510(k) Report

510(k) · Cleared

Cleared

Indus Anterior Cervical Plate System

K093776510(k) TraditionalCleared Mar 26, 2010108-day reviewClass II21 CFR 888.3060

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

Spinefrontier, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Mar 26, 2010 as substantially equivalent to K073232 (Spinefrontier, Inc., 2008) and 3 other predicates after a 108-day review. Its family tree reaches back 3 generations to 2000. 16 later devices descend from it.

Decided
Mar 26, 2010
Review
108 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K002592 (2000). 7 ancestors in all. 16 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2005: 1 other ancestor2003: 2 other ancestors2012: 1 descendant cleared2023: 2 descendants cleared2016: 2 descendants cleared2014: 1 descendant cleared2024: 2 descendants cleared2019: 1 descendant cleared2018: 2 descendants cleared2022: 2 descendants cleared2025: 2 descendants cleared2026: 1 descendant clearedK002592 · Interpore Cross Anterior Cervical Plate System · Interpore Cross Intl. · 2000K040844 · Life Spine Neo Anterior Cervical Plate System · Life Spine, LLC · 2004K062831 · Modification to Life Spine Neo Anterior Cervical Plate System · Life Spine · 2006200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors3 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 5 descendants4 generations forward: 5 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant K062831 · Modification to Life Spine Neo Anterior Cervical Plate System · Life Spine · 2006K040844 · Life Spine Neo Anterior Cervical Plate System · Life Spine, LLC · 2004K002592 · Interpore Cross Anterior Cervical Plate System · Interpore Cross Intl. · 20000+5
  1. Root · 3 generations backK002592 Interpore Cross Anterior Cervical Plate SystemInterpore Cross Intl. · 2000
  2. 2 generations backK040844 Life Spine Neo Anterior Cervical Plate SystemLife Spine, LLC · 2004
  3. 1 generation backK062831 Modification to Life Spine Neo Anterior Cervical Plate SystemLife Spine · 2006
  4. This deviceK093776 Indus Anterior Cervical Plate SystemSpinefrontier, Inc. · 2010
  5. Descendant · cites it directly · 15 of its ownK121060 Spine Frontier Indus Acp SystemSpinefrontier, Inc. · 2012 · Recalled
  6. Descendant · 2 generations on · 6 of its ownK153526 Pyrenees Cervical Plate SystemK2m · 2016
  7. Descendant · 2 generations on · 6 of its ownK140234 Aspiron Acp SystemU&I Corp. · 2014
  8. Descendant · 3 generations on · 5 of its ownK162664 Pyrenees Cervical Plate SystemK2m, Inc. · 2016
  9. Descendant · 4 generations on · 4 of its ownK182473 PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System…K2m, Inc. · 2018

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2012: 12014: 12016: 22018: 22019: 12022: 22023: 22024: 22025: 22026: 1
2012high 2 (2016) · low 0 (2013)2026

Most influential descendants

Showing 5 of 16 · See all
  • K121060Spine Frontier Indus Acp SystemSpinefrontier, Inc. · 2012 · cites it directly15descendants
  • K153526Pyrenees Cervical Plate SystemK2m · 2016 · 2 generations on6descendants
  • K140234Aspiron Acp SystemU&I Corp. · 2014 · 2 generations on6descendants
  • K162664Pyrenees Cervical Plate SystemK2m, Inc. · 2016 · 3 generations on5descendants
  • K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc. · 2018 · 4 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K002592Interpore Cross Anterior Cervical Plate SystemInterpore Cross Intl.2000—
−2K040844Life Spine Neo Anterior Cervical Plate SystemLife Spine, LLC2004—
−1K062831Modification to Life Spine Neo Anterior Cervical Plate SystemLife Spine2006—
0 (this device)K093776Indus Anterior Cervical Plate SystemSpinefrontier, Inc.2010—
+1K121060Spine Frontier Indus Acp SystemSpinefrontier, Inc.20126
+2K153526Pyrenees Cervical Plate SystemK2m2016—
+2K140234Aspiron Acp SystemU&I Corp.2014—
+3K162664Pyrenees Cervical Plate SystemK2m, Inc.2016—
+4K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK…K2m, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200320
200510
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201410
201620
201820
201910
202220
202320
202420
202520
202610
FIG. 1 — Lineage of K093776, 2000–2026Source: 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 KWQ? 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 KWQ device

