# K032473: Dekompressor Percutaneous Discectomy Probe

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Nov 7, 2003 after 87 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 K844131 (1984). 9 ancestors in all.
28 later devices descend from it; 5 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013513: Dekompressor Percutaneous Lumbar Discectomy Probe, Pain Concepts, Inc. (2002)
- 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.
- K914282: Nucleotome (R) II (VERSION2) Tissue Aspira/Cutter, Surgical Dynamics, Inc. (1991) Summary page 1.
- K913145: Nucleotome Tissue Aspirator/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.
- K010811: Perc-D Spinewand, Arthrocare Corp. (2001)

## Most influential descendants
- K040919: Nucleotome Probe Set, Model 21200 (2004), 17 descendants of its own
- 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
- K090278: Enspire Debrider System (2009), 7 descendants of its own

## Recalls of this device
- Nov 4, 2013 · Class II · Z-0127-2014: Stryker has identified a potential for the auger and/or cannula to fracture when the Dekompressor is used contrary to the warnings in the Instructions For Use (IFU). Specifically, manually bending the
- Feb 3, 2011 · Not classified · Z-1829-2011: The firm received five complaints that the stylet did not fit down the cannula. The investigation revealed that the incorrect probe assembly was packaged for two DeKompressor part numbers with the lot
- Feb 3, 2011 · Not classified · Z-1830-2011: The firm received five complaints that the stylet did not fit down the cannula. The investigation revealed that the incorrect probe assembly was packaged for two DeKompressor part numbers with the lot

## Indications for use
The Dekompressor Percutaneous Discectomy Probe is intended 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/K032473
Methodology: https://510kreport.com/methodology