510(k) Report

510(k) · Cleared

Cleared

Aero-LL Lumbar Cage System

K142066510(k) TraditionalCleared Nov 13, 2014106-day reviewClass II21 CFR 888.3080

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

Stryker Corporation · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

Cleared on Nov 13, 2014 as substantially equivalent to K082014 (Stryker Corp., 2008) and 4 other predicates after a 106-day review. Its family tree reaches back 15 generations to 1984. 2 later devices descend from it.

Decided
Nov 13, 2014
Review
106 days
Class
Class II
Product code
OVD
Recalls
None
Predicates
5

Its longest line of descent runs back 15 generations to K841189 (1984). 100 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2014: 1 other ancestor2012: 3 other ancestors2008: 11 other ancestors2013: 1 other ancestor2011: 6 other ancestors2009: 5 other ancestors2007: 7 other ancestors1999: 2 other ancestors1996: 2 other ancestors2010: 3 other ancestors2005: 5 other ancestors2004: 11 other ancestors2003: 9 other ancestors2002: 8 other ancestors2001: 10 other ancestors2000: 1 other ancestor2023: 1 descendant cleared2026: 1 descendant 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. · 2007K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K090353 · Perimeter Interbody Fusion Device · Medtronic Sofamor Danek · 2009×3: 3 generations cleared close together, K111525 (2011), K113642 (2012), K121982 (2012) K131276 · Lateral Synfix · Synthes (USA) Products, LLC · 201419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 12 other ancestors3 generations back: 15 other ancestors4 generations back: 15 other ancestors5 generations back: 12 other ancestors6 generations back: 13 other ancestors7 generations back: 7 other ancestors8 generations back: 4 other ancestors9 generations back: 2 other ancestors10 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant K131276 · Lateral Synfix · Synthes (USA) Products, LLC · 2014K121982 · Sovereign Spinal System · Medtronic Sofamor Danek · 2012K113642 · Perimeter Interbody Fusion Device · Medtronic Sofamor Danek USA · 2012K111525 · Perimeter Interbody Fusion Device · Medtronic Sofamor Danek · 2011K090353 · Perimeter Interbody Fusion Device · Medtronic Sofamor Danek · 2009K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K072120 · 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. · 1984−15−10−50
  1. Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 11 generations between
  3. 3 generations backK113642 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA · 2012
  4. 2 generations backK121982 Sovereign Spinal SystemMedtronic Sofamor Danek · 2012
  5. 1 generation backK131276 Lateral SynfixSynthes (USA) Products, LLC · 2014
  6. This deviceK142066 Aero-LL Lumbar Cage SystemStryker Corporation · 2014
  7. Descendant · cites it directly · 1 of its ownK221490 Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL…Stryker Spine · 2023
  8. Descendant · 2 generations on · 0 of its ownK262061 Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium®…Stryker Spine · 2026
Show all 15 generations
  1. Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 8 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 7 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 6 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  11. 5 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
  12. 4 generations backK111525 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2011
  13. 3 generations backK113642 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA · 2012
  14. 2 generations backK121982 Sovereign Spinal SystemMedtronic Sofamor Danek · 2012
  15. 1 generation backK131276 Lateral SynfixSynthes (USA) Products, LLC · 2014
  16. This deviceK142066 Aero-LL Lumbar Cage SystemStryker Corporation · 2014

