SE 11-24-08) * DePuy Acromned Moss Miami Spinal System (K030383 *SE 2-26-20 10) * DePuy Acromed Isola System (K993030 SE 12/2… | 2003 |
| * | K993030 | Modification to Isola Spinal SystemSummary page 2…* DePuy Acromned Moss Miami Spinal System (K030383 *SE 2-26-20 10) * DePuy Acromed Isola System (K993030 SE 12/29/1999) * DePuy Acromed Monarch Spine System (K024348 SE… | 1999 |
| * | K024348 | Monarch Spine SystemSummary page 2…2-26-20 10) * DePuy Acromed Isola System (K993030 SE 12/29/1999) * DePuy Acromed Monarch Spine System (K024348 SE 1/28/2003) Intended Use /Indications for Use The Firebird Spinal Fixation… | 2003 |
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 12 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- 6 of the 88 ancestors have a recall of any class.
- Of its descendants, K130932 (Orthofix, Inc., 2013) has gone furthest, with 81 descendants of its own.
- 4 other devices also cite its predicate K092624.
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 Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/Ilium). The system is limited to use in skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications: 1) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic…
Read the full statement (151 words)
The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/Ilium). The system is limited to use in skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications:
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
8) failed previous fusion
When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.
The Firebird Spinal Fixation System components are used with certain components of the SFS system, including rod connectors and cross-connectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093926 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093926: Firebird Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093926
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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