510(k) · Cleared

Cleared

Midas Rex Curved Bur

K072315510(k) SpecialCleared Sep 18, 200729-day reviewClass II21 CFR 882.4310

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

Medtronic Powered Surgical Solutions · HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)

Cleared on Sep 18, 2007 as substantially equivalent to K020069 (Medtronic Midas Rex, 2002) after a 29-day review. Its family tree reaches back 1 generation to 2002. 13 later devices descend from it.

Decided: Sep 18, 2007
Review: 29 days
Class: Class II
Product code: HBE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K020069 (2002). 13 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK020069 Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High…Medtronic Midas Rex · 2002 · Recalled
This deviceK072315 Midas Rex Curved BurMedtronic Powered Surgical Solutions · 2007
Descendant · cites it directly · 11 of its ownK170312 IPC systems, Legend EHS handpieces and Legend Stylus Touch…Medtronic Powered Surgical Solutions · 2017
Descendant · cites it directly · 10 of its ownK163182 Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill…Medtronic Powered Surgical Solutions · 2017
Descendant · 2 generations on · 4 of its ownK191597 Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc. · 2019 · Recalled
Descendant · 2 generations on · 4 of its ownK183515 MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions · 2019
Descendant · 3 generations on · 3 of its ownK183644 Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions · 2019

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2017high 3 (2019) · low 0 (2018)2026

Most influential descendants

Showing 5 of 13 · See all

K170312IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw…Medtronic Powered Surgical Solutions · 2017 · cites it directly11descendants
K163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating…Medtronic Powered Surgical Solutions · 2017 · cites it directly10descendants
K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc. · 2019 · 2 generations on4descendants
K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions · 2019 · 2 generations on4descendants
K183644Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions · 2019 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K020069	Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System…	Medtronic Midas Rex	2002	9
0 (this device)	K072315	Midas Rex Curved Bur	Medtronic Powered Surgical Solutions	2007	—
+1	K170312	IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw…	Medtronic Powered Surgical Solutions	2017	—
+1	K163182	Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System…	Medtronic Powered Surgical Solutions	2017	—
+2	K191597	Stealth Autoguide System, Midas Rex Legend Depth Stop System	Medtronic Navigation, Inc.	2019	1
+2	K183515	MR8 Drill System, Midas Rex MR8 ClearView Tools	Medtronic Powered Surgical Solutions	2019	—
+3	K183644	Stealth-Midas MR8 System	Medtronic Powered Surgical Solutions	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	2	0
2019	3	0
2020	1	0
2021	2	0
2023	1	0
2024	2	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K072315, 2002–2026Source: 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 HBE? 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 HBE device

#1 K251433 Surgify Halo (54.085.SHD.H1); Surgify Halo…score 13.2 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin 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
*	K020069	Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend… Summary page 1 …(882.4310) Predicate Device Identification: Medtronic Midas Rex® Legend® Pneumatic High Speed System (K020069) Description: Midas Rex Curved Bur is a sterile, single use, one piece device which includes the dissection tool (bur head, bur w…	Medtronic Midas Rex	2002	9

Also cleared against K020069: 10 other devices →

What descends from it? (13)

See all 13

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K170312	IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw…	Medtronic Powered Surgical Solutions	2017	11
K163182	Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating…	Medtronic Powered Surgical Solutions	2017	10

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?

Its one ancestor has a recall.
Of its descendants, K170312 (Medtronic Powered Surgical Solutions, 2017) has gone furthest, with 11 descendants of its own.
10 other devices also cite its predicate K020069.

How does its category compare?

All HBE devices

HBE Drills, Burrs, Trephines & Accessories (Simple, Powered): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · HBE

6in 2025

2007high 6 (2021) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HBE

30in 2025

2007high 193 (2021) · low 30 (2025)2026

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

Recalls per year · HBE

1in 2024

2007high 47 (2008) · low 0 (2007)2026

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

Adverse event reports per year · HBE

1,924in 2025

2007high 1,924 (2025) · low 14 (2007)2025

MAUDE reports naming product code HBE, 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	2	—	0	14
2008	2	—	47	14
2009	0	—	7	242
2010	0	—	23	492
2011	2	—	1	1,013
2012	1	—	26	1,146
2013	1	—	4	1,583
2014	2	—	0	559
2015	3	155	0	483
2016	2	—	7	848
2017	2	—	3	848
2018	2	—	0	787
2019	5	133	0	836
2020	0	—	0	1,025
2021	6	193	1	1,047
2022	2	—	0	900
2023	2	—	3	948
2024	0	—	1	1,153
2025	6	30	0	1,924
2026	1	—	19	—

What is it indicated for?

The Midas Rex Curved Burs are intended for use in surgical procedures for the following medical applications: Neurosurgical; Spine; Ear, Nose and Throat (ENT), Orthopedic Surgery, and General and Plastic Surgery including Maxillofacial, Craniofacial and Sternotomy. The Curved bur will be used to cut and/or remove bone and biomaterial.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072315 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072315: Midas Rex Curved Bur.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072315

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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