510(k) · Cleared

Cleared

Stabilizer Soft Tissue Anchor, 5 and 8MM; Anchor Inserter, 5 and 8MM; Stabilizer Drill, 5 and 8MM, Nonsterile; Stabilize

K984200510(k) TraditionalCleared Jan 21, 199958-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

R. Thomas Grotz, M.D., Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Jan 21, 1999 as substantially equivalent to K964927 (R. Thomas Grotz, M.D., Inc., 1997) and 1 other predicate after a 58-day review. Its family tree reaches back 2 generations to 1997.

Decided: Jan 21, 1999
Review: 58 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K964927 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK964927 Stabilizer Soft Tissue Anchor, 8MM Model TA1008, Anchor…R. Thomas Grotz, M.D., Inc. · 1997
1 generation backK973031 Stabilizer Soft Tissue Anchor 5MM Model TA1005, Anchor…R. Thomas Grotz, M.D., Inc. · 1997
This deviceK984200 Stabilizer Soft Tissue Anchor, 5 and 8MM; Anchor Inserter, 5 and…R. Thomas Grotz, M.D., Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K964927	Stabilizer Soft Tissue Anchor, 8MM Model TA1008, Anchor Inserter/Suture…	R. Thomas Grotz, M.D., Inc.	1997	—
−1	K973031	Stabilizer Soft Tissue Anchor 5MM Model TA1005, Anchor Inserter/Suture…	R. Thomas Grotz, M.D., Inc.	1997	—
0 (this device)	K984200	Stabilizer Soft Tissue Anchor, 5 and 8MM; Anchor Inserter, 5 and 8MM…	R. Thomas Grotz, M.D., Inc.	1999	—

FIG. 1 — Lineage of K984200, 1997–1999Source: 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? (3)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K964927	Stabilizer Soft Tissue Anchor, 8MM Model TA1008, Anchor Inserter/Suture Organizer, 8MM… Summary page 1 …tissue Common/Usual Name: Soft Tissue Anchor Proprietary Name: Stabilizer™ Soft Tissue Anchor PREDICATE DEVICES Stabilizer Soft Tissue Anchors cleared under 510(k)'s 964927 and 973031, and Mitek Ligament Anchor manufactured by Mitek Surgical Products, Inc. [510(k) K92670). DEVICE DESCRIPTION The Sta…	R. Thomas Grotz, M.D., Inc.	1997	—
*	K973031	Stabilizer Soft Tissue Anchor 5MM Model TA1005, Anchor Inserter/Suture Organizer 5MM… Summary page 1 …mon/Usual Name: Soft Tissue Anchor Proprietary Name: Stabilizer™ Soft Tissue Anchor PREDICATE DEVICES Stabilizer Soft Tissue Anchors cleared under 510(k)'s 964927 and 973031, and Mitek Ligament Anchor manufactured by Mitek Surgical Products, Inc. [510(k) K92670). DEVICE DESCRIPTION The Stabilizer Sof…	R. Thomas Grotz, M.D., Inc.	1997	—
Kept off the family tree	K092670	FDA’s K092670 is Biodrive Micro Screw System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Ebi,Llc D/B/A Biomet Trauma	2009	—

Also cleared against K964927: 1 other device →

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?

The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 1.2 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K964927.

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 Stabilizer Soft Tissue Anchor is a titanium alloy implant intended for use with or without USP Sutures as an attachment means for soft tissue and bone in Anterior Cruciate Ligament (ACL) repair or reconstruction. Stabilizer instruments must be used to install the Stabilizer Soft Tissue Anchor.

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/K984200 · printed Nov 5, 2026

Cite this page

510(k) Report. “K984200: Stabilizer Soft Tissue Anchor, 5 and 8MM; Anchor Inserter, 5 and 8MM; Stabilizer Drill, 5 and 8MM, Nonsterile; Stabilize.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984200

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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