Who is the manufacturer of STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES?

Stryker Instruments filed the 510(k) submission for STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES (K962800).

What is the FDA product code for STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES?

HWE. It is classified under 21 CFR 878.4820 as a Class 1 device in the General, Plastic Surgery panel.

What is the regulatory pathway for STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES

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

Intended 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

Related Devices

K961970 — COMMAND 2 MICOELECTRIC SURGICAL SYSTEM · Stryker Corp. · Jul 26, 1996
K210377 — Stryker iBur hubs and cutting accessories · Stryker Corporation · Jun 30, 2021
K954690 — STRYKER ORAL MAX SYSTEM · Stryker Corp. · Aug 20, 1996
K233153 — Traus SSG10 Surgical System · Saeshin Precision Co., Ltd. · Sep 20, 2024
K133604 — ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS · The Anspach Effort, Inc. · Jan 10, 2014

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. {1} 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