K962800 · Stryker Instruments · HWE · Sep 11, 1996 · General, Plastic Surgery
Device Facts
Record ID
K962800
Device Name
STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES
Applicant
Stryker Instruments
Product Code
HWE · General, Plastic Surgery
Decision Date
Sep 11, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4820
Device Class
Class 1
Attributes
Therapeutic
Indications for Use
The Stryker Universal Drill Attachments and Accessories are intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures including: ENT, orthopedic, maxillofacial, neuro, and plastics.
Device Story
System consists of surgical drill attachments and accessories used with Stryker 75K Drill motor; powered by DC electric current via Total Performance System Console. Attachments include extra-long variants (up to 400 mm) and Hudson Chuck (reduces speed from 75,000 rpm to 700-1200 rpm) for cranial perforators. Used by surgeons in OR settings for bone tissue manipulation. Provides mechanical cutting/drilling action; output is physical bone modification. Benefits include surgical versatility and compatibility with standard Hudson shank fittings.
Clinical Evidence
Bench testing only; no clinical data provided.
Technological Characteristics
Mechanical surgical attachments; includes Hudson Chuck for speed reduction. Materials and cutting configurations equivalent to predicate surgical accessories. Powered by DC electric motor (Stryker 75K). Sterile or non-sterile delivery.
Indications for Use
Indicated for patients requiring bone cutting, drilling, reaming, decorticating, or smoothing during ENT, orthopedic, maxillofacial, neuro, or plastic surgical procedures.
Regulatory Classification
Identification
Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
Reference Devices
Midas Rex powered instrument attachments
Codman powered instrument attachments
Stryker 75K Drill
Zimmer/Hall cutting accessories
Submission Summary (Full Text)
{0}
K 96280D
stryker
SEP 11 1996
4100 East Milham Avenue
Kalamazoo, MI 49001-6197
(616) 323-7700 (800) 253-3210
## Device Name:
**Classification Names:** Instrument, Surgical, Orthopedic, DC Powered Motor and Accessories/Attachments:
21 CFR 878.4820, Class I
**Bur, Surgical, General and Plastic Surgery**
21 CFR 878.4820, Class I
**Blade, Surgical, General and Plastic Surgery**
21 CFR 878.4820, Class I
**Common/Usual Name:** Surgical Instrument Motors and Accessories/Attachments
**Proprietary Name:** Stryker Universal Drill Attachments and Accessories
## Device Sponsor:
Stryker Corporation
Instruments Division
4100 E. Milham Avenue
Kalamazoo, MI 49001
Registration No: 1811755
## Regulatory Classification: Class I
## Summary of Safety and Effectiveness:
The Stryker Universal Drill Attachments and Accessories are intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures including: ENT, orthopedic, maxillofacial, neuro, and plastics.
The Stryker Universal Drill Attachments are used in conjunction with the previously 510(k) cleared Stryker 75K Drill. The 75K drill motor is powered by DC electric current via the Total Performance System Console. The Extra Long Attachments are up to 400 mm in length. The Hudson Chuck reduces the speed of the 75K drill from 75,000 rpm to 700 - 1200 rpm. This chuck with Hudson fitting holds cranial perforators with a standard Hudson shank fitting.
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The Stryker Universal Attachments are equivalent in intended use, safety, and effectiveness to existing powered instrument attachments marketed by companies such as Midas Rex and Codman.
The cutting accessories available will be provided sterile or nonsterile. The materials of construction, cutting action, and cutting surface configuration are equivalent to pre-1976 Medical Device Amendment cutting accessories distributed by Stryker as well as cutting accessories distributed by Midas Rex and Zimmer/Hall.
The Stryker Universal Drill Attachments and Accessories do not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Stryker Universal Drill Attachments and Accessories are substantially equivalent to these existing devices.
Diane Davis
Regulatory Affairs Representative
Stryker Instruments
