510(k) Report

510(k) · Cleared

Cleared

Sapphire Anterior Cervical Plate System

K101848510(k) TraditionalCleared Oct 14, 2010105-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

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

Cleared on Oct 14, 2010 as substantially equivalent to K060491 (Quantum Orthopedics, Inc., 2006) and 3 other predicates after a 105-day review. Its family tree reaches back 3 generations to 1979. 2 later devices descend from it.

Decided
Oct 14, 2010
Review
105 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K792352 (1979). 9 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor1993: 1 other ancestor2004: 1 other ancestor2000: 1 other ancestor1998: 1 other ancestor1980: 1 other ancestor2020: 1 descendant cleared2023: 1 descendant clearedK792352 · Synthes Cervical Vertabrae Plates · DePuy Synthes · 1979K042499 · Orion Anterior Cervical Plating System · Medtronic Sofamor Danek · 2004K100265 · Diamond Anterior Cervical Plate System · Amendia, Inc. · 201019801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K100265 · Diamond Anterior Cervical Plate System · Amendia, Inc. · 2010K042499 · Orion Anterior Cervical Plating System · Medtronic Sofamor Danek · 2004K792352 · Synthes Cervical Vertabrae Plates · DePuy Synthes · 19790
  1. Root · 3 generations backK792352 Synthes Cervical Vertabrae PlatesDePuy Synthes · 1979
  2. 2 generations backK042499 Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek · 2004
  3. 1 generation backK100265 Diamond Anterior Cervical Plate SystemAmendia, Inc. · 2010
  4. This deviceK101848 Sapphire Anterior Cervical Plate SystemSpinal Elements, Inc. · 2010
  5. Descendant · cites it directly · 1 of its ownK201029 Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal…Spinal Elements, Inc. · 2020
  6. Descendant · 2 generations on · 0 of its ownK231593 Sapphire X3 Anterior Cervical Plate SystemSpinal Elements, Inc. · 2023

Most influential descendants

Showing 2 of 2 · See all
  • K201029Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal SystemSpinal Elements, Inc. · 2020 · cites it directly1descendant
  • K231593Sapphire X3 Anterior Cervical Plate SystemSpinal Elements, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K792352Synthes Cervical Vertabrae PlatesDePuy Synthes1979—
−2K042499Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek2004—
−1K100265Diamond Anterior Cervical Plate SystemAmendia, Inc.2010—
0 (this device)K101848Sapphire Anterior Cervical Plate SystemSpinal Elements, Inc.2010—
+1K201029Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal SystemSpinal Elements, Inc.2020—
+2K231593Sapphire X3 Anterior Cervical Plate SystemSpinal Elements, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
199310
199810
200010
200410
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202310
FIG. 1 — Lineage of K101848, 1979–2023Source: 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? (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
*K060491Quantum Anterior Cervical Plate System
Summary page 2
…own to be substantially equivalent previously cleared devices in indications for use, design, function, and materials used. > Atomic® Anterior Cervical Plate System (K060491). > Synthes Anterior Cervical Vertebrae Plate (K(926453). > Amendia, LLC. Dianond Anterior Cervical Plate System (KI10026…
Quantum Orthopedics, Inc.2006—
*K926453Synthes (U.S.a.) Anterior Cervical Vertebrae Plate
Summary page 2
…in indications for use, design, function, and materials used. > Atomic® Anterior Cervical Plate System (K060491). > Synthes Anterior Cervical Vertebrae Plate (K(926453). > Amendia, LLC. Dianond Anterior Cervical Plate System (KI100265). > Medtronic, Orion Anterior Cervical Plate System (K…
Synthes (Usa)1993—
*K100265Diamond Anterior Cervical Plate System
Summary page 2
…omic® Anterior Cervical Plate System (K060491). > Synthes Anterior Cervical Vertebrae Plate (K(926453). > Amendia, LLC. Dianond Anterior Cervical Plate System (KI100265). > Medtronic, Orion Anterior Cervical Plate System (K(042499). Performance Data Mechanical testing was conducted in accorda…
Amendia, Inc.2010—
*K042499Orion Anterior Cervical Plating System
Summary page 2
…rior Cervical Vertebrae Plate (K(926453). > Amendia, LLC. Dianond Anterior Cervical Plate System (KI100265). > Medtronic, Orion Anterior Cervical Plate System (K(042499). Performance Data Mechanical testing was conducted in accordance with ASTM F 1717, and included: > Dynamic compression…
Medtronic Sofamor Danek2004—

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K201029Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal SystemSpinal Elements, Inc.20201

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?

  • The line of descent spans 31 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
  • 1 of the 9 ancestors has a recall of any class.
  • Of its descendants, K201029 (Spinal Elements, Inc., 2020) has gone furthest, with 1 descendant 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. 2010, 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 Sapphire Anterior Cervical Plate System is intended for anterior cervical fixation (C2 - C7) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fracture or dislocation), spinal stenosis, deformities or curvatures (kyphosis, lordlosis or scoliosis), tumor, pseudoarthrosis, and failed previous fusion.

Indications for use as stated in the FDA summary.

More from Spinal Elements, Inc.

49 FDA decisions under this applicant name. See the company

  • K260506Ventana® P/T Lumbar Interbody SystemSpinal Elements, Inc. · 2026
  • K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc. · 2026
  • K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc. · 2026
  • K242527The Karma® Fixation SystemSpinal Elements, Inc. · 2025
  • K243916Primus Spinal Fixation SystemSpinal Elements, Inc. · 2025

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/K101848 · printed Nov 5, 2026

Cite this page

510(k) Report. “K101848: Sapphire Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K101848

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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