510(k) · Cleared
ClearedConmed Linvatec Osprey Drill System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Linvatec · HBC Motor, Drill, Electric
Cleared on Apr 2, 2008 as substantially equivalent to K072706 (Conmed Linvatec, 2007) and 3 other predicates after a 43-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Apr 2, 2008
- Review
- 43 days
- Class
- Class II
- Product code
- HBC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K931783 (1993). 27 ancestors in all, the oldest K862807 (1986). No later device cites it as a predicate yet.
- Root · 6 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 5 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 4 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 3 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 2 generations backK991696 Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999
- 1 generation backK014060 Microaire 1000E SystemMicroaire Surgical Instruments, Inc. · 2002
- This deviceK080444 Conmed Linvatec Osprey Drill SystemConmed Linvatec · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −5 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −4 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −3 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −2 | K991696 | Stryker Hermes-Ready Total Performance System | Stryker Instruments | 1999 | — |
| −1 | K014060 | Microaire 1000E System | Microaire Surgical Instruments, Inc. | 2002 | — |
| 0 (this device) | K080444 | Conmed Linvatec Osprey Drill System | Conmed Linvatec | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
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 HBC? 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 HBC device
- #1 K254174 Surgical Power Systemscore 14.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072706 | Microchoice Drills and Saws, Micropower Drills and Saws, Micropower Oralmax High Speed…Summary page 1…82.4360 Proposed Class/Device: Class II Product Code: HBC D. Predicate/Legally Marketed Devices MicroPower Handpiece System 510(k) # K072706 ConMed Linvatec Microspeed Uni Motor System 510(k) # K053526 Aesculap, Inc. MicroAire 1000E System… | 2007 |
| * | K053526 | Microspeed Uni Motor SystemSummary page 1…HBC D. Predicate/Legally Marketed Devices MicroPower Handpiece System 510(k) # K072706 ConMed Linvatec Microspeed Uni Motor System 510(k) # K053526 Aesculap, Inc. MicroAire 1000E System 510(k) # K014060 MicroAire Surgical Instruments Anspach eMax Drill… | 2006 |
| * | K014060 | Microaire 1000E SystemSummary page 1…em 510(k) # K072706 ConMed Linvatec Microspeed Uni Motor System 510(k) # K053526 Aesculap, Inc. MicroAire 1000E System 510(k) # K014060 MicroAire Surgical Instruments Anspach eMax Drill 510(k) # KO1 1444 The Anspach Effort, Inc. Hall® U… | 2002 |
| * | K011444 | Anspach Emax Drill System | 2001 |
| Kept off the family tree | K781979 | FDA’s K781979 is Surgairtome Two Our reading of the summary gave K781979, FDA’s number for Surgairtome Two (American Sterilizer Co.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Hall® UltraPower® Drill”. Kept off the family tree. Summary page 1…0 MicroAire Surgical Instruments Anspach eMax Drill 510(k) # KO1 1444 The Anspach Effort, Inc. Hall® UltraPower® Drill 510(k) # K781979 Linvatec Corporation (acquired from AMSCO/Hall® Surgical)… | 1978 |
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 4 companies; a new generation was cleared every 2.4 years on median.
- 5 of the 27 ancestors have a recall of any class.
- 1 other device also cites its predicate K072706.
How does its category compare?
All HBC devicesHBC Motor, Drill, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · HBC
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HBC
Too few HBC 510(k)s in any year since 2007 to give a median.
Recalls per year · HBC
9in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBC
635in 2025
MAUDE reports naming product code HBC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 5 |
| 2008 | 1 | — | 0 | 6 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 9 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 2 | — | 0 | 10,670 |
| 2014 | 1 | — | 1 | 2,643 |
| 2015 | 0 | — | 0 | 1,953 |
| 2016 | 1 | — | 0 | 2,541 |
| 2017 | 2 | — | 0 | 2,079 |
| 2018 | 1 | — | 0 | 1,779 |
| 2019 | 1 | — | 0 | 1,703 |
| 2020 | 0 | — | 0 | 1,304 |
| 2021 | 1 | — | 0 | 946 |
| 2022 | 2 | — | 9 | 760 |
| 2023 | 0 | — | 0 | 663 |
| 2024 | 2 | — | 0 | 427 |
| 2025 | 0 | — | 0 | 635 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ConMed Linvatec OspreyTM Drill System is intended for cutting, drilling, and manipulation of soft tissue and bone in the following applications: orthopedic, neurosurgical, spinal, cranial, otolaryngological, oral/maxillofacial, reconstructive, and plastic.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080444 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080444: Conmed Linvatec Osprey Drill System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080444
Report an extraction error
Are you the manufacturer?
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