510(k) · Cleared
ClearedZavation Z-Link Lumbar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zavation, LLC · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Dec 19, 2014 as substantially equivalent to K072253 (Synthes Spine Co.Lp, 2007) and 1 other predicate after a 126-day review. Its family tree reaches back 14 generations to 1984. 9 later devices descend from it.
- Decided
- Dec 19, 2014
- Review
- 126 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K841189 (1984). 66 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- 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 deviceK142271 Zavation Z-Link LumbarZavation, LLC · 2014
- Descendant · cites it directly · 5 of its ownK191339 Zavation eZspand Interbody SystemZavation Medical Products, LLC · 2019
- Descendant · 2 generations on · 4 of its ownK220581 Zavation eZspand Interbody SystemZavation Medical Products, LLC · 2022
- Descendant · 3 generations on · 3 of its ownK223174 X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK230731 Zavation ALIF SystemZavation Medical Products, LLC · 2023
- Descendant · 2 generations on · 1 of its ownK233509 Zavation IBF System, Zavation Varisync Plate System and Varisync…Zavation Medical Products, LLC · 2024
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 deviceK142271 Zavation Z-Link LumbarZavation, LLC · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC · 2019 · cites it directly5descendants
- K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC · 2022 · 2 generations on4descendants
- K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc. · 2023 · 3 generations on3descendants
- K230731Zavation ALIF SystemZavation Medical Products, LLC · 2023 · cites it directly2descendants
- K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC · 2024 · 2 generations on1descendant
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) | K142271 | Zavation Z-Link Lumbar | Zavation, LLC | 2014 | — |
| +1 | K191339 | Zavation eZspand Interbody System | Zavation Medical Products, LLC | 2019 | — |
| +2 | K220581 | Zavation eZspand Interbody System | Zavation Medical Products, LLC | 2022 | — |
| +3 | K223174 | X-Pac Expandable LLIF Cage System | Expanding Innovations, Inc. | 2023 | — |
| +1 | K230731 | Zavation ALIF System | Zavation Medical Products, LLC | 2023 | — |
| +2 | K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer… | Zavation Medical Products, LLC | 2024 | — |
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 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 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 OVD? 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 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 |
|---|---|---|---|
| * | K072253 | Synfix-LR SpacerSummary page 5…Zeniva ZA-500 (ASTM F2026) with a Tantalum alloy position marker (ASTM F560). The plate and screws are titanium alloy (ASTM F136). Predicate Devices: Synthes SynFix-LR (K072253) - Primary Zavation IBF System (K120576) Performance Data: Mechanical test results demonstrated that the Zavation Z-Link Lumbar… | 2007 |
| * | K120576 | Zavation Ibf SystemSummary page 5…um alloy position marker (ASTM F560). The plate and screws are titanium alloy (ASTM F136). Predicate Devices: Synthes SynFix-LR (K072253) - Primary Zavation IBF System (K120576) Performance Data: Mechanical test results demonstrated that the Zavation Z-Link Lumbar is substantially equivalent to the predi… | 2012 |
What descends from it? (9)
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 30 years and passes through 9 companies; a new generation was cleared every 1.3 years on median.
- 9 of the 66 ancestors have a recall of any class.
- Of its descendants, K191339 (Zavation Medical Products, LLC, 2019) has gone furthest, with 5 descendants of its own.
- 27 other devices also cite its predicate K072253.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The Zavation Z-Link Lumbar is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S 1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the Z-Link Lumbar is to be filled with autogenous bone graft material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142271 · printed Nov 4, 2026
Cite this page
510(k) Report. “K142271: Zavation Z-Link Lumbar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K142271
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