# K964927: Stabilizer Soft Tissue Anchor, 8MM Model TA1008, Anchor Inserter/Suture Organizer, 8MM Model AI1008, Stabilizer Drill, 8

- Pathway: 510(k) (Traditional)
- Applicant: R. Thomas Grotz, M.D., Inc.
- Decided: Feb 7, 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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 Ligament Anchor: named in the summary without a submission number

## Most influential descendants
- K973031: Stabilizer Soft Tissue Anchor 5MM Model TA1005, Anchor Inserter/Suture Organizer 5MM AI1005, Stabilizer Drill 5MM Nonste (1997), 1 descendant of its own
- K984200: Stabilizer Soft Tissue Anchor, 5 and 8MM; Anchor Inserter, 5 and 8MM; Stabilizer Drill, 5 and 8MM, Nonsterile; Stabilize (1999), 0 descendants of its own

## Indications for use
The Stabilizer Soft Tissue Anchor is a 316L stainless steel implant intended for use with 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.

Source page: https://510kreport.com/device/K964927
Methodology: https://510kreport.com/methodology