510(k) Report

510(k) · Cleared

Cleared

Altiva Classic Acp System

K070891510(k) TraditionalCleared Jun 11, 200773-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

Altiva Corp. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Jun 11, 2007 after a 73-day review. The FDA summary names no predicate by number. 12 later devices descend from it.

Decided
Jun 11, 2007
Review
73 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

12 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2015: 1 descendant cleared2014: 1 descendant cleared2022: 1 descendant cleared2018: 1 descendant cleared2019: 1 descendant cleared2020: 1 descendant cleared2024: 2 descendants cleared2026: 2 descendants cleared2025: 1 descendant cleared20052010201520202025
  1. This deviceK070891 Altiva Classic Acp SystemAltiva Corp. · 2007
  2. Descendant · cites it directly · 7 of its ownK143576 Exactech AmbassadorExactech, Inc. · 2015 · Recalled
  3. Descendant · 2 generations on · 4 of its ownK190227 Boomerang™ Anterior Cervical Plate SystemChoicespine, LP · 2019
  4. Descendant · cites it directly · 3 of its ownK122216 Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC · 2012
  5. Descendant · 3 generations on · 2 of its ownK243015 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024
  6. Descendant · 2 generations on · 2 of its ownK140742 Reliance Anterior Cervical PlateReliance Medical Systems, LLC · 2014

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2012: 12014: 12015: 12018: 12019: 12020: 12022: 12024: 22025: 12026: 2
2012high 2 (2024) · low 0 (2013)2026

Most influential descendants

Showing 5 of 12 · See all
  • K143576Exactech AmbassadorExactech, Inc. · 2015 · cites it directly7descendants
  • K190227Boomerang™ Anterior Cervical Plate SystemChoicespine, LP · 2019 · 2 generations on4descendants
  • K122216Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC · 2012 · cites it directly3descendants
  • K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024 · 3 generations on2descendants
  • K140742Reliance Anterior Cervical PlateReliance Medical Systems, LLC · 2014 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K070891Altiva Classic Acp SystemAltiva Corp.2007—
+1K143576Exactech AmbassadorExactech, Inc.20151
+2K190227Boomerang™ Anterior Cervical Plate SystemChoicespine, LP2019—
+1K122216Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC2012—
+3K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.2024—
+2K140742Reliance Anterior Cervical PlateReliance Medical Systems, LLC2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201410
201510
201810
201910
202010
202210
202420
202510
202620
FIG. 1 — Lineage of K070891, 2007–2026Source: 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
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What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K143576Exactech AmbassadorExactech, Inc.20157
K122216Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC20123

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?

  • Of its descendants, K143576 (Exactech, Inc., 2015) has gone furthest, with 7 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. 2007, 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 Altiva Classic ACP System is intended for anterior screw fixation to the cervical spine (C2 to C7). The system is intended for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

* degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),

* spondylolisthesis,

* trauma (i.e. fractures or dislocations),

* tumors,

* deformity (defined by kyphosis, lordosis, or scoliosis),

* pseudoarthrosis, and

* failed previous fusion.

Indications for use as stated in the FDA summary.

More from Altiva Corp.

5 FDA decisions under this applicant name. See the company

  • K061482Altes Buttress Plating SystemAltiva Corp. · 2006
  • K053070Contour II Spinal SystemAltiva Corp. · 2006
  • K051044Arctec Semirigid Plating SystemAltiva Corp. · 2005
  • K051216Hydralok SystemAltiva Corp. · 20051 recall

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/K070891 · printed Nov 5, 2026

Cite this page

510(k) Report. “K070891: Altiva Classic Acp System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070891

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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