  1. #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 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
*K073232Indus Anterior Cervical Plate System, Model IM3XXX
Summary page 1
…on Orthosis (21 CFR 888.3060), Class 11 Product Code: KWQ 3. Predicate Devices K073232 - SpineFrontier - Indus Anterior Cervical Plate System K030866 - Synthes Spine - Anterior CSLP System K05…
Spinefrontier, Inc.2008—
*K030866Synthes Anterior CSLP System
Summary page 1
…ass 11 Product Code: KWQ 3. Predicate Devices K073232 - SpineFrontier - Indus Anterior Cervical Plate System K030866 - Synthes Spine - Anterior CSLP System K052292 - X-Spine - Spider Cervical Plate K062831 - Life Spine - N…
Synthes (Usa)2003—
*K052292Spider Cervical Plating (SCP) System
Summary page 1
…3. Predicate Devices K073232 - SpineFrontier - Indus Anterior Cervical Plate System K030866 - Synthes Spine - Anterior CSLP System K052292 - X-Spine - Spider Cervical Plate K062831 - Life Spine - NEO 4. Device Description The IndusTm…
X-Spine Systems, Inc.2005—
*K062831Modification to Life Spine Neo Anterior Cervical Plate System
Summary page 1
…ntier - Indus Anterior Cervical Plate System K030866 - Synthes Spine - Anterior CSLP System K052292 - X-Spine - Spider Cervical Plate K062831 - Life Spine - NEO 4. Device Description The IndusTm Anterior Cervical Plate System consists of a variety o…
Life Spine2006—

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K121060Spine Frontier Indus Acp SystemSpinefrontier, Inc.201215
K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230

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 10 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K121060 (Spinefrontier, Inc., 2012) has gone furthest, with 15 descendants of its own.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · KWQ

7in 2025

2007: 272008: 322009: 232010: 232011: 222012: 262013: 222014: 172015: 252016: 152017: 202018: 222019: 262020: 262021: 172022: 182023: 162024: 172025: 72026 (partial year): 10
2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007: 101 days median2008: 70 days median2009: 90 days median2010: 104 days median2011: 95 days median2012: 90 days median2013: 88 days median2014: 124 days median2015: 102 days median2016: 121 days median2017: 67 days median2018: 95 days median2019: 81 days median2020: 55 days median2021: 59 days median2022: 85 days median2023: 59 days median2024: 64 days median2025: 64 days median2026 (partial year): 76 days median
2007high 124 (2014) · low 55 (2020)2026

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

Recalls per year · KWQ

1in 2018

2007: 22008: 332009: 352010: 22011: 52012: 72013: 62015: 22016: 92017: 82018: 1
2007high 35 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWQ

248in 2025

2007: 2882008: 3482009: 3552010: 6912011: 4152012: 5442013: 7962014: 5462015: 5622016: 5022017: 4922018: 3412019: 2982020: 4002021: 5912022: 3922023: 3202024: 4192025: 248
2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, 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
2007271012288
2008327033348
2009239035355
2010231042691
201122955415
201226907544
201322886796
2014171240546
2015251022562
2016151219502
201720678492
201822951341
201926810298
202026550400
202117590591
202218850392
202316590320
202417640419
20257640248
202610760—

What is it indicated for?

The Indusrm Anterior Cervical Plate System is intended for anterior spine fixation for use in providing temporary stabilization during the development of cervical spinal fusions. The levels of treatment range from 02 to Ti. Indications include symptomatic cervical spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, deformities or curvatures (scoliosis, kyphosis and or lordosis), tumor, pseudoarthrosis, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), and re-operation for failed fusion or instability following surgery for above indications.

Indications for use as stated in the FDA summary.

More from Spinefrontier, Inc.

24 FDA decisions under this applicant name. See the company

  • K193106SpineFrontier Lumbar Interbody Fusion Device SystemSpinefrontier, Inc. · 2020
  • K172484A-CIFT SoloFuseSpinefrontier, Inc. · 20181 recall
  • K151198A-CIFT SoloFuseSpinefrontier, Inc. · 2015
  • K142504SpineFrontier Lumbar Interbody Fusion Device SystemSpinefrontier, Inc. · 2015
  • K150017SpineFrontier SIJFuse Sacroiliac Joint Fusion Device SystemSpinefrontier, Inc. · 2015

Recent decisions in KWQ

The KWQ category page

  • K262149corra® cervical plating systemCarlsmed, Inc. · 2026
  • K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC · 2026
  • K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
  • K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2026
  • K260570corra™ cervical plating systemCarlsmed, Inc. · 2026

https://510kreport.com/device/K093776 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093776: Indus Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093776

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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