510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

A-Link Z

K133827510(k) TraditionalCleared Nov 17, 2014335-day reviewClass II21 CFR 888.3080Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Osteo Vasive, LLC · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

Cleared on Nov 17, 2014 as substantially equivalent to K102090 (Spine Smith Partners L.P., 2010) and 8 other predicates after a 335-day review. Its family tree reaches back 13 generations to 1984. 26 later devices descend from it. It has been recalled 2 times.

Decided
Nov 17, 2014
Review
335 days
Class
Class II
Product code
OVD
Recalls
2
Predicates
9

Its longest line of descent runs back 13 generations to K841189 (1984). 90 ancestors in all. 26 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2013: 1 other ancestor2012: 1 other ancestor2011: 3 other ancestors2010: 1 other ancestor2008: 11 other ancestors2007: 5 other ancestors2009: 7 other ancestors2006: 3 other ancestors2005: 8 other ancestors2004: 10 other ancestors1999: 2 other ancestors1996: 2 other ancestors2003: 6 other ancestors2002: 7 other ancestors2001: 9 other ancestors2000: 1 other ancestor2021: 1 descendant cleared2025: 5 descendants cleared2024: 9 descendants cleared2022: 3 descendants cleared2026: 8 descendants clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007×3: 3 generations cleared close together, K080083 (2008), K073109 (2008), K081849 (2008) K091301 · Life Spine Stand-Alone Spacer System · Life Spine · 200919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 25 other ancestors3 generations back: 20 other ancestors4 generations back: 14 other ancestors5 generations back: 9 other ancestors6 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 5 descendants3 generations forward: 8 descendants4 generations forward: 7 descendants5 generations forward: 5 descendants K091301 · Life Spine Stand-Alone Spacer System · Life Spine · 2009K081849 · Blackstone Pillar SA Partial Vertebral Body Replacement Device · Blackstone Medical, Inc. · 2008 · recalledK073109 · Stalif TT Intervertebral Body Fusion System · Surgicraft, Ltd. · 2008K080083 · Intrepid Spinal System · Medtronic Sofamor Danek · 2008 · recalledK072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−10−50+5
  1. Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 9 generations between
  3. 3 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
  4. 2 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
  5. 1 generation backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
  6. This deviceK133827 A-Link ZOsteo Vasive, LLC · 2014
  7. Descendant · cites it directly · 25 of its ownK201671 A-Link ZAcuity Surgical Devices, LLC · 2021
  8. Descendant · 2 generations on · 14 of its ownK222561 AlignAcuity Surgical Devices, LLC · 2022
  9. Descendant · 3 generations on · 8 of its ownK232432 E3D™-A Interbody SystemEvolution Spine · 2024
  10. Descendant · 2 generations on · 8 of its ownK233694 Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2024
  11. Descendant · 4 generations on · 7 of its ownK240368 E3D™-A Interbody SystemEvolution Spine · 2024
Show all 13 generations
  1. Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 10 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 9 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 8 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 7 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 6 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 5 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 4 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
  11. 3 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
  12. 2 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
  13. 1 generation backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
  14. This deviceK133827 A-Link ZOsteo Vasive, LLC · 2014

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2021: 12022: 32024: 92025: 52026: 8
2021high 9 (2024) · low 0 (2023)2026

