510(k) Report

510(k) · Cleared

Cleared

Depuy Motech Peak Polyaxial Anterior Cervical Plate System

K971730510(k) TraditionalCleared Nov 3, 1997178-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

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

Cleared on Nov 3, 1997 after a 178-day review. The FDA summary names its predicate without a number. 394 later devices descend from it.

Decided
Nov 3, 1997
Review
178 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

394 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2007: 5 descendants cleared2015: 14 descendants cleared2004: 4 descendants cleared2002: 1 descendant cleared2011: 7 descendants cleared2005: 2 descendants cleared2010: 5 descendants cleared2016: 11 descendants cleared2008: 7 descendants cleared2014: 9 descendants cleared2019: 19 descendants cleared2018: 10 descendants cleared2009: 2 descendants cleared2012: 6 descendants cleared2013: 10 descendants cleared2020: 28 descendants cleared2017: 11 descendants cleared2021: 25 descendants cleared2025: 46 descendants cleared2022: 37 descendants cleared2023: 47 descendants cleared2024: 48 descendants cleared2026: 40 descendants cleared1995200020052010201520202025
  1. This deviceK971730 Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc. · 1997
  2. Descendant · cites it directly · 217 of its ownK040655 Swift Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004
  3. Descendant · cites it directly · 215 of its ownK040197 Eagle Anterior Cervial Plate SystemDepuyacromed · 2004
  4. Descendant · 2 generations on · 204 of its ownK070994 Eagle + Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
  5. Descendant · 2 generations on · 195 of its ownK072546 Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
  6. Descendant · 2 generations on · 193 of its ownK080646 C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · Recalled

Showing 5 of 394 descendants. See all descendants

Descendants cleared per year

2002: 12004: 42005: 22007: 52008: 72009: 22010: 52011: 72012: 62013: 102014: 92015: 142016: 112017: 112018: 102019: 192020: 282021: 252022: 372023: 472024: 482025: 462026: 40
2002high 48 (2024) · low 0 (2003)2026

Most influential descendants

Showing 5 of 394 · See all
  • K040655Swift Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004 · cites it directly217descendants
  • K040197Eagle Anterior Cervial Plate SystemDepuyacromed · 2004 · cites it directly215descendants
  • K070994Eagle + Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007 · 2 generations on204descendants
  • K072546Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007 · 2 generations on195descendants
  • K080646C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · 2 generations on193descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K971730Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc.1997—
+1K040655Swift Anterior Cervical Plate SystemDepuy Spine, Inc.2004—
+1K040197Eagle Anterior Cervial Plate SystemDepuyacromed2004—
+2K070994Eagle + Anterior Cervical Plate SystemDepuy Spine, Inc.2007—
+2K072546Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc.2007—
+2K080646C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine20082

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200440
200520
200750
200870
200920
201050
201170
201260
2013100
201490
2015140
2016110
2017110
2018100
2019190
2020280
2021250
2022370
2023470
2024480
2025460
2026400
FIG. 1 — Lineage of K971730, 1997–2026Source: 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
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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
*—DePuy Motech PEAK Anterior Compression Plate System
Named without a submission number
—

What descends from it? (394)

See all 394

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

NumberDeviceApplicantDecidedDescendants
K040655Swift Anterior Cervical Plate SystemDepuy Spine, Inc.2004217
K040197Eagle Anterior Cervial Plate SystemDepuyacromed2004215
K040721Assure Anterior Cervical Plate SystemGlobus Medical, Inc.2004178
K013439Anterior Cervical Plate SystemScien'Tx USA, Inc.200264
K063544Modification to Pyrenees Cervical Plate SystemK2m, Inc.200738
K043066Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology200527
K092474Pyrenees Cervical Plate System, Semi-Constrained ScrewsK2m, Inc.20108
K150983Pyrenees Cervical Plate SystemK2m20157
K103505Altum Anterior Cervical PlateSpinecraft, LLC20111

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, K040655 (Depuy Spine, Inc., 2004) has gone furthest, with 217 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 DePuy Motech PEAK Polyaxial Anterior Cervical Plate System is intended for anterior cervical screw fixation in the treatment of anterior cervical spine instability as a result of fractures (dislocations and subluxations), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), or a failed previous cervical spine surgery.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K971730: Depuy Motech Peak Polyaxial 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/K971730

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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