510(k) Report

510(k) · Cleared

Cleared

Basis Spinal System

K051039510(k) TraditionalCleared May 12, 200517-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

Medtronic Sofamor Danek USA, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on May 12, 2005 as substantially equivalent to K792352 (DePuy Synthes, 1979) and 5 other predicates after a 17-day review. Its family tree reaches back 1 generation to 1979.

Decided
May 12, 2005
Review
17 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K792352 (1979). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestor1993: 1 other ancestor1980: 1 other ancestorK792352 · Synthes Cervical Vertabrae Plates · DePuy Synthes · 19791975198019851990199520002005
Other ancestors, by generation 1 generation back: 5 other ancestors K792352 · Synthes Cervical Vertabrae Plates · DePuy Synthes · 19790
  1. Root · 1 generation backK792352 Synthes Cervical Vertabrae PlatesDePuy Synthes · 1979
  2. This deviceK051039 Basis Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K792352Synthes Cervical Vertabrae PlatesDePuy Synthes1979—
0 (this device)K051039Basis Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
199310
199810
199910
200210
FIG. 1 — Lineage of K051039, 1979–2005Source: 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? (6)

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
*K792352Synthes Cervical Vertabrae Plates
Summary page 2
…Spinal System to be substantially equivalent to the following systems: SYNTHES® Cervical Vertebrae Plates (K792352), SYNTHES® Spinal Implant System (K802462), ORION® Anterior Cervical Plate System (K973854), ZPLATE-ATLTm Anterior Fixation Syste…
DePuy Synthes1979—
*K802462Synthes Spinal Implant System
Summary page 2
…Spinal System to be substantially equivalent to the following systems: SYNTHES® Cervical Vertebrae Plates (K792352), SYNTHES® Spinal Implant System (K802462), ORION® Anterior Cervical Plate System (K973854), ZPLATE-ATLTm Anterior Fixation System and ZPLATE-ATLTM Anterior Fixation Syste…
Synthes (Usa)1980—
*K973854Orion Anterior Cervical Plate System
Summary page 2
…ially equivalent to the following systems: SYNTHES® Cervical Vertebrae Plates (K792352), SYNTHES® Spinal Implant System (K802462), ORION® Anterior Cervical Plate System (K973854), ZPLATE-ATLTm Anterior Fixation System and ZPLATE-ATLTM Anterior Fixation System ZPLATE-ll (K922543 and K990603) and the VANTAGE…
Sofamor Danek USA,Inc.1998—
*K922543Z-Plate Anterior Fixation System
Summary page 2
…nal Implant System (K802462), ORION® Anterior Cervical Plate System (K973854), ZPLATE-ATLTm Anterior Fixation System and ZPLATE-ATLTM Anterior Fixation System ZPLATE-ll (K922543 and K990603) and the VANTAGETM Anterior Fixation System Plate (K023797). DEPARTMENT OF HEALTH & HUMAN SERVICES…
Sofamor Danek Mfg., Inc.1993—
*K990603Modification of the Zplate-Atl Anterior Fixation System
Summary page 2
…System (K802462), ORION® Anterior Cervical Plate System (K973854), ZPLATE-ATLTm Anterior Fixation System and ZPLATE-ATLTM Anterior Fixation System ZPLATE-ll (K922543 and K990603) and the VANTAGETM Anterior Fixation System Plate (K023797). DEPARTMENT OF HEALTH & HUMAN SERVICES…
Danek Medical, Inc.1999—
*K023797Laurain Dewald Anterior Fixation System
Summary page 2
…73854), ZPLATE-ATLTm Anterior Fixation System and ZPLATE-ATLTM Anterior Fixation System ZPLATE-ll (K922543 and K990603) and the VANTAGETM Anterior Fixation System Plate (K023797). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service…
Medtronic Sofamor Danek2002—

Also cleared against K792352: 6 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?

  • None of the 6 ancestors has a recall.
  • 6 other devices also cite its predicate K792352.

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 BASIS™ anterior cervical plates are intended for the following indications: (1) spinal stenosis, (2) spondylolisthesis, (3) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (4) fracture, (5) pseudarthrosis,(.6) tumor resection, and/or (7) failed previous fusion. The BASIS™ anterior Thoracic and Lumbar plates are intended for the following indications: (1) spinal stenosis, (2) spondylolisthesis, (3) spinal deformities (i.e., scoliosis…

Read the full statement (116 words)

The BASIS™ anterior cervical plates are intended for the following indications: (1) spinal stenosis, (2) spondylolisthesis, (3) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (4) fracture, (5) pseudarthrosis,(.6) tumor resection, and/or (7) failed previous fusion.

The BASIS™ anterior Thoracic and Lumbar plates are intended for the following indications: (1) spinal stenosis, (2) spondylolisthesis, (3) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion.

When used as an anterolateral thoracic/lumbar, or anterior cervical system, BASIS™ components are intended for the following indications: (1) spinal stenosis, (2) spondylolisthesis, (3) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion.

Indications for use as stated in the FDA summary.

Also cleared against K792352

6 other devices cite the same predicate.

  • K1824894CIS® Pinehurst Anterior Cervical Plate systemSolco Biomedical Co., Ltd. · 2019
  • K153042TRYPTIK2C-plate Anterior Cervical Plate SystemSpineart · 20167 recalls
  • K133906C-Jaws Cervical Compressive StapleMedicrea International · 2014
  • K071667Synthes Vectra-One SystemSynthes Spine · 20073 recalls
  • K042499Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek · 2004
  • K981008Simal Cervical Stabilization SystemTop Surgical Products GmbH · 1998

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 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/K051039 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051039: Basis Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051039

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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