510(k) · Cleared
ClearedFlospine Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flospine · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 27, 2014 as substantially equivalent to K120838 (Synthes Spine, 2012) and 1 other predicate after a 110-day review. Its family tree reaches back 11 generations to 2004. 1 of the 201 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 27, 2014
- Review
- 110 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K040583 (2004). 200 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 201 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations between
- 3 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 2 generations backK113529 CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek · 2012
- 1 generation backK120838 Synthes Matrix SystemSynthes Spine · 2012
- This deviceK141850 Flospine Pedicle Screw SystemFlospine · 2014
Show all 11 generations
- Root · 11 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 8 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 7 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 6 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 5 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 4 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 3 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 2 generations backK113529 CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek · 2012
- 1 generation backK120838 Synthes Matrix SystemSynthes Spine · 2012
- This deviceK141850 Flospine Pedicle Screw SystemFlospine · 2014
Class I recalls in this family
- K100952 Modification to Synthes Matrix System2 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −10 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −8 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −7 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −6 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −5 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −4 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −3 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −2 | K113529 | CD Horizon Voyager Spinal System | Medtronic Sofamor Danek | 2012 | — |
| −1 | K120838 | Synthes Matrix System | Synthes Spine | 2012 | — |
| 0 (this device) | K141850 | Flospine Pedicle Screw System | Flospine | 2014 | — |
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 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 6 | 0 |
| 1998 | 10 | 0 |
| 1999 | 8 | 0 |
| 2000 | 16 | 0 |
| 2001 | 12 | 0 |
| 2002 | 13 | 0 |
| 2003 | 15 | 0 |
| 2004 | 18 | 0 |
| 2005 | 16 | 0 |
| 2006 | 10 | 0 |
| 2007 | 9 | 0 |
| 2008 | 10 | 0 |
| 2009 | 7 | 0 |
| 2010 | 5 | 1 |
| 2011 | 5 | 0 |
| 2012 | 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.
1 device in this family has a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K120838 | Synthes Matrix SystemSummary page 5…om cobalt chrome which complies with ASTM F1537. Predicate Device(s): The FloSpine Pedicle Screw is substantially equivalent to the Synthes Matrix Pedicle Screw System (K120838)*, The Orthofix Matrix Spinal System (K120838) and the U&I Optimal System (K031585). Performance Standards: The pre-clinical tes… | 2012 |
| * | K031585 | U&I, Optima, Spinal SystemSummary page 5…Pedicle Screw is substantially equivalent to the Synthes Matrix Pedicle Screw System (K120838)*, The Orthofix Matrix Spinal System (K120838) and the U&I Optimal System (K031585). Performance Standards: The pre-clinical testing performed includes static and dynamic compression bending, and static torsion… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 5 companies; a new generation was cleared every 4 months on median.
- 27 of the 200 ancestors have a recall of any class; 1 has a Class I recall.
- 9 other devices also cite its predicate K120838.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 FloSpine Canaveral Pedicle System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e.…
Read the full statement (147 words)
The FloSpine Canaveral Pedicle System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Canaveral Pedicle Screw System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Canaveral Pedicle Screw System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to the posterior approach.
The Canaveral Pedicle Screw System is indicated to provide the surgeon with a minimally invasive approach for posterior spine surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141850 · printed Nov 4, 2026
Cite this page
510(k) Report. “K141850: Flospine Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K141850
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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