510(k) · Cleared

Cleared

Silhouette Featherlift

K171005510(k) SpecialCleared May 3, 201729-day reviewClass II21 CFR 878.5010

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

Silhouette Lift, Inc. · GAW Suture, Nonabsorbable, Synthetic, Polypropylene

Cleared on May 3, 2017 as substantially equivalent to K060414 (Kmi Kolster Methods, Inc., 2006) after a 29-day review. Its family tree reaches back 1 generation to 2006. 1 later device descends from it.

Decided: May 3, 2017
Review: 29 days
Class: Class II
Product code: GAW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K060414 (2006). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK060414 Kolster Methods, Inc., Featherlift Silhouette SutureKmi Kolster Methods, Inc. · 2006 · Recalled
This deviceK171005 Silhouette FeatherliftSilhouette Lift, Inc. · 2017
Descendant · cites it directly · 0 of its ownK191299 Silhouette Featherlift / Silhouette LiftSilhouette Lift, Inc. · 2019

Most influential descendants

Showing 1 of 1 · See all

K191299Silhouette Featherlift / Silhouette LiftSilhouette Lift, Inc. · 2019 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K060414	Kolster Methods, Inc., Featherlift Silhouette Suture	Kmi Kolster Methods, Inc.	2006	1
0 (this device)	K171005	Silhouette Featherlift	Silhouette Lift, Inc.	2017	—
+1	K191299	Silhouette Featherlift / Silhouette Lift	Silhouette Lift, Inc.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0

FIG. 1 — Lineage of K171005, 2006–2019Source: 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 GAW? 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 GAW device

#1 K253572 STRATAFIX™ Spiral PRONOVA™ Unidirectional…score 14.4 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin 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
*	K060414	Kolster Methods, Inc., Featherlift Silhouette Suture Summary page 5 …, SMS 02-PP-2.0.1-B, SMS 03-PP-3.0.1-CL, SMS 06-PP-3.0.1-B-L 510(k) Number: K060414 Regulation Name: Nonabsorbable polypropylene surgical suture. Regulation Number: 21 CFR 878.5010 Regulatory Cl…	Kmi Kolster Methods, Inc.	2006	1

Also cleared against K060414: 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
K191299	Silhouette Featherlift / Silhouette Lift	Silhouette Lift, Inc.	2019	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 a recall.
Of its descendants, K191299 (Silhouette Lift, Inc., 2019) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K060414.

How does its category compare?

All GAW devices

GAW Suture, Nonabsorbable, Synthetic, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · GAW

1in 2024

2007high 3 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAW

80in 2018

2007high 252 (2015) · low 36 (2013)2026

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

Recalls per year · GAW

2so far in 2026, the most since 2007

2007high 2 (2026) · low 0 (2008)2026

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

Adverse event reports per year · GAW

2,545in 2025

2007high 2,545 (2025) · low 71 (2009)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	1	73
2008	0	—	0	75
2009	0	—	0	71
2010	2	—	0	85
2011	0	—	0	84
2012	3	86	0	194
2013	3	36	0	191
2014	2	—	0	437
2015	3	252	0	422
2016	1	—	0	440
2017	3	145	0	413
2018	3	80	0	685
2019	1	—	0	1,803
2020	2	—	0	1,493
2021	0	—	0	1,652
2022	2	—	0	1,563
2023	1	—	0	1,811
2024	1	—	0	2,348
2025	0	—	0	2,545
2026	1	—	2	—

What is it indicated for?

Silhouette Lift Sutures are for use in Midface suspension surgery to fixate the cheek sub dermis in an elevated position.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K171005 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171005: Silhouette Featherlift.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171005

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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