510(k) Report

510(k) · Cleared

Cleared

Butterfly Plate Function System

K010632510(k) TraditionalCleared May 31, 200190-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 USA, Inc. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on May 31, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 423 devices in its family, counting itself, has a Class I recall. 422 later devices descend from it.

Decided
May 31, 2001
Review
90 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
0

422 later devices descend from it, 2 citing it directly. 1 of the 423 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2002: 4 descendants cleared2013: 4 descendants cleared2005: 3 descendants cleared2009: 2 descendants cleared2006: 3 descendants cleared2007: 3 descendants cleared2008: 1 descendant cleared2017: 11 descendants cleared2020: 34 descendants cleared2010: 2 descendants cleared2023: 52 descendants cleared2012: 3 descendants cleared2018: 12 descendants cleared2011: 1 descendant cleared2019: 26 descendants cleared2014: 1 descendant cleared2021: 33 descendants cleared, 1 with a Class I recall12016: 5 descendants cleared2022: 49 descendants cleared2026: 57 descendants cleared2015: 4 descendants cleared2024: 61 descendants cleared2025: 51 descendants cleared200020052010201520202025
  1. This deviceK010632 Butterfly Plate Function SystemMedtronic Sofamor Danek USA, Inc. · 2001
  2. Descendant · cites it directly · 278 of its ownK014267 Butterfly Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
  3. Descendant · 2 generations on · 277 of its ownK022070 Xantus Anterior Lateral Supplemental Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
  4. Descendant · 3 generations on · 276 of its ownK071416 Pyramid +4 Anterior Lumbar Spine Plate SystemMedtronic Sofamor Danek USA, Inc. · 2007
  5. Descendant · cites it directly · 248 of its ownK013665 Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
  6. Descendant · 4 generations on · 228 of its ownK150135 DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015

Showing 5 of 422 descendants. See all descendants

Descendants cleared per year

2002: 42005: 32006: 32007: 32008: 12009: 22010: 22011: 12012: 32013: 42014: 12015: 42016: 52017: 112018: 122019: 262020: 342021: 332022: 492023: 522024: 612025: 512026: 57
2002high 61 (2024) · low 0 (2003)2026

Class I recalls in this family

  • K211616 ExcelsiusHub7 generations on · 2021

Most influential descendants

Showing 5 of 422 · See all
  • K014267Butterfly Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2002 · cites it directly278descendants
  • K022070Xantus Anterior Lateral Supplemental Fixation SystemMedtronic Sofamor Danek, Inc. · 2002 · 2 generations on277descendants
  • K071416Pyramid +4 Anterior Lumbar Spine Plate SystemMedtronic Sofamor Danek USA, Inc. · 2007 · 3 generations on276descendants
  • K013665Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2002 · cites it directly248descendants
  • K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2015 · 4 generations on228descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010632Butterfly Plate Function SystemMedtronic Sofamor Danek USA, Inc.2001—
+1K014267Butterfly Plate Fixation SystemMedtronic Sofamor Danek, Inc.2002—
+2K022070Xantus Anterior Lateral Supplemental Fixation SystemMedtronic Sofamor Danek, Inc.2002—
+3K071416Pyramid +4 Anterior Lumbar Spine Plate SystemMedtronic Sofamor Danek USA, Inc.2007—
+1K013665Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc.2002—
+4K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200240
200530
200630
200730
200810
200920
201020
201110
201230
201340
201410
201540
201650
2017110
2018120
2019260
2020340
2021331
2022490
2023520
2024610
2025510
2026570
FIG. 1 — Lineage of K010632, 2001–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (422)

See all 422

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

NumberDeviceApplicantDecidedDescendants
K014267Butterfly Plate Fixation SystemMedtronic Sofamor Danek, Inc.2002278
K013665Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc.2002248

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K014267 (Medtronic Sofamor Danek, Inc., 2002) has gone furthest, with 278 descendants of its own.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWP

9in 2015

2007: 142008: 132009: 122010: 142011: 122012: 182013: 122014: 132015: 9
2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007: 96 days median2008: 50 days median2009: 89 days median2010: 186 days median2011: 67 days median2012: 112 days median2013: 99 days median2014: 138 days median2015: 113 days median
2007high 186 (2010) · low 50 (2008)2026

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

Recalls per year · KWP

2in 2022

2007: 22008: 12009: 232010: 22011: 62012: 12013: 32015: 12016: 32018: 12019: 22022: 2
2007high 23 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWP

494in 2025

2007: 2102008: 5942009: 6822010: 4742011: 7922012: 9182013: 1,0902014: 1,0222015: 1,3482016: 1,3792017: 8642018: 6572019: 5182020: 7962021: 5252022: 3352023: 3322024: 4362025: 494
2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, 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
200714962210
200813501594
2009128923682
2010141862474
201112676792
2012181121918
2013129931,090
20141313801,022
2015911311,348
20160—31,379
20170—0864
20180—1657
20190—2518
20200—0796
20210—0525
20220—2335
20230—0332
20240—0436
20250—0494
20260—0—

More from Medtronic Sofamor Danek USA, Inc.

366 FDA decisions under this applicant name. See the company

  • P000058/S095Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion DeviceMedtronic Sofamor Danek USA, Inc. · 2026
  • P000054/S075Infuse Bone GraftMedtronic Sofamor Danek USA, Inc. · 2026
  • P000058/S099Infuse TM Bone Graft/Medtronic lnterbody Fusion DeviceMedtronic Sofamor Danek USA, Inc. · 2026
  • P000054/S078Infuse™ Bone GraftMedtronic Sofamor Danek USA, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026

Recent decisions in KWP

The KWP category page

  • K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
  • K150753OASYS SystemStryker Corporation · 2015
  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
  • K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 20153 recalls

https://510kreport.com/device/K010632 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010632: Butterfly Plate Function System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010632

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026