510(k) Report

510(k) · Cleared

Cleared

K7 Lumbar Spacers

K133126510(k) TraditionalCleared Dec 9, 201370-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

K7, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Dec 9, 2013 as substantially equivalent to K090064 (Eminent Spine, 2009) and 11 other predicates after a 70-day review. Its family tree reaches back 12 generations to 1984. 1 later device descends from it.

Decided
Dec 9, 2013
Review
70 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
12

Its longest line of descent runs back 12 generations to K841189 (1984). 82 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 2 other ancestors2010: 2 other ancestors2009: 5 other ancestors2008: 13 other ancestors1999: 2 other ancestors2007: 4 other ancestors2005: 6 other ancestors2004: 9 other ancestors2002: 7 other ancestors2001: 10 other ancestors2000: 1 other ancestor1996: 2 other ancestors2003: 7 other ancestors2017: 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) K051454 · Aleutian Spacer System · K2m, LLC · 2005K063399 · Aleutian Spacer System · K2m, Inc. · 2007K082698 · Aleutian Ibf System · K2m, Inc. · 2009K101302 · Aleutian Ibf System · K2m, Inc. · 2010K110843 · Aleutian Spacer System · K2m, Inc. · 201119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 26 other ancestors3 generations back: 14 other ancestors4 generations back: 10 other ancestors5 generations back: 7 other ancestors6 generations back: 4 other ancestors 1 generation forward: 1 descendant K110843 · Aleutian Spacer System · K2m, Inc. · 2011K101302 · Aleutian Ibf System · K2m, Inc. · 2010K082698 · Aleutian Ibf System · K2m, Inc. · 2009K063399 · Aleutian Spacer System · K2m, Inc. · 2007K051454 · Aleutian Spacer System · K2m, LLC · 2005K042930 · 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
  1. Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 8 generations between
  3. 3 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
  4. 2 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
  5. 1 generation backK110843 Aleutian Spacer SystemK2m, Inc. · 2011
  6. This deviceK133126 K7 Lumbar SpacersK7, LLC · 2013
  7. Descendant · cites it directly · 0 of its ownK170243 LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd. · 2017
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 backK051454 Aleutian Spacer SystemK2m, LLC · 2005
  9. 4 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
  10. 3 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
  11. 2 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
  12. 1 generation backK110843 Aleutian Spacer SystemK2m, Inc. · 2011
  13. This deviceK133126 K7 Lumbar SpacersK7, LLC · 2013

Most influential descendants

Showing 1 of 1 · See all
  • K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd. · 2017 · cites it directly0descendants
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—
−5K051454Aleutian Spacer SystemK2m, LLC2005—
−4K063399Aleutian Spacer SystemK2m, Inc.2007—
−3K082698Aleutian Ibf SystemK2m, Inc.2009—
−2K101302Aleutian Ibf SystemK2m, Inc.2010—
−1K110843Aleutian Spacer SystemK2m, Inc.2011—
0 (this device)K133126K7 Lumbar SpacersK7, LLC2013—
+1K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199920
200010
2001100
200270
200370
200490
200560
200740
2008130
200950
201020
201120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
FIG. 1 — Lineage of K133126, 1984–2017Source: 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 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? (12)

