# K984200: Stabilizer Soft Tissue Anchor, 5 and 8MM; Anchor Inserter, 5 and 8MM; Stabilizer Drill, 5 and 8MM, Nonsterile; Stabilize

- Pathway: 510(k) (Traditional)
- Applicant: R. Thomas Grotz, M.D., Inc.
- Decided: Jan 21, 1999 after 58 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
Longest line of descent: 2 generations back to K964927 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964927: Stabilizer Soft Tissue Anchor, 8MM Model TA1008, Anchor Inserter/Suture Organizer, 8MM Model AI1008, Stabilizer Drill, 8, R. Thomas Grotz, M.D., Inc. (1997) Summary page 1.
- K973031: Stabilizer Soft Tissue Anchor 5MM Model TA1005, Anchor Inserter/Suture Organizer 5MM AI1005, Stabilizer Drill 5MM Nonste, R. Thomas Grotz, M.D., Inc. (1997) Summary page 1.

## Cited in the summary but kept off the family tree
- K092670: Biodrive Micro Screw System, Ebi,Llc D/B/A Biomet Trauma (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
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.

Source page: https://510kreport.com/device/K984200
Methodology: https://510kreport.com/methodology