510(k) Report

510(k) · Cleared

Cleared

Rema Shaver Blades

K060172510(k) TraditionalCleared May 31, 2006128-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

Rema Medizintechnik GmbH. · HRX Arthroscope

Cleared on May 31, 2006 as substantially equivalent to K023777 (Arthronet Medical, Inc., 2002) and 8 other predicates after a 128-day review. Its family tree reaches back 5 generations to 1986.

Decided
May 31, 2006
Review
128 days
Class
Class II
Product code
HRX
Recalls
None
Predicates
9

Its longest line of descent runs back 5 generations to K862807 (1986). 29 ancestors in all, the oldest K852143 (1985). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor2003: 1 other ancestor2002: 1 other ancestor1996: 3 other ancestors1995: 6 other ancestors1994: 7 other ancestors1990: 1 other ancestor1998: 1 other ancestor1991: 1 other ancestor1986: 1 other ancestor1985: 1 other ancestorK862807 · Treace Drill System · Treace Medical, Inc. · 1986K964548 · Apex Universal Drive System · Linvatec Corp. · 1997K971059 · Universal Drive System · Linvatec Corp. · 1997K981637 · Integrated Drive/Pump System for Otolaryngology · Linvatec Corp. · 1998K990524 · E9000 System · Linvatec Corp. · 199919851990199520002005
Other ancestors, by generation 1 generation back: 8 other ancestors2 generations back: 7 other ancestors3 generations back: 7 other ancestors4 generations back: 2 other ancestors K990524 · E9000 System · Linvatec Corp. · 1999K981637 · Integrated Drive/Pump System for Otolaryngology · Linvatec Corp. · 1998K971059 · Universal Drive System · Linvatec Corp. · 1997K964548 · Apex Universal Drive System · Linvatec Corp. · 1997K862807 · Treace Drill System · Treace Medical, Inc. · 1986−50
  1. Root · 5 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
  2. 4 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
  3. 3 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
  4. 2 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
  5. 1 generation backK990524 E9000 SystemLinvatec Corp. · 1999
  6. This deviceK060172 Rema Shaver BladesRema Medizintechnik GmbH. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K862807Treace Drill SystemTreace Medical, Inc.1986—
−4K964548Apex Universal Drive SystemLinvatec Corp.1997—
−3K971059Universal Drive SystemLinvatec Corp.1997—
−2K981637Integrated Drive/Pump System for OtolaryngologyLinvatec Corp.1998—
−1K990524E9000 SystemLinvatec Corp.1999—
0 (this device)K060172Rema Shaver BladesRema Medizintechnik GmbH.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198610
199010
199110
199470
199560
199630
199810
200210
200310
200510
FIG. 1 — Lineage of K060172, 1986–2006Source: 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
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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
*K023777Arthronet Blackline 2 and 3 Piece Arthroscopic Blades, Models 123, 133, 153, 163, 173…
Summary page 1
…: Arthroscope Accessories Classification Number: 888.1100 Class II Proprietary Name: REMA Shaver Blades 3. Predicate Device: K023777, Arthronet Blackline Shaver Blades K953695, Smith & Nephew Dyonics Arthroscopic Blades K955914, Smith & Nephew Dyonic…
Arthronet Medical, Inc.2002—
*K953695Dyonics Disposable Arthroscopic Blades
Summary page 1
…ation Number: 888.1100 Class II Proprietary Name: REMA Shaver Blades 3. Predicate Device: K023777, Arthronet Blackline Shaver Blades K953695, Smith & Nephew Dyonics Arthroscopic Blades K955914, Smith & Nephew Dyonics Arthroscopic Blades K901735, MicroAire Su…
Smith & Nephew Dyonics, Inc.1995—
*K955914Limited Reuse Arthroscopic Blades
Summary page 1
…me: REMA Shaver Blades 3. Predicate Device: K023777, Arthronet Blackline Shaver Blades K953695, Smith & Nephew Dyonics Arthroscopic Blades K955914, Smith & Nephew Dyonics Arthroscopic Blades K901735, MicroAire Surgical Blades K963332, Stryker Shaver Blades K…
Smith & Nephew Dyonics, Inc.1996—
*K901735Arthroscopic Surgery Blades DY-3440, 3443, 3444
Summary page 1
…K023777, Arthronet Blackline Shaver Blades K953695, Smith & Nephew Dyonics Arthroscopic Blades K955914, Smith & Nephew Dyonics Arthroscopic Blades K901735, MicroAire Surgical Blades K963332, Stryker Shaver Blades K943985, Linvatec Shaver Blades K990524, Linvatec E90…
Micro-Aire Surgical Instruments, Inc.1990—
*K963332Thermo-Plastic Shaver Blades
Summary page 1
…Blades K953695, Smith & Nephew Dyonics Arthroscopic Blades K955914, Smith & Nephew Dyonics Arthroscopic Blades K901735, MicroAire Surgical Blades K963332, Stryker Shaver Blades K943985, Linvatec Shaver Blades K990524, Linvatec E9000 System K041824, NeXtra Arthrosco…
Stryker Endoscopy1996—
*K943985Limited Reuse Blades
Summary page 1
…Dyonics Arthroscopic Blades K955914, Smith & Nephew Dyonics Arthroscopic Blades K901735, MicroAire Surgical Blades K963332, Stryker Shaver Blades K943985, Linvatec Shaver Blades K990524, Linvatec E9000 System K041824, NeXtra Arthroscopic Shaver K030009, Karl Storz…
Linvatec Corp.1994—
*K990524E9000 System
Summary page 1
…914, Smith & Nephew Dyonics Arthroscopic Blades K901735, MicroAire Surgical Blades K963332, Stryker Shaver Blades K943985, Linvatec Shaver Blades K990524, Linvatec E9000 System K041824, NeXtra Arthroscopic Shaver K030009, Karl Storz Powershaver System S2…
Linvatec Corp.1999—
*K041824X-Treme Arthroscopic Pump and Shaver System
Summary page 1
…pic Blades K901735, MicroAire Surgical Blades K963332, Stryker Shaver Blades K943985, Linvatec Shaver Blades K990524, Linvatec E9000 System K041824, NeXtra Arthroscopic Shaver K030009, Karl Storz Powershaver System S2 (e…
Future Medical Systems, SA20052
*K030009Ksea Powershaver System S2
Summary page 1
…al Blades K963332, Stryker Shaver Blades K943985, Linvatec Shaver Blades K990524, Linvatec E9000 System K041824, NeXtra Arthroscopic Shaver K030009, Karl Storz Powershaver System S2 (e'6 o/7 4. Description of Device: The…
Karl Storz Endoscopy20031

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 20 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
  • 5 of the 29 ancestors have a recall of any class.

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 REMA Shaver Blades are intended to provide shaving, cutting and abrading of bone and tissue during arthroscopic surgical procedures conducted by qualified surgeons.

Indications for use as stated in the FDA summary.

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/K060172 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060172: Rema Shaver Blades.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060172

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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