510(k) · Cleared
ClearedZavation Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zavation, LLC · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Apr 21, 2016 as substantially equivalent to K112484 (Zavation, LLC, 2011) and 4 other predicates after a 149-day review. Its family tree reaches back 11 generations to 2004. 1 of the 204 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Apr 21, 2016
- Review
- 149 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 11 generations to K040583 (2004). 202 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly. 1 of the 204 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 deviceK153404 Zavation Spinal SystemZavation, LLC · 2016
- Descendant · cites it directly · 0 of its ownK190361 Zavation Spinal SystemZavation Medical Products, LLC · 2019
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 deviceK153404 Zavation Spinal SystemZavation, LLC · 2016
Class I recalls in this family
- K100952 Modification to Synthes Matrix System2 generations back · 2010
Most influential descendants
Showing 1 of 1 · See all- K190361Zavation Spinal SystemZavation Medical Products, LLC · 2019 · cites it directly0descendants
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) | K153404 | Zavation Spinal System | Zavation, LLC | 2016 | — |
| +1 | K190361 | Zavation Spinal System | Zavation Medical Products, LLC | 2019 | — |
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 | 17 | 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 | 6 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K112484 | Zavation Spinal SystemSummary page 5…Materials: The Zavation Spinal System components are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136. Predicate Devices: Zavation Spinal System (K112484) -primary Depuy Spine Moss Miami Spine System (K955348) U&I Corporation OPTIMA Spinal System (K024096) Depuy Synergy VLS open (K0… | 2011 |
| * | K955348 | Titanium Moss Miami Spinal SystemSummary page 5…anufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136. Predicate Devices: Zavation Spinal System (K112484) -primary Depuy Spine Moss Miami Spine System (K955348) U&I Corporation OPTIMA Spinal System (K024096) Depuy Synergy VLS open (K000236) Synthes Matrix System (K120838) Performance Dat… | 1996 |
| * | K024096 | Optima, Spinal SystemSummary page 5…described by ASTM F136. Predicate Devices: Zavation Spinal System (K112484) -primary Depuy Spine Moss Miami Spine System (K955348) U&I Corporation OPTIMA Spinal System (K024096) Depuy Synergy VLS open (K000236) Synthes Matrix System (K120838) Performance Data: Static compression bending and torsion, and… | 2003 |
| * | K000236 | Synergy VLS Cap Nut Models 2206, 6102Summary page 5…e Devices: Zavation Spinal System (K112484) -primary Depuy Spine Moss Miami Spine System (K955348) U&I Corporation OPTIMA Spinal System (K024096) Depuy Synergy VLS open (K000236) Synthes Matrix System (K120838) Performance Data: Static compression bending and torsion, and dynamic compression bending were… | 2000 |
| * | K120838 | Synthes Matrix SystemSummary page 5…m (K112484) -primary Depuy Spine Moss Miami Spine System (K955348) U&I Corporation OPTIMA Spinal System (K024096) Depuy Synergy VLS open (K000236) Synthes Matrix System (K120838) Performance Data: Static compression bending and torsion, and dynamic compression bending were performed according to ASTM F171… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190361 | Zavation Spinal System | 2019 | 0 |
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 12 years and passes through 5 companies; a new generation was cleared every 4 months on median.
- 27 of the 202 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K190361 (Zavation Medical Products, LLC, 2019) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K112484.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
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/K153404 · printed Nov 3, 2026
Cite this page
510(k) Report. “K153404: Zavation Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K153404
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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