510(k) Report

510(k) · Cleared

Cleared

Centerpiece Plate Fixation System

K050082510(k) TraditionalCleared Jun 6, 2005144-day reviewClass II21 CFR 888.3050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Sofamor Danek, Inc. · NQW Orthosis, Spine, Plate, Laminoplasty, Metal

Cleared on Jun 6, 2005 as substantially equivalent to K850631 (Kirschner Medical Corp., 1985) after a 144-day review. Its family tree reaches back 1 generation to 1985. 31 later devices descend from it.

Decided
Jun 6, 2005
Review
144 days
Class
Class II
Product code
NQW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K850631 (1985). 31 later devices descend from it, 12 citing it directly.

Descendants, by year cleared 2012: 3 descendants cleared2018: 4 descendants cleared2013: 2 descendants cleared2010: 1 descendant cleared2008: 1 descendant cleared2024: 7 descendants cleared2019: 4 descendants cleared2021: 2 descendants cleared2017: 1 descendant cleared2016: 1 descendant cleared2026: 3 descendants cleared2023: 2 descendants clearedK850631 · Kirschner Orthopedic Wire, Eyelet Cerclage Wires · Kirschner Medical Corp. · 19851990200020102020
Descendants, by generation 1 generation forward: 12 descendants2 generations forward: 9 descendants3 generations forward: 5 descendants4 generations forward: 5 descendants K850631 · Kirschner Orthopedic Wire, Eyelet Cerclage Wires · Kirschner Medical Corp. · 19850
  1. Root · 1 generation backK850631 Kirschner Orthopedic Wire, Eyelet Cerclage WiresKirschner Medical Corp. · 1985
  2. This deviceK050082 Centerpiece Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2005
  3. Descendant · cites it directly · 17 of its ownK091994 Mountaineer Laminoplasty SystemDepuy Spine, Inc. · 2010
  4. Descendant · cites it directly · 11 of its ownK080664 Relieve Laminoplasty Fixation SystemGlobus Medical, Inc. · 2008
  5. Descendant · cites it directly · 10 of its ownK121732 Canopy Laminoplasty Fixation SystemGlobus Medical, Inc. · 2012
  6. Descendant · cites it directly · 7 of its ownK113802 Escalate Laminoplasty SystemStryker Spine · 2012
  7. Descendant · 2 generations on · 6 of its ownK171413 HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation SystemGlobus Medical, Inc. · 2017

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2008: 12010: 12012: 32013: 22016: 12017: 12018: 42019: 42021: 22023: 22024: 72026: 3
2008high 7 (2024) · low 0 (2009)2026

Most influential descendants

Showing 5 of 31 · See all
  • K091994Mountaineer Laminoplasty SystemDepuy Spine, Inc. · 2010 · cites it directly17descendants
  • K080664Relieve Laminoplasty Fixation SystemGlobus Medical, Inc. · 2008 · cites it directly11descendants
  • K121732Canopy Laminoplasty Fixation SystemGlobus Medical, Inc. · 2012 · cites it directly10descendants
  • K113802Escalate Laminoplasty SystemStryker Spine · 2012 · cites it directly7descendants
  • K171413HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation SystemGlobus Medical, Inc. · 2017 · 2 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K850631Kirschner Orthopedic Wire, Eyelet Cerclage WiresKirschner Medical Corp.1985—
0 (this device)K050082Centerpiece Plate Fixation SystemMedtronic Sofamor Danek, Inc.2005—
+1K091994Mountaineer Laminoplasty SystemDepuy Spine, Inc.2010—
+1K080664Relieve Laminoplasty Fixation SystemGlobus Medical, Inc.2008—
+1K121732Canopy Laminoplasty Fixation SystemGlobus Medical, Inc.2012—
+1K113802Escalate Laminoplasty SystemStryker Spine2012—
+2K171413HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation SystemGlobus Medical, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201010
201230
201320
201610
201710
201840
201940
202120
202320
202470
202630
FIG. 1 — Lineage of K050082, 1985–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 NQW? 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 NQW device

