510(k) Report

510(k) · Cleared

Cleared

Reprocessed Linvatec Arthroscopic Burs

K012630510(k) TraditionalCleared Nov 9, 200188-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

Alliance Medical, Inc. · HRX Arthroscope

Cleared on Nov 9, 2001 as substantially equivalent to K940515 (Linvatec Corp., 1994) and 4 other predicates after an 88-day review. Its family tree reaches back 5 generations to 1986.

Decided
Nov 9, 2001
Review
88 days
Class
Class II
Product code
HRX
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K862807 (1986). 20 ancestors in all, the oldest K852143 (1985). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 2 other ancestors1994: 4 other ancestors1995: 5 other ancestors1989: 1 other ancestor1986: 1 other ancestor1996: 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. · 19991985199019952000
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 5 other ancestors3 generations back: 7 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 deviceK012630 Reprocessed Linvatec Arthroscopic BursAlliance Medical, Inc. · 2001
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)K012630Reprocessed Linvatec Arthroscopic BursAlliance Medical, Inc.2001—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198610
198910
199440
199550
199610
199820
FIG. 1 — Lineage of K012630, 1986–2001Source: 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
*K940515Poly Blades
Summary page 1
…Oval Bur H9102 Linvatec Corporation Spherical Bur H9110 Linvatec Corporation Vortex Router Hooder H9131 Linvatec Corporation Vortex Router H9132 Predicate device(s): K940515 Linvatec® Merlin Polyblade Shavers K971059 Linvatec® Universal Drive System K981269 Linvatec® Universal Drive System K981636 Linv…
Linvatec Corp.1994—
*K971059Universal Drive System
Summary page 1
…cal Bur H9110 Linvatec Corporation Vortex Router Hooder H9131 Linvatec Corporation Vortex Router H9132 Predicate device(s): K940515 Linvatec® Merlin Polyblade Shavers K971059 Linvatec® Universal Drive System K981269 Linvatec® Universal Drive System K981636 Linvatec® Integrated Drive/Pump System K990524…
Linvatec Corp.1997—
*K981269Universal Drive System
Summary page 1
…x Router Hooder H9131 Linvatec Corporation Vortex Router H9132 Predicate device(s): K940515 Linvatec® Merlin Polyblade Shavers K971059 Linvatec® Universal Drive System K981269 Linvatec® Universal Drive System K981636 Linvatec® Integrated Drive/Pump System K990524 Linvatec® E9000 System Device descriptio…
Linvatec Corp.19983
*K981636Integrated Drive/Pump System
Summary page 1
…on Vortex Router H9132 Predicate device(s): K940515 Linvatec® Merlin Polyblade Shavers K971059 Linvatec® Universal Drive System K981269 Linvatec® Universal Drive System K981636 Linvatec® Integrated Drive/Pump System K990524 Linvatec® E9000 System Device description: Arthroscopic shavers can be used to a…
Linvatec Corp.19981
*K990524E9000 System
Summary page 1
…40515 Linvatec® Merlin Polyblade Shavers K971059 Linvatec® Universal Drive System K981269 Linvatec® Universal Drive System K981636 Linvatec® Integrated Drive/Pump System K990524 Linvatec® E9000 System Device description: Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove l…
Linvatec Corp.1999—

Also cleared against K940515: 2 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 15 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
  • 3 of the 20 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K940515.

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?

Reprocessed Arthroscopic Shavers are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.

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 K940515

2 other devices cite the same predicate.

  • K012613Reprocssed Linvatec ShaversAlliance Medical, Inc. · 20011 recall
  • K963332Thermo-Plastic Shaver BladesStryker Endoscopy · 1996

More from Alliance Medical, Inc.

11 FDA decisions under this applicant name. See the company

  • K051438Vanguard Reprocessed Compression Garments (Hill-Rom)Alliance Medical, Inc. · 20061 recall
  • K050518Reprocessed Phacoemuisification TipsAlliance Medical, Inc. · 2005
  • K030187Reprocessed Electrophysiology CatheterAlliance Medical, Inc. · 200328 recalls
  • K021654Reprocessed Compression SleeveAlliance Medical, Inc. · 2003
  • K012634Reprocessed External Fixation DeviceAlliance Medical, Inc. · 2002

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/K012630 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012630: Reprocessed Linvatec Arthroscopic Burs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012630

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026