# K080444: Conmed Linvatec Osprey Drill System

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Linvatec
- Decided: Apr 2, 2008 after 43 days
- Product code: HBC (Motor, Drill, Electric)
- Device class: 2
- Regulation: 21 CFR 882.4360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K931783 (1993). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072706: Microchoice Drills and Saws, Micropower Drills and Saws, Micropower Oralmax High Speed Drill, Conmed Linvatec (2007) Summary page 1.
- K053526: Microspeed Uni Motor System, Aesculap, Inc. (2006) Summary page 1.
- K014060: Microaire 1000E System, Microaire Surgical Instruments, Inc. (2002) Summary page 1.
- K011444: Anspach Emax Drill System, The Anspach Effort, Inc. (2001)

## Cited in the summary but kept off the family tree
- K781979: Surgairtome Two, American Sterilizer Co. (1978). 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K080444
Methodology: https://510kreport.com/methodology