510(k) Report

510(k) · Cleared

Cleared

Vertex Reconstruction System

K123568510(k) SpecialCleared Dec 18, 201228-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 Dec 18, 2012 as substantially equivalent to K082728 (Medtronic Sofamor Danek USA, Inc., 2009) and 1 other predicate after a 28-day review. Its family tree reaches back 3 generations to 2001.

Decided
Dec 18, 2012
Review
28 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K003780 (2001). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor2008: 1 other ancestor2004: 1 other ancestorReference device: K121191 · Vertex Rcconstruction System · Medtronic Sofamor Danek, Inc. · 2012K003780 · Vertex Reconstruction System · Medtronic Sofamor Danek, Inc. · 2001K042402 · Modification to Vertex Reconstruction System · Medtronic Sofamor Danek, Inc. · 2004K082728 · Vertex Recontruction System, Vertex Select Reconstruction System · Medtronic Sofamor Danek USA, Inc. · 200920002002200420062008201020122014
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors K082728 · Vertex Recontruction System, Vertex Select Reconstruction System · Medtronic Sofamor Danek USA, Inc. · 2009K042402 · Modification to Vertex Reconstruction System · Medtronic Sofamor Danek, Inc. · 2004K003780 · Vertex Reconstruction System · Medtronic Sofamor Danek, Inc. · 20010
  1. Root · 3 generations backK003780 Vertex Reconstruction SystemMedtronic Sofamor Danek, Inc. · 2001
  2. 2 generations backK042402 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek, Inc. · 2004
  3. 1 generation backK082728 Vertex Recontruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2009
  4. This deviceK123568 Vertex Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K003780Vertex Reconstruction SystemMedtronic Sofamor Danek, Inc.2001—
−2K042402Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek, Inc.2004—
−1K082728Vertex Recontruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2009—
0 (this device)K123568Vertex Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210
200410
200810
FIG. 1 — Lineage of K123568, 2001–2012Source: 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
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What was it cleared against? (2)

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
*K082728Vertex Recontruction System, Vertex Select Reconstruction System
Our reading of the summary gave K062728, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “VERTEX® Reconstruction System”.
Medtronic Sofamor Danek USA, Inc.2009—
*K023555Modification to Vertex Reconstruction System
Summary page 4
…and indications for use of the subject devices are equivalent to the predicate VERTEX® Reconstruction System devices (K062728 - SE 01/16/2009 and K023555 - SE 11/22/2002). The labeling is identical to that cleared in K121 191 (S.E. 06/29/1 2). Vill. Discussion of the Non…
Medtronic Sofamor Danek, Inc.2002—
†K121191Vertex Rcconstruction SystemMedtronic Sofamor Danek, Inc.2012—

Also cleared against K082728: 8 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?

  • The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • 8 other devices also cite its predicate K082728.

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. 2012, this device’s year, is highlighted.

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 intended as an adjunct to fusion of the occipitocervical spine, cervical spine, and the thoracic spine (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft for the following: DOD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion, and/or…

Read the full statement (294 words)

When intended as an adjunct to fusion of the occipitocervical spine, cervical spine, and the thoracic spine (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft for the following:

DOD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion, and/or tumors.

Occjpitocervical Components: Plate Rod/Plates/Rods/Occipital Screws/Hooks

The occihitocervical plate rods, plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction .of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine.

Occipitocervical constructs require bilateral fixation to C2 and below.

Note: Segmental fixation is recommended for these constructs.

Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (ClI-T3) spine.

Multi-axial Screws

The use of multi-axial screws is limited to placement in TI-T3. The screws are not intended to be placed in the cervical spine.

Titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment'to the posterior cervical or thoracic spine.

Connectors

In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX®V rod connectors. Transition rods with differing diameters may also be used to connect the VERTEX® Reconstruction System to the CD HORIZON® Spinal System screws, hooks, and connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.

Indications for use as stated in the FDA summary.

Also cleared against K082728

8 other devices cite the same predicate.

  • K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc. · 20175 recalls
  • K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2013
  • K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod, Gibralt Occipital PlatesExactech, Inc. · 2013
  • K121191Vertex Rcconstruction SystemMedtronic Sofamor Danek, Inc. · 2012
  • K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
  • K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011

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/K123568 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123568: Vertex Reconstruction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123568

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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