510(k) · Cleared

Cleared

Duralastic Anatomical Malar Implant

K973574510(k) TraditionalCleared Oct 24, 199735-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

Hanson Medical, Inc. · LZK Implant, Malar

Cleared on Oct 24, 1997 as substantially equivalent to K952707 (Spirit Ridge Technologies, 1995) after a 35-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided: Oct 24, 1997
Review: 35 days
Class: Class II
Product code: LZK
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K952707 (1995). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK952707 Silicone Elastomer Malar ImplantSpirit Ridge Technologies · 1995
This deviceK973574 Duralastic Anatomical Malar ImplantHanson Medical, Inc. · 1997
Descendant · cites it directly · 0 of its ownK090803 Hanson Medical Facial ImplantsHanson Medical, Inc. · 2010

Most influential descendants

Showing 1 of 1 · See all

K090803Hanson Medical Facial ImplantsHanson Medical, Inc. · 2010 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K952707	Silicone Elastomer Malar Implant	Spirit Ridge Technologies	1995	—
0 (this device)	K973574	Duralastic Anatomical Malar Implant	Hanson Medical, Inc.	1997	—
+1	K090803	Hanson Medical Facial Implants	Hanson Medical, Inc.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0

FIG. 1 — Lineage of K973574, 1995–2010Source: 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.

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

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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
*	K952707	Silicone Elastomer Malar Implant Summary page 1 …und in Applied Silicone's Master File MAF- 562. The Duralastic Malar Implants will be provided sterile and nonsterile. SUBSTANTIAL EQUIVALENCE Under it original 510(k) K952707, Duralastic Malar implants were found SE to the Applied Biomedical malar implants. In fact the very same molds and materials used…	Spirit Ridge Technologies	1995	—

Also cleared against K952707: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K090803	Hanson Medical Facial Implants	Hanson Medical, Inc.	2010	0

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 no recall.
Of its descendants, K090803 (Hanson Medical, Inc., 2010) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K952707.

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?

To augment or reconstruct the malar cheek contour or the maxillary Zygoma.

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/K973574 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973574: Duralastic Anatomical Malar Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973574

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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