510(k) · Cleared

Cleared

Ams Mainstay Urologic Bone Anchor

K971332510(k) TraditionalCleared Jul 9, 199790-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

American Medical Systems, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Jul 9, 1997 as substantially equivalent to K953531 (Howmedica Corp., 1995) after a 90-day review. Its family tree reaches back 1 generation to 1995.

Decided: Jul 9, 1997
Review: 90 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K953531 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK953531 Howmedica Mainstay AnchorHowmedica Corp. · 1995
This deviceK971332 Ams Mainstay Urologic Bone AnchorAmerican Medical Systems, Inc. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K953531	Howmedica Mainstay Anchor	Howmedica Corp.	1995	—
0 (this device)	K971332	Ams Mainstay Urologic Bone Anchor	American Medical Systems, Inc.	1997	—

FIG. 1 — Lineage of K971332, 1995–1997Source: 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 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

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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
*	K953531	Howmedica Mainstay Anchor Summary page 1 …one Appliance for Reconstruction of Bone to Soft Tissue Device Trade Name: AMS Mainstay™ Urologic Bone Anchor PREDICATE DEVICE Howmedica® Mainstay™ Soft Tissue Anchor K953531 DEVICE DESCRIPTION The AMS Mainstay™ Urologic Bone Anchor for bladder neck suspension procedures are titanium alloy implants. Th…	Howmedica Corp.	1995	—
†	K926384	Statak & Mini-Statak Soft Tissue Attachment Device	Zimmer, Inc.	1993	—

Also cleared against K953531: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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.
2 other devices also cite its predicate K953531.

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	—

What is it indicated for?

The AMS Mainstay™ Urologic Bone Anchor is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency

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/K971332 · printed Nov 5, 2026

Cite this page

510(k) Report. “K971332: Ams Mainstay Urologic Bone Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971332

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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