Most influential descendants

Showing 2 of 2 · See all
  • K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine · 2023 · cites it directly1descendant
  • K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−15K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−14K990148Stackable Cage SystemDepuy Motech Acromed1999—
−13K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−12K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−11K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−10K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−9K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−8K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−7K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−6K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
−5K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009—
−4K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011—
−3K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012—
−2K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012—
−1K131276Lateral SynfixSynthes (USA) Products, LLC2014—
0 (this device)K142066Aero-LL Lumbar Cage SystemStryker Corporation2014—
+1K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved…Stryker Spine2023—
+2K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved…Stryker Spine2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199920
200010
2001100
200280
200390
2004110
200550
200770
2008110
200950
201030
201160
201230
201310
201410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
202610
FIG. 1 — Lineage of K142066, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K082014Stryker Spine Avs PL Peek Spacers
Summary page 4
…substantially equivalent to the devices listed below: Primary Predicate Device: Stryker Spine AVS PL (K082014) Additional Predicate Devices: Stryker Spine Aero™-AL Lumbar Cage System (K13…
Stryker Corp.2008—
*K133328Aero-AL Lumbar Cage System
Summary page 4
…Stryker Spine AVS PL (K082014) Additional Predicate Devices: Stryker Spine Aero™-AL Lumbar Cage System (K133328) Stryker Spine AVS Anchor-L (K120869) LDR Spine Avenue L (K113285)…
Stryker Corporation2014—
*K120869Anchor-L Lumbar Cage
Summary page 4
…Additional Predicate Devices: Stryker Spine Aero™-AL Lumbar Cage System (K133328) Stryker Spine AVS Anchor-L (K120869) LDR Spine Avenue L (K113285) Depuy Synthes SYNFIX Lateral Spacer (K13127…
Stryker Spine2012—
*K113285LDR Spine Usa Avenue L Interbody Fusion
Summary page 4
…Stryker Spine Aero™-AL Lumbar Cage System (K133328) Stryker Spine AVS Anchor-L (K120869) LDR Spine Avenue L (K113285) Depuy Synthes SYNFIX Lateral Spacer (K131276) Device Description The Aero™-LL Cage is a hollow,…
Ldr Spine USA, Inc.2012—
*K131276Lateral Synfix
Summary page 4
…Stryker Spine AVS Anchor-L (K120869) LDR Spine Avenue L (K113285) Depuy Synthes SYNFIX Lateral Spacer (K131276) Device Description The Aero™-LL Cage is a hollow, bullet-shaped PEEK Optima cage surrounded by a ti…
Synthes (USA) Products, LLC2014—

Also cleared against K082014: 11 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231

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 12 companies; a new generation was cleared every 1.0 years on median.
  • 12 of the 100 ancestors have a recall of any class.
  • Of its descendants, K221490 (Stryker Spine, 2023) has gone furthest, with 1 descendant of its own.
  • 11 other devices also cite its predicate K082014.

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?

The Stryker Spine Aero™-LL is an intervertebral body fusion device indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be…

Read the full statement (142 words)

The Stryker Spine Aero™-LL is an intervertebral body fusion device indicated for use with autogenous bone graft in

patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic

studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be

skeletally mature and have six months of nonoperative therapy.

The Aero™-LL Lumbar Cage System is to be implanted via a lateral approach.

The Aero™-LL Lumbar Cage System is intended to be used with supplemental spinal fixation systems that have been

cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems). In addition, the device may be

used with or without the included fixation anchors.

Indications for use as stated in the FDA summary.

Also cleared against K082014

11 other devices cite the same predicate.

  • K152200SurgTech Interbody SystemSurgtech, Inc. · 2016
  • K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway · 2015
  • K133126K7 Lumbar SpacersK7, LLC · 2013
  • K120869Anchor-L Lumbar CageStryker Spine · 2012
  • K120345Honour Spacer SystemNexxt Spine, LLC · 2012
  • K111792Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and MiniSignus Medizintechnik GmbH · 2012

More from Stryker Corporation

87 FDA decisions under this applicant name. See the company

  • K232157Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice…Stryker Corporation · 2023
  • K223770Sonopet 1Q 3 7cm 1Q LargeStryker Corporation · 2023
  • K212194Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker…Stryker Corporation · 20232 recalls
  • K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating…Stryker Corporation · 2022
  • K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceStryker Corporation · 2022

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/K142066 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142066: Aero-LL Lumbar Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142066

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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