Most influential descendants

Showing 5 of 26 · See all
  • K201671A-Link ZAcuity Surgical Devices, LLC · 2021 · cites it directly25descendants
  • K222561AlignAcuity Surgical Devices, LLC · 2022 · 2 generations on14descendants
  • K232432E3D™-A Interbody SystemEvolution Spine · 2024 · 3 generations on8descendants
  • K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2024 · 2 generations on8descendants
  • K240368E3D™-A Interbody SystemEvolution Spine · 2024 · 4 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−12K990148Stackable Cage SystemDepuy Motech Acromed1999—
−11K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−10K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−9K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−8K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−7K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−6K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−5K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−4K080083Intrepid Spinal SystemMedtronic Sofamor Danek20088
−3K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008—
−2K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20081
−1K091301Life Spine Stand-Alone Spacer SystemLife Spine2009—
0 (this device)K133827A-Link ZOsteo Vasive, LLC2014—
+1K201671A-Link ZAcuity Surgical Devices, LLC2021—
+2K222561AlignAcuity Surgical Devices, LLC2022—
+3K232432E3D™-A Interbody SystemEvolution Spine2024—
+2K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation2024—
+4K240368E3D™-A Interbody SystemEvolution Spine2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199920
200010
200190
200270
200360
2004100
200580
200630
200750
2008110
200970
201010
201130
201210
201310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
202230
202490
202550
202680
FIG. 1 — Lineage of K133827, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (9)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K102090Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant System
Summary page 6
…vice is substantially equivalent to the following predicate devices:  SpineSmith Partners, LP, Cynch Spinal System – Visualif Interbody Fusion Implant System (K102090)  RSB Spine, LLC, InterPlate® (K071922)  LDR Spine USA, LDR Spine ROI-A Implant System (K110327)  Spinal USA, Spinal…
Spine Smith Partners L.P.20101
*K071922Interplate Interbody Fusion Device, Models C, CGC, L and LGC
Summary page 6
…lowing predicate devices:  SpineSmith Partners, LP, Cynch Spinal System – Visualif Interbody Fusion Implant System (K102090)  RSB Spine, LLC, InterPlate® (K071922)  LDR Spine USA, LDR Spine ROI-A Implant System (K110327)  Spinal USA, Spinal USA Interbody Fusion Device (K080314) …
Rsb Spine, LLC2007—
*K110327LDR Spine Roi-a Interbody Fusion System
Summary page 6
…Spinal System – Visualif Interbody Fusion Implant System (K102090)  RSB Spine, LLC, InterPlate® (K071922)  LDR Spine USA, LDR Spine ROI-A Implant System (K110327)  Spinal USA, Spinal USA Interbody Fusion Device (K080314)  Lanx, Inc., Lanx Lateral-SA System (K123767)  Nexxt Spine…
Ldr Spine USA2011—
*K080314Spinal Usa Interbody Fusion Device
Summary page 6
…em (K102090)  RSB Spine, LLC, InterPlate® (K071922)  LDR Spine USA, LDR Spine ROI-A Implant System (K110327)  Spinal USA, Spinal USA Interbody Fusion Device (K080314)  Lanx, Inc., Lanx Lateral-SA System (K123767)  Nexxt Spine, LLC, Honour Spacer System (K120345)  Surgicraft Ltd., St…
Spinal USA2008—
*K123767Lanx Fusion System- SA
Summary page 6
…1922)  LDR Spine USA, LDR Spine ROI-A Implant System (K110327)  Spinal USA, Spinal USA Interbody Fusion Device (K080314)  Lanx, Inc., Lanx Lateral-SA System (K123767)  Nexxt Spine, LLC, Honour Spacer System (K120345)  Surgicraft Ltd., Stalif™ TT Intervertebral Body Fusion System (K07310…
Lanx, Inc.20134
*K120345Honour Spacer System
Summary page 6
…em (K110327)  Spinal USA, Spinal USA Interbody Fusion Device (K080314)  Lanx, Inc., Lanx Lateral-SA System (K123767)  Nexxt Spine, LLC, Honour Spacer System (K120345)  Surgicraft Ltd., Stalif™ TT Intervertebral Body Fusion System (K073109)  Life Spine, Inc., Life Spine Stand-Alone Space…
Nexxt Spine, LLC2012—
*K073109Stalif TT Intervertebral Body Fusion System
Summary page 6
… Lanx, Inc., Lanx Lateral-SA System (K123767)  Nexxt Spine, LLC, Honour Spacer System (K120345)  Surgicraft Ltd., Stalif™ TT Intervertebral Body Fusion System (K073109)  Life Spine, Inc., Life Spine Stand-Alone Spacer System (K091301)  Titan Spine, LLC, Endoskeleton® TAS (K111626) The pr…
Surgicraft, Ltd.2008—
*K091301Life Spine Stand-Alone Spacer System
Summary page 6
…Honour Spacer System (K120345)  Surgicraft Ltd., Stalif™ TT Intervertebral Body Fusion System (K073109)  Life Spine, Inc., Life Spine Stand-Alone Spacer System (K091301)  Titan Spine, LLC, Endoskeleton® TAS (K111626) The primary predicate device is K102090. The implants of the subject device…
Life Spine2009—
*K111626Endoskeleton (R) Tas
Summary page 6
…., Stalif™ TT Intervertebral Body Fusion System (K073109)  Life Spine, Inc., Life Spine Stand-Alone Spacer System (K091301)  Titan Spine, LLC, Endoskeleton® TAS (K111626) The primary predicate device is K102090. The implants of the subject device, A-Link Z, have footprint, height, and lordotic an…
Titan Spine, LLC2011—

