510(k) Report

510(k) · Cleared

Cleared

Cranioplastic, Acrylic Cranioplasty Material

K873689510(k) TraditionalCleared Oct 26, 198745-day reviewClass II21 CFR 882.5300

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

Dentsply Intl. · GXP Methyl Methacrylate For Cranioplasty

Cleared on Oct 26, 1987 after a 45-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 92 later devices descend from it.

Decided
Oct 26, 1987
Review
45 days
Class
Class II
Product code
GXP
Recalls
None
Predicates
0

92 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2007: 6 descendants cleared2004: 3 descendants cleared1996: 1 descendant cleared1997: 1 descendant cleared2005: 4 descendants cleared2003: 6 descendants cleared1999: 3 descendants cleared2000: 1 descendant cleared2009: 3 descendants cleared2014: 2 descendants cleared2011: 4 descendants cleared2018: 5 descendants cleared2013: 1 descendant cleared2012: 2 descendants cleared2002: 2 descendants cleared1998: 2 descendants cleared2015: 1 descendant cleared2020: 4 descendants cleared2019: 2 descendants cleared2025: 2 descendants cleared2022: 4 descendants cleared2010: 3 descendants cleared2006: 4 descendants cleared2024: 6 descendants cleared2026: 8 descendants cleared2023: 8 descendants cleared2017: 2 descendants cleared2016: 1 descendant cleared2021: 1 descendant cleared1990200020102020
  1. This deviceK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
  2. Descendant · cites it directly · 55 of its ownK953339 Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1996
  3. Descendant · cites it directly · 50 of its ownK964537 Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1997
  4. Descendant · 2 generations on · 49 of its ownK973789 Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian…Norian Corp. · 1998
  5. Descendant · 2 generations on · 45 of its ownK991398 Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger · 1999
  6. Descendant · 2 generations on · 43 of its ownK021440 Bonesource HacStryker Instruments · 2002

Showing 5 of 92 descendants. See all descendants

Descendants cleared per year

1996: 11997: 11998: 21999: 32000: 12002: 22003: 62004: 32005: 42006: 42007: 62009: 32010: 32011: 42012: 22013: 12014: 22015: 12016: 12017: 22018: 52019: 22020: 42021: 12022: 42023: 82024: 62025: 22026: 8
1996high 8 (2023) · low 0 (2001)2026

Most influential descendants

Showing 5 of 92 · See all
  • K953339Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1996 · cites it directly55descendants
  • K964537Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1997 · cites it directly50descendants
  • K973789Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair System…Norian Corp. · 1998 · 2 generations on49descendants
  • K991398Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger · 1999 · 2 generations on45descendants
  • K021440Bonesource HacStryker Instruments · 2002 · 2 generations on43descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K873689Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl.1987—
+1K953339Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc.1996—
+1K964537Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc.1997—
+2K973789Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair…Norian Corp.1998—
+2K991398Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger1999—
+2K021440Bonesource HacStryker Instruments2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
199820
199930
200010
200220
200360
200430
200540
200640
200760
200930
201030
201140
201220
201310
201420
201510
201610
201720
201850
201920
202040
202110
202240
202380
202460
202520
202680
FIG. 1 — Lineage of K873689, 1987–2026Source: 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 GXP? 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 GXP device

  1. #1 K241027 Permatage Settable Bone Puttyscore 16.5 · 9 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? (92)

See all 92

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

NumberDeviceApplicantDecidedDescendants
K953339Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc.199655
K964537Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc.199750
K072601Osteosymbionics Patient Specific Cranial ImplantOsteosymbionics, LLC200720
K043406Vertebroplastic Radiopaque Bone CementDepuy Spine, Inc.20053
K991893Parallax Tracer Radiopaque ParticlesParallax Medical, Inc.19992
K042414Visioplast Acrylic ResinTecres20041
K040152Bone Cement for CranioplastyCardinalhealth20041
K071791Modification to Cranioplastic, Model 43-1280Codman & Shurtleff, Inc.20070
K023575Concert CranioplastImmedica, Inc.20030
K994022Parallax CraniosetParallax Medical, Inc.20000

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, K953339 (Osteogenics, Inc., 1996) has gone furthest, with 55 descendants of its own.

How does its category compare?

All GXP devices

GXP Methyl Methacrylate For Cranioplasty: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GXP

4so far in 2026, the most since 2007

2007: 32009: 12010: 12015: 12017: 12019: 12023: 22024: 22026 (partial year): 4
2007high 4 (2026) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXP

87in 2007

2007: 87 days median2026 (partial year): 85 days median
2007high 87 (2007)2026

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

Recalls per year · GXP

2in 2019

2009: 12011: 12012: 12019: 2
2007high 2 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GXP

1in 2025

2007: 82008: 102009: 222010: 592011: 312012: 282013: 182014: 192015: 132016: 172017: 162018: 92019: 92020: 312021: 142022: 32023: 22024: 102025: 1
2007high 59 (2010) · low 1 (2025)2025

MAUDE reports naming product code GXP, 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
200738708
20080—010
20091—122
20101—059
20110—131
20120—128
20130—018
20140—019
20151—013
20160—017
20171—016
20180—09
20191—29
20200—031
20210—014
20220—03
20232—02
20242—010
20250—01
20264850—

More from Dentsply Intl.

279 FDA decisions under this applicant name. See the company

  • K123615Iris - High Strength Glass CeramicDentsply Intl. · 2013
  • K072730Friadent Cercon and Ankylos Cercon Balance AbutmentsDentsply Intl. · 2008
  • K070538XP Bond Dual Cure Universal Total Etch AdhesiveDentsply Intl. · 2007
  • K070019Carrara VolumiaDentsply Intl. · 2007
  • K061427Pre-Impression Conditioning SolutionDentsply Intl. · 2006

Recent decisions in GXP

The GXP category page

  • K251959TnR Cranial ImplantT&R BIOFAB CO., Ltd. · 2026
  • K261265Permatage XT Settable Bone PuttyOrthocon, Inc. · 2026
  • K253732Permatage Flowable, Settable Bone PasteOrthocon, Inc. · 2026
  • K253854MONTAGE XT Cranial CementOrthocon, Inc. · 2026
  • K241027Permatage Settable Bone PuttyOrthocon, Inc. · 2024

https://510kreport.com/device/K873689 · printed Nov 4, 2026

Cite this page

510(k) Report. “K873689: Cranioplastic, Acrylic Cranioplasty Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K873689

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