# K040919: Nucleotome Probe Set, Model 21200

- Pathway: 510(k) (Traditional)
- Applicant: Clarus Medical, LLC
- Decided: Jun 1, 2004 after 54 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922881 (1992). 18 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032473: Dekompressor Percutaneous Discectomy Probe, Stryker Instruments (2003) Summary page 1.
- K844131: Nucleotome, Medical Instrument Development Laboratories, Inc. (1984) Summary page 1.
- K902778: Surgical Dynamics Nucleotome II Tissue Aspir/Cuter, Surgical Dynamics, Inc. (1990) Summary page 1.
- K913145: Nucleotome Tissue Aspirator/Cutter, Surgical Dynamics, Inc. (1991) Summary page 1.
- K914282: Nucleotome (R) II (VERSION2) Tissue Aspira/Cutter, Surgical Dynamics, Inc. (1991) Summary page 1.
- K923525: Nucleotome 3.5 MM Automated Percutaneous Lumbar, Surgical Dynamics, Inc. (1993) Summary page 1.
- K931109: Nucleotome E Kit, Surgical Dynamics, Inc. (1994) Summary page 1.
- K942987: Nucleotome L Kit, Surgical Dynamics, Inc. (1995) Summary page 1.
- K011454: Spine Scope, Model 2180, Clarus Medical, LLC (2001) Summary page 1.
- K040424: Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy Kit, Model 1120, Clarus Medical, LLC (2004). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K062038: X-Sten Mild Tool Kit, Model MTK-0001 (2006), 14 descendants of its own
- 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

## Recalls of this device
- Feb 5, 2010 · Not classified · Z-1795-2010: Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.

## Indications for use
The Clarus Model 21200 Nucleotome Probe Set is indicated for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine.

Source page: https://510kreport.com/device/K040919
Methodology: https://510kreport.com/methodology