# K965111: Stabilizer Soft Tissue Anchor Model Number TA1005, TA1008, Anchor Inserter/Suture Organizer Model Numbers AI1005, AI1008

- Pathway: 510(k) (Traditional)
- Applicant: R. Thomas Grotz, M.D., Inc.
- Decided: Feb 18, 1997 after 60 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Mitek Superanchor™: named in the summary without a submission number

## Indications for use
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

Source page: https://510kreport.com/device/K965111
Methodology: https://510kreport.com/methodology