510(k) · Cleared

Cleared

Conmed Linvatec Smart Guard Irrigator

K070233510(k) SpecialCleared Apr 2, 200767-day reviewClass II21 CFR 888.1100

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

Cleared on Apr 2, 2007 as substantially equivalent to K971059 (Linvatec Corp., 1997) and 3 other predicates after a 67-day review. Its family tree reaches back 4 generations to 1986.

Decided: Apr 2, 2007
Review: 67 days
Class: Class II
Product code: HRX
Recalls: None
Predicates: 4

Its longest line of descent runs back 4 generations to K862807 (1986). 10 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
3 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
2 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
1 generation backK060260 Micropower Hand Piece High Speed DrillLinvatec Corp. · 2006
This deviceK070233 Conmed Linvatec Smart Guard IrrigatorConmed Linvatec · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K862807	Treace Drill System	Treace Medical, Inc.	1986	—
−3	K964548	Apex Universal Drive System	Linvatec Corp.	1997	—
−2	K971059	Universal Drive System	Linvatec Corp.	1997	—
−1	K060260	Micropower Hand Piece High Speed Drill	Linvatec Corp.	2006	—
0 (this device)	K070233	Conmed Linvatec Smart Guard Irrigator	Conmed Linvatec	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	2	0
1995	2	0
2006	2	0

FIG. 1 — Lineage of K070233, 1986–2007Source: 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 HRX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HRX device

#1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
#2 Held for the reportin 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	Applicant	Decided	Recalls
*	K971059	Universal Drive System Summary page 1 …ame: Universal Drive System 2. Company name: Linvatec Corporation 3. 51 0(k) 4: K971 059 This 51 0(k) also includes the modified devices cleared in Special 51 0(k) #s: K0601 98, MicroPower Handpiece Medium…	Linvatec Corp.	1997	—
*	K060198	Micropower Hand Piece : Medium Speed Drill, Saggital Saw, Reciprocating Saw, and… Summary page 1 …invatec Corporation 3. 51 0(k) 4: K971 059 This 51 0(k) also includes the modified devices cleared in Special 51 0(k) #s: K0601 98, MicroPower Handpiece Medium Speed Drill K060260, MicroPower Handpiece High Speed Drill; and K060270, MicroPower Handpiece Or…	Linvatec Corp.	2006	—
*	K060260	Micropower Hand Piece High Speed Drill Summary page 1 …K971 059 This 51 0(k) also includes the modified devices cleared in Special 51 0(k) #s: K0601 98, MicroPower Handpiece Medium Speed Drill K060260, MicroPower Handpiece High Speed Drill; and *K060270, MicroPower Handpiece Oral Max High Speed Drill. E. Device Descript…	Linvatec Corp.	2006	—
*	K060270	Micropower Hand Piece: Oral Max High Speed Drill Summary page 1 …includes the modified devices cleared in Special 51 0(k) #s: K0601 98, MicroPower Handpiece Medium Speed Drill K060260, MicroPower Handpiece High Speed Drill; and *K060270, MicroPower Handpiece Oral Max High Speed Drill. E. Device Description The descriptions of the handpiece proposed…	Linvatec Corp.	2006	—

Also cleared against K971059: 10 other devices →

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 21 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
1 of the 10 ancestors has a recall of any class.
10 other devices also cite its predicate K971059.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · HRX

9in 2025

2007high 12 (2013) · low 3 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRX

107in 2025

2007high 249 (2023) · low 45 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRX

1in 2024

2007high 23 (2009) · low 0 (2012)2026

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

Adverse event reports per year · HRX

2,076in 2025

2007high 2,427 (2024) · low 421 (2007)2025

MAUDE reports naming product code HRX, 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	7	89	3	421
2008	9	115	13	441
2009	11	139	23	558
2010	9	114	12	612
2011	3	84	6	631
2012	11	102	0	778
2013	12	90	4	678
2014	9	140	0	802
2015	4	132	7	763
2016	8	89	0	469
2017	4	97	0	934
2018	12	101	1	1,581
2019	12	45	0	1,676
2020	7	141	0	1,706
2021	7	57	3	1,908
2022	3	89	0	1,406
2023	4	249	0	1,852
2024	6	110	1	2,427
2025	9	107	0	2,076
2026	7	217	0	—

What is it indicated for?

The Hall®Smart Guard® Irrigator is an accessory to a powered instrument system consisting of drills, saws and associated handpieces to perform the cutting of soft tissue and bone. The fields of application include: orthopedic, arthroscopic, neurosurgical, otolaryngological, plastic/reconstructive and oral/maxillofacial procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070233 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070233: Conmed Linvatec Smart Guard Irrigator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070233

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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