# K973031: Stabilizer Soft Tissue Anchor 5MM Model TA1005, Anchor Inserter/Suture Organizer 5MM AI1005, Stabilizer Drill 5MM Nonste

- Pathway: 510(k) (Traditional)
- Applicant: R. Thomas Grotz, M.D., Inc.
- Decided: Nov 3, 1997 after 81 days
- Product code: MRI (Orthosis, Truncal/Orthosis, Limb)
- Device class: 1
- Regulation: 21 CFR 890.3490
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964927 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites 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)
- 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). Our OCR of the scanned summary read K964297, FDA’s number for N-Assay Tia C4 Test Kit (Crestat Diagnostics, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Stabilizer Soft Tissue Anchor, 8mm”.

## Cited in the summary but kept off the family tree
- K092670: Biodrive Micro Screw System, Ebi,Llc D/B/A Biomet Trauma (2009). Our OCR of the scanned summary read K092670, which FDA decided on Nov 19, 2009, after this device was decided (Nov 3, 1997), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree.

## Most influential descendants
- 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 stainless steel implant intended for use 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/K973031
Methodology: https://510kreport.com/methodology