# K062038: X-Sten Mild Tool Kit, Model MTK-0001

- Pathway: 510(k) (Traditional)
- Applicant: X-Sten Corp.
- Decided: Dec 19, 2006 after 153 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
Longest line of descent: 4 generations back to K922881 (1992). 37 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053267: Endius Atavi System, Endius, Inc. (2006) Summary page 1.
- K022578: Endius Flextip Blade, Endius, Inc. (2002) Summary page 1.
- K991794: Endoscopic Spinal Access System, Endius, Inc. (1999) Summary page 1.
- K983144: Flexposure Retractor, Endius, Inc. (1999) Summary page 1.
- K052241: Disc-FX System, Ellman International, Inc. (2006) Summary page 1.
- K043602: Quadrant Retractor System, Medtronic Sofamor Danek (2005) Summary page 1.
- K002931: Metrx System, Medtronic Sofamor Danek, Inc. (2000) Summary page 1.
- K040919: Nucleotome Probe Set, Model 21200, Clarus Medical, LLC (2004) Summary page 1.
- K032473: Dekompressor Percutaneous Discectomy Probe, Stryker Instruments (2003) Summary page 1.
- K002008: Surgical Dynamics Spinal Retractor, United States Surgical, A Division of Tyco Healthc (2000) Summary page 1.
- K992898: The Bright Medical Dilation Retractor System, Bright Medical Instruments (1999) Summary page 1.

## Cited in the summary but kept off the family tree
- K041123: Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703, Kerberos Proximal Solutions, Inc. (2004). Our reading of the summary gave K041123, FDA’s number for Rinspiration System,Rinspiration System Short Tip, Models… (Kerberos Proximal Solutions, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “HydroCision AthroJet Resector XT”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K093062: Vertos Medical Mild Device Kit (2010), 13 descendants of its own
- K180876: DTRAX Spinal System (2018), 7 descendants of its own
- K190201: CORUS Spinal System (2019), 6 descendants of its own
- K212636: CORUS Spinal System-X (2021), 5 descendants of its own
- K240625: CORUS Navigation Access System (2024), 4 descendants of its own

## Indications for use
The X-Sten MILD Tool Kit is a set of specialized surgical instruments intended to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions.

Source page: https://510kreport.com/device/K062038
Methodology: https://510kreport.com/methodology