510(k) Report

510(k) · Cleared

Cleared

MSD Wire System

K020426510(k) SpecialCleared Feb 26, 200218-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. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Feb 26, 2002 as substantially equivalent to K934007 (Sofamor Co., 1994) after an 18-day review. Its family tree reaches back 1 generation to 1994. 68 later devices descend from it.

Decided
Feb 26, 2002
Review
18 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K934007 (1994). 68 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2018: 3 descendants cleared2016: 2 descendants cleared2017: 1 descendant cleared2012: 1 descendant cleared2021: 3 descendants cleared2022: 5 descendants cleared2019: 2 descendants cleared2023: 9 descendants cleared2020: 3 descendants cleared2024: 9 descendants cleared2025: 14 descendants cleared2026: 15 descendants clearedK934007 · Sofamor Orfil Spine Fixation System · Sofamor Co. · 19941990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 7 descendants3 generations forward: 7 descendants4 generations forward: 11 descendants5 generations forward: 17 descendants6 generations forward: 16 descendants7 generations forward: 9 descendants K934007 · Sofamor Orfil Spine Fixation System · Sofamor Co. · 19940+5
  1. Root · 1 generation backK934007 Sofamor Orfil Spine Fixation SystemSofamor Co. · 1994
  2. This deviceK020426 MSD Wire SystemMedtronic Sofamor Danek, Inc. · 2002
  3. Descendant · cites it directly · 67 of its ownK072605 Malibu Spinal SystemSeaspine, Inc. · 2007
  4. Descendant · 2 generations on · 62 of its ownK122571 Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc. · 2012
  5. Descendant · 2 generations on · 60 of its ownK160902 Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2016
  6. Descendant · 2 generations on · 56 of its ownK173882 SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2018 · Recalled
  7. Descendant · 3 generations on · 49 of its ownK191648 Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation · 2019

Showing 5 of 68 descendants. See all descendants

Descendants cleared per year

2007: 12012: 12016: 22017: 12018: 32019: 22020: 32021: 32022: 52023: 92024: 92025: 142026: 15
2007high 15 (2026) · low 0 (2008)2026

Most influential descendants

Showing 5 of 68 · See all
  • K072605Malibu Spinal SystemSeaspine, Inc. · 2007 · cites it directly67descendants
  • K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc. · 2012 · 2 generations on62descendants
  • K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2016 · 2 generations on60descendants
  • K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2018 · 2 generations on56descendants
  • K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation · 2019 · 3 generations on49descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K934007Sofamor Orfil Spine Fixation SystemSofamor Co.1994—
0 (this device)K020426MSD Wire SystemMedtronic Sofamor Danek, Inc.2002—
+1K072605Malibu Spinal SystemSeaspine, Inc.2007—
+2K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.2012—
+2K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2016—
+2K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation20181
+3K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201210
201620
201710
201830
201920
202030
202130
202250
202390
202490
2025140
2026150
FIG. 1 — Lineage of K020426, 1994–2026Source: 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 KWP? 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? (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
*K934007Sofamor Orfil Spine Fixation System
Summary page 1
…Spinal Fixation Orthosis, Class II Predicate Device(s): The MSD WIRE System is substantially equivalent to itself, the ORFIL Spine Fixation System, which was cleared in K934007 on June 06, 1994. Device Description: The MSD WIRE System construct consists of rods and segmental sublaminal wiring, being pre-…
Sofamor Co.1994—

What descends from it? (68)

See all 68

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K072605Malibu Spinal SystemSeaspine, Inc.200767

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, K072605 (Seaspine, Inc., 2007) has gone furthest, with 67 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—

What is it indicated for?

When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. This system is intended for use only in the thoracic, lumbar and sacral levels of the spine. This system is not for use in the cervical spine. Specific indications include:

1. Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).

Pseudoarthrosis.

Stenosis

Spondylolisthesis.

Spinal deformities such as scoliosis and lordosis.

Fracture.

Unsuccessful previous fusion surgery.

Tumor resection.

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

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 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/K020426 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020426: MSD Wire System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020426

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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