510(k) Report

510(k) · Cleared

Cleared

Macroporens Craniloc

K002334510(k) TraditionalCleared May 2, 2001274-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

Macropore Biosurgery, Inc. · GXR Cover, Burr Hole

Cleared on May 2, 2001 after a 274-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 73 later devices descend from it.

Decided
May 2, 2001
Review
274 days
Class
Class II
Product code
GXR
Recalls
None
Predicates
0

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

Descendants, by year cleared 2003: 1 descendant cleared2004: 1 descendant cleared2006: 1 descendant cleared2010: 2 descendants cleared2013: 3 descendants cleared2007: 1 descendant cleared2023: 9 descendants cleared2016: 3 descendants cleared2012: 1 descendant cleared2014: 3 descendants cleared2011: 1 descendant cleared2024: 13 descendants cleared2020: 1 descendant cleared2021: 3 descendants cleared2025: 14 descendants cleared2022: 3 descendants cleared2026: 11 descendants cleared2015: 2 descendants cleared200020052010201520202025
  1. This deviceK002334 Macroporens CranilocMacropore Biosurgery, Inc. · 2001
  2. Descendant · cites it directly · 63 of its ownK022277 Osteomed Cranial Flap Fixation SystemOsteomed Corp. · 2003
  3. Descendant · 2 generations on · 62 of its ownK062857 KLS Martin Quick DiscKLS Martin L.P. · 2006
  4. Descendant · 3 generations on · 61 of its ownK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
  5. Descendant · 4 generations on · 45 of its ownK151983 KLS Martin LSS Plating SystemKLS Martin L.P. · 2016
  6. Descendant · 5 generations on · 39 of its ownK202889 Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021

Showing 5 of 73 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12006: 12007: 12010: 22011: 12012: 12013: 32014: 32015: 22016: 32020: 12021: 32022: 32023: 92024: 132025: 142026: 11
2003high 14 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 73 · See all
  • K022277Osteomed Cranial Flap Fixation SystemOsteomed Corp. · 2003 · cites it directly63descendants
  • K062857KLS Martin Quick DiscKLS Martin L.P. · 2006 · 2 generations on62descendants
  • K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007 · 3 generations on61descendants
  • K151983KLS Martin LSS Plating SystemKLS Martin L.P. · 2016 · 4 generations on45descendants
  • K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021 · 5 generations on39descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002334Macroporens CranilocMacropore Biosurgery, Inc.2001—
+1K022277Osteomed Cranial Flap Fixation SystemOsteomed Corp.2003—
+2K062857KLS Martin Quick DiscKLS Martin L.P.2006—
+3K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.2007—
+4K151983KLS Martin LSS Plating SystemKLS Martin L.P.2016—
+5K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200610
200710
201020
201110
201210
201330
201430
201520
201630
202010
202130
202230
202390
2024130
2025140
2026110
FIG. 1 — Lineage of K002334, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (73)

See all 73

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

NumberDeviceApplicantDecidedDescendants
K022277Osteomed Cranial Flap Fixation SystemOsteomed Corp.200363
K040080Aesculap Absorbable CraniofixAesculap, Inc.20048

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, K022277 (Osteomed Corp., 2003) has gone furthest, with 63 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 Macropore Biosurgery, Inc.

17 FDA decisions under this applicant name. See the company

  • K042261Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004
  • K041105Macropore Hydrosorb Spine SystemMacropore Biosurgery, Inc. · 2004
  • K031955Macropore Surgi-Wrap Mast Bioresorbable SheetMacropore Biosurgery, Inc. · 2003
  • K031785Macropore Cardio-Wrap (TS)Macropore Biosurgery, Inc. · 2003
  • K024169Macropore OS ReconstructionMacropore Biosurgery, Inc. · 2003

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/K002334 · printed Nov 5, 2026

Cite this page

510(k) Report. “K002334: Macroporens Craniloc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002334

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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