510(k) Report

510(k) · Cleared

Cleared

XPS Straightshot Microbrider System or Trebay Shaver System

K973499510(k) TraditionalCleared Jan 30, 1998136-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

Xomed, Inc. · HRX Arthroscope

Cleared on Jan 30, 1998 after a 136-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.

Decided
Jan 30, 1998
Review
136 days
Class
Class II
Product code
HRX
Recalls
None
Predicates
0

11 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2008: 2 descendants cleared2003: 1 descendant cleared2004: 1 descendant cleared2011: 1 descendant cleared2023: 1 descendant cleared2020: 1 descendant cleared2026: 2 descendants cleared2024: 1 descendant cleared1995200020052010201520202025
  1. This deviceK973499 XPS Straightshot Microbrider System or Trebay Shaver SystemXomed, Inc. · 1998
  2. Descendant · cites it directly · 9 of its ownK984521 Riwo Drive System 2302 with Generator, Small Motor Handles…Richard Wolf Medical Instruments Corp. · 1999
  3. Descendant · 2 generations on · 8 of its ownK030082 Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911…Richard Wolf Medical Instruments Corp. · 2003
  4. Descendant · 3 generations on · 6 of its ownK041610 Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207Richard Wolf Medical Instruments Corp. · 2004
  5. Descendant · 4 generations on · 2 of its ownK192499 Cyber BladeSIDAM S.r.l. · 2020
  6. Descendant · 4 generations on · 1 of its ownK213597 MultiCut SoloAsclepion Laser Technologies GmbH · 2023

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

1999: 12003: 12004: 12008: 22011: 12020: 12023: 12024: 12026: 2
1999high 2 (2008) · low 0 (2000)2026

Most influential descendants

Showing 5 of 11 · See all
  • K984521Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351Richard Wolf Medical Instruments Corp. · 1999 · cites it directly9descendants
  • K030082Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851Richard Wolf Medical Instruments Corp. · 2003 · 2 generations on8descendants
  • K041610Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207Richard Wolf Medical Instruments Corp. · 2004 · 3 generations on6descendants
  • K192499Cyber BladeSIDAM S.r.l. · 2020 · 4 generations on2descendants
  • K213597MultiCut SoloAsclepion Laser Technologies GmbH · 2023 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K973499XPS Straightshot Microbrider System or Trebay Shaver SystemXomed, Inc.1998—
+1K984521Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351Richard Wolf Medical Instruments Corp.1999—
+2K030082Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851Richard Wolf Medical Instruments Corp.2003—
+3K041610Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207Richard Wolf Medical Instruments Corp.2004—
+4K192499Cyber BladeSIDAM S.r.l.2020—
+4K213597MultiCut SoloAsclepion Laser Technologies GmbH2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200310
200410
200820
201110
202010
202310
202410
202620
FIG. 1 — Lineage of K973499, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (5)

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
*—Linvatec Apex
Named without a submission number
—
*—Stryker SE5
Named without a submission number
—
*—S&N Dyonics PS3500EP
Named without a submission number
—
*—S&N Dyonics Arthroscopic MicroDiscectomy (AMD) System
Named without a submission number
—
*—Sofamor Danek Tissue Resecting System
Named without a submission number
—

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K984521Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351Richard Wolf Medical Instruments Corp.19999
K083013PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…Gyrus Acmi, Inc.20080

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?

  • Of its descendants, K984521 (Richard Wolf Medical Instruments Corp., 1999) has gone furthest, with 9 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 Xomed XPS StraightShot Microdebrider System is intended for the cutting and removal of soft and hard tissue or bone in otorhinolaryngology, head and neck, and orthopedic surgery.

It is indicated for use in orthopedic surgical procedures where the cutting and removal of soft and hard tissue or bone is needed. These include spinal and small and large joint arthroscopic procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Xomed, Inc.

82 FDA decisions under this applicant name. See the company

  • K002395Model 30 Classic PneumatonometerXomed, Inc. · 2000
  • K002987Redtronic Xomed Monopolar Energized BladeXomed, Inc. · 2000
  • K002828XPS Nitro SystemXomed, Inc. · 20001 recall
  • K002897Titanium Middle Ear ProsthesesXomed, Inc. · 20001 recall
  • K993653Micro-France Trocars and AccessoriesXomed, Inc. · 2000

Recent decisions in HRX

The HRX category page

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  • K260156TruVision Single-Use 1.9mm Arthroscopy SystemNexus CMF, LLC · 2026
  • K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd. · 2026
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https://510kreport.com/device/K973499 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973499: XPS Straightshot Microbrider System or Trebay Shaver System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973499

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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