510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Spine Frontier Indus Acp System

K121060510(k) SpecialCleared Jul 3, 201288-day reviewClass II21 CFR 888.3060Recalls 6

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 Jul 3, 2012 as substantially equivalent to K093776 (Spinefrontier, Inc., 2010) and 3 other predicates after an 88-day review. Its family tree reaches back 4 generations to 2000. 15 later devices descend from it. It has been recalled 6 times.

Decided
Jul 3, 2012
Review
88 days
Class
Class II
Product code
KWQ
Recalls
6
Predicates
4

Its longest line of descent runs back 4 generations to K002592 (2000). 11 ancestors in all. 15 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 2 other ancestors2005: 2 other ancestors2003: 2 other ancestors2001: 1 other ancestor2016: 2 descendants cleared2014: 1 descendant cleared2023: 2 descendants 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 · 2006K093776 · Indus Anterior Cervical Plate System · Spinefrontier, Inc. · 2010200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 3 other ancestors4 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 5 descendants3 generations forward: 5 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K093776 · Indus Anterior Cervical Plate System · Spinefrontier, Inc. · 2010K062831 · 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 · 4 generations backK002592 Interpore Cross Anterior Cervical Plate SystemInterpore Cross Intl. · 2000
  2. 3 generations backK040844 Life Spine Neo Anterior Cervical Plate SystemLife Spine, LLC · 2004
  3. 2 generations backK062831 Modification to Life Spine Neo Anterior Cervical Plate SystemLife Spine · 2006
  4. 1 generation backK093776 Indus Anterior Cervical Plate SystemSpinefrontier, Inc. · 2010
  5. This deviceK121060 Spine Frontier Indus Acp SystemSpinefrontier, Inc. · 2012
  6. Descendant · cites it directly · 6 of its ownK153526 Pyrenees Cervical Plate SystemK2m · 2016
  7. Descendant · cites it directly · 6 of its ownK140234 Aspiron Acp SystemU&I Corp. · 2014
  8. Descendant · 2 generations on · 5 of its ownK162664 Pyrenees Cervical Plate SystemK2m, Inc. · 2016
  9. Descendant · 3 generations on · 4 of its ownK182473 PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System…K2m, Inc. · 2018
  10. Descendant · 2 generations on · 2 of its ownK231251 FlexWing Anterior Cervical Plate SystemJeil Medical Corporation · 2024

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2014: 12016: 22018: 22019: 12022: 22023: 22024: 22025: 22026: 1
2014high 2 (2016) · low 0 (2015)2026

Most influential descendants

Showing 5 of 15 · See all
  • K153526Pyrenees Cervical Plate SystemK2m · 2016 · cites it directly6descendants
  • K140234Aspiron Acp SystemU&I Corp. · 2014 · cites it directly6descendants
  • K162664Pyrenees Cervical Plate SystemK2m, Inc. · 2016 · 2 generations on5descendants
  • K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc. · 2018 · 3 generations on4descendants
  • K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation · 2024 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K002592Interpore Cross Anterior Cervical Plate SystemInterpore Cross Intl.2000—
−3K040844Life Spine Neo Anterior Cervical Plate SystemLife Spine, LLC2004—
−2K062831Modification to Life Spine Neo Anterior Cervical Plate SystemLife Spine2006—
−1K093776Indus Anterior Cervical Plate SystemSpinefrontier, Inc.2010—
0 (this device)K121060Spine Frontier Indus Acp SystemSpinefrontier, Inc.2012—
+1K153526Pyrenees Cervical Plate SystemK2m2016—
+1K140234Aspiron Acp SystemU&I Corp.2014—
+2K162664Pyrenees Cervical Plate SystemK2m, Inc.2016—
+3K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK…K2m, Inc.2018—
+2K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200320
200520
200820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201620
201820
201910
202220
202320
202420
202520
202610
FIG. 1 — Lineage of K121060, 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
*K093776Indus Anterior Cervical Plate System
Summary page 1
…is (21 Q.FR 868.3060). Class 11 Product Code: --KWVQ' 3. Predicate Devices. K093776- SpineFrontier - Ind usT m Anterior Cervical Plate System K050588- Innovative Spinal - Verteview.ACP System…
Spinefrontier, Inc.2010—
*K050588Verteview Anterior Cervical Plate System
Summary page 1
…Product Code: --KWVQ' 3. Predicate Devices. K093776- SpineFrontier - Ind usT m Anterior Cervical Plate System K050588- Innovative Spinal - Verteview.ACP System K(073275- NuVasive - Helix Mini AGP System K(030866- Sy…
Innovative Spinal Design, LLC2005—
*K073275Nuvasive Helix Mini Acp System
Summary page 1
…s. K093776- SpineFrontier - Ind usT m Anterior Cervical Plate System K050588- Innovative Spinal - Verteview.ACP System K(073275- NuVasive - Helix Mini AGP System K(030866- Synthes - Anterior CSLP System 4. Device.Description'…
Nuvasive, Inc.2008—
*K030866Synthes Anterior CSLP System
Summary page 1
…rior Cervical Plate System K050588- Innovative Spinal - Verteview.ACP System K(073275- NuVasive - Helix Mini AGP System K(030866- Synthes - Anterior CSLP System 4. Device.Description' The SpineFrontier Indus' m ACP System consists…
Synthes (Usa)2003—

Also cleared against K093776: 1 other device →

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K153526Pyrenees Cervical Plate SystemK2m20166
K140234Aspiron Acp SystemU&I Corp.20146
K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 20, 2013Class IIZ-0574-2014Packaging process controlMismarked and unmarked screws
Nov 20, 2013Class IIZ-0575-2014Packaging process controlMismarked and unmarked screws
Nov 20, 2013Class IIZ-0573-2014Packaging process controlMismarked and unmarked screws
Nov 20, 2013Class IIZ-0576-2014Packaging process controlMismarked and unmarked screws
Jun 21, 2013Class IIZ-1933-2013Device DesignDifficulty removing screws from the Invue caddies.
May 9, 2012Class IIZ-1957-2013Device DesignThe nipple of the tipped driver broke off when surgeons were attempting to insert the screw.

The 5 latest of 6 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
  • None of the 11 ancestors has a recall.
  • Of its descendants, K153526 (K2m, 2016) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K093776.

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. 2012, 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 SpineFrontier Indus ACP System (Indus InVue, Indus InVue 2, Indus Inset) 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 C2 to T1. 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.

Also cleared against K093776

1 other device cites the same predicate.

  • K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset…Lesspine Innovations · 2023

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/K121060 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121060: Spine Frontier Indus Acp System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121060

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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