510(k) · Cleared
ClearedFirebird 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 Mar 28, 2013 as substantially equivalent to K122901 (Orthofix, 2012) after a 62-day review. Its family tree reaches back 10 generations to 1998. 5 later devices descend from it.
- Decided
- Mar 28, 2013
- Review
- 62 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K980447 (1998). 67 ancestors in all, the oldest K901587 (1990). 5 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK980447 Depuy Motech Moss Miami Spinal SystemDePuy Orthopaedics, Inc. · 1998
- 6 generations between
- 3 generations backK092624 Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · Recalled
- 2 generations backK100044 Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone · 2010
- 1 generation backK122901 Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix · 2012
- This deviceK130176 Firebird Spinal Fixation SystemOrthofix · 2013
- Descendant · cites it directly · 3 of its ownK173180 Mega Plus Spine SystemBk Meditech, Co., Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK183080 Mega Plus Spine SystemBk Meditech, Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK240963 Spinal SystemTeslake, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK200981 Mega Plus MIS Spine SystemBk Meditech, Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK191655 MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd. · 2020
Show all 10 generations
- Root · 10 generations backK980447 Depuy Motech Moss Miami Spinal SystemDePuy Orthopaedics, Inc. · 1998
- 9 generations backK013558 Blackstone Spinal Fixation System 4.5MM Mono-Axial ScrewBlackstone Medical, Inc. · 2002
- 8 generations backK022399 Blackstone Spinal Fixation System SpacerBlackstone Medical, Inc. · 2002
- 7 generations backK030241 Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc. · 2003
- 6 generations backK080407 Blackstone SFS Parallel Rod ConnectorsBlackstone Medical, Inc. · 2008 · Recalled
- 5 generations backK081684 Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008 · Recalled
- 4 generations backK082797 Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008
- 3 generations backK092624 Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · Recalled
- 2 generations backK100044 Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone · 2010
- 1 generation backK122901 Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix · 2012
- This deviceK130176 Firebird Spinal Fixation SystemOrthofix · 2013
Most influential descendants
Showing 5 of 5 · See all- K173180Mega Plus Spine SystemBk Meditech, Co., Ltd. · 2018 · cites it directly3descendants
- K183080Mega Plus Spine SystemBk Meditech, Co., Ltd. · 2018 · cites it directly2descendants
- K240963Spinal SystemTeslake, Inc. · 2024 · cites it directly0descendants
- K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd. · 2020 · 2 generations on0descendants
- K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K980447 | Depuy Motech Moss Miami Spinal System | DePuy Orthopaedics, Inc. | 1998 | — |
| −9 | K013558 | Blackstone Spinal Fixation System 4.5MM Mono-Axial Screw | Blackstone Medical, Inc. | 2002 | — |
| −8 | K022399 | Blackstone Spinal Fixation System Spacer | Blackstone Medical, Inc. | 2002 | — |
| −7 | K030241 | Modification to Blackstone Spinal Fixation System | Blackstone Medical, Inc. | 2003 | — |
| −6 | K080407 | Blackstone SFS Parallel Rod Connectors | Blackstone Medical, Inc. | 2008 | 1 |
| −5 | K081684 | Blackstone Pedicle Screw System | Blackstone Medical, Inc. | 2008 | 3 |
| −4 | K082797 | Blackstone Pedicle Screw System | Blackstone Medical, Inc. | 2008 | — |
| −3 | K092624 | Firebird Spinal Fixation System | Blackstone Medical, Inc. | 2009 | 1 |
| −2 | K100044 | Firebird Spinal Fixation System, Firebird Side-Loading Body | Blackstone | 2010 | — |
| −1 | K122901 | Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation System | Orthofix | 2012 | — |
| 0 (this device) | K130176 | Firebird Spinal Fixation System | Orthofix | 2013 | — |
| +1 | K173180 | Mega Plus Spine System | Bk Meditech, Co., Ltd. | 2018 | — |
| +1 | K183080 | Mega Plus Spine System | Bk Meditech, Co., Ltd. | 2018 | — |
| +1 | K240963 | Spinal System | Teslake, Inc. | 2024 | — |
| +2 | K200981 | Mega Plus MIS Spine System | Bk Meditech, Co., Ltd. | 2020 | — |
| +2 | K191655 | MEGAFIX® Pedicle Screw Spinal System | Seohancare Co., Ltd. | 2020 | — |
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 |
|---|---|---|
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2024 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K122901 | Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemSummary page 2…ices: The Firebird Spinal Fixation System is substantially equivalent to the previously cleared Firebird Spinal Fixation System (122901) 2… | 2012 |
What descends from it? (5)
3 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 15 years and passes through 4 companies; a new generation was cleared every 7 months on median.
- 6 of the 67 ancestors have a recall of any class.
- Of its descendants, K173180 (Bk Meditech, Co., Ltd., 2018) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K122901.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 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: a) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) b) spondylolisthesis, c)…
Read the full statement (146 words)
The Firebird 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:
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
The Firebird Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation 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/K130176 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130176: 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/K130176
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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