Also cleared against K102090: 4 other devices →

What descends from it? (26)

See all 26

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K201671A-Link ZAcuity Surgical Devices, LLC202125

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 7, 2019Class IIZ-2354-2020Process controlDue to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
Jan 7, 2019Class IIZ-2355-2020Process controlDue to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 30 years and passes through 12 companies; a new generation was cleared every 1.0 years on median.
  • 14 of the 90 ancestors have a recall of any class.
  • Of its descendants, K201671 (Acuity Surgical Devices, LLC, 2021) has gone furthest, with 25 descendants of its own.
  • 4 other devices also cite its predicate K102090.

How does its category compare?

All OVD devices

OVD 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

2007: 22008: 82009: 32010: 82011: 92012: 102013: 112014: 142015: 122016: 132017: 122018: 142019: 122020: 142021: 72022: 142023: 122024: 122025: 102026 (partial year): 8
2007high 14 (2014) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OVD

100in 2025

2008: 84 days median2009: 152 days median2010: 117 days median2011: 167 days median2012: 78 days median2013: 137 days median2014: 139 days median2015: 166 days median2016: 127 days median2017: 127 days median2018: 126 days median2019: 91 days median2020: 91 days median2021: 108 days median2022: 133 days median2023: 92 days median2024: 110 days median2025: 100 days median2026 (partial year): 93 days median
2007high 167 (2011) · low 78 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OVD

1in 2025

2013: 42016: 12021: 12022: 12025: 12026 (partial year): 1
2007high 4 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OVD

50in 2025

2009: 22010: 22011: 62012: 162013: 172014: 352015: 432016: 552017: 722018: 1122019: 1712020: 2032021: 2212022: 742023: 672024: 922025: 50
2007high 221 (2021) · low 0 (2007)2025

MAUDE reports naming product code OVD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
200888400
2009315202
2010811702
2011916706
20121078016
201311137417
201414139035
201512166043
201613127155
201712127072
2018141260112
201912910171
202014910203
202171081221
202214133174
20231292067
202412110092
202510100150
20268931—

What is it indicated for?

A-Link Z is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral body space. A-Link Z is 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…

Read the full statement (150 words)

A-Link Z is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral body space.

A-Link Z is 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.

A-Link Z may be used as a stand alone device when all four (4) vertebral body bone screws are used. If the physician chooses to use fewer than the four (4) screws, then an additional supplemental spinal fixation system cleared for use in the lumbosacral spine must be used.

Indications for use as stated in the FDA summary.

Also cleared against K102090

4 other devices cite the same predicate.

  • K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP · 2018
  • K141942Midline II TICentinel Spine, Inc. · 2014
  • K122168Visualif Challenging Access PlateSpine Smith Partners L.P. · 2012
  • K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc. · 2012

Recent decisions in OVD

The OVD category page

  • K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium…INNO Holdings Inc. DBA Innovasis · 2026
  • K261408SABER-XA SystemElevation Spine · 2026
  • K261809Interwedge® Standalone LateralFoundation Surgical Group · 2026
  • K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc. · 2026
  • K260810Anteralign LS coverplateTyber Medical, LLC · 2026

https://510kreport.com/device/K133827 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133827: A-Link Z.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133827

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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