510(k) · Cleared

Recalled · 2005

Metrx System

K993021510(k) TraditionalCleared Nov 10, 199963-day reviewClass II21 CFR 888.1100Recalls 3

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

Surgical Navigation Technologies, Inc. · HRX Arthroscope

Cleared on Nov 10, 1999 as substantially equivalent to K943356 (Danek Medical, Inc., 1995) and 2 other predicates after a 63-day review. Its family tree reaches back 1 generation to 1995. It has been recalled 3 times.

Decided: Nov 10, 1999
Review: 63 days
Class: Class II
Product code: HRX
Recalls: 3
Predicates: 3

Its longest line of descent runs back 1 generation to K943356 (1995). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK943356 Inclusive EndoscopeDanek Medical, Inc. · 1995
This deviceK993021 Metrx SystemSurgical Navigation Technologies, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K943356	Inclusive Endoscope	Danek Medical, Inc.	1995	—
0 (this device)	K993021	Metrx System	Surgical Navigation Technologies, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	2	0

FIG. 1 — Lineage of K993021, 1995–1999Source: 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
#3 Held for the reportin the report

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What was it cleared against? (3)

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
*	K943356	Inclusive Endoscope Summary page 1 …e: Arthroscope Classification name: Arthroscope and Accessories (HRX per 21 CFR 888.1100) III. The above device is substantially equivalent to the Endoscopes cleared in K943356, K946087, and K955471. This submission describes a change to the indications for use and minor design changes. IV. This submissi…	Danek Medical, Inc.	1995	—
*	K946087	Inclusice II (TM) Endoscope Summary page 1 …scope Classification name: Arthroscope and Accessories (HRX per 21 CFR 888.1100) III. The above device is substantially equivalent to the Endoscopes cleared in K943356, K946087, and K955471. This submission describes a change to the indications for use and minor design changes. IV. This submission descri…	Sofamor Danek USA,Inc.	1995	—
*	K955471	Incl Endoscope Summary page 1 …ication name: Arthroscope and Accessories (HRX per 21 CFR 888.1100) III. The above device is substantially equivalent to the Endoscopes cleared in K943356, K946087, and K955471. This submission describes a change to the indications for use and minor design changes. IV. This submission describes a modific…	Sofamor Danek USA,Inc.	1995	—

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 20, 2005	Not classified	Z-0991-05	Package design/selection	The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.
Jun 20, 2005	Not classified	Z-0992-05	Package design/selection	The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.
Jun 20, 2005	Not classified	Z-0993-05	Package design/selection	The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 3 ancestors has a recall.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 METRx™ Endoscope is indicated for visualization of herniated disc material, visualization of the circumferential decompression of the nerve roots, and aiding in the search and removal of nucleus material. It is intended for use in the lumbar spine. The endoscope is also indicated for use in the knee, shoulder, wrist and temporomandibular joint (TMJ).

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/K993021 · printed Nov 4, 2026

Cite this page

510(k) Report. “K993021: Metrx System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993021

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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