510(k) · Cleared

Cleared

Powerpro Battery System

K012320510(k) TraditionalCleared Oct 19, 200188-day reviewClass I21 CFR 878.4820

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Linvatec Corp. · HAB Saw, Powered, And Accessories

Cleared on Oct 19, 2001 after an 88-day review. The FDA summary names its predicate without a number.

Decided: Oct 19, 2001
Review: 88 days
Class: Class I
Product code: HAB
Recalls: None
Predicates: 0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K012320Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HAB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Recalls
*	—	PowerPro™ Electric System Named without a submission number	—
*	—	Advantage™ System Named without a submission number	—
*	—	Synthes® Power Drive System Named without a submission number	—
*	—	Allegiance Genesis™ Container System Named without a submission number	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All HAB devices

HAB Saw, Powered, And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HAB

FDA has decided no HAB device since 2007.

Median 510(k) review, days · HAB

Too few HAB 510(k)s in any year since 2007 to give a median.

Recalls per year · HAB

1in 2018

2007high 3 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HAB

476in 2025

2007high 1,719 (2021) · low 1 (2007)2025

MAUDE reports naming product code HAB, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	1
2008	—	3	2
2009	—	0	4
2010	—	0	28
2011	—	2	76
2012	—	0	117
2013	—	0	181
2014	—	1	133
2015	—	2	485
2016	—	1	358
2017	—	0	1,363
2018	—	1	681
2019	—	0	676
2020	—	0	1,462
2021	—	0	1,719
2022	—	0	387
2023	—	0	734
2024	—	0	746
2025	—	0	476
2026	—	0	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012320 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012320: Powerpro Battery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012320

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Page last updated Nov 3, 2026