# K972480: 3I Bioresorbable Fixation Tack

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Dec 23, 1997 after 175 days
- Product code: DZL (Screw, Fixation, Intraosseous)
- Device class: 2
- Regulation: 21 CFR 872.4880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Instrument Makar, Inc. “Biologically Quiet Screw”: named in the summary without a submission number
- (no number) W. Lorenz “LactoSorb Resorbable Craniomaxillofacial Fixation”: named in the summary without a submission number
- (no number) WL Gore & Associates “Resolut” Membrane: named in the summary without a submission number
- (no number) Linvatec Corporation “Bio-Anchor”: named in the summary without a submission number
- (no number) Mitek “GLS”: named in the summary without a submission number

## Most influential descendants
- K982951: Imtec Biopin (1999), 0 descendants of its own

## Indications for use
The 3i Bioresorbable Fixation Tack is indicated for use as a means of membrane fixation in Guided Bone Regeneration (GBR) procedures.

Source page: https://510kreport.com/device/K972480
Methodology: https://510kreport.com/methodology