# K970040: Spine-Tech Bone Harvester

- Pathway: 510(k) (Traditional)
- Applicant: Spine-Tech, Inc.
- Decided: Feb 28, 1997 after 53 days
- Product code: HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment)
- Device class: 1
- Regulation: 21 CFR 878.4820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Acumed Bone Graft System: named in the summary without a submission number

## Indications for use
The Spine-Tech Bone Harvester is indicated for the cutting and collection of morselized autogenous bone graft from the anterior or posterior iliac crest, tibia or femur. This device is intended to cut and collect finely morselized autogenous bone graft for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects. These procedures include; spinal fusion, joint arthrodesis, total joint replacement, fracture repair, maxillofacial reconstruction and tumor removal. All components of the Spine-Tech Bone Harvested are intended for single use only.

Source page: https://510kreport.com/device/K970040
Methodology: https://510kreport.com/methodology