510(k) · Cleared
ClearedZavation Posterior LEIF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zavation, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Apr 29, 2015 as substantially equivalent to K120576 (Zavation, LLC, 2012) and 1 other predicate after a 245-day review. Its family tree reaches back 14 generations to 1984.
- Decided
- Apr 29, 2015
- Review
- 245 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K841189 (1984). 71 ancestors in all. No later device cites it as a predicate yet.
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations between
- 3 generations backK110843 Aleutian Spacer SystemK2m, Inc. · 2011
- 2 generations backK112664 Zavation Ibf SystemsZavation, LLC · 2011
- 1 generation backK120576 Zavation Ibf SystemZavation, LLC · 2012
- This deviceK142392 Zavation Posterior LEIFZavation, LLC · 2015
Show all 14 generations
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 12 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 11 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 8 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 7 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 6 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 5 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 4 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- 3 generations backK110843 Aleutian Spacer SystemK2m, Inc. · 2011
- 2 generations backK112664 Zavation Ibf SystemsZavation, LLC · 2011
- 1 generation backK120576 Zavation Ibf SystemZavation, LLC · 2012
- This deviceK142392 Zavation Posterior LEIFZavation, LLC · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −13 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −12 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −11 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −8 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −7 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −6 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −5 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| −4 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| −3 | K110843 | Aleutian Spacer System | K2m, Inc. | 2011 | — |
| −2 | K112664 | Zavation Ibf Systems | Zavation, LLC | 2011 | — |
| −1 | K120576 | Zavation Ibf System | Zavation, LLC | 2012 | — |
| 0 (this device) | K142392 | Zavation Posterior LEIF | Zavation, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 7 | 0 |
| 2004 | 9 | 0 |
| 2005 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 7 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 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 MAX? 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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 |
|---|---|---|---|
| * | K120576 | Zavation Ibf SystemSummary page 5…rade PEEK Zeniva ZA-500 (ASTM F2026) with a Tantalum alloy position marker (ASTM F560). And pins per titanium alloy (ASTM F136). Predicate Devices: Zavation IBF System (K120576) Primary Vertebral Technologies InterFuse T (K110226) Performance Data: Mechanical test results demonstrated that the Zavation P… | 2012 |
| * | K110226 | Interfuse T Invertebral Body Fusion DeviceSummary page 5…alloy position marker (ASTM F560). And pins per titanium alloy (ASTM F136). Predicate Devices: Zavation IBF System (K120576) Primary Vertebral Technologies InterFuse T (K110226) Performance Data: Mechanical test results demonstrated that the Zavation Posterior LEIF is substantially equivalent to the pred… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 9 companies; a new generation was cleared every 1.3 years on median.
- 9 of the 71 ancestors have a recall of any class.
- 3 other devices also cite its predicate K120576.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The Zavation Posterior LEIF(Lateral Expandable Interbody Fusion) implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Zavation Posterior LEIF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic…
Read the full statement (124 words)
The Zavation Posterior LEIF(Lateral Expandable Interbody Fusion) implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Zavation Posterior LEIF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended to be used in patients who have had six months of non-operative treatment.
The Zavation Posterior LEIF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Spinal System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142392: Zavation Posterior LEIF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142392
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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