← Product Code [KIJ](/submissions/SU/subpart-e%E2%80%94surgical-devices/KIJ) · K972367 # STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT (K972367) _Stryker Instruments · KIJ · Sep 4, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/KIJ/K972367 ## Device Facts - **Applicant:** Stryker Instruments - **Product Code:** [KIJ](/submissions/SU/subpart-e%E2%80%94surgical-devices/KIJ.md) - **Decision Date:** Sep 4, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4820 - **Device Class:** Class 1 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use The Stryker System 4000 Battery Powered Heavy Duty System is intended for use in the cutting, drilling, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. It is also usable in the placement or cutting of screws, wires, pins, and other fixation devices. It can also be used to cut metal. ## Device Story Stryker System 4000 is a battery-powered surgical instrument system for orthopedic and general surgical procedures. System components include handpieces (drills, reamer, rotary driver, saws), rechargeable batteries, battery chargers, battery protector kits, sterilization cases/racks, and various cutting accessories. Operated by surgeons in clinical/surgical settings to perform bone manipulation (cutting, drilling, reaming, smoothing) and fixation device placement. Device provides mechanical power to surgical attachments; output is physical bone/metal modification. System design adheres to IEC 601.1 safety standards. ## Clinical Evidence No clinical data. Substantial equivalence is based on bench testing and design comparison to existing legally marketed powered surgical instrument systems. ## Technological Characteristics Battery-powered surgical handpieces (drills, reamers, saws). Components include rechargeable batteries, chargers, and sterilization accessories. Designed to meet IEC 601.1 safety standards. Mechanical energy source. No software or electronic processing described. ## Regulatory 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 - 3M powered instrument systems - Zimmer powered instrument systems - Sodem powered instrument systems ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ SEP - 4 1997 stryker® 4100 East Milham Avenue Kalamazoo, MI 49001 (616) 323-7700 (800) 253-3210 K972367 ## Device Name: | Classification Name: | Surgical Instrument Motors and Accessories/Attachments
21 CFR 878.4820, Class I | |----------------------|-------------------------------------------------------------------------------------------------------------------------| | Common/Usual Name: | Battery Powered Surgical Instruments and Accessories | | Proprietary Name: | Stryker System 4000 | | Device Sponsor: | Stryker Corporation
Instruments Division
4100 E. Milham Avenue
Kalamazoo, MI 49001
Registration No: 1811755 | | Regulatory Class: | Class I | ## Summary of Safety and Effectiveness: The Stryker System 4000 Battery Powered Heavy Duty Handpieces and Accessories are intended for use in cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. It is also usable in the placement or cutting of screws, wires, pins, and other fixation devices. It can also be used to cut metal. The Stryker System 4000 is comprised of drills, a reamer, a rotary driver, saws, rechargeable batteries, battery chargers, a battery protector kit, sterilization cases and racks, and cutting accessories. The system is designed to meet the IEC 601.1 safety standards. The Stryker System 4000 handpieces, batteries, battery charger, battery protector kit, and other system accessories are equivalent in intended use, safety, and effectiveness to existing powered instrument systems and accessories being marketed by companies such as 3M, Zimmer, and Sodem. The Stryker sterilization cases, rack, and cutting accessories are equivalent in intended use, safety, and effectiveness to existing products being marketed by Stryker Pre- The 1976 Medical Device Amendment. The Stryker System 4000 Handpieces and Accessories do not raise any new safety and {1}------------------------------------------------ effectiveness concerns when compared to similar devices already legally marketed. Therefore, the Stryker System 4000 Handpieces and Accessories are substantially equivalent to these existing devices mentioned above. Melissa Harriger Melissa Harriger Regulatory Affairs Representative Stryker Instruments {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "U.S. HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure. The image is black and white. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP - 4 1997 Ms. Melissa Harriger Regulatory Affairs Representative Stryker® Instruments ... ................................................................................................... 4100 East Milham Avenue Kalamazoo, Michigan 49001-6197 Re: K972367 > Trade Name: Stryker System 4000 Heavy Duty Battery Powered Equipment Regulatory Class: I Product Code: KIJ Dated: June 24, 1997 Received: June 25, 1997 Dear Ms. Harriger: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3}------------------------------------------------ Page 2 - Ms. Melissa Harriger This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. .... .......................................................................................................................................................... If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Celia M. Witten, Ph.D., M.D. Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page 1 of 1 k972367 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name: Stryker System 4000 Heavy Duty Battery Power Indications For Use: The Stryker System 4000 Battery Powered Heavy Duty System is intended for use in the cutting, drilling, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. It is also usable in the placement or cutting of screws, wires, pins, and other fixation devices. It can also be used to cut metal. ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ## Concurrence of CDHR, Office of Device Evaluation (ODE) OR ign-Off) General Re-·············································································································································································· ちょった/ Number Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use_ (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/KIJ/K972367](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/KIJ/K972367) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com