510(k) Report

510(k) · Cleared

Cleared

Reprocessed Shavers/Burs

K172092510(k) TraditionalCleared Oct 4, 201785-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

Renovo, Inc. · HRX Arthroscope

Cleared on Oct 4, 2017 as substantially equivalent to K973195 (Stryker Endoscopy, 1997) and 2 other predicates after an 85-day review. Its family tree reaches back 2 generations to 1995.

Decided
Oct 4, 2017
Review
85 days
Class
Class II
Product code
HRX
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K953096 (1995). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 1 other ancestor1998: 1 other ancestorK953096 · Essential Shaver System · Smith & Nephew Richards, Inc. · 1995K973195 · Total Performance System Shaver · Stryker Endoscopy · 199719952000200520102015
Other ancestors, by generation 1 generation back: 2 other ancestors K973195 · Total Performance System Shaver · Stryker Endoscopy · 1997K953096 · Essential Shaver System · Smith & Nephew Richards, Inc. · 19950
  1. Root · 2 generations backK953096 Essential Shaver SystemSmith & Nephew Richards, Inc. · 1995
  2. 1 generation backK973195 Total Performance System ShaverStryker Endoscopy · 1997
  3. This deviceK172092 Reprocessed Shavers/BursRenovo, Inc. · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K953096Essential Shaver SystemSmith & Nephew Richards, Inc.1995—
−1K973195Total Performance System ShaverStryker Endoscopy1997—
0 (this device)K172092Reprocessed Shavers/BursRenovo, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200710
FIG. 1 — Lineage of K172092, 1995–2017Source: 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? (3)

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
*K973195Total Performance System Shaver
Summary page 19
…Predicate Manufacturer: Stryker Endoscopy Predicate Trade Name: Total Performance System Shaver Predicate 510(k): K973195 Predicate Manufacturer: Linvatec Corporation Predicate Trade Name: Integrated Drive/Pump Syste…
Stryker Endoscopy1997—
*K981636Integrated Drive/Pump System
Summary page 19
…Predicate Manufacturer: Linvatec Corporation Predicate Trade Name: Integrated Drive/Pump System Predicate 510(k): K981636 Predicate Manufacturer: Smith & Nephew, Inc., Endoscopy Division Predicate Trade Name: DYONICS…
Linvatec Corp.19981
*K062849Smith & Nephew Duonics Power II Shaver System
Summary page 19
…acturer: Smith & Nephew, Inc., Endoscopy Division Predicate Trade Name: DYONICS Power II Shaver System Predicate 510(k): K062849 V. DEVICE DESCRIPTION The Reprocessed Shavers and Burs are intended to be used for arthroscopic and laparoscopic…
Smith & Nephew, Inc.2007—

Also cleared against K973195: 4 other devices →

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 22 years and passes through 3 companies; a new generation was cleared every 19.9 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • 4 other devices also cite its predicate K973195.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

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 Reprocessed Linvatec shavers and burs are intended for use with the Linvatec Integrated Drive/Pump System to perform resection of soft tissue and bone. The fields of application include Otolaryngology, Neurological Surgical, Orthopedic, and Spinal surgical procedures. The Reprocessed Smith & Nephew shavers and burs are intended for use with the Smith & Nephew DYONICS Power 11 Shaver System control unit, for resection of soft and osseous tissues…

Read the full statement (185 words)

The Reprocessed Linvatec shavers and burs are intended for use with the Linvatec Integrated Drive/Pump System to perform resection of soft tissue and bone. The fields of application include Otolaryngology, Neurological Surgical, Orthopedic, and Spinal surgical procedures.

The Reprocessed Smith & Nephew shavers and burs are intended for use with the Smith & Nephew DYONICS Power 11 Shaver System control unit, for resection of soft and osseous tissues including but not limited to, use in large articular cavities, small articular cavities, and Functional Endoscopic Sinus Surgery (FESS). The FESS application is limited to those small blades which are appropriate for the procedure.

The Reprocessed Styker Shavers and Burs are intended for use with the Styker Total Performance System Shaver handpiece and the Stryker Total Performance System by surgeons in the following orthopedic joints:

> Knee

> Shoulder

> Ankle

> Elbow

> Wrist

> Hip

> Temporamandibular

The Reprocessed Styker Shavers and Burs will be used to resect tissue and bur bone.

Examples of uses of the product would include resection of torn knee cartilage, subacromial decompression and resection of synovial tissue in other joints.

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

Also cleared against K973195

4 other devices cite the same predicate.

  • K071859Stryker Crossfire SystemStryker Endoscopy · 20072 recalls
  • K061134Eberle Shaver System C2 and Shaver BladesEfs Eberle Feinwerktechnische Systeme · 2006
  • K012635Reprocessed Stryker Arthroscopic ShaversAlliance Medical Corp. · 20018 recalls
  • K012605Reprocessed Athroscopics BursAlliance Medical Corp. · 20019 recalls

More from Renovo, Inc.

6 FDA decisions under this applicant name. See the company

  • K173740Reprocessed DePuy Mitek Ablation WandRenovo, Inc. · 2018
  • K173741Reprocessed ArthoCare Ablation WandRenovo, Inc. · 2018
  • K172647Reprocessed ArthroCare ENT CoblatorRenovo, Inc. · 2018
  • K172097Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar SleevesRenovo, Inc. · 2017
  • K172093Reprocessed Covidien TrocarRenovo, Inc. · 2017

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/K172092 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172092: Reprocessed Shavers/Burs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172092

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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