510(k) Report

510(k) · Cleared

Cleared

Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXX

K101051510(k) TraditionalCleared Aug 12, 2010119-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 · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Aug 12, 2010 as substantially equivalent to P960025 (Depuy Spine, Inc., 1999) and 5 other predicates after a 119-day review. Its family tree reaches back 10 generations to 1984. 641 later devices descend from it.

Decided
Aug 12, 2010
Review
119 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
6

Its longest line of descent runs back 10 generations to K841189 (1984). 30 ancestors in all. 641 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2008: 6 other ancestors2007: 4 other ancestors1999: 1 other ancestor2001: 3 other ancestors2000: 1 other ancestor1996: 2 other ancestors2003: 1 other ancestor2002: 1 other ancestor2018: 41 descendants cleared2015: 6 descendants cleared2014: 1 descendant cleared2013: 1 descendant cleared2017: 38 descendants cleared2025: 68 descendants cleared2016: 17 descendants cleared2023: 83 descendants cleared2020: 68 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 · 2001K020522 · Modification to Surgical Titanium Mesh System · Depuyacromed · 2002×2: 2 generations cleared close together, K030833 (2003), K031635 (2003) K041722 · Modification to VBR Spinal System · Depuy Spine, Inc. · 2004K052746 · Concorde VBR Spinal System · Depuy Spine, Inc. · 2005K090899 · Depuy Spine Lateral System · Depuy Spine, Inc. · 2009K093242 · Patriot Transcontinental Llif Spacer · Globus Medical, Inc. · 200919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 4 other ancestors3 generations back: 5 other ancestors4 generations back: 3 other ancestors5 generations back: 3 other ancestors 1 generation forward: 4 descendants2 generations forward: 14 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 K093242 · Patriot Transcontinental Llif Spacer · Globus Medical, Inc. · 2009K090899 · Depuy Spine Lateral System · Depuy Spine, Inc. · 2009K052746 · Concorde VBR Spinal System · Depuy Spine, Inc. · 2005K041722 · Modification to VBR Spinal System · Depuy Spine, Inc. · 2004K031635 · Depuy Acromed VBR System · Depuyacromed · 2003K030833 · Depuy Acromed VBR System · Depuyacromed · 2003K020522 · Modification to Surgical Titanium Mesh System · Depuyacromed · 2002K003043 · 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 · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 6 generations between
  3. 3 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
  4. 2 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
  5. 1 generation backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
  6. This deviceK101051 Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXStryker Spine · 2010
  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 10 generations
  1. Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 9 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 8 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 7 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
  5. 6 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
  6. 5 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
  7. 4 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
  8. 3 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
  9. 2 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
  10. 1 generation backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
  11. This deviceK101051 Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXStryker Spine · 2010

Showing 5 of 641 descendants. See all descendants

Descendants cleared per year

2013: 12014: 12015: 62016: 172017: 382018: 412019: 532020: 682021: 562022: 692023: 832024: 832025: 682026: 57
2013high 83 (2023) · low 1 (2013)2026

Most influential descendants

Showing 5 of 641 · 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
−10K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−9K990148Stackable Cage SystemDepuy Motech Acromed1999—
−8K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−7K020522Modification to Surgical Titanium Mesh SystemDepuyacromed2002—
−6K030833Depuy Acromed VBR SystemDepuyacromed2003—
−5K031635Depuy Acromed VBR SystemDepuyacromed2003—
−4K041722Modification to VBR Spinal SystemDepuy Spine, Inc.2004—
−3K052746Concorde VBR Spinal SystemDepuy Spine, Inc.2005—
−2K090899Depuy Spine Lateral SystemDepuy Spine, Inc.2009—
−1K093242Patriot Transcontinental Llif SpacerGlobus Medical, Inc.2009—
0 (this device)K101051Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXStryker Spine2010—
+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
199910
200010
200130
200210
200310
200740
200860
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201410
201560
2016170
2017380
2018410
2019530
2020680
2021560
2022690
2023830
2024830
2025680
2026570
FIG. 1 — Lineage of K101051, 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 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. #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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? (6)

