510(k) Report

510(k) · Cleared

Cleared

Memograph; Osstaple - Neurosurgical Uses for Craniofacial Fractures and Cranioplasty for the Memograph Staple System

K001353510(k) TraditionalCleared Mar 13, 2001319-day reviewClass II21 CFR 882.5360

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

Biomedical Ent., Inc. · HBW Fastener, Plate, Cranioplasty

Cleared on Mar 13, 2001 after a 319-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Mar 13, 2001
Review
319 days
Class
Class II
Product code
HBW
Recalls
None
Predicates
0

3 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2002: 3 descendants cleared200020052010201520202025
  1. This deviceK001353 Memograph; Osstaple - Neurosurgical Uses for Craniofacial Fractures…Biomedical Ent., Inc. · 2001
  2. Descendant · cites it directly · 0 of its ownK023488 Osstaple, CraniofacialBiomedical Enterprises, Inc. · 2002
  3. Descendant · cites it directly · 0 of its ownK023486 Osstaple, MaxillofacialBiomedical Enterprises, Inc. · 2002
  4. Descendant · cites it directly · 0 of its ownK023203 OsstapleBiomedical Ent., Inc. · 2002

Most influential descendants

Showing 3 of 3 · See all
  • K023488Osstaple, CraniofacialBiomedical Enterprises, Inc. · 2002 · cites it directly0descendants
  • K023486Osstaple, MaxillofacialBiomedical Enterprises, Inc. · 2002 · cites it directly0descendants
  • K023203OsstapleBiomedical Ent., Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001353Memograph; Osstaple - Neurosurgical Uses for Craniofacial Fractures and…Biomedical Ent., Inc.2001—
+1K023488Osstaple, CraniofacialBiomedical Enterprises, Inc.2002—
+1K023486Osstaple, MaxillofacialBiomedical Enterprises, Inc.2002—
+1K023203OsstapleBiomedical Ent., Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200230
FIG. 1 — Lineage of K001353, 2001–2002Source: 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 HBW? 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 HBW device

  1. #1 K251472 Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation…score 10.0 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
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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? (3)

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

NumberDeviceApplicantDecidedDescendants
K023488Osstaple, CraniofacialBiomedical Enterprises, Inc.20020
K023486Osstaple, MaxillofacialBiomedical Enterprises, Inc.20020
K023203OsstapleBiomedical Ent., Inc.20020

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, K023488 (Biomedical Enterprises, Inc., 2002) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HBW devices

HBW Fastener, Plate, Cranioplasty: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HBW

1in 2025

2010: 12015: 22017: 12023: 12025: 1
2007high 2 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HBW

Too few HBW 510(k)s in any year since 2007 to give a median.

Recalls per year · HBW

No recall names HBW since 2007.

Adverse event reports per year · HBW

3in 2025

2007: 12011: 12013: 22014: 32017: 142018: 222019: 202020: 12021: 22022: 22023: 12024: 32025: 3
2007high 22 (2018) · low 0 (2008)2025

MAUDE reports naming product code HBW, 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
20070—01
20080—00
20090—00
20101—00
20110—01
20120—00
20130—02
20140—03
20152—00
20160—00
20171—014
20180—022
20190—020
20200—01
20210—02
20220—02
20231—01
20240—03
20251—03
20260—0—

More from Biomedical Ent., Inc.

13 FDA decisions under this applicant name. See the company

  • K133844Speed TriadBiomedical Ent., Inc. · 2014
  • K133780Speed XLBiomedical Ent., Inc. · 2014
  • K131640Smooth or Threaded Metallic Bone FastenerBiomedical Ent., Inc. · 2013
  • K102107Osstaple ChillBiomedical Ent., Inc. · 2010
  • K091951HammerlockBiomedical Ent., Inc. · 2010

Recent decisions in HBW

The HBW category page

  • K251472Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation SystemInion OY · 2025
  • K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG · 2023
  • K171152Stryker Universal Neuro III System AXS ScrewStryker · 2017
  • K151387Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver BladeStryker · 2015
  • K141385Depuy Synthes Injectable Polymer System (Ips)Depuy Synthes Companies of Johnson & Johnson · 20151 recall

https://510kreport.com/device/K001353 · printed Nov 5, 2026

Cite this page

510(k) Report. “K001353: Memograph; Osstaple - Neurosurgical Uses for Craniofacial Fractures and Cranioplasty for the Memograph Staple System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001353

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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