  1. #1 K243137 Curiteva Porous PEEK Laminoplasty Systemscore 13.1 · 7 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
*K850631Kirschner Orthopedic Wire, Eyelet Cerclage Wires
Summary page 1
…lly equivalent to a previously cleared device used to perform larminoplasty procedures, namely the Kirschner Orthopedic Wire, K850631 Kirschner Medical Corp. (SE 05/01/85).…
Kirschner Medical Corp.1985—

Also cleared against K850631: 2 other devices →

What descends from it? (31)

See all 31

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

NumberDeviceApplicantDecidedDescendants
K091994Mountaineer Laminoplasty SystemDepuy Spine, Inc.201017
K080664Relieve Laminoplasty Fixation SystemGlobus Medical, Inc.200811
K121732Canopy Laminoplasty Fixation SystemGlobus Medical, Inc.201210
K113802Escalate Laminoplasty SystemStryker Spine20127
K122822Spectrum Spine Laminoplasty Plating SystemSpectrum Spine, LLC20135
K173215Choice Spine Laminoplasty™ Fixation SystemChoicespine, LP20184
K212428Centerpiece Plate Fixation SystemMedtronic Sofamor Danek20211
K191169NuVasive® Camber Laminoplasty SystemNu Vasive, Incorporated20191
K181717Life Spine Laminoplasty SystemLife Spine, Inc.20181
K113218Pioneer Release Laminoplasty Plating SystemPioneer Surgical Technology, Inc.20121

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?

  • Its one ancestor has no recall.
  • Of its descendants, K091994 (Depuy Spine, Inc., 2010) has gone furthest, with 17 descendants of its own.
  • 2 other devices also cite its predicate K850631.

How does its category compare?

All NQW devices

NQW Orthosis, Spine, Plate, Laminoplasty, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NQW

2in 2024

2008: 12009: 22010: 32012: 42013: 32015: 12016: 22017: 12018: 22019: 22021: 12023: 22024: 22026 (partial year): 1
2007high 4 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NQW

84in 2013

2010: 120 days median2012: 120 days median2013: 84 days median
2007high 120 (2010) · low 84 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NQW

No recall names NQW since 2007.

Adverse event reports per year · NQW

33in 2025

2009: 22012: 12013: 492014: 52015: 112016: 72017: 192018: 52019: 82020: 22021: 72022: 162023: 52024: 152025: 33
2007high 49 (2013) · low 0 (2007)2025

MAUDE reports naming product code NQW, 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
20070—00
20081—00
20092—02
2010312000
20110—00
2012412001
2013384049
20140—05
20151—011
20162—07
20171—019
20182—05
20192—08
20200—02
20211—07
20220—016
20232—05
20242—015
20250—033
20261—0—

What is it indicated for?

The CENTERPIECE™ Plate Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The CENTERPIECE™ Plate Fixation System is used to hold the graft material in place in order to prevent the graft material from expulsion, or impinging the spinal cord.

Indications for use as stated in the FDA summary.

Also cleared against K850631

2 other devices cite the same predicate.

  • K032534Synthes AfsSynthes Spine · 2004
  • K011451Reunite Fusion ScrewBiomet, Inc. · 2001

More from Medtronic Sofamor Danek, Inc.

125 FDA decisions under this applicant name. See the company

  • K251193Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone GraftMedtronic Sofamor Danek, Inc. · 2025
  • K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc. · 2025
  • K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc. · 2023
  • P060018/S005Prestige Cervical Disc SystemMedtronic Sofamor Danek, Inc. · 2016
  • P060018/S004PRESTIGE® Cervical DiscMedtronic Sofamor Danek, Inc. · 2016

Recent decisions in NQW

The NQW category page

  • K252930AQUA Laminoplasty SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
  • K243137Curiteva Porous PEEK Laminoplasty SystemCuriteva, Inc. · 2024
  • K242784Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC · 2024
  • K232471Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC · 2023
  • K231232Curiteva Laminoplasty SystemCuriteva, Inc. · 2023

https://510kreport.com/device/K050082 · printed Nov 5, 2026

Cite this page

510(k) Report. “K050082: Centerpiece Plate Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050082

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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