510(k) Report

510(k) · Cleared

Cleared

Archimed Remedy Cervical Plate

K100215510(k) TraditionalCleared Apr 7, 201072-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

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

Cleared on Apr 7, 2010 as substantially equivalent to K021461 (Medtronic Sofamor Danek, 2002) and 11 other predicates after a 72-day review. Its family tree reaches back 3 generations to 1995.

Decided
Apr 7, 2010
Review
72 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
12

Its longest line of descent runs back 3 generations to K953730 (1995). 24 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 2 other ancestors2006: 1 other ancestor2004: 6 other ancestors2003: 3 other ancestors2002: 1 other ancestor2000: 1 other ancestor1999: 1 other ancestor1997: 1 other ancestor1992: 1 other ancestor1998: 1 other ancestor1993: 1 other ancestor1980: 1 other ancestor1979: 1 other ancestorReference device: K060442 · Pyrenees Cervical Plate System · K2m, LLC · 2006K953730 · Codman Anterior Cervical Plate System · Johnson & Johnson Professionals, Inc. · 1995K013877 · Codman Slim-Loc System · Codman & Shurtleff, Inc. · 2001K040655 · Swift Anterior Cervical Plate System · Depuy Spine, Inc. · 20041980199020002010
Other ancestors, by generation 1 generation back: 11 other ancestors2 generations back: 5 other ancestors3 generations back: 5 other ancestors K040655 · Swift Anterior Cervical Plate System · Depuy Spine, Inc. · 2004K013877 · Codman Slim-Loc System · Codman & Shurtleff, Inc. · 2001K953730 · Codman Anterior Cervical Plate System · Johnson & Johnson Professionals, Inc. · 19950
  1. Root · 3 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
  2. 2 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
  3. 1 generation backK040655 Swift Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004
  4. This deviceK100215 Archimed Remedy Cervical PlateArchimed, Inc. · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K953730Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc.1995—
−2K013877Codman Slim-Loc SystemCodman & Shurtleff, Inc.2001—
−1K040655Swift Anterior Cervical Plate SystemDepuy Spine, Inc.2004—
0 (this device)K100215Archimed Remedy Cervical PlateArchimed, Inc.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
199210
199310
199710
199810
199910
200010
200210
200330
200460
200610
200720
FIG. 1 — Lineage of K100215, 1995–2010Source: 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? (14)

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
*K021461Atlantis Vision Anterior Cervical Plate System
Summary page 1
…bstantially Equivalent to the predicate devices. IAtlantis Vision - Medtronic - 1021461 Venture Medtronic K042922…
Medtronic Sofamor Danek20023
*K042922Venture Anterior Cervical Plating System
Summary page 1
…IAtlantis Vision - Medtronic - 1021461 Venture Medtronic K042922 premeir Medtronic K9921 10…
Medtronic Sofamor Danek, Inc.2004—
*K992110Premier Anterior Cervical Plate System
Summary page 1
…Venture Medtronic K042922 premeir Medtronic K9921 10 Zephir Medtronic K030327…
Sofamor Danek USA1999—
*K030327Zephir Anterior Cervical System
Summary page 1
…premeir Medtronic K9921 10 Zephir Medtronic K030327 I'Skyl..ne - ]De~puy 1025…
Medtronic Sofamor Danek2003—
*K042544Uniplate Anterior Cervical Plate System
Summary page 1
…I'Skyl..ne - ]De~puy 1025 Uniplate Depuy K042544 Swift Depuy K040655…
Depuy Spine, Inc.2004—
*K040655Swift Anterior Cervical Plate System
Summary page 1
…Uniplate Depuy K042544 Swift Depuy K040655 Reflex Hybrid Stryker Spine K040261I…
Depuy Spine, Inc.2004—
*K040261Reflex Hybrid Anterior Cervical Plate System
Summary page 1
…Swift Depuy K040655 Reflex Hybrid Stryker Spine K040261I Trinica&Iect ? Zimmner< (234-…
Stryker Spine20044
*K070775Modification to: Providence Anterior Cervical Plate System
Summary page 1
…Trinica&Iect ? Zimmner< (234- Providence Globus K070775 Vectra-T ~~~Synthes Spine K(030866…
Globus Medical, Inc.2007—
*K030866Synthes Anterior CSLP System
Summary page 1
…Providence Globus K070775 Vectra-T ~~~Synthes Spine K(030866 CSLP Synthes Spine -K000536 [Pji…
Synthes (Usa)2003—
*K000536Synthes Anterior CSLP System
Summary page 1
…Vectra-T ~~~Synthes Spine K(030866 CSLP Synthes Spine -K000536 [Pjirehnee~s: :-: KIM 1(0604422…
Synthes Spine20001
*K071329Nuvasive Helix Acp System
Summary page 1
…[Pjirehnee~s: :-: KIM 1(0604422 Helix ACP Nuvasive K07 1329 Gradient Plus S Nuvasive K(053581 DEPA…
Nuvasive, Inc.2007—
*K053581Nuvasive Smartplate Gradient Plus System
Summary page 1
…Helix ACP Nuvasive K07 1329 Gradient Plus S Nuvasive K(053581 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service…
Nuvasive, Inc.2006—
*—Skyline
Named without a submission number
—
*—Trinica Select
Named without a submission number
—
†K060442Pyrenees Cervical Plate SystemK2m, LLC2006—

Also cleared against K021461: 13 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 15 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
  • 3 of the 24 ancestors have a recall of any class.
  • 13 other devices also cite its predicate K021461.

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 REMEDY™ Cervical Plate System is intended for anterior interbody screw/plate fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) Trauma (including fractures), 3)…

Read the full statement (108 words)

The REMEDY™ Cervical Plate System is intended for anterior interbody screw/plate fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with:

1) Degenerative Disc Disease

(as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),

2) Trauma (including fractures),

3) Tumors,

4) Deformity (defined as kyphosis, lordosis, or scoliosis),

5) Pseudarthrosis, and/or

6) Failed previous fusions.

Warning: This device is not intended for screw attachment or 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 K021461

13 other devices cite the same predicate.

  • K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
  • K203154KASILOF Cervical Plate SystemKahtnu Surgical, Inc. · 2020
  • K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical…Medtronic Sofamor Danek USA, Inc. · 2019
  • K173867Axis Anterior Cervical Plate SystemAxis Orthopaedics · 2018
  • K152623ATLANTIS Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2015
  • K131025Archon Anterior Cervical Plate SystemNuvasive, Inc. · 2013

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/K100215 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100215: Archimed Remedy 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/K100215

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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