510(k) Report

510(k) · Cleared

Cleared

Kobra GPS Fixation System

K042859510(k) TraditionalCleared Nov 24, 200440-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 Vertelink, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Nov 24, 2004 as substantially equivalent to K032102 (Vertelink Corporation, 2003) and 1 other predicate after a 40-day review. Its family tree reaches back 2 generations to 2003.

Decided
Nov 24, 2004
Review
40 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K030932 (2003). 3 ancestors in all, the oldest K000453 (2000). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestorK030932 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2003K032102 · Vertelink Kobra Spinal Fixation System · Vertelink Corporation · 20032000200220042006
Other ancestors, by generation 1 generation back: 1 other ancestor K032102 · Vertelink Kobra Spinal Fixation System · Vertelink Corporation · 2003K030932 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 20030
  1. Root · 2 generations backK030932 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2003
  2. 1 generation backK032102 Vertelink Kobra Spinal Fixation SystemVertelink Corporation · 2003
  3. This deviceK042859 Kobra GPS Fixation SystemMedtronic Vertelink, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K030932CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2003—
−1K032102Vertelink Kobra Spinal Fixation SystemVertelink Corporation2003—
0 (this device)K042859Kobra GPS Fixation SystemMedtronic Vertelink, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
FIG. 1 — Lineage of K042859, 2003–2004Source: 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
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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
*K032102Vertelink Kobra Spinal Fixation System
Summary page 1
…ded which demonstrated the Vertelink KOBRATM GPS Fixation System to be substantially equivalent to the Vertelink KOBRATM Fixation System components previously cleared in K032102 and to the CD HORIZON® Spinal System (K000453).…
Vertelink Corporation2003—
*K000453Modification to CD Spinal System
Summary page 1
…PS Fixation System to be substantially equivalent to the Vertelink KOBRATM Fixation System components previously cleared in K032102 and to the CD HORIZON® Spinal System (K000453). 0L ( oft DEPAR…
Medtronic Sofamor Danek, Inc.2000—

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 1 year and passes through 3 companies; a new generation was cleared every 11 months on median.
  • None of the 3 ancestors has a recall.

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?

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the KOBRATMGPS Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation…

Read the full statement (137 words)

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the KOBRATMGPS Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the KOBRATmGPS Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S 1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

Indications for use as stated in the FDA summary.

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https://510kreport.com/device/K042859 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042859: Kobra GPS 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/K042859

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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