510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Dekompressor Percutaneous Discectomy Probe

K032473510(k) TraditionalCleared Nov 7, 200387-day reviewClass II21 CFR 888.1100Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stryker Instruments · HRX Arthroscope

Cleared on Nov 7, 2003 as substantially equivalent to K013513 (Pain Concepts, Inc., 2002) and 8 other predicates after an 87-day review. Its family tree reaches back 1 generation to 1984. 28 later devices descend from it. It has been recalled 3 times.

Decided
Nov 7, 2003
Review
87 days
Class
Class II
Product code
HRX
Recalls
3
Predicates
9

Its longest line of descent runs back 1 generation to K844131 (1984). 9 ancestors in all. 28 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2001: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor1993: 1 other ancestor1991: 2 other ancestors1990: 1 other ancestor2004: 1 descendant cleared2006: 1 descendant cleared2018: 2 descendants cleared2009: 3 descendants cleared2014: 1 descendant cleared2010: 1 descendant cleared2011: 1 descendant cleared2012: 5 descendants cleared2021: 1 descendant cleared2024: 2 descendants cleared2013: 2 descendants cleared2019: 1 descendant cleared2025: 3 descendants cleared2026: 4 descendants clearedK844131 · Nucleotome · Medical Instrument Development Laboratories, Inc. · 198419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors 1 generation forward: 5 descendants2 generations forward: 4 descendants3 generations forward: 7 descendants4 generations forward: 8 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant K844131 · Nucleotome · Medical Instrument Development Laboratories, Inc. · 19840+5
  1. Root · 1 generation backK844131 NucleotomeMedical Instrument Development Laboratories, Inc. · 1984
  2. This deviceK032473 Dekompressor Percutaneous Discectomy ProbeStryker Instruments · 2003
  3. Descendant · cites it directly · 17 of its ownK040919 Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 2004 · Recalled
  4. Descendant · cites it directly · 14 of its ownK062038 X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006
  5. Descendant · 2 generations on · 13 of its ownK093062 Vertos Medical Mild Device KitX-Sten Corp. · 2010
  6. Descendant · 3 generations on · 7 of its ownK180876 DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018
  7. Descendant · cites it directly · 7 of its ownK090278 Enspire Debrider SystemSpine View, Inc. · 2009

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2004: 12006: 12009: 32010: 12011: 12012: 52013: 22014: 12018: 22019: 12021: 12024: 22025: 32026: 4
2004high 5 (2012) · low 0 (2005)2026

Most influential descendants

Showing 5 of 28 · See all
  • K040919Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 2004 · cites it directly17descendants
  • K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006 · cites it directly14descendants
  • K093062Vertos Medical Mild Device KitX-Sten Corp. · 2010 · 2 generations on13descendants
  • K180876DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018 · 3 generations on7descendants
  • K090278Enspire Debrider SystemSpine View, Inc. · 2009 · cites it directly7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K844131NucleotomeMedical Instrument Development Laboratories, Inc.1984—
0 (this device)K032473Dekompressor Percutaneous Discectomy ProbeStryker Instruments2003—
+1K040919Nucleotome Probe Set, Model 21200Clarus Medical, LLC20041
+1K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp.2006—
+2K093062Vertos Medical Mild Device KitX-Sten Corp.2010—
+3K180876DTRAX Spinal SystemProvidence Medical Technology, Inc.2018—
+1K090278Enspire Debrider SystemSpine View, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199120
199310
199410
199510
200110
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200610
200930
201010
201110
201250
201320
201410
201820
201910
202110
202420
202530
202640
FIG. 1 — Lineage of K032473, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HRX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HRX device

