510(k) Report

510(k) · Cleared

Cleared

Phoenix Burr Hole Button, Burr 1

K913490510(k) TraditionalCleared Jan 13, 1992160-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

Phoenix Bioengineering, Inc. · GXR Cover, Burr Hole

Cleared on Jan 13, 1992 after a 160-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Jan 13, 1992
Review
160 days
Class
Class II
Product code
GXR
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1990200020102020
  1. This deviceK913490 Phoenix Burr Hole Button, Burr 1Phoenix Bioengineering, Inc. · 1992
  2. Descendant · cites it directly · 0 of its ownK960656 Gore Burr Hole CoverW. L. Gore & Associates, Inc. · 1996

Most influential descendants

Showing 1 of 1 · See all
  • K960656Gore Burr Hole CoverW. L. Gore & Associates, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K913490Phoenix Burr Hole Button, Burr 1Phoenix Bioengineering, Inc.1992—
+1K960656Gore Burr Hole CoverW. L. Gore & Associates, Inc.1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
FIG. 1 — Lineage of K913490, 1992–1996Source: 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K960656Gore Burr Hole CoverW. L. Gore & Associates, Inc.19960

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, K960656 (W. L. Gore & Associates, Inc., 1996) has gone furthest, with 0 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 Phoenix Bioengineering, Inc.

3 FDA decisions under this applicant name. See the company

  • K930125Phoenix Bone Screws PBS-Type SeriesPhoenix Bioengineering, Inc. · 1993
  • K904434Sexton Cystotomy Urine Pump (SCUP2)Phoenix Bioengineering, Inc. · 1991

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/K913490 · printed Nov 5, 2026

Cite this page

510(k) Report. “K913490: Phoenix Burr Hole Button, Burr 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K913490

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026