510(k) Report

510(k) · Cleared

Cleared

Magnes-C Anterior Cervical Plate System

K221053510(k) TraditionalCleared Mar 1, 2023324-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

Fellowship of Orthopaedic Researchers, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Mar 1, 2023 as substantially equivalent to K130030 (Zavation, LLC, 2013) and 2 other predicates after a 324-day review. Its family tree reaches back 6 generations to 1997.

Decided
Mar 1, 2023
Review
324 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
3

Its longest line of descent runs back 6 generations to K971730 (1997). 28 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2014: 1 other ancestor1995: 2 other ancestors2008: 1 other ancestor2007: 3 other ancestors2004: 4 other ancestors1994: 1 other ancestor2006: 1 other ancestor2005: 1 other ancestor2001: 1 other ancestor2000: 2 other ancestors1993: 1 other ancestor1992: 1 other ancestor1979: 1 other ancestor2003: 1 other ancestor1998: 1 other ancestorK971730 · Depuy Motech Peak Polyaxial Anterior Cervical Plate System · Depuy, Inc. · 1997K013439 · Anterior Cervical Plate System · Scien'Tx USA, Inc. · 2002K042317 · Cervical Plate · Scient'X · 2004K070681 · Next Generation Anterior Cervical Plating System · Alphatec Spine, Inc. · 2007 · recalledK112533 · Zavation Cervical Plate System · Zavation, LLC · 2011K130030 · Zavation Cervical Plate System · Zavation, LLC · 201319801990200020102020
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 4 other ancestors3 generations back: 11 other ancestors4 generations back: 3 other ancestors5 generations back: 1 other ancestor6 generations back: 1 other ancestor K130030 · Zavation Cervical Plate System · Zavation, LLC · 2013K112533 · Zavation Cervical Plate System · Zavation, LLC · 2011K070681 · Next Generation Anterior Cervical Plating System · Alphatec Spine, Inc. · 2007 · recalledK042317 · Cervical Plate · Scient'X · 2004K013439 · Anterior Cervical Plate System · Scien'Tx USA, Inc. · 2002K971730 · Depuy Motech Peak Polyaxial Anterior Cervical Plate System · Depuy, Inc. · 1997−50
  1. Root · 6 generations backK971730 Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc. · 1997
  2. 5 generations backK013439 Anterior Cervical Plate SystemScien'Tx USA, Inc. · 2002
  3. 4 generations backK042317 Cervical PlateScient'X · 2004
  4. 3 generations backK070681 Next Generation Anterior Cervical Plating SystemAlphatec Spine, Inc. · 2007 · Recalled
  5. 2 generations backK112533 Zavation Cervical Plate SystemZavation, LLC · 2011
  6. 1 generation backK130030 Zavation Cervical Plate SystemZavation, LLC · 2013
  7. This deviceK221053 Magnes-C Anterior Cervical Plate SystemFellowship of Orthopaedic Researchers, Inc. · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K971730Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc.1997—
−5K013439Anterior Cervical Plate SystemScien'Tx USA, Inc.2002—
−4K042317Cervical PlateScient'X2004—
−3K070681Next Generation Anterior Cervical Plating SystemAlphatec Spine, Inc.20071
−2K112533Zavation Cervical Plate SystemZavation, LLC2011—
−1K130030Zavation Cervical Plate SystemZavation, LLC2013—
0 (this device)K221053Magnes-C Anterior Cervical Plate SystemFellowship of Orthopaedic Researchers, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
199210
199310
199410
199520
199810
200020
200110
200310
200440
200510
200610
200730
200810
201410
FIG. 1 — Lineage of K221053, 1997–2023Source: 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? (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
*K130030Zavation Cervical Plate System
Summary page 4
…ls according to ASTM F899, some of which have silicone or Radel handles. Primary Predicate: Zavation Cervical Plate System (Zavation LLC – K130030) Additional Predicates: Cervical Spine Locking Plate (CSLP) (Synthes Spine – K945700), Biomet MaxAn® A…
Zavation, LLC2013—
*K945700Synthes (Usa) Anterior Cervical Vertebrae Plate System
Summary page 4
…handles. Primary Predicate: Zavation Cervical Plate System (Zavation LLC – K130030) Additional Predicates: Cervical Spine Locking Plate (CSLP) (Synthes Spine – K945700), Biomet MaxAn® Anterior Cervical Plate System (Biomet Spine LLC – K133518) Performance Data: Mec…
Synthes (Usa)1995—
*K133518Maxan Anterior Cervical Plate System
Summary page 4
…al Predicates: Cervical Spine Locking Plate (CSLP) (Synthes Spine – K945700), Biomet MaxAn® Anterior Cervical Plate System (Biomet Spine LLC – K133518) Performance Data: Mechanical testing of the worst case Magnes-C™ Anterior Cervical Plate System…
Biomet Spine (Aka Ebi, LLC)20141

Also cleared against K130030: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 26 years and passes through 6 companies; a new generation was cleared every 4.2 years on median.
  • 6 of the 28 ancestors have a recall of any class.
  • 5 other devices also cite its predicate K130030.

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. 2023, 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 Magnes-C™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumors, pseudarthrosis or failed previous fusion.

Indications for use as stated in the FDA summary.

Also cleared against K130030

5 other devices cite the same predicate.

  • K200170SpineNet SSP SystemSpinenet, LLC · 2020
  • K181549Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System)Curiteva, LLC · 2018
  • K172104Ozark (tm) Cervical Plate SystemK2m, Inc. · 2017
  • K152455Amendia Cervical Plate SystemAmendia, Inc. · 2015
  • K150666uNion Cervical Plate SystemUlrich Medical USA · 20151 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/K221053 · printed Nov 4, 2026

Cite this page

510(k) Report. “K221053: Magnes-C Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221053

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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