510(k) · Cleared

Cleared

Questus Polyester Suture Soft Tissue Anchor System

K953264510(k) TraditionalCleared Oct 20, 199599-day reviewClass II21 CFR 888.3040

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

Wrightmedicaltechnologyinc · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Oct 20, 1995 after a 99-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 41 later devices descend from it.

Decided: Oct 20, 1995
Review: 99 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 0

41 later devices descend from it, 1 citing it directly.

This deviceK953264 Questus Polyester Suture Soft Tissue Anchor SystemWrightmedicaltechnologyinc · 1995
Descendant · cites it directly · 40 of its ownK970292 IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone…Influence, Inc. · 1997 · Recalled
Descendant · 2 generations on · 23 of its ownK972023 Sleep-in Bone Screw SystemInfluence, Inc. · 1997
Descendant · 2 generations on · 16 of its ownK981677 Repose Bone Screw SystemInfluence, Inc. · 1999 · Recalled
Descendant · 3 generations on · 15 of its ownK101060 Siesta Medical, Inc., Prelude Tongue Suspension SystemSiesta Medical, Inc. · 2010
Descendant · 4 generations on · 14 of its ownK103179 Prelude II Tounge Suspension SystemSiesta Medical, Inc. · 2010

Showing 5 of 41 descendants. See all descendants

Descendants cleared per year

1997high 6 (2012) · low 0 (2000)2026

Most influential descendants

Showing 5 of 41 · See all

K970292IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone ScrewInfluence, Inc. · 1997 · cites it directly40descendants
K972023Sleep-in Bone Screw SystemInfluence, Inc. · 1997 · 2 generations on23descendants
K981677Repose Bone Screw SystemInfluence, Inc. · 1999 · 2 generations on16descendants
K101060Siesta Medical, Inc., Prelude Tongue Suspension SystemSiesta Medical, Inc. · 2010 · 3 generations on15descendants
K103179Prelude II Tounge Suspension SystemSiesta Medical, Inc. · 2010 · 4 generations on14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K953264	Questus Polyester Suture Soft Tissue Anchor System	Wrightmedicaltechnologyinc	1995	—
+1	K970292	IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw	Influence, Inc.	1997	1
+2	K972023	Sleep-in Bone Screw System	Influence, Inc.	1997	—
+2	K981677	Repose Bone Screw System	Influence, Inc.	1999	2
+3	K101060	Siesta Medical, Inc., Prelude Tongue Suspension System	Siesta Medical, Inc.	2010	—
+4	K103179	Prelude II Tounge Suspension System	Siesta Medical, Inc.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	3	0
1998	1	0
1999	2	0
2001	1	0
2002	2	0
2004	1	0
2006	2	0
2008	1	0
2009	1	0
2010	3	0
2011	3	0
2012	6	0
2013	2	0
2014	2	0
2018	2	0
2019	1	0
2020	2	0
2021	2	0
2022	1	0
2023	2	0
2024	1	0

FIG. 1 — Lineage of K953264, 1995–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 MBI? 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 MBI device

#1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (41)

See all 41

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

Number	Device	Applicant	Decided	Descendants
K970292	IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw	Influence, Inc.	1997	40

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, K970292 (Influence, Inc., 1997) has gone furthest, with 40 descendants of its own.

How does its category compare?

All MBI devices

MBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MBI

27in 2025

2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007high 107 (2021) · low 30 (2024)2026

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

Recalls per year · MBI

1in 2025

2007high 24 (2007) · low 0 (2014)2026

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

Adverse event reports per year · MBI

3,826in 2025

2007high 3,826 (2025) · low 240 (2007)2025

MAUDE reports naming product code MBI, 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	16	80	24	240
2008	10	69	6	338
2009	19	82	2	355
2010	17	76	3	291
2011	30	75	23	328
2012	24	94	6	371
2013	31	100	2	442
2014	23	101	0	504
2015	23	85	0	507
2016	17	94	0	795
2017	17	70	4	675
2018	16	91	2	1,072
2019	31	90	0	1,303
2020	35	83	1	1,454
2021	18	107	0	1,890
2022	19	64	0	1,591
2023	52	57	1	2,503
2024	22	30	1	3,779
2025	27	58	1	3,826
2026	30	63	0	—

https://510kreport.com/device/K953264 · printed Nov 4, 2026

Cite this page

510(k) Report. “K953264: Questus Polyester Suture Soft Tissue Anchor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953264

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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