510(k) Report

510(k) · Cleared

Cleared

Anchor-L Lumbar Cage

K120869510(k) TraditionalCleared Oct 25, 2012217-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 Spine · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

Cleared on Oct 25, 2012 as substantially equivalent to K110063 (Medtronic Sofamor Danek, Inc., 2011) and 3 other predicates after a 217-day review. Its family tree reaches back 12 generations to 1984. 638 later devices descend from it.

Decided
Oct 25, 2012
Review
217 days
Class
Class II
Product code
OVD
Recalls
None
Predicates
4

Its longest line of descent runs back 12 generations to K841189 (1984). 44 ancestors in all. 638 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 5 other ancestors2007: 3 other ancestors2005: 2 other ancestors2004: 5 other ancestors1999: 2 other ancestors1996: 2 other ancestors2002: 5 other ancestors2001: 5 other ancestors2000: 1 other ancestor2003: 2 other ancestors2015: 6 descendants cleared2014: 1 descendant cleared2020: 68 descendants cleared2023: 83 descendants cleared2016: 17 descendants cleared2018: 40 descendants cleared2025: 68 descendants cleared2017: 37 descendants cleared2019: 53 descendants cleared2026: 57 descendants cleared2021: 56 descendants cleared2022: 69 descendants cleared2024: 83 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. · 2007K080083 · Intrepid Spinal System · Medtronic Sofamor Danek · 2008 · recalledK091813 · Intrepid Spinal System · Medtronic Sofamor Danek · 2009K110063 · Sovereign Spinal System · Medtronic Sofamor Danek, Inc. · 201119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 8 other ancestors3 generations back: 7 other ancestors4 generations back: 2 other ancestors5 generations back: 2 other ancestors6 generations back: 4 other ancestors7 generations back: 3 other ancestors8 generations back: 2 other ancestors9 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 12 descendants3 generations forward: 36 descendants4 generations forward: 92 descendants5 generations forward: 166 descendants6 generations forward: 168 descendants7 generations forward: 102 descendants8 generations forward: 37 descendants9 generations forward: 17 descendants10 generations forward: 5 descendants K110063 · Sovereign Spinal System · Medtronic Sofamor Danek, Inc. · 2011K091813 · Intrepid Spinal System · Medtronic Sofamor Danek · 2009K080083 · 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+10
  1. Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 8 generations between
  3. 3 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
  4. 2 generations backK091813 Intrepid Spinal SystemMedtronic Sofamor Danek · 2009
  5. 1 generation backK110063 Sovereign Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  6. This deviceK120869 Anchor-L Lumbar CageStryker Spine · 2012
  7. Descendant · cites it directly · 636 of its ownK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
  8. Descendant · 2 generations on · 469 of its ownK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
  9. Descendant · 2 generations on · 448 of its ownK152304 Tritanium PL CageStryker · 2015 · Recalled
  10. Descendant · 2 generations on · 390 of its ownK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
  11. Descendant · 3 generations on · 381 of its ownK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
Show all 12 generations
  1. Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 7 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 6 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 5 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 4 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 3 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
  11. 2 generations backK091813 Intrepid Spinal SystemMedtronic Sofamor Danek · 2009
  12. 1 generation backK110063 Sovereign Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  13. This deviceK120869 Anchor-L Lumbar CageStryker Spine · 2012

Showing 5 of 638 descendants. See all descendants

Descendants cleared per year

2014: 12015: 62016: 172017: 372018: 402019: 532020: 682021: 562022: 692023: 832024: 832025: 682026: 57
2014high 83 (2023) · low 1 (2014)2026

Most influential descendants

Showing 5 of 638 · See all
  • K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation · 2015 · cites it directly636descendants
  • K143616AccuLIF TL and PL CageStryker Corporation · 2015 · 2 generations on469descendants
  • K152304Tritanium PL CageStryker · 2015 · 2 generations on448descendants
  • K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016 · 2 generations on390descendants
  • K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016 · 3 generations on381descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−11K990148Stackable Cage SystemDepuy Motech Acromed1999—
−10K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−9K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−8K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−7K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−6K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−5K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−4K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−3K080083Intrepid Spinal SystemMedtronic Sofamor Danek20088
−2K091813Intrepid Spinal SystemMedtronic Sofamor Danek2009—
−1K110063Sovereign Spinal SystemMedtronic Sofamor Danek, Inc.2011—
0 (this device)K120869Anchor-L Lumbar CageStryker Spine2012—
+1K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK…Stryker Corporation2015—
+2K143616AccuLIF TL and PL CageStryker Corporation20154
+2K152304Tritanium PL CageStryker20151
+2K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016—
+3K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199920
200010
200150
200250
200320
200450
200520
200730
200850

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201560
2016170
2017370
2018400
2019530
2020680
2021560
2022690
2023830
2024830
2025680
2026570
FIG. 1 — Lineage of K120869, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (4)

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
*K110063Sovereign Spinal SystemMedtronic Sofamor Danek, Inc.2011—
*K073109Stalif TT Intervertebral Body Fusion System
Summary page 1
…equivalent to the devices listed below: * iMedtroic SO VEREIGN(KI 10063) * Surgicraft STALIF7 TT(K073 109) * Stryker Spine A VS PL (K073470 & K0820 14) Device Description The AVS® Anc…
Surgicraft, Ltd.2008—
*K073470Avs PL Peek Spacers, Models 48351XXX and 48353XXX
Summary page 1
…* iMedtroic SO VEREIGN(KI 10063) * Surgicraft STALIF7 TT(K073 109) * Stryker Spine A VS PL (K073470 & K0820 14) Device Description The AVS® Anchor-L Lumbar Cage Systemn is a…
Stryker Spine2008—
*K082014Stryker Spine Avs PL Peek Spacers
Summary page 1
…* iMedtroic SO VEREIGN(KI 10063) * Surgicraft STALIF7 TT(K073 109) * Stryker Spine A VS PL (K073470 & K0820 14) Device Description The AVS® Anchor-L Lumbar Cage Systemn is a…
Stryker Corp.2008—

Also cleared against K110063: 2 other devices →

What descends from it? (638)

See all 638

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636
K201585Monterey AL Interbody SystemStryker Corporation20204
K142066Aero-LL Lumbar Cage SystemStryker Corporation20142

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 28 years and passes through 10 companies; a new generation was cleared every 1.6 years on median.
  • 6 of the 44 ancestors have a recall of any class.
  • Of its descendants, K143163 (Stryker Corporation, 2015) has gone furthest, with 636 descendants of its own.
  • 2 other devices also cite its predicate K110063.

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. 2012, 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 AVS® Anchor-L Lumbar Cage System 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. DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These…

Read the full statement (211 words)

The Stryker Spine AVS® Anchor-L Lumbar Cage System 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. 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 AVS® Anchor-L Lumbar Cage System is to be implanted via an open, anterior approach.

The AVS® Anchor-L Lumbar Cage System may be used as an intervertebral device with integrated fixation or in conjunction with supplemental fixation. When used as an intervertebral device with integrated fixation, the AVS® Anchor-L Lumbar Cage must be used with the three internal screws and plate fixation provided by AVS® Anchor-L Fixation Screws and Clip Plate. If AVS® Anchor-L is used with less than three or none of the provided screws, additional supplemental fixation that has been cleared by the FDA for use in the lumbosacral spine must be used to augment stability. The accompanying Clip Plate must be used anytime the device is used with any number of screws.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K120869: Anchor-L Lumbar Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120869

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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