# K971036: Odontit Autogenous Bone Collection Device

- Pathway: 510(k) (Traditional)
- Applicant: Interpore Intl.
- Decided: Jun 3, 1997 after 75 days
- Product code: GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered)
- Device class: 1
- Regulation: 21 CFR 878.4680
- 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 K822065 (1982). 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)
- K822065: Kam Sucker, The Anspach Effort, Inc. (1982) Summary page 1.

## Most influential descendants
- K973248: Imtec Bone Collector System (1997), 0 descendants of its own

## Indications for use
The Odontit Autogenous Bone Collection Device is indicated for use as an aspirator for the removal and collection of blood, autogenous bone chips, or other extraneous fluids from a surgical site. Using a vacuum source, the Odontit aspirator will remove materials (including blood, bone chips and other fluids) from the surgical site and pass them through a stainless steel screen which is designed to capture and collect autogenous bone. At the option of the surgeon, this bone may be removed from the aspirator, washed and cleansed as necessary, and returned to the same patient as an autogenous bone graft. The capacity for bone collection in the screen is approximately 16 cc.

Source page: https://510kreport.com/device/K971036
Methodology: https://510kreport.com/methodology