← Product Code [DZI](/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI) · K032117 # STRYKER TOTAL PERFORMANCE (TPS) SYSTEM (K032117) _Stryker Instruments · DZI · Aug 8, 2003 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI/K032117 ## Device Facts - **Applicant:** Stryker Instruments - **Product Code:** [DZI](/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI.md) - **Decision Date:** Aug 8, 2003 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 872.4120 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Intended Use The Stryker Total Performance (TPS) System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone, teeth and other bone related tissue in a variety of surgical procedures, including but not limited to Dental, ENT, Neuro, and Endoscopic. It is also usable in the placement of cutting of screws, wires, pins, and other fixation devices. It can also be used to cut metal. ## Device Story Stryker Total Performance (TPS) System is a surgical power tool system comprising console, motors, drills, shavers, saws, and accessories. System operates via electric or pneumatic power to drive various handpieces for bone/tissue manipulation. Used in OR/clinical settings by surgeons (Dental, ENT, Neuro, Endoscopic). Console controls power delivery to handpieces; surgeon operates via footswitch or handswitch. Provides mechanical force for cutting, drilling, reaming, and smoothing bone or metal fixation hardware. Benefits include precise tissue/bone removal and efficient hardware placement during surgical procedures. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics System includes console, motors, drills, shavers, saws, and accessories. Powered by electric or pneumatic energy. Materials and design are consistent with previously cleared Stryker TPS systems. Connectivity includes footswitch/handswitch interfaces. Sterilization via standard surgical instrument protocols. ## Regulatory Identification A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw. ## Predicate Devices - Stryker TPS ([K943540](/device/K943540.md)) - Stryker TPS ([K943569](/device/K943569.md)) - Stryker TPS ([K943541](/device/K943541.md)) - TPS Hermes ([K991696](/device/K991696.md)) - Stryker Navigation System ([K012380](/device/K012380.md)) - Dyonics ([K771218](/device/K771218.md)) ## 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}------------------------------------------------ ## Ko32117 AUG - 8 2003 , ## 510(k) Summary | Trade Name: | Stryker Total Performance (TPS) System | |------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Console | | Classification Names: | Bone Cutting Instruments and Accessories. (per 21 CFR section
872.4120)
Ear, Nose and Throat Electric or Pneumatic Surgical Drill. (per
21 CFR section 874.4250)
Powered Simple Cranial Drill, Burrs, Trephines and their
Accessories (per 21 CFR section 882.4310) | | Equivalent to: | Stryker TPS (Dental-K943540, ENT-K943569, Neuro- 943541),
TPS Hermes (991696), Stryker Navigation System (K012380)
and Dyonics (K771218). | | Device Description: | The device description of the Stryker System includes drills,
shavers, shields, guards, motors, attachments, saws, wire drivers,
collets, console, irrigation pump, cords, footswitch, handswitch,
clips, tubing, cutting accessories, and sterilization cases.
The scope of this modification is limited to the console of the
system. | | Intended Use: | The Stryker Total Performance (TPS) System is intended for use
in the cutting, drilling, reaming, decorticating, and smoothing of
bone, teeth and other bone related tissue in a variety of surgical
procedures, including but not limited to Dental, ENT, Neuro, and
Endoscopic. It is also usable in the placement of cutting of
screws, wires, pins, and other fixation devices. It can also be
used to cut metal. | | Technological
Comparison: | Technological characteristics are the same as previously cleared
for the Stryker TPS System (K943540, K943569, K943541, and
K991696), Stryker Navigation System (K012380) and Dyonics
(K771218). | | Submitted by: | Jean W. Sheppard
Sr. Regulatory Affairs Representative
Stryker Instruments | | Date Submitted: | July 8, 2003 | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG - 8 2003 Ms. Jean W. Sheppard Senior Regulatory Affairs Representative Stryker Instruments 4100 E. Milham Avenue Kalamazoo, Michigan 49001 Re: K032117 Trade/Device Name: Stryker Total Performance System Regulation Number: 21 CFR 872.4120, 874.4250, 882.4310, 882.6640 Regulation Name: Bone cutting instrument and accessories; Ear, nose, and throat electric pneumatic surgical drill Powered simple cranial drills, burrs, trephines, and their accessories Dental operative unit and accessories Regulatory Class: II Product Code: DZI, ERL, HBE, EIA, HBC, HBE, HSZ, GEY Dated: July 8, 2003 Received: July 9, 2003 Dear Ms. Sheppard: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ Page 2 - Ms. Jean W. Sheppard This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Miriam C. Provost Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Page __ 1__ of _______________________________________________________________________________________________________________________________________________________________ ## Indications for Use Statement | 510(k)
Number | K032117 | |------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | The Stryker Total Performance (TPS) System | | Indications | The Stryker Total Performance (TPS) System is intended for use in
the cutting, drilling, reaming, decorticating, and smoothing of
bone, teeth and other bone related tissue in a variety of surgical
procedures, including but not limited to Dental, ENT Neuro and
Endoscopic. It is also usable in the placement of 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 CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Miriam C. Provost (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number K032117 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI/K032117](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZI/K032117) **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