510(k) · Cleared
ClearedNOVA Minimally Invasive System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baui Biotech Co., Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jun 11, 2019 as substantially equivalent to K171082 (Orthofix, Inc., 2017) after a 280-day review. Its family tree reaches back 17 generations to 2004. 2 later devices descend from it.
- Decided
- Jun 11, 2019
- Review
- 280 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K040583 (2004). 228 ancestors in all, the oldest K781443 (1978). 2 later devices descend from it, 2 citing it directly.
- Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations between
- 3 generations backK151488 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · Recalled
- 2 generations backK153428 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016 · Recalled
- 1 generation backK171082 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System…Orthofix, Inc. · 2017 · Recalled
- This deviceK182416 NOVA Minimally Invasive SystemBaui Biotech Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK251251 ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK242899 NOVA Minimally Invasive SystemBaui Biotech Co., Ltd. · 2024
Show all 17 generations
- Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 14 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 13 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 12 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 11 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 10 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 9 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 8 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 7 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 6 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 5 generations backK121630 Range Spinal SystemK2m, Inc. · 2012
- 4 generations backK130932 Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · Recalled
- 3 generations backK151488 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · Recalled
- 2 generations backK153428 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016 · Recalled
- 1 generation backK171082 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System…Orthofix, Inc. · 2017 · Recalled
- This deviceK182416 NOVA Minimally Invasive SystemBaui Biotech Co., Ltd. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −16 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −14 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −13 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −12 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −11 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −10 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −9 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −8 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −7 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −6 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −5 | K121630 | Range Spinal System | K2m, Inc. | 2012 | — |
| −4 | K130932 | Firebird Spinal Fixation System | Orthofix, Inc. | 2013 | 1 |
| −3 | 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 |
| −1 | K171082 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS… | Orthofix, Inc. | 2017 | 1 |
| 0 (this device) | K182416 | NOVA Minimally Invasive System | Baui Biotech Co., Ltd. | 2019 | — |
| +1 | K251251 | ChanPin Pedicle Screw Spinal System | Chanpin Medtak Co., Ltd. | 2026 | — |
| +1 | K242899 | NOVA Minimally Invasive System | Baui Biotech Co., Ltd. | 2024 | — |
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 |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K171082 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Summary page 4…888.3070) Classification Identification: Class II Product code: NKB Primary Predicate Device: Firebird Spinal Fixation System (K171082) Device Description: The NOVA Minimally Invasive System consists of cannulated polyaxial screws, straight and pre-bent rods, an… | 2017 |
What descends from it? (2)
2 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 6 companies; a new generation was cleared every 7 months on median.
- 29 of the 228 ancestors have a recall of any class.
- Of its descendants, K251251 (Chanpin Medtak Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K171082.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 NOVA Minimally Invasive 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:
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 previouis fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182416 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182416: NOVA Minimally Invasive System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182416
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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