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
*K090064Eminent Spine Interbody Fusion System
Summary page 1
…gral marker pins are manufactured from tantalum according to ASTM F560. Predicate Devices: Eminent Spine, Eminent Spine Interbody Fusion System (K090064) DePuy AcroMed, Lumbar I/F Cage@ (P960025) DePuy Spine, Cougar LS Lateral Cage System…
Eminent Spine20091
*P960025Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws
Summary page 1
…talum according to ASTM F560. Predicate Devices: Eminent Spine, Eminent Spine Interbody Fusion System (K090064) DePuy AcroMed, Lumbar I/F Cage@ (P960025) DePuy Spine, Cougar LS Lateral Cage System (K090899, K1 10454) Choice Spine LP, ORIA…
Depuy Spine, Inc.1999—
*K090899Depuy Spine Lateral System
Summary page 1
…Spine Interbody Fusion System (K090064) DePuy AcroMed, Lumbar I/F Cage@ (P960025) DePuy Spine, Cougar LS Lateral Cage System (K090899, K1 10454) Choice Spine LP, ORIA Natura® (K073669) K2M, Aleutian® OBF System (K082698…
Depuy Spine, Inc.2009—
*K110454Cougar LS Lateral Cage System
Summary page 1
…erbody Fusion System (K090064) DePuy AcroMed, Lumbar I/F Cage@ (P960025) DePuy Spine, Cougar LS Lateral Cage System (K090899, K1 10454) Choice Spine LP, ORIA Natura® (K073669) K2M, Aleutian® OBF System (K082698, K101302…
Johnson & Johnson2011—
*K073669Oria Natura Spacer
Summary page 1
…Med, Lumbar I/F Cage@ (P960025) DePuy Spine, Cougar LS Lateral Cage System (K090899, K1 10454) Choice Spine LP, ORIA Natura® (K073669) K2M, Aleutian® OBF System (K082698, K101302 and K1 10843) Stryker Spine, AVS® PEEK S…
Choicespine, LP2008—
*K082698Aleutian Ibf System
Summary page 1
…y Spine, Cougar LS Lateral Cage System (K090899, K1 10454) Choice Spine LP, ORIA Natura® (K073669) K2M, Aleutian® OBF System (K082698, K101302 and K1 10843) Stryker Spine, AVS® PEEK Spacers (K073470, K082014, K101051) I…
K2m, Inc.2009—
*K101302Aleutian Ibf System
Summary page 1
…Cougar LS Lateral Cage System (K090899, K1 10454) Choice Spine LP, ORIA Natura® (K073669) K2M, Aleutian® OBF System (K082698, K101302 and K1 10843) Stryker Spine, AVS® PEEK Spacers (K073470, K082014, K101051) Icotec, ET…
K2m, Inc.2010—
*K110843Aleutian Spacer System
Summary page 1
…teral Cage System (K090899, K1 10454) Choice Spine LP, ORIA Natura® (K073669) K2M, Aleutian® OBF System (K082698, K101302 and K1 10843) Stryker Spine, AVS® PEEK Spacers (K073470, K082014, K101051) Icotec, ETurn Spinal Im…
K2m, Inc.2011—
*K073470Avs PL Peek Spacers, Models 48351XXX and 48353XXX
Summary page 1
…Spine LP, ORIA Natura® (K073669) K2M, Aleutian® OBF System (K082698, K101302 and K1 10843) Stryker Spine, AVS® PEEK Spacers (K073470, K082014, K101051) Icotec, ETurn Spinal Implant (K100305)…
Stryker Spine2008—
*K082014Stryker Spine Avs PL Peek Spacers
Summary page 1
…, ORIA Natura® (K073669) K2M, Aleutian® OBF System (K082698, K101302 and K1 10843) Stryker Spine, AVS® PEEK Spacers (K073470, K082014, K101051) Icotec, ETurn Spinal Implant (K100305)…
Stryker Corp.2008—
*K101051Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXX
Summary page 1
…tura® (K073669) K2M, Aleutian® OBF System (K082698, K101302 and K1 10843) Stryker Spine, AVS® PEEK Spacers (K073470, K082014, K101051) Icotec, ETurn Spinal Implant (K100305)…
Stryker Spine2010—
*K100305Eturn Spinal Implant Model Eturn XX-12; Eturn XX-16 Where XX=07, 09, 11, 13, or 15 and…
Summary page 1
…em (K082698, K101302 and K1 10843) Stryker Spine, AVS® PEEK Spacers (K073470, K082014, K101051) Icotec, ETurn Spinal Implant (K100305) Page 118…
Icotec2011—

Also cleared against K090064: 33 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170

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 29 years and passes through 9 companies; a new generation was cleared every 1.6 years on median.
  • 10 of the 82 ancestors have a recall of any class.
  • Of its descendants, K170243 (Corentec Co., Ltd., 2017) has gone furthest, with 0 descendants of its own.
  • 33 other devices also cite its predicate K090064.

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. 2013, 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 K7 Lumbar Spacers are Indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, In skeletally mature patients who have had six months of non-operative treatment The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DOD) with up to Grade I spondlylolisthesis or retralisthesis. DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device isintended for use with supplemental fixation and with autograft to facilitate fusion.

Indications for use as stated in the FDA summary.

Also cleared against K090064

33 other devices cite the same predicate.

  • K230219Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC · 2023
  • K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine · 2023
  • K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC · 2019
  • K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC · 2019
  • K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC · 20181 recall
  • K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc. · 2018

More from K7, LLC

3 FDA decisions under this applicant name. See the company

  • K133103Aversion Pedicle Screw SystemK7, LLC · 2014
  • K123388K7C SpacerK7, LLC · 2013

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/K133126 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133126: K7 Lumbar Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133126

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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