510(k) Report

510(k) · Cleared

Cleared

Exojet Tissue Management System

K031406510(k) TraditionalCleared May 30, 200325-day reviewClass II21 CFR 888.1100

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

Mitek Worldwide · HRX Arthroscope

Cleared on May 30, 2003 as substantially equivalent to K020688 (Hydrocision, Inc., 2002) and 3 other predicates after a 25-day review. Its family tree reaches back 4 generations to 1995.

Decided
May 30, 2003
Review
25 days
Class
Class II
Product code
HRX
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K943450 (1995). 13 ancestors in all, the oldest K791638 (1979). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor2000: 1 other ancestor1998: 1 other ancestor2001: 1 other ancestor1997: 1 other ancestor1986: 1 other ancestor1979: 1 other ancestor1996: 2 other ancestorsK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961747 (1996), K963123 (1996) K993009 · Hydrocision Arthrojet System with Cautery · Hydrocision, Inc. · 19991975198019851990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 4 other ancestors3 generations back: 2 other ancestors K993009 · Hydrocision Arthrojet System with Cautery · Hydrocision, Inc. · 1999K963123 · Arthrocare Arthroscopic Eletrosurgery System (Model 980) · Arthrocare Corp. · 1996K961747 · Arthrocare Arthroscopic Electrosurgery System (Model 970) · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 19950
  1. Root · 4 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 3 generations backK961747 Arthrocare Arthroscopic Electrosurgery System (Model 970)Arthrocare Corp. · 1996
  3. 2 generations backK963123 Arthrocare Arthroscopic Eletrosurgery System (Model 980)Arthrocare Corp. · 1996
  4. 1 generation backK993009 Hydrocision Arthrojet System with CauteryHydrocision, Inc. · 1999
  5. This deviceK031406 Exojet Tissue Management SystemMitek Worldwide · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−3K961747Arthrocare Arthroscopic Electrosurgery System (Model 970)Arthrocare Corp.1996—
−2K963123Arthrocare Arthroscopic Eletrosurgery System (Model 980)Arthrocare Corp.1996—
−1K993009Hydrocision Arthrojet System with CauteryHydrocision, Inc.1999—
0 (this device)K031406Exojet Tissue Management SystemMitek Worldwide2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198610
199620
199710
199810
200010
200110
200210
FIG. 1 — Lineage of K031406, 1995–2003Source: 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? (4)

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
*K020688Hydrocision Arthojet System with Cautery and Turboburr
Summary page 1
…ement System is substantially equivalent to: Hydrocision ARTHROJET System with Cautery and TurboBurr K020688, K002764, K993009, K982266 - Distributed by Mitek Worldwide a division of Ethicon, Inc., a John…
Hydrocision, Inc.2002—
*K002764Hydrocision Arthrojet System with Cautery and Burr
Summary page 1
…tem is substantially equivalent to: Hydrocision ARTHROJET System with Cautery and TurboBurr K020688, K002764, K993009, K982266 - Distributed by Mitek Worldwide a division of Ethicon, Inc., a Johnson &John…
Hydrocision, Inc.2000—
*K993009Hydrocision Arthrojet System with Cautery
Summary page 1
…bstantially equivalent to: Hydrocision ARTHROJET System with Cautery and TurboBurr K020688, K002764, K993009, K982266 - Distributed by Mitek Worldwide a division of Ethicon, Inc., a Johnson &Johnson…
Hydrocision, Inc.1999—
*K982266Hydrocision Arthrojet System
Summary page 1
…ly equivalent to: Hydrocision ARTHROJET System with Cautery and TurboBurr K020688, K002764, K993009, K982266 - Distributed by Mitek Worldwide a division of Ethicon, Inc., a Johnson &Johnson…
Hydrocision, Inc.1998—

Also cleared against K020688: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
  • 1 of the 13 ancestors has a recall of any class.
  • 1 other device also cites its predicate K020688.

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 Mitek EXOJET system is indicated for orthopedic surgical procedures where the cutting and removal of soft tissue, hard tissue, or bone is required, with control of bleeding during those procedures as needed. Specific functions include cutting, ablation, and shaping of soft tissue, and decorticating, removing, and smoothing of bone and other bone-related tissue in a variety of small and large joint arthroscopic procedures.

Indications for use as stated in the FDA summary.

Also cleared against K020688

1 other device cites the same predicate.

  • K032529Hydrocision Arthrojet System with Cautery, Turboburr and Curette, Models 51300, 51310Hydrocision, Inc. · 20032 recalls

More from Mitek Worldwide

10 FDA decisions under this applicant name. See the company

  • K032717Biocryl Rapide Interference ScrewMitek Worldwide · 2004
  • K032167Bio-Intrafix Tibial Screw and SheathMitek Worldwide · 2003
  • K032078Mitek Micro QuickanchorMitek Worldwide · 2003
  • K030995Minilok Quickanchor PlusMitek Worldwide · 2003
  • K031519Cufflok AnchorMitek Worldwide · 2003

Recent decisions in HRX

The HRX category page

  • K263208Vantage Lumbar Decompression KitSurGenTec, LLC · 2026
  • K260156TruVision Single-Use 1.9mm Arthroscopy SystemNexus CMF, LLC · 2026
  • K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd. · 2026
  • K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KG · 2026
  • K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLC · 2026

https://510kreport.com/device/K031406 · printed Nov 5, 2026

Cite this page

510(k) Report. “K031406: Exojet Tissue Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031406

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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