510(k) Report

510(k) · Cleared

Recalled · 2011

Altum Anterior Cervical Plate

K103505510(k) TraditionalCleared Mar 15, 2011106-day reviewClass II21 CFR 888.3060Recalls 1

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

Spinecraft, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Mar 15, 2011 as substantially equivalent to K020649 (Ortho Development Corp., 2002) and 2 other predicates after a 106-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it. It has been recalled once.

Decided
Mar 15, 2011
Review
106 days
Class
Class II
Product code
KWQ
Recalls
1
Predicates
3

Its longest line of descent runs back 1 generation to K971730 (1997). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2002: 1 other ancestor2013: 1 descendant clearedK971730 · Depuy Motech Peak Polyaxial Anterior Cervical Plate System · Depuy, Inc. · 19971995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant K971730 · Depuy Motech Peak Polyaxial Anterior Cervical Plate System · Depuy, Inc. · 19970
  1. Root · 1 generation backK971730 Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc. · 1997
  2. This deviceK103505 Altum Anterior Cervical PlateSpinecraft, LLC · 2011
  3. Descendant · cites it directly · 0 of its ownK131521 Velox Anterior Cervical Plate SystemSpinecraft, LLC · 2013

Most influential descendants

Showing 1 of 1 · See all
  • K131521Velox Anterior Cervical Plate SystemSpinecraft, LLC · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K971730Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc.1997—
0 (this device)K103505Altum Anterior Cervical PlateSpinecraft, LLC2011—
+1K131521Velox Anterior Cervical Plate SystemSpinecraft, LLC2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K103505, 1997–2013Source: 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 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? (3)

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
*K020649Envision Anterior Cervical Plate System
Summary page 1
…87 Predicate or legally marketed devices which are substantially equivalent: Envision2 Anterior Cervical Plate System (K020649) / Ortho Development Spider Cervical Plating System (K052292) / X-Spine Systems Description of the device: The ALTUM Anterior C…
Ortho Development Corp.2002—
*K971730Depuy Motech Peak Polyaxial Anterior Cervical Plate System
Summary page 2
…Substantial equivalence claimed to predicate devices ALTUM Anterior Cervical Plate system is substantially equivalent to the Envision 2 Anterior Cervical Plate System (K971 730) and Spider Cervical Plating System (K052292) in terms of intended use, design, materials used, mechanical safety and performance…
Depuy, Inc.1997—
*K052292Spider Cervical Plating (SCP) System
Summary page 1
…e or legally marketed devices which are substantially equivalent: Envision2 Anterior Cervical Plate System (K020649) / Ortho Development Spider Cervical Plating System (K052292) / X-Spine Systems Description of the device: The ALTUM Anterior Cervical Plate System is intended for anterior screw fixation…
X-Spine Systems, Inc.2005—

Also cleared against K020649: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K131521Velox Anterior Cervical Plate SystemSpinecraft, LLC20130

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 9, 2011Not classifiedZ-0459-2012Component design/selectionReports of gantry rotation without receiving a movement command caused by an overload within the drive signal power line.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K131521 (Spinecraft, LLC, 2013) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K020649.

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. 2011, 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 ALTUM Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated 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,

* pseudarthrosis,

* failed previous fusion,

" spinal stenosis.

Indications for use as stated in the FDA summary.

Also cleared against K020649

1 other device cites the same predicate.

  • K131521Velox Anterior Cervical Plate SystemSpinecraft, LLC · 2013

More from Spinecraft, LLC

12 FDA decisions under this applicant name. See the company

  • K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC · 2023
  • K223273ASTRA Spine SystemSpinecraft, LLC · 2022
  • K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC · 2021
  • K211323ASTRA Spine SystemSpinecraft, LLC · 2021
  • K181350ASTRA-OCT Spine SystemSpinecraft, LLC · 2018

Recent decisions in KWQ

The KWQ category page

  • K262149corra® cervical plating systemCarlsmed, Inc. · 2026
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  • K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
  • K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2026
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https://510kreport.com/device/K103505 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103505: Altum Anterior Cervical Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103505

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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