510(k) · Cleared

Cleared

Smarto

K163308510(k) SpecialCleared Dec 27, 201634-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

Jeil Medical Corporation · KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Cleared on Dec 27, 2016 as substantially equivalent to K101563 (Jeil Medical Corporation, 2010) after a 34-day review. Its family tree reaches back 2 generations to 1994.

Decided: Dec 27, 2016
Review: 34 days
Class: Class I
Product code: KIJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K933101 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK933101 The Osteomed B Power System and AccessoriesOsteomed Corp. · 1994
1 generation backK101563 SmartoJeil Medical Corporation · 2010
This deviceK163308 SmartoJeil Medical Corporation · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K933101	The Osteomed B Power System and Accessories	Osteomed Corp.	1994	—
−1	K101563	Smarto	Jeil Medical Corporation	2010	—
0 (this device)	K163308	Smarto	Jeil Medical Corporation	2016	—

FIG. 1 — Lineage of K163308, 1994–2016Source: FDA 510(k) summaries, read by 510(k) Report · 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 KIJ? 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? (1)

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	Applicant	Decided	Recalls
*	K101563	Smarto Summary page 4 …dentification of Predicate Device(s) [21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follow; • 510(k) Number: K101563 • Applicant: Jeil Medical Corporation • Common Name: Surgical motor unit for surgery • Device Nam…	Jeil Medical Corporation	2010	—

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.

What does this lineage say?

The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 16.1 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All KIJ devices

KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · KIJ

1in 2016

2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KIJ

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

Recalls per year · KIJ

10in 2008

2007high 10 (2008) · low 0 (2007)2026

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

Adverse event reports per year · KIJ

4in 2025

2007high 1,080 (2011) · low 0 (2021)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	10
2008	0	—	10	4
2009	0	—	0	265
2010	1	—	0	424
2011	0	—	0	1,080
2012	1	—	0	615
2013	0	—	0	288
2014	0	—	0	36
2015	0	—	0	36
2016	1	—	0	11
2017	0	—	0	1
2018	0	—	0	1
2019	0	—	0	1
2020	0	—	0	1
2021	0	—	0	0
2022	0	—	0	4
2023	0	—	0	6
2024	0	—	0	8
2025	0	—	0	4
2026	0	—	0	—

What is it indicated for?

The SMARTO is intended for use in driving screws, and drilling in conjunction with craniofacial (does not include

oromaxillofacial applications), craniotomnies, hand, foot, wrist and extremity reconstruction surgical procedures. It is supplied sterile and single use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K163308 · printed Nov 4, 2026

Cite this page

510(k) Report. “K163308: Smarto.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163308

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026