510(k) · Cleared
ClearedFirebird Spinal Fixation System, Phoenix Mis Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Dec 3, 2012 as substantially equivalent to K082797 (Blackstone Medical, Inc., 2008) and 2 other predicates after a 73-day review. Its family tree reaches back 9 generations to 1998. 116 later devices descend from it.
- Decided
- Dec 3, 2012
- Review
- 73 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K980447 (1998). 66 ancestors in all, the oldest K901587 (1990). 116 later devices descend from it, 6 citing it directly.
- Root · 9 generations backK980447 Depuy Motech Moss Miami Spinal SystemDePuy Orthopaedics, Inc. · 1998
- 5 generations between
- 3 generations backK082797 Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008
- 2 generations backK092624 Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · Recalled
- 1 generation backK100044 Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone · 2010
- This deviceK122901 Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix · 2012
- 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
Show all 9 generations
- Root · 9 generations backK980447 Depuy Motech Moss Miami Spinal SystemDePuy Orthopaedics, Inc. · 1998
- 8 generations backK013558 Blackstone Spinal Fixation System 4.5MM Mono-Axial ScrewBlackstone Medical, Inc. · 2002
- 7 generations backK022399 Blackstone Spinal Fixation System SpacerBlackstone Medical, Inc. · 2002
- 6 generations backK030241 Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc. · 2003
- 5 generations backK080407 Blackstone SFS Parallel Rod ConnectorsBlackstone Medical, Inc. · 2008 · Recalled
- 4 generations backK081684 Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008 · Recalled
- 3 generations backK082797 Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008
- 2 generations backK092624 Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · Recalled
- 1 generation backK100044 Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone · 2010
- This deviceK122901 Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix · 2012
Showing 5 of 116 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 116 · 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 |
|---|---|---|---|---|---|
| −9 | K980447 | Depuy Motech Moss Miami Spinal System | DePuy Orthopaedics, Inc. | 1998 | — |
| −8 | K013558 | Blackstone Spinal Fixation System 4.5MM Mono-Axial Screw | Blackstone Medical, Inc. | 2002 | — |
| −7 | K022399 | Blackstone Spinal Fixation System Spacer | Blackstone Medical, Inc. | 2002 | — |
| −6 | K030241 | Modification to Blackstone Spinal Fixation System | Blackstone Medical, Inc. | 2003 | — |
| −5 | K080407 | Blackstone SFS Parallel Rod Connectors | Blackstone Medical, Inc. | 2008 | 1 |
| −4 | K081684 | Blackstone Pedicle Screw System | Blackstone Medical, Inc. | 2008 | 3 |
| −3 | K082797 | Blackstone Pedicle Screw System | Blackstone Medical, Inc. | 2008 | — |
| −2 | K092624 | Firebird Spinal Fixation System | Blackstone Medical, Inc. | 2009 | 1 |
| −1 | K100044 | Firebird Spinal Fixation System, Firebird Side-Loading Body | Blackstone | 2010 | — |
| 0 (this device) | K122901 | Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation System | Orthofix | 2012 | — |
| +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 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 6 | 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 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 6 | 0 |
| 2017 | 11 | 0 |
| 2018 | 7 | 0 |
| 2019 | 8 | 0 |
| 2020 | 7 | 0 |
| 2021 | 9 | 0 |
| 2022 | 13 | 0 |
| 2023 | 15 | 0 |
| 2024 | 10 | 0 |
| 2025 | 12 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K081684 | FDA’s K081684 is Blackstone Pedicle Screw System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2008 |
| * | K082797 | Blackstone Pedicle Screw SystemSummary page 2…Spinal Fixation System are substantially equivalent to the previously cleared Firebird Spinal Fixation System (KOS 1684, K082797, K092624, K 100044). Page 2 of 3… | 2008 |
| * | K092624 | Firebird Spinal Fixation SystemSummary page 2…Fixation System are substantially equivalent to the previously cleared Firebird Spinal Fixation System (KOS 1684, K082797, K092624, K 100044). Page 2 of 3… | 2009 |
| * | K100044 | Firebird Spinal Fixation System, Firebird Side-Loading BodySummary page 2…System are substantially equivalent to the previously cleared Firebird Spinal Fixation System (KOS 1684, K082797, K092624, K 100044). Page 2 of 3… | 2010 |
What descends from it? (116)
See all 1166 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 14 years and passes through 4 companies; a new generation was cleared every 7 months on median.
- 6 of the 66 ancestors have a recall of any class.
- Of its descendants, K130932 (Orthofix, Inc., 2013) has gone furthest, with 81 descendants of its own.
- 8 other devices also cite its predicate K082797.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 fixation. Pedicle screw fixation is limited to 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: *degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) *spondylolisthesis…
Read the full statement (138 words)
The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle fixation. Pedicle screw fixation is limited to 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:
*degenerative disc disease (defined as discogenic back pain 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
The Firebird Spinal Fixation System components are used with certain components of the Blackstone SFS system, including rods, rod connectors and cross-connectors.
The Phoenix MIS Spinal Fixation System when used with the Firebird Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122901 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122901: Firebird Spinal Fixation System, Phoenix Mis 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/K122901
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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