# K012320: Powerpro Battery System

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Oct 19, 2001 after 88 days
- Product code: HAB (Saw, Powered, And Accessories)
- 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) PowerPro™ Electric System: named in the summary without a submission number
- (no number) Advantage™ System: named in the summary without a submission number
- (no number) Synthes® Power Drive System: named in the summary without a submission number
- (no number) Allegiance Genesis™ Container System: named in the summary without a submission number

## Indications for use
The PowerPro™ Battery System functions as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone. The fields of application include orthopedic procedures such as osteotomies, small and large bone trauma, orthopedic reconstruction, and total joint replacement, neurosurgical fusion and plating procedures, and medial sternotomy. The PowerPro Battery System also includes a sterilization case to enclose the rechargeable batteries during sterilization, and also to maintain sterility of the batteries until used.

Source page: https://510kreport.com/device/K012320
Methodology: https://510kreport.com/methodology