510(k) · Cleared
ClearedZavation Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zavation Medical Products, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jul 12, 2021 as substantially equivalent to K190317 (Zavation Medical Products, LLC, 2019) and 1 other predicate after an 89-day review. Its family tree reaches back 18 generations to 2004. 4 later devices descend from it.
- Decided
- Jul 12, 2021
- Review
- 89 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to K040583 (2004). 241 ancestors in all, the oldest K781443 (1978). 4 later devices descend from it, 1 citing it directly.
- Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations between
- 3 generations backK153428 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016 · Recalled
- 2 generations backK171082 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System…Orthofix, Inc. · 2017 · Recalled
- 1 generation backK180179 Firebird® Spinal Fixation Systems: Firebird System; Firebird…Orthofix, Inc. · 2018
- This deviceK211113 Zavation Spinal SystemZavation Medical Products, LLC · 2021
- Descendant · cites it directly · 3 of its ownK222614 Zavation Spinal SystemZavation Medical Products, LLC · 2022
- Descendant · 2 generations on · 1 of its ownK243908 Tiger 2 SystemZavation Medical Products, LLC · 2025
- Descendant · 3 generations on · 0 of its ownK253943 Tiger 2 SystemZavation Medical Products, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK231811 Zavation Connector SystemZavation Medical Products, LLC · 2023
Show all 18 generations
- Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 17 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 15 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 14 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 13 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 12 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 11 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 10 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 9 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 8 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 7 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 6 generations backK121630 Range Spinal SystemK2m, Inc. · 2012
- 5 generations backK130932 Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · Recalled
- 4 generations backK151488 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · Recalled
- 3 generations backK153428 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016 · Recalled
- 2 generations backK171082 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System…Orthofix, Inc. · 2017 · Recalled
- 1 generation backK180179 Firebird® Spinal Fixation Systems: Firebird System; Firebird…Orthofix, Inc. · 2018
- This deviceK211113 Zavation Spinal SystemZavation Medical Products, LLC · 2021
Most influential descendants
Showing 4 of 4 · See all- K222614Zavation Spinal SystemZavation Medical Products, LLC · 2022 · cites it directly3descendants
- K243908Tiger 2 SystemZavation Medical Products, LLC · 2025 · 2 generations on1descendant
- K253943Tiger 2 SystemZavation Medical Products, LLC · 2026 · 3 generations on0descendants
- K231811Zavation Connector SystemZavation Medical Products, LLC · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −17 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −16 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −15 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −14 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −13 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −12 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −11 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −10 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −9 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −8 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −7 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −6 | K121630 | Range Spinal System | K2m, Inc. | 2012 | — |
| −5 | K130932 | Firebird Spinal Fixation System | Orthofix, Inc. | 2013 | 1 |
| −4 | K151488 | Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System | Orthofix, Inc. | 2015 | 1 |
| −3 | K153428 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System | Orthofix, Inc. | 2016 | 1 |
| −2 | K171082 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS… | Orthofix, Inc. | 2017 | 1 |
| −1 | K180179 | Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System… | Orthofix, Inc. | 2018 | — |
| 0 (this device) | K211113 | Zavation Spinal System | Zavation Medical Products, LLC | 2021 | — |
| +1 | K222614 | Zavation Spinal System | Zavation Medical Products, LLC | 2022 | — |
| +2 | K243908 | Tiger 2 System | Zavation Medical Products, LLC | 2025 | — |
| +3 | K253943 | Tiger 2 System | Zavation Medical Products, LLC | 2026 | — |
| +2 | K231811 | Zavation Connector System | Zavation Medical Products, LLC | 2023 | — |
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 | 20 | 0 |
| 2002 | 17 | 0 |
| 2003 | 16 | 0 |
| 2004 | 24 | 0 |
| 2005 | 18 | 0 |
| 2006 | 13 | 0 |
| 2007 | 5 | 0 |
| 2008 | 12 | 0 |
| 2009 | 4 | 0 |
| 2010 | 8 | 0 |
| 2011 | 7 | 0 |
| 2012 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K190317 | Zavation Spinal SystemSummary page 5…Mo) as described by ASTM F1537. The Hydroxyapatite (HA) coating is applied in compliance with ASTM F1185, ASTM F1044, & ASTM F1147 Predicate Devices: Primary predicate: K190317 Zavation Spinal System [Zavation] Additional predicate: K180179 Firebird Spinal Fixation System [Orthofix] Performance Data: Sta… | 2019 |
| * | K180179 | Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Summary page 5…is applied in compliance with ASTM F1185, ASTM F1044, & ASTM F1147 Predicate Devices: Primary predicate: K190317 Zavation Spinal System [Zavation] Additional predicate: K180179 Firebird Spinal Fixation System [Orthofix] Performance Data: Static compression bending and torsion, and dynamic compression ben… | 2018 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222614 | Zavation Spinal System | 2022 | 3 |
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 17 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 34 of the 241 ancestors have a recall of any class.
- Of its descendants, K222614 (Zavation Medical Products, LLC, 2022) has gone furthest, with 3 descendants of its own.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Zavation Spinal System is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed…
Read the full statement (176 words)
The Zavation Spinal System is a pedicle screw system 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:
degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The Zavation Spinal Systems is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The Zavation Spinal Systems when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211113: Zavation Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211113
Report an extraction error
Are you the manufacturer?
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