510(k) · Cleared

Cleared

Bone Source Hydroxyapatite

K970400510(k) TraditionalCleared May 2, 199788-day reviewClass II21 CFR 878.3550

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

Cleared on May 2, 1997 as substantially equivalent to K922489 (Porex Technologies Corp., 1992) after an 88-day review. Its family tree reaches back 1 generation to 1992. 50 later devices descend from it.

Decided: May 2, 1997
Review: 88 days
Class: Class II
Product code: LZK
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K922489 (1992). 50 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK922489 Medpor Surg Implant Material:Prefor Cran/Fac ImplaPorex Technologies Corp. · 1992 · Recalled
This deviceK970400 Bone Source HydroxyapatiteOrthofix, Inc. · 1997
Descendant · cites it directly · 49 of its ownK973789 Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian…Norian Corp. · 1998
Descendant · cites it directly · 45 of its ownK991398 Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger · 1999
Descendant · cites it directly · 43 of its ownK021440 Bonesource HacStryker Instruments · 2002
Descendant · 2 generations on · 41 of its ownK032366 Bonesource Hac Fast Setting CementStryker Instruments · 2003
Descendant · 3 generations on · 36 of its ownK043334 Bone Source Hac Rapid Setting CementStryker Instruments · 2005

Showing 5 of 50 descendants. See all descendants

Descendants cleared per year

1998high 7 (2023) · low 0 (2000)2026

Most influential descendants

Showing 5 of 50 · See all

K973789Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair System…Norian Corp. · 1998 · cites it directly49descendants
K991398Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger · 1999 · cites it directly45descendants
K021440Bonesource HacStryker Instruments · 2002 · cites it directly43descendants
K032366Bonesource Hac Fast Setting CementStryker Instruments · 2003 · 2 generations on41descendants
K043334Bone Source Hac Rapid Setting CementStryker Instruments · 2005 · 3 generations on36descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K922489	Medpor Surg Implant Material:Prefor Cran/Fac Impla	Porex Technologies Corp.	1992	1
0 (this device)	K970400	Bone Source Hydroxyapatite	Orthofix, Inc.	1997	—
+1	K973789	Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair…	Norian Corp.	1998	—
+1	K991398	Bonesource Hydroxyapatite Cement (Hac) Expanded Kit	Stryker Leibinger	1999	—
+1	K021440	Bonesource Hac	Stryker Instruments	2002	—
+2	K032366	Bonesource Hac Fast Setting Cement	Stryker Instruments	2003	—
+3	K043334	Bone Source Hac Rapid Setting Cement	Stryker Instruments	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	2	0
2002	2	0
2003	2	0
2004	1	0
2005	3	0
2006	4	0
2007	2	0
2009	1	0
2010	1	0
2011	1	0
2014	1	0
2015	1	0
2016	1	0
2017	2	0
2018	3	0
2019	1	0
2020	1	0
2021	1	0
2022	3	0
2023	7	0
2024	5	0
2026	4	0

FIG. 1 — Lineage of K970400, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LZK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K922489	Medpor Surg Implant Material:Prefor Cran/Fac Impla Summary page 1 …MEDPOR® Surgical Implants (porous polyethylene) manufactured by Porex Surgical Inc. of College Park, Georgia. MEDPOR® Surgical Implants were cleared by FDA under 510(k) K922489 on September 2, 1992. DEVICE DESCRIPTION . BoneSource® Hydroxyapatite Cement (HAC) is a self-setting, calcium phosphate cement…	Porex Technologies Corp.	1992	1

Also cleared against K922489: 8 other devices →

What descends from it? (50)

See all 50

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

Number	Device	Applicant	Decided	Descendants
K973789	Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair System…	Norian Corp.	1998	49
K991398	Bonesource Hydroxyapatite Cement (Hac) Expanded Kit	Stryker Leibinger	1999	45
K021440	Bonesource Hac	Stryker Instruments	2002	43

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?

Its one ancestor has a recall.
Of its descendants, K973789 (Norian Corp., 1998) has gone furthest, with 49 descendants of its own.
8 other devices also cite its predicate K922489.

How does its category compare?

All LZK devices

LZK Implant, Malar: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZK

FDA has decided no LZK device since 2007.

Median 510(k) review, days · LZK

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

Recalls per year · LZK

1in 2025

2007high 3 (2007) · low 0 (2008)2026

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

Adverse event reports per year · LZK

1in 2022

2007high 10 (2007) · low 0 (2023)2025

MAUDE reports naming product code LZK, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	3	10
2008	—	0	5
2009	—	0	2
2010	—	0	4
2011	—	0	4
2012	—	0	7
2013	—	0	1
2014	—	0	1
2015	—	0	3
2016	—	0	1
2017	—	0	3
2018	—	0	2
2019	—	0	2
2020	—	0	1
2021	—	0	1
2022	—	0	1
2023	—	0	0
2024	—	0	0
2025	—	1	0
2026	—	0	—

What is it indicated for?

BoneSource® Hydroxyapatite Cement (HAC) is cement indicated for the augmentation

or restoration of bony contour in the craniofacial skeleton.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K970400 · printed Nov 6, 2026

Cite this page

510(k) Report. “K970400: Bone Source Hydroxyapatite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970400

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026