# K960914: 3I Osseous Fixation System (S)

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Apr 4, 1996 after 29 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- 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 K952167 (1995). 2 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955369: Memfix, The Straumann Co. (1996) Summary page 4.
- K952167: Imz Bone Tack System, Interpore Intl. (1995) Summary page 4.

## Most influential descendants
- K011698: Straumann GBR System (2001), 12 descendants of its own
- K050669: Jeil Bone Fixation System (2005), 8 descendants of its own
- K063769: Alpha Bio Bone Fixation Screw System (2007), 4 descendants of its own
- K141764: Tristar Bone Graft Fixation System (2014), 3 descendants of its own
- K170697: GBR system (2018), 2 descendants of its own

## Indications for use
NON-RESORBABLE MEMBRANE FIXATION FOR ENDOSSEOUS DENTAL IMPLANT AND/OR GUIDED TISSUE REGENERATION PROCEDURES, USING OSSEOUS FIXATION (PLATE AND SCREW) SYSTEMS.

Source page: https://510kreport.com/device/K960914
Methodology: https://510kreport.com/methodology