510(k) Report

510(k) · Cleared

Cleared

K7C Spacer

K123388510(k) TraditionalCleared Jan 4, 201363-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 · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Jan 4, 2013 as substantially equivalent to K090064 (Eminent Spine, 2009) and 6 other predicates after a 63-day review. Its family tree reaches back 12 generations to 1984.

Decided
Jan 4, 2013
Review
63 days
Class
Class II
Product code
ODP
Recalls
None
Predicates
7

Its longest line of descent runs back 12 generations to K841189 (1984). 62 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2009: 4 other ancestors2005: 4 other ancestors2001: 9 other ancestors2008: 5 other ancestors2004: 9 other ancestors2002: 7 other ancestors1999: 2 other ancestors1996: 2 other ancestors2003: 7 other ancestors2000: 1 other ancestorK841189 · 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) K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K051454 · Aleutian Spacer System · K2m, LLC · 2005K063399 · Aleutian Spacer System · K2m, Inc. · 2007K082698 · Aleutian Ibf System · K2m, Inc. · 2009K101302 · Aleutian Ibf System · K2m, Inc. · 2010K103169 · Aleuttian · K2m, Inc. · 201119801985199019952000200520102015
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 14 other ancestors3 generations back: 13 other ancestors4 generations back: 13 other ancestors5 generations back: 4 other ancestors6 generations back: 2 other ancestors K103169 · Aleuttian · 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 backK103169 AleuttianK2m, Inc. · 2011
  6. This deviceK123388 K7C SpacerK7, LLC · 2013
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 backK103169 AleuttianK2m, Inc. · 2011
  13. This deviceK123388 K7C SpacerK7, LLC · 2013
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—
−1K103169AleuttianK2m, Inc.2011—
0 (this device)K123388K7C SpacerK7, LLC2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199920
200010
200190
200270
200370
200490
200540
200850
200940
FIG. 1 — Lineage of K123388, 1984–2013Source: 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 ODP? 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 ODP device

  1. #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 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? (7)

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
…Technologies GmbH). Integral marker pins are manufactured from tantalum according to ASTIM F560. Predicate Devices: Eminent Spine (K090064) CenterPulse Spine-Tech (P980048) MC+ (K043479 and K091088) K…
Eminent Spine20091
*P980048Bak/Cervical (Bak/C) Interbody Fusion System
Summary page 1
…are manufactured from tantalum according to ASTIM F560. Predicate Devices: Eminent Spine (K090064) CenterPulse Spine-Tech (P980048) MC+ (K043479 and K091088) K2M, Inc. (K082698, K101302 and K103169) Technological…
Sulzer Spine-Tech2001—
*K043479MC+ Partial VBR
Summary page 1
…tantalum according to ASTIM F560. Predicate Devices: Eminent Spine (K090064) CenterPulse Spine-Tech (P980048) MC+ (K043479 and K091088) K2M, Inc. (K082698, K101302 and K103169) Technological The K7CTM Spacers possessat…
Ldr Spine USA2005—
*K091088LDR Spine Cervical Interbody Fusion System
Summary page 1
…alum according to ASTIM F560. Predicate Devices: Eminent Spine (K090064) CenterPulse Spine-Tech (P980048) MC+ (K043479 and K091088) K2M, Inc. (K082698, K101302 and K103169) Technological The K7CTM Spacers possessathe same tech…
Ldr Spine USA2009—
*K082698Aleutian Ibf System
Summary page 1
…ces: Eminent Spine (K090064) CenterPulse Spine-Tech (P980048) MC+ (K043479 and K091088) K2M, Inc. (K082698, K101302 and K103169) Technological The K7CTM Spacers possessathe same technological characteristics Characteristics:…
K2m, Inc.2009—
*K101302Aleutian Ibf System
Summary page 1
…minent Spine (K090064) CenterPulse Spine-Tech (P980048) MC+ (K043479 and K091088) K2M, Inc. (K082698, K101302 and K103169) Technological The K7CTM Spacers possessathe same technological characteristics Characteristics: as…
K2m, Inc.2010—
*K103169Aleuttian
Summary page 1
…(K090064) CenterPulse Spine-Tech (P980048) MC+ (K043479 and K091088) K2M, Inc. (K082698, K101302 and K103169) Technological The K7CTM Spacers possessathe same technological characteristics Characteristics: as the predicat…
K2m, Inc.2011—

Also cleared against K090064: 33 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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.
  • 8 of the 62 ancestors have a recall of any class.
  • 33 other devices also cite its predicate K090064.

How does its category compare?

All ODP devices

ODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · ODP

11in 2025

2008: 82009: 122010: 92011: 252012: 172013: 182014: 262015: 242016: 172017: 332018: 252019: 222020: 142021: 182022: 122023: 342024: 102025: 112026 (partial year): 19
2007high 34 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODP

87in 2025

2008: 89 days median2009: 127 days median2010: 151 days median2011: 113 days median2012: 93 days median2013: 187 days median2014: 118 days median2015: 180 days median2016: 112 days median2017: 104 days median2018: 133 days median2019: 92 days median2020: 89 days median2021: 121 days median2022: 92 days median2023: 165 days median2024: 76 days median2025: 87 days median2026 (partial year): 117 days median
2007high 187 (2013) · low 76 (2024)2026

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

Recalls per year · ODP

2in 2025

2009: 12011: 12013: 12020: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

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

Adverse event reports per year · ODP

57in 2025

2008: 22009: 212010: 542011: 382012: 922013: 782014: 432015: 512016: 372017: 392018: 512019: 1412020: 862021: 1612022: 502023: 362024: 552025: 57
2007high 161 (2021) · low 0 (2007)2025

MAUDE reports naming product code ODP, 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
20070—00
200888902
200912127121
20109151054
201125113138
20121793092
201318187178
201426118043
201524180051
201617112037
201733104039
201825133051
201922920141
20201489186
2021181210161
20221292050
202334165036
20241076055
20251187257
2026191170—

What is it indicated for?

When used as a cervical intervertebral fusion device, the K7CTM spacers are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DOD) with up to Grade 1 spondylolisthesis. ODD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the cervical spine.

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
  • K133126K7 Lumbar SpacersK7, LLC · 2013

Recent decisions in ODP

The ODP category page

  • K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc. · 2026
  • K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026
  • K2530413d Cage CervicalFims Co., Ltd. · 2026
  • K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero®…Stryker Spine · 2026
  • K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC · 2026

https://510kreport.com/device/K123388 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123388: K7C Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123388

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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