510(k) Report

510(k) · Cleared

Cleared

Pureform Eptfe Facial Implants (Nasal, Chin, Maler)

K091011510(k) TraditionalCleared Apr 22, 200913-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

Surgical Technology Laboratories, Inc ("Stl") · FWP Prosthesis, Chin, Internal

Cleared on Apr 22, 2009 as substantially equivalent to K933367 (W. L. Gore & Associates, Inc., 1994) and 5 other predicates after a 13-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.

Decided
Apr 22, 2009
Review
13 days
Class
Class II
Product code
FWP
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K933367 (1994). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2000: 1 other ancestor1998: 3 other ancestors2023: 1 descendant clearedK933367 · Gore-Tex Facial Implant · W. L. Gore & Associates, Inc. · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors 1 generation forward: 1 descendant K933367 · Gore-Tex Facial Implant · W. L. Gore & Associates, Inc. · 19940
  1. Root · 1 generation backK933367 Gore-Tex Facial ImplantW. L. Gore & Associates, Inc. · 1994
  2. This deviceK091011 Pureform Eptfe Facial Implants (Nasal, Chin, Maler)Surgical Technology Laboratories, Inc ("Stl") · 2009
  3. Descendant · cites it directly · 0 of its ownK201153 Tisuthes e-PTFE Surgical PatchShanghai Suokang Medical Implants Co., Ltd. · 2023

Most influential descendants

Showing 1 of 1 · See all
  • K201153Tisuthes e-PTFE Surgical PatchShanghai Suokang Medical Implants Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K933367Gore-Tex Facial ImplantW. L. Gore & Associates, Inc.1994—
0 (this device)K091011Pureform Eptfe Facial Implants (Nasal, Chin, Maler)Surgical Technology Laboratories, Inc ("Stl")2009—
+1K201153Tisuthes e-PTFE Surgical PatchShanghai Suokang Medical Implants Co., Ltd.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199830
200010
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
FIG. 1 — Lineage of K091011, 1994–2023Source: 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), 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 FWP? 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 FWP device

  1. #1 K254233 MEDPOR Customized Implant Kitscore 13.1 · 8 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? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K933367Gore-Tex Facial Implant
Summary page 1
…, Nasal (LZK) Name Predicate Devices Gore-Tex SAM Facial Implant, manufactured by W. L. Gore and Associates, Flagstaff, AZ (K933367) Surgiform Augmentation Material (SFAM), manufactured by Surgical Technology Labor…
W. L. Gore & Associates, Inc.1994—
*K021889Surgiform Augmentation Material (S.F.a.M.)
Summary page 1
…Surgiform Augmentation Material (SFAM), manufactured by Surgical Technology Laboratories, Inc., Columbia, SC (K021889) Surgiform Silicone Facial Implants (Chin, Malar, Nasal), Manufactured by Surgical…
Surgical Technology Laboratories, Inc.2002—
*K983754Standard Chin
Summary page 1
…giform Silicone Facial Implants (Chin, Malar, Nasal), Manufactured by Surgical Technology Laboratories, Inc., Columbia, SC (K983754, K983755, K983756) Implantech Composite Facial Implants (Malar, Chin,…
Surgical Technology Laboratories, Inc.1998—
*K983755Nasal Dorsal Series
Summary page 1
…licone Facial Implants (Chin, Malar, Nasal), Manufactured by Surgical Technology Laboratories, Inc., Columbia, SC (K983754, K983755, K983756) Implantech Composite Facial Implants (Malar, Chin,…
Surgical Technology Laboratories, Inc.1998—
*K983756Surgiform Anatomical Malar
Summary page 1
…lar, Nasal), Manufactured by Surgical Technology Laboratories, Inc., Columbia, SC (K983754, K983755, K983756) Implantech Composite Facial Implants (Malar, Chin, and Nasal), Manufactured by Impl…
Surgical Technology Laboratories, Inc.1998—
*K002886Implantech Composite Facial Implants (Malar, Chin, and Nasal)
Summary page 1
…Implantech Composite Facial Implants (Malar, Chin, and Nasal), Manufactured by Implantech Associates, Inc., Ventura, CA (K002886) Page 4 of 47 Device Description The Pure…
Implantech Associates, Inc.2000—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K201153Tisuthes e-PTFE Surgical PatchShanghai Suokang Medical Implants Co., Ltd.20230

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?

  • None of the 6 ancestors has a recall.
  • Of its descendants, K201153 (Shanghai Suokang Medical Implants Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FWP devices

FWP Prosthesis, Chin, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · FWP

1in 2023

2009: 12012: 12014: 12015: 12016: 22019: 22020: 12023: 12026 (partial year): 1
2007high 2 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FWP

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

Recalls per year · FWP

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

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

Adverse event reports per year · FWP

17in 2025

2007: 32008: 32009: 52010: 12011: 222012: 62013: 92014: 52015: 82016: 62017: 132018: 72019: 152020: 62021: 132022: 122023: 62024: 102025: 17
2007high 22 (2011) · low 1 (2010)2025

MAUDE reports naming product code FWP, 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—03
20080—03
20091—05
20100—01
20110—022
20121—06
20130—09
20141—05
20151—08
20162—06
20170—013
20180—07
20192—015
20201—06
20210—013
20220—012
20231—06
20240—010
20250—117
20261—0—

What is it indicated for?

PureForm ePTFE Facial Implants are indicated for use in facial plastic and reconstructive surgery.

Indications for use as stated in the FDA summary.

Recent decisions in FWP

The FWP category page

  • K254233MEDPOR Customized Implant KitStryker Leibinger GmbH & Co KG · 2026
  • K232593FITme Customized Silicone ImplantKeosan Trading Co. · 2023
  • K200610Customized Contour ImplantImplantech Associates, Inc. · 2020
  • K191130Customized Contour ImplantImplantech Associates, Inc. · 2019
  • K191916Stryker CMF MEDPOR Priority Customized Implant KitStryker Leibinger GmbH & Co KG · 2019

https://510kreport.com/device/K091011 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091011: Pureform Eptfe Facial Implants (Nasal, Chin, Maler).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091011

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
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026