510(k) · Cleared
Recalled · Class II · 2016Firebird 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, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jan 29, 2016 as substantially equivalent to K130932 (Orthofix, Inc., 2013) and 2 other predicates after a 65-day review. Its family tree reaches back 15 generations to 2004. 73 later devices descend from it. It has been recalled once.
- Decided
- Jan 29, 2016
- Review
- 65 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 15 generations to K040583 (2004). 226 ancestors in all, the oldest K781443 (1978). 73 later devices descend from it, 3 citing it directly.
- Root · 15 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations between
- 3 generations backK121630 Range Spinal SystemK2m, Inc. · 2012
- 2 generations backK130932 Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · Recalled
- 1 generation backK151488 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · Recalled
- This deviceK153428 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016
- Descendant · cites it directly · 61 of its ownK171082 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System…Orthofix, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 37 of its ownK180179 Firebird® Spinal Fixation Systems: Firebird System; Firebird…Orthofix, Inc. · 2018
- Descendant · 2 generations on · 21 of its ownK173130 Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017
- Descendant · cites it directly · 18 of its ownK170647 Connector SystemOrthofix, Inc. · 2017
- Descendant · 2 generations on · 16 of its ownK172194 Connector SystemOrthofix, Inc. · 2017 · Recalled
Show all 15 generations
- Root · 15 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 12 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 11 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 10 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 9 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 8 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 7 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 6 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 5 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 4 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 3 generations backK121630 Range Spinal SystemK2m, Inc. · 2012
- 2 generations backK130932 Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · Recalled
- 1 generation backK151488 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · Recalled
- This deviceK153428 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016
Showing 5 of 73 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 73 · See all- K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc. · 2017 · cites it directly61descendants
- K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc. · 2018 · 2 generations on37descendants
- K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017 · 2 generations on21descendants
- K170647Connector SystemOrthofix, Inc. · 2017 · cites it directly18descendants
- K172194Connector SystemOrthofix, Inc. · 2017 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −12 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −11 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −10 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −9 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −8 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −7 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −6 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −5 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −4 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −3 | K121630 | Range Spinal System | K2m, Inc. | 2012 | — |
| −2 | K130932 | Firebird Spinal Fixation System | Orthofix, Inc. | 2013 | 1 |
| −1 | K151488 | Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System | Orthofix, Inc. | 2015 | 1 |
| 0 (this device) | K153428 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System | Orthofix, Inc. | 2016 | — |
| +1 | K171082 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS… | Orthofix, Inc. | 2017 | 1 |
| +2 | K180179 | Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System… | Orthofix, Inc. | 2018 | — |
| +2 | K173130 | Reform® Midline Cortical Screw System | Precision Spine, Inc. | 2017 | — |
| +1 | K170647 | Connector System | Orthofix, Inc. | 2017 | — |
| +2 | K172194 | Connector System | Orthofix, Inc. | 2017 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 7 | 0 |
| 1996 | 9 | 0 |
| 1997 | 6 | 0 |
| 1998 | 14 | 0 |
| 1999 | 5 | 0 |
| 2000 | 16 | 0 |
| 2001 | 19 | 0 |
| 2002 | 17 | 0 |
| 2003 | 16 | 0 |
| 2004 | 21 | 0 |
| 2005 | 17 | 0 |
| 2006 | 12 | 0 |
| 2007 | 5 | 0 |
| 2008 | 12 | 0 |
| 2009 | 4 | 0 |
| 2010 | 7 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 3 | 0 |
| 2021 | 7 | 0 |
| 2022 | 12 | 0 |
| 2023 | 14 | 0 |
| 2024 | 6 | 0 |
| 2025 | 9 | 0 |
| 2026 | 10 | 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? (3)
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 |
|---|---|---|---|
| * | K130932 | Firebird Spinal Fixation SystemSummary page 5…el: Orthopedic Device Panel Primary Predicate: Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (K130932) Additional Predicates: Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (K… | 2013 |
| * | K151488 | Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemSummary page 5…tem (K130932) Additional Predicates: Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (K151488) Spinal Fixation System (K023498) Reason for 510(k) Submission: Orthofix is submitting this Traditi… | 2015 |
| * | K023498 | Modification to Blackstone Spinal Fixation SystemSummary page 5…tes: Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (K151488) Spinal Fixation System (K023498) Reason for 510(k) Submission: Orthofix is submitting this Traditional 510(k) premarket notification for the addition of the bel… | 2002 |
What descends from it? (73)
See all 733 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 27, 2016 | Class II | Z-1881-2016 | Device Design | There is a possibility that the subject set screw driver could disengage from the torque limiting handle when the counter torque wrench is allowed to contact the counter torque handle. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 5 months on median.
- 27 of the 226 ancestors have a recall of any class.
- Of its descendants, K171082 (Orthofix, Inc., 2017) has gone furthest, with 61 descendants of its own.
- 3 other devices also cite its predicate K130932.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 and Phoenix MIS Spinal Fixation System are intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/Ilium). 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: a) degenerative disc disease (defined as discogenic back pain with degeneration of the…
Read the full statement (249 words)
The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are intended for posterior, non-cervical
pedicle, and non-pedicle fixation (T1-S2/Ilium). 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:
a) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and
radiographic studies)
b) spondylolisthesis,
c) trauma (i.e., fracture or dislocation),
d) spinal stenosis,
e) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
f) tumor,
g) pseudoarthrosis, and
h) 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 Phoenix MIS 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.
The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System components are used with certain
components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation System
implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Firebird Spinal Fixation System
for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a
posterior approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153428: 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 6, 2026. https://510kreport.com/device/K153428
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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