  1. #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (9)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K013513Dekompressor Percutaneous Lumbar Discectomy ProbePain Concepts, Inc.2002—
*K844131Nucleotome
Summary page 1
…o: Stryker DekompressorTMLumbar Discectomy Probe (KO135 13), Surgical Dynamics' Nucleotome Tissue Cutter/Aspirator (K844131, K902778, K914282, K913145, K923525, K931109, K942987), Arthrocare Perc-DTMSpinewandTMfamily (KO108 1 1)…
Medical Instrument Development Laboratories, Inc.1984—
*K902778Surgical Dynamics Nucleotome II Tissue Aspir/Cuter
Summary page 1
…Stryker DekompressorTMLumbar Discectomy Probe (KO135 13), Surgical Dynamics' Nucleotome Tissue Cutter/Aspirator (K844131, K902778, K914282, K913145, K923525, K931109, K942987), Arthrocare Perc-DTMSpinewandTMfamily (KO108 1 1) Device De…
Surgical Dynamics, Inc.1990—
*K914282Nucleotome (R) II (VERSION2) Tissue Aspira/Cutter
Summary page 1
…DekompressorTMLumbar Discectomy Probe (KO135 13), Surgical Dynamics' Nucleotome Tissue Cutter/Aspirator (K844131, K902778, K914282, K913145, K923525, K931109, K942987), Arthrocare Perc-DTMSpinewandTMfamily (KO108 1 1) Device Description…
Surgical Dynamics, Inc.1991—
*K913145Nucleotome Tissue Aspirator/Cutter
Summary page 1
…ssorTMLumbar Discectomy Probe (KO135 13), Surgical Dynamics' Nucleotome Tissue Cutter/Aspirator (K844131, K902778, K914282, K913145, K923525, K931109, K942987), Arthrocare Perc-DTMSpinewandTMfamily (KO108 1 1) Device Description: The…
Surgical Dynamics, Inc.1991—
*K923525Nucleotome 3.5 MM Automated Percutaneous Lumbar
Summary page 1
…bar Discectomy Probe (KO135 13), Surgical Dynamics' Nucleotome Tissue Cutter/Aspirator (K844131, K902778, K914282, K913145, K923525, K931109, K942987), Arthrocare Perc-DTMSpinewandTMfamily (KO108 1 1) Device Description: The Dekompres…
Surgical Dynamics, Inc.1993—
*K931109Nucleotome E Kit
Summary page 1
…ctomy Probe (KO135 13), Surgical Dynamics' Nucleotome Tissue Cutter/Aspirator (K844131, K902778, K914282, K913145, K923525, K931109, K942987), Arthrocare Perc-DTMSpinewandTMfamily (KO108 1 1) Device Description: The DekompressorTMis a…
Surgical Dynamics, Inc.1994—
*K942987Nucleotome L Kit
Summary page 1
…Surgical Dynamics' Nucleotome Tissue Cutter/Aspirator (K844131, K902778, K914282, K913145, K923525, K931109, K942987), Arthrocare Perc-DTMSpinewandTMfamily (KO108 1 1) Device Description: The DekompressorTMis a single use disposable discectom…
Surgical Dynamics, Inc.1995—
*K010811Perc-D SpinewandArthrocare Corp.2001—

What descends from it? (28)

See all 28

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K040919Nucleotome Probe Set, Model 21200Clarus Medical, LLC200417
K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp.200614
K090278Enspire Debrider SystemSpine View, Inc.20097
K141557Herniatome Percutaneous Disectomy Device - Cervical, Herniatome Percutaneous Disectomy…Gallini Medical Devices, Srl20141
K180315DiskomBiopsybell S.R.L.20180

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 4, 2013Class IIZ-0127-2014Device DesignStryker 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 cannula can weaken the device and may…
Feb 3, 2011Not classifiedZ-1829-2011OtherThe 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 number of 10214012.
Feb 3, 2011Not classifiedZ-1830-2011OtherThe 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 number of 10214012.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 9 ancestors has a recall.
  • Of its descendants, K040919 (Clarus Medical, LLC, 2004) has gone furthest, with 17 descendants of its own.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRX

9in 2025

2007: 72008: 92009: 112010: 92011: 32012: 112013: 122014: 92015: 42016: 82017: 42018: 122019: 122020: 72021: 72022: 32023: 42024: 62025: 92026 (partial year): 7
2007high 12 (2013) · low 3 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRX

107in 2025

2007: 89 days median2008: 115 days median2009: 139 days median2010: 114 days median2011: 84 days median2012: 102 days median2013: 90 days median2014: 140 days median2015: 132 days median2016: 89 days median2017: 97 days median2018: 101 days median2019: 45 days median2020: 141 days median2021: 57 days median2022: 89 days median2023: 249 days median2024: 110 days median2025: 107 days median2026 (partial year): 217 days median
2007high 249 (2023) · low 45 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRX

1in 2024

2007: 32008: 132009: 232010: 122011: 62013: 42015: 72018: 12021: 32024: 1
2007high 23 (2009) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRX

2,076in 2025

2007: 4212008: 4412009: 5582010: 6122011: 6312012: 7782013: 6782014: 8022015: 7632016: 4692017: 9342018: 1,5812019: 1,6762020: 1,7062021: 1,9082022: 1,4062023: 1,8522024: 2,4272025: 2,076
2007high 2,427 (2024) · low 421 (2007)2025

MAUDE reports naming product code HRX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20077893421
2008911513441
20091113923558
2010911412612
20113846631
2012111020778
201312904678
201491400802
201541327763
20168890469
20174970934
20181210111,581
2019124501,676
2020714101,706
202175731,908
202238901,406
2023424901,852
2024611012,427
2025910702,076
202672170—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

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https://510kreport.com/device/K032473 · printed Nov 5, 2026

Cite this page

510(k) Report. “K032473: Dekompressor Percutaneous Discectomy Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032473

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026