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
*P960025Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws
Summary page 1
…ent to the devices listed below: * DePuy Acro Mcd, Inc. ILumbar I/F Cage®(9 with vsP®'~ Spine System, PMA/I 11960025 * Stryker Spine AVS® PL i-ISI3K Spacers, 510O(k) It K082014 * GlobLuS P…
Depuy Spine, Inc.1999—
*K082014Stryker Spine Avs PL Peek Spacers
Summary page 1
…mbar I/F Cage®(9 with vsP®'~ Spine System, PMA/I 11960025 * Stryker Spine AVS® PL i-ISI3K Spacers, 510O(k) It K082014 * GlobLuS PATRIO0''(T® Tanisconitiniental® Spacer, 5 10(k) it K093242…
Stryker Corp.2008—
*K093242Patriot Transcontinental Llif Spacer
Summary page 1
…ine AVS® PL i-ISI3K Spacers, 510O(k) It K082014 * GlobLuS PATRIO0''(T® Tanisconitiniental® Spacer, 5 10(k) it K093242 * Stryker Spine AVS® TIL PEEK Spacers, 510O(1k) It K083661I * NLuVasive…
Globus Medical, Inc.2009—
*K083661Avs TL Peek Spacers
Summary page 1
…ATRIO0''(T® Tanisconitiniental® Spacer, 5 10(k) it K093242 * Stryker Spine AVS® TIL PEEK Spacers, 510O(1k) It K083661I * NLuVasive CoRoenit® XL Spacers, SI 0 (k)s it K07 1795 and K08 1611…
Stryker Corp.2009—
*K071795Nuvasive Coroent System
Summary page 1
…3242 * Stryker Spine AVS® TIL PEEK Spacers, 510O(1k) It K083661I * NLuVasive CoRoenit® XL Spacers, SI 0 (k)s it K07 1795 and K08 1611 Device IDescription Th V®ALAT Pleek Spacers are intervertebral body fusion…
Nuvasive, Inc.2007—
*K081611Nuvasive Coroent System
Summary page 1
…Spine AVS® TIL PEEK Spacers, 510O(1k) It K083661I * NLuVasive CoRoenit® XL Spacers, SI 0 (k)s it K07 1795 and K08 1611 Device IDescription Th V®ALAT Pleek Spacers are intervertebral body fusion devices intended f…
Nuvasive, Inc.2008—

Also cleared against P960025: 98 other devices →

What descends from it? (641)

See all 641

4 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
K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142
K133126K7 Lumbar SpacersK7, LLC20131
K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180

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 26 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
  • 2 of the 30 ancestors have a recall of any class.
  • Of its descendants, K143163 (Stryker Corporation, 2015) has gone furthest, with 636 descendants of its own.
  • 98 other devices also cite its predicate P960025.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007: 72008: 352009: 312010: 292011: 492012: 482013: 582014: 582015: 532016: 642017: 762018: 642019: 602020: 562021: 532022: 412023: 302024: 382025: 292026 (partial year): 18
2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007: 86 days median2008: 88 days median2009: 102 days median2010: 137 days median2011: 98 days median2012: 69 days median2013: 102 days median2014: 115 days median2015: 113 days median2016: 124 days median2017: 116 days median2018: 114 days median2019: 131 days median2020: 106 days median2021: 109 days median2022: 95 days median2023: 87 days median2024: 91 days median2025: 85 days median2026 (partial year): 95 days median
2007high 137 (2010) · low 69 (2012)2026

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

Recalls per year · MAX

5in 2025

2008: 22009: 92011: 32012: 11, 1 Class I2014: 32015: 12016: 62017: 12018: 42019: 12022: 12024: 12025: 5
2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007: 122008: 192009: 902010: 1542011: 2012012: 3272013: 3802014: 3662015: 5242016: 6472017: 5962018: 6162019: 6992020: 6402021: 6222022: 6182023: 5762024: 7292025: 811
2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, 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
2007786012
20083588219
200931102990
2010291370154
201149983201
2012486911 (1)327
2013581020380
2014581153366
2015531131524
2016641246647
2017761161596
2018641144616
2019601311699
2020561060640
2021531090622
202241951618
202330870576
202438911729
202529855811
202618950—

What is it indicated for?

The Stryker Spine AVS® A-LAT PEEK Spacers are intervertebral body fusion devices 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 AVS® A-LAT PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

Indications for use as stated in the FDA summary.

Also cleared against P960025

98 other devices cite the same predicate.

  • K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with NanotechnologyNanovis, LLC · 2024
  • K191822Nano FortiCore, FortiCoreNanovis, LLC · 2019
  • K180230NEST Interbody SystemPaonan Biotech Co., Ltd. · 2019
  • K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd. · 2019
  • K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC · 2019
  • K181963ostaPek Interbody Fusion CagesColigne AG · 2018

More from Stryker Spine

92 FDA decisions under this applicant name. See the company

  • K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero®…Stryker Spine · 2026
  • K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute…Stryker Spine · 2026
  • K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System…Stryker Spine · 2024
  • K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute…Stryker Spine · 2024
  • K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA®…Stryker Spine · 2023

Recent decisions in MAX

The MAX category page

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261049Scala® TLSpineart SA · 2026
  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026

https://510kreport.com/device/K101051 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101051: Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101051

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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