# K002931: Metrx System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Nov 24, 2000 after 65 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
82 later devices descend from it; 8 cite it directly.
1 of 83 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K022199: Endius Atavi System (2002), 43 descendants of its own
- K053267: Endius Atavi System (2006), 42 descendants of its own
- K072879: Innervue Diagnostic Scope System (2008), 30 descendants of its own
- K043602: Quadrant Retractor System (2005), 29 descendants of its own
- K061246: Endoscopic Spine System (2006), 25 descendants of its own

## Indications for use
The METRxTM Microscope is indicated for visualization of the surgical field in any area of the body cut open during a surgical procedure. When used in the cervial, thoracic, or lumbar spine either from an anterior or posterior direction, for example, the METRx Microscope and accessories are intended to aid the surgeon's visualization of the surgical area and allow him/her to perform any type of surgical spinal procedure such as herniated disc repair, visualization of the circumferential decompression of the nerve roots, aiding in the search and removal of nucleus material, spinal fusion, or insertion of spinal implants. Other examples of generic surgical use of the METRx Microscope would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TM7).

Source page: https://510kreport.com/device/K002931
Methodology: https://510kreport.com/methodology