510(k) Report

510(k) · Cleared

Cleared

Modification to: Spectrumtm Cervical Spinal System

K050804510(k) SpecialCleared Apr 11, 200512-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

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

Cleared on Apr 11, 2005 as substantially equivalent to K022997 (Spinal Innovations, LLC, 2002) and 1 other predicate after a 12-day review. Its family tree reaches back 1 generation to 1999. 11 later devices descend from it.

Decided
Apr 11, 2005
Review
12 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K993855 (1999). 2 ancestors in all. 11 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2010: 1 descendant cleared2014: 1 descendant cleared2012: 1 descendant cleared2023: 1 descendant cleared2018: 1 descendant cleared2020: 1 descendant cleared2021: 1 descendant cleared2025: 2 descendants cleared2024: 1 descendant cleared2026: 1 descendant clearedK993855 · Atlantis Anterior Cervical Plate System · Danek Medical, Inc. · 19991995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 3 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant K993855 · Atlantis Anterior Cervical Plate System · Danek Medical, Inc. · 19990+5
  1. Root · 1 generation backK993855 Atlantis Anterior Cervical Plate SystemDanek Medical, Inc. · 1999
  2. This deviceK050804 Modification to: Spectrumtm Cervical Spinal SystemAesculap, Inc. · 2005
  3. Descendant · cites it directly · 10 of its ownK100243 Quintex Cervical Plating SystemAesculap Implant Systems, LLC · 2010 · Recalled
  4. Descendant · 2 generations on · 8 of its ownK141993 Nakoma AcpAlliance Partners, LLC · 2014 · Recalled
  5. Descendant · 3 generations on · 3 of its ownK231766 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023
  6. Descendant · 4 generations on · 2 of its ownK243015 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024
  7. Descendant · 3 generations on · 2 of its ownK173128 Alamo® CAlliance Partners, LLC · 2018

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2010: 12012: 12014: 12018: 12020: 12021: 12023: 12024: 12025: 22026: 1
2010high 2 (2025) · low 0 (2011)2026

Most influential descendants

Showing 5 of 11 · See all
  • K100243Quintex Cervical Plating SystemAesculap Implant Systems, LLC · 2010 · cites it directly10descendants
  • K141993Nakoma AcpAlliance Partners, LLC · 2014 · 2 generations on8descendants
  • K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023 · 3 generations on3descendants
  • K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024 · 4 generations on2descendants
  • K173128Alamo® CAlliance Partners, LLC · 2018 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K993855Atlantis Anterior Cervical Plate SystemDanek Medical, Inc.1999—
0 (this device)K050804Modification to: Spectrumtm Cervical Spinal SystemAesculap, Inc.2005—
+1K100243Quintex Cervical Plating SystemAesculap Implant Systems, LLC20101
+2K141993Nakoma AcpAlliance Partners, LLC20141
+3K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)2023—
+4K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.2024—
+3K173128Alamo® CAlliance Partners, LLC2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201210
201410
201810
202010
202110
202310
202410
202520
202610
FIG. 1 — Lineage of K050804, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (2)

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
*K022997Spectrum Cervical Spinal System
Summary page 2
…BSTANTIAL EQUIVALENCE Aesculap believes that the modified SPECTRUMTM Cervical Spinal System is substantially equivalent to our current SPECTRUMTM Cervical Spinal System (K022997) and to the following competitor's predicate device. * Sofamor Danek AtlantisTM Anterior Cervical Plate System (K99…
Spinal Innovations, LLC2002—
*K993855Atlantis Anterior Cervical Plate System
Summary page 2
…SPECTRUMTM Cervical Spinal System (K022997) and to the following competitor's predicate device. * Sofamor Danek AtlantisTM Anterior Cervical Plate System (K993855) 6 DEPARTMENT OF HEALTH & HUMAN SERVICES…
Danek Medical, Inc.1999—

Also cleared against K022997: 2 other devices →

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K100243Quintex Cervical Plating SystemAesculap Implant Systems, LLC201010

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K100243 (Aesculap Implant Systems, LLC, 2010) has gone furthest, with 10 descendants of its own.
  • 2 other devices also cite its predicate K022997.

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.

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 SPECTRUMTM Cervical Plating System is intended for anterior intervertebral body screw fixation of the cervical spine. The system implants are indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disk confirmed by patient history and radiographic studies), trauma (including…

Read the full statement (106 words)

The SPECTRUMTM Cervical Plating System is intended for anterior intervertebral body screw fixation of the cervical spine. The system implants are indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disk confirmed by patient history and radiographic studies), trauma (including fractures or dislocation), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/of failed previous fusions.

WARNING: This device is not approved for screw attachment of fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Indications for use as stated in the FDA summary.

Also cleared against K022997

2 other devices cite the same predicate.

  • K173935Mediant Anterior Cervical Plating SystemIntelligent Implant Systems, LLC · 2018
  • K100243Quintex Cervical Plating SystemAesculap Implant Systems, LLC · 20101 recall

More from Aesculap, Inc.

208 FDA decisions under this applicant name. See the company

  • K260044Ventricular Catheters, Thomale CatheterAesculap, Inc. · 2026
  • K242762Aesculap Aicon® Series Container SystemAesculap, Inc. · 2025
  • K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetAesculap, Inc. · 2024
  • K223596SQ.line KERRISONAesculap, Inc. · 2023
  • K214041Aesculap AICON ContainerAesculap, Inc. · 2022

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/K050804 · printed Nov 3, 2026

Cite this page

510(k) Report. “K050804: Modification to: Spectrumtm Cervical Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050804

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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