510(k) Report

510(k) · Cleared

Cleared

Stabilizer Soft Tissue Anchor Model Number TA1005, TA1008, Anchor Inserter/Suture Organizer Model Numbers AI1005, AI1008

K965111510(k) TraditionalCleared Feb 18, 199760-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 Feb 18, 1997 after a 60-day review. The FDA summary names its predicate without a number.

Decided
Feb 18, 1997
Review
60 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K965111Source: FDA 510(k) database · How lineage is built

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

TypeNumberDeviceApplicantDecidedRecalls
*—Mitek Superanchor™
Named without a submission number
—

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.

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

2007: 162008: 102009: 192010: 172011: 302012: 242013: 312014: 232015: 232016: 172017: 172018: 162019: 312020: 352021: 182022: 192023: 522024: 222025: 272026 (partial year): 30
2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007: 80 days median2008: 69 days median2009: 82 days median2010: 76 days median2011: 75 days median2012: 94 days median2013: 100 days median2014: 101 days median2015: 85 days median2016: 94 days median2017: 70 days median2018: 91 days median2019: 90 days median2020: 83 days median2021: 107 days median2022: 64 days median2023: 57 days median2024: 30 days median2025: 58 days median2026 (partial year): 63 days median
2007high 107 (2021) · low 30 (2024)2026

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

Recalls per year · MBI

1in 2025

2007: 242008: 62009: 22010: 32011: 232012: 62013: 22017: 42018: 22020: 12023: 12024: 12025: 1
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

2007: 2402008: 3382009: 3552010: 2912011: 3282012: 3712013: 4422014: 5042015: 5072016: 7952017: 6752018: 1,0722019: 1,3032020: 1,4542021: 1,8902022: 1,5912023: 2,5032024: 3,7792025: 3,826
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007168024240
200810696338
200919822355
201017763291
2011307523328
201224946371
2013311002442
2014231010504
201523850507
201617940795
201717704675
2018169121,072
2019319001,303
2020358311,454
20211810701,890
2022196401,591
2023525712,503
2024223013,779
2025275813,826
202630630—

What is it indicated for?

The Stabilizer Soft Tissue Anchor is intended for use with USP Sutures as an attachment means for soft tissue and bone for the indications listed below: Shoulder 1. Bankart repair 2. SLAP lesion repair 3. Acromioclavicular separation 4. Rotator cuff repair 5. Capsule shift\capsulolabral reconstruction 6. Biceps tenodesis 7. Deltoid repair Elbow 1. Tennis elbow repair 2. Biceps tendon reattachment 3. Medial and lateral repairs Knee 1. Extra-capsular…

Read the full statement (112 words)

The Stabilizer Soft Tissue Anchor is intended for use with USP Sutures as

an attachment means for soft tissue and bone for the indications listed

below:

Shoulder

1. Bankart repair

2. SLAP lesion repair

3. Acromioclavicular separation

4. Rotator cuff repair

5. Capsule shift\capsulolabral reconstruction

6. Biceps tenodesis

7. Deltoid repair

Elbow

1. Tennis elbow repair

2. Biceps tendon reattachment

3. Medial and lateral repairs

Knee

1. Extra-capsular repairs and attachment of:

- medial collateral ligament

- lateral collateral ligament

- posterior oblique ligament

and joint capsule to tibia

2. Extra-capsular reconstruction, ITB tenodesis

3. Patellar ligament and tendon avulsions repairs

Ankle

1. Lateral instability

2. Medial instability

3. Achilles tendon repair/reconstruction

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from R. Thomas Grotz, M.D., Inc.

4 FDA decisions under this applicant name. See the company

  • K984200Stabilizer Soft Tissue Anchor, 5 and 8MM; Anchor Inserter, 5 and 8MM; Stabilizer Drill, 5 and 8MM…R. Thomas Grotz, M.D., Inc. · 1999
  • K973031Stabilizer Soft Tissue Anchor 5MM Model TA1005, Anchor Inserter/Suture Organizer 5MM AI1005, Stabilizer…R. Thomas Grotz, M.D., Inc. · 1997
  • K964927Stabilizer Soft Tissue Anchor, 8MM Model TA1008, Anchor Inserter/Suture Organizer, 8MM Model AI1008…R. Thomas Grotz, M.D., Inc. · 1997

Recent decisions in MBI

The MBI category page

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K263352TeKBrace Knotless AnchorTheraMicro · 2026
  • K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc. · 2026
  • K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc. · 2026
  • K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026

https://510kreport.com/device/K965111 · printed Nov 5, 2026

Cite this page

510(k) Report. “K965111: Stabilizer Soft Tissue Anchor Model Number TA1005, TA1008, Anchor Inserter/Suture Organizer Model Numbers AI1005, AI1008.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K965111

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026