510(k) Report

510(k) · Cleared

Cleared

Medtronic PS Medical Invisx Cranial Fixation System, Model 60100-60900

K010361510(k) TraditionalCleared May 7, 200190-day reviewClass II21 CFR 882.5250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic PS Medical · GXR Cover, Burr Hole

Cleared on May 7, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided
May 7, 2001
Review
90 days
Class
Class II
Product code
GXR
Recalls
None
Predicates
0

6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared2010: 1 descendant cleared2013: 1 descendant cleared2020: 1 descendant cleared2024: 1 descendant cleared2016: 1 descendant cleared200020052010201520202025
  1. This deviceK010361 Medtronic PS Medical Invisx Cranial Fixation System, Model 60100-60900Medtronic PS Medical · 2001
  2. Descendant · cites it directly · 4 of its ownK101235 Cranial Loop Cranial Bone Fixation SystemNeos Surgery S.L · 2010
  3. Descendant · 2 generations on · 3 of its ownK132044 Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone…Neos Surgery S.L · 2013
  4. Descendant · 3 generations on · 1 of its ownK160739 Cranial COVERNeos Surgery S.L · 2016
  5. Descendant · 3 generations on · 0 of its ownK240137 Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone…Neos Surgery S.L · 2024
  6. Descendant · 3 generations on · 0 of its ownK192310 Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd. · 2020

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2001: 12010: 12013: 12016: 12020: 12024: 1
2001high 1 (2001) · low 0 (2002)2026

Most influential descendants

Showing 5 of 6 · See all
  • K101235Cranial Loop Cranial Bone Fixation SystemNeos Surgery S.L · 2010 · cites it directly4descendants
  • K132044Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation SystemNeos Surgery S.L · 2013 · 2 generations on3descendants
  • K160739Cranial COVERNeos Surgery S.L · 2016 · 3 generations on1descendant
  • K240137Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemNeos Surgery S.L · 2024 · 3 generations on0descendants
  • K192310Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd. · 2020 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010361Medtronic PS Medical Invisx Cranial Fixation System, Model 60100-60900Medtronic PS Medical2001—
+1K101235Cranial Loop Cranial Bone Fixation SystemNeos Surgery S.L2010—
+2K132044Cranial Loop, Cranial Loop L and Cranial Loop XL and Cranial Bone Fixation…Neos Surgery S.L2013—
+3K160739Cranial COVERNeos Surgery S.L2016—
+3K240137Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemNeos Surgery S.L2024—
+3K192310Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
201010
201310
201610
202010
202410
FIG. 1 — Lineage of K010361, 2001–2024Source: 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.

Planning a device in GXR? 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 GXR device

  1. #1 K253447 Montage Flowable Settable, Resorbable Bone…score 13.7 · 10 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?

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

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K101235Cranial Loop Cranial Bone Fixation SystemNeos Surgery S.L20104
K013000Medtronic Invisx Burr Hole Lock, Model 60520Medtronic Neurosurgery20010

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?

  • Of its descendants, K101235 (Neos Surgery S.L, 2010) has gone furthest, with 4 descendants of its own.

How does its category compare?

All GXR devices

GXR Cover, Burr Hole: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GXR

1in 2024

2007: 12010: 22013: 42014: 22016: 22018: 22020: 22023: 12024: 12026 (partial year): 1
2007high 4 (2013) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXR

116in 2013

2013: 116 days median
2007high 116 (2013)2026

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

Recalls per year · GXR

No recall names GXR since 2007.

Adverse event reports per year · GXR

10in 2025

2007: 32008: 22010: 12011: 42012: 42013: 42014: 22015: 72016: 72017: 72018: 452019: 282020: 162021: 282022: 132023: 112024: 32025: 10
2007high 45 (2018) · low 0 (2009)2025

MAUDE reports naming product code GXR, 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
20071—03
20080—02
20090—00
20102—01
20110—04
20120—04
2013411604
20142—02
20150—07
20162—07
20170—07
20182—045
20190—028
20202—016
20210—028
20220—013
20231—011
20241—03
20250—010
20261—0—

More from Medtronic PS Medical

14 FDA decisions under this applicant name. See the company

  • K012052Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical · 2002
  • K010487Bipolar Pencil, Model 3901-002, 3900-002Medtronic PS Medical · 2001
  • K010341Medtronic PS Medical Murphyscope, Models 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161…Medtronic PS Medical · 20012 recalls
  • K003914Medtronic PS Medical Neuropen Endoscope and Optical AccessoriesMedtronic PS Medical · 2001
  • K002572Medtronic PS Medical Channelscope Endoscope, Models 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005Medtronic PS Medical · 2000

Recent decisions in GXR

The GXR category page

  • K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc. · 2026
  • K240137Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemNeos Surgery S.L · 2024
  • K221606Absorbable Cranial Flap Fixation SystemChendu Medart Medical Scientific Co., Ltd. · 2023
  • K192310Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd. · 2020
  • K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLC · 2020

https://510kreport.com/device/K010361 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010361: Medtronic PS Medical Invisx Cranial Fixation System, Model 60100-60900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010361

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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