# K993021: Metrx System

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Navigation Technologies, Inc.
- Decided: Nov 10, 1999 after 63 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943356 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943356: Inclusive Endoscope, Danek Medical, Inc. (1995) Summary page 1.
- K946087: Inclusice II (TM) Endoscope, Sofamor Danek USA,Inc. (1995) Summary page 1.
- K955471: Incl Endoscope, Sofamor Danek USA,Inc. (1995) Summary page 1.

## Recalls of this device
- Jun 20, 2005 · Not classified · Z-0991-05: 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: 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: The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.

## Indications for use
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).

Source page: https://510kreport.com/device/K993021
Methodology: https://510kreport.com/methodology