510(k) Report

510(k) · Cleared

Cleared

Silicone Elastomer Malar Implant

K952707510(k) TraditionalCleared Aug 28, 199575-day reviewClass II21 CFR 878.3680

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

Spirit Ridge Technologies · FZE Prosthesis, Nose, Internal

Cleared on Aug 28, 1995 after a 75-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Aug 28, 1995
Review
75 days
Class
Class II
Product code
FZE
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared2010: 1 descendant cleared1995200020052010201520202025
  1. This deviceK952707 Silicone Elastomer Malar ImplantSpirit Ridge Technologies · 1995
  2. Descendant · cites it directly · 1 of its ownK973574 Duralastic Anatomical Malar ImplantHanson Medical, Inc. · 1997
  3. Descendant · 2 generations on · 0 of its ownK090803 Hanson Medical Facial ImplantsHanson Medical, Inc. · 2010
  4. Descendant · cites it directly · 0 of its ownK971479 Duralastic Anatomical Malar ImplantsAllied Biomedical Corp. · 1997

Most influential descendants

Showing 3 of 3 · See all
  • K973574Duralastic Anatomical Malar ImplantHanson Medical, Inc. · 1997 · cites it directly1descendant
  • K090803Hanson Medical Facial ImplantsHanson Medical, Inc. · 2010 · 2 generations on0descendants
  • K971479Duralastic Anatomical Malar ImplantsAllied Biomedical Corp. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952707Silicone Elastomer Malar ImplantSpirit Ridge Technologies1995—
+1K973574Duralastic Anatomical Malar ImplantHanson Medical, Inc.1997—
+2K090803Hanson Medical Facial ImplantsHanson Medical, Inc.2010—
+1K971479Duralastic Anatomical Malar ImplantsAllied Biomedical Corp.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
201010
FIG. 1 — Lineage of K952707, 1995–2010Source: 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 FZE? 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 FZE device

  1. #1 K241253 Medicon Epiplating Systemscore 9.1 · 3 generations · no Class I recall
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? (3)

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

NumberDeviceApplicantDecidedDescendants
K973574Duralastic Anatomical Malar ImplantHanson Medical, Inc.19971
K971479Duralastic Anatomical Malar ImplantsAllied Biomedical Corp.19970

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, K973574 (Hanson Medical, Inc., 1997) has gone furthest, with 1 descendant of its own.

How does its category compare?

All FZE devices

FZE Prosthesis, Nose, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FZE

1in 2024

2007: 12009: 12010: 12016: 12024: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FZE

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

Recalls per year · FZE

No recall names FZE since 2007.

Adverse event reports per year · FZE

13in 2025

2008: 22016: 72017: 132018: 122019: 242020: 232021: 322022: 302023: 142024: 262025: 13
2007high 32 (2021) · low 0 (2007)2025

MAUDE reports naming product code FZE, 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—00
20080—02
20091—00
20101—00
20110—00
20120—00
20130—00
20140—00
20150—00
20161—07
20170—013
20180—012
20190—024
20200—023
20210—032
20220—030
20230—014
20241—026
20250—013
20260—0—

More from Spirit Ridge Technologies

5 FDA decisions under this applicant name. See the company

  • K952706Spirit Ridge Silicone Carving BlockSpirit Ridge Technologies · 1995
  • K952705Spirit Ridge Nasal ImplantSpirit Ridge Technologies · 1995
  • K952709Prothesis, Chin, InternalSpirit Ridge Technologies · 1995
  • K952708Pectoralis ImplantSpirit Ridge Technologies · 1995

Recent decisions in FZE

The FZE category page

  • K241253Medicon Epiplating SystemCmf Medicon Surgical, Inc. · 2024
  • K161548Osseointegrated FixturesSouthern Implants (Pty), Ltd. · 2016
  • K090803Hanson Medical Facial ImplantsHanson Medical, Inc. · 2010
  • K090630Nobel Biocare Endosseous Implants (Maxillofacial Indication)Nobel Biocare AB · 2009
  • K071018Monarch Nasal ImplantHanson Medical, Inc. · 2007

https://510kreport.com/device/K952707 · printed Nov 6, 2026

Cite this page

510(k) Report. “K952707: Silicone Elastomer 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/K952707

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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