# K960711: Acumed Bone Graft System

- Pathway: 510(k) (Traditional)
- Applicant: Acu Med, Inc.
- Decided: May 7, 1996 after 76 days
- Product code: KIJ (Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment)
- Device class: 1
- Regulation: 21 CFR 878.4820
- Recalls of this device: 2 (0 Class I)
- 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) Wright Medical Technology’s Precision Bone Grafting System: named in the summary without a submission number

## Recalls of this device
- Feb 14, 2008 · Not classified · Z-2119-2008: Product sterility may be compromised.
- Feb 14, 2008 · Not classified · Z-2118-2008: Product sterility may be compromised.

Source page: https://510kreport.com/device/K960711
Methodology: https://510kreport.com/methodology