510(k) Report

510(k) · Cleared

Cleared

Spider Cervical Plating (SCP) System

K052292510(k) TraditionalCleared Oct 21, 200559-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

X-Spine Systems, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Oct 21, 2005 after a 59-day review. The FDA summary names its predicate without a number. 137 later devices descend from it.

Decided
Oct 21, 2005
Review
59 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

137 later devices descend from it, 15 citing it directly.

Descendants, by year cleared 2012: 3 descendants cleared2010: 2 descendants cleared2016: 4 descendants cleared2011: 3 descendants cleared2015: 3 descendants cleared2019: 4 descendants cleared2018: 3 descendants cleared2017: 3 descendants cleared2008: 1 descendant cleared2023: 17 descendants cleared2013: 2 descendants cleared2014: 3 descendants cleared2022: 16 descendants cleared2020: 5 descendants cleared2026: 22 descendants cleared2021: 3 descendants cleared2025: 24 descendants cleared2024: 19 descendants cleared20052010201520202025
  1. This deviceK052292 Spider Cervical Plating (SCP) SystemX-Spine Systems, Inc. · 2005
  2. Descendant · cites it directly · 93 of its ownK190546 NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019
  3. Descendant · 2 generations on · 72 of its ownK200543 NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC · 2020
  4. Descendant · 3 generations on · 67 of its ownK202812 IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020
  5. Descendant · 4 generations on · 59 of its ownK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
  6. Descendant · 4 generations on · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022

Showing 5 of 137 descendants. See all descendants

Descendants cleared per year

2008: 12010: 22011: 32012: 32013: 22014: 32015: 32016: 42017: 32018: 32019: 42020: 52021: 32022: 162023: 172024: 192025: 242026: 22
2008high 24 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 137 · See all
  • K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019 · cites it directly93descendants
  • K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC · 2020 · 2 generations on72descendants
  • K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020 · 3 generations on67descendants
  • K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021 · 4 generations on59descendants
  • K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · 4 generations on36descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K052292Spider Cervical Plating (SCP) SystemX-Spine Systems, Inc.2005—
+1K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC2019—
+2K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC2020—
+3K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.2020—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.2021—
+4K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System…Alphatec Spine, Inc.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201020
201130
201230
201320
201430
201530
201640
201730
201830
201940
202050
202130
2022160
2023170
2024190
2025240
2026220
FIG. 1 — Lineage of K052292, 2005–2026Source: 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? (1)

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
*—Synthes CSLP System
Named without a submission number
—

What descends from it? (137)

See all 137

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

NumberDeviceApplicantDecidedDescendants
K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993
K093776Indus Anterior Cervical Plate SystemSpinefrontier, Inc.201016
K103137Venus Anterior Cervical PlateVerticor, Ltd.20115
K111132Genesys Spine Anterior Cervical Plate SystemGenesys Spine20114
K122216Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC20123
K112809Blue Mountain Cervical PlateQualgenix, LLC20122
K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191
K170224Spider Cervical Plating SystemX-Spine Systems, Inc.20171
K153042TRYPTIK2C-plate Anterior Cervical Plate SystemSpineart20161
K143706FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC20151

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, K190546 (Nexxt Spine, LLC, 2019) has gone furthest, with 93 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.

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 X-Spine SCP System is intended for anterior screw fixation to the cervical spine. 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 (defined as kyphosis, lordosis, or scoliosis), Pseudoarthrosis, and/or Failed previous fusions.

Indications for use as stated in the FDA summary.

More from X-Spine Systems, Inc.

34 FDA decisions under this applicant name. See the company

  • K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc. · 20181 recall
  • K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc. · 2018
  • K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc. · 20171 recall
  • K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc. · 20171 recall
  • K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc. · 2017

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/K052292 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052292: Spider Cervical Plating (SCP) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052292

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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