STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
K032303 · Stryker Instruments · HBE · Jan 16, 2004 · Neurology
Device Facts
| Record ID | K032303 |
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| Device Name | STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM |
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| Applicant | Stryker Instruments |
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| Product Code | HBE · Neurology |
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| Decision Date | Jan 16, 2004 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 882.4310 |
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| Device Class | Class 2 |
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| Attributes | Therapeutic |
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Intended Use
The Stryker Consolidated Operating Room Equipment (CORE) System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and bone cement in a variety of surgical procedures, including but not limited to Neuro and Endoscopic. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices. The endoscopic applications with CORE include use with the SE5 Small Joint Shaver in the wrist for any need for morselization of tissue within the joint. Cutters will be used to debride synovitis, articular cartilage flaps, or torn ligaments when surgeons deem resection appropriate. Burs are indicated for management of osseous lesions such as eburnated articular surfaces or osteophytes.
Device Story
Stryker CORE System is a powered surgical console for driving various surgical instruments; includes drills, shavers, saws, and wire drivers. System components include console, irrigation pump, footswitch, handswitch, and handpieces. Used in operating rooms by surgeons for bone/tissue manipulation and fixation hardware placement. Console provides power and control to attachments; surgeon operates via footswitch or handswitch. Output is mechanical rotation or oscillation of surgical bits/blades. Benefits include precise bone/tissue resection and efficient hardware installation during orthopedic, neuro, and endoscopic procedures.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Powered surgical console system. Includes motors, attachments, irrigation pump, and control interfaces (footswitch/handswitch). Connectivity via cords/cables. System is designed for integration with various surgical handpieces (drills, shavers, saws).
Indications for Use
Indicated for patients requiring bone/bone cement cutting, drilling, reaming, decorticating, or smoothing during surgical procedures (e.g., Neuro, Endoscopic). Includes endoscopic tissue morselization, debridement of synovitis/cartilage/ligaments, and management of osseous lesions (osteophytes/eburnated surfaces). Also indicated for placement/cutting of fixation hardware (screws, wires, pins).
Regulatory Classification
Identification
Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.
Predicate Devices
- Stryker TPS (Dental-K943540)
- Stryker TPS (ENT-K943569)
- Stryker TPS (Neuro-K943541)
- TPS Hermes (K991696)
- Stryker Navigation System (K012380)
- Dyonics (K771218)
Related Devices
- K040369 — STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM · Stryker Instruments · Apr 1, 2004
- K112593 — STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM · Stryker Corporation · May 1, 2012
- K040300 — STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) · Stryker Instruments · Mar 3, 2004
- K032117 — STRYKER TOTAL PERFORMANCE (TPS) SYSTEM · Stryker Instruments · Aug 8, 2003
- K961970 — COMMAND 2 MICOELECTRIC SURGICAL SYSTEM · Stryker Corp. · Jul 26, 1996
Submission Summary (Full Text)
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## 510(k) Summary
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大032303
| Trade Name: | Stryker Consolidated Operating Room Equipment (CORE) System |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Console |
| Classification Names: | Bone Cutting Instruments and Accessories. (per 21 CFR section<br>872.4120)<br>Ear, Nose and Throat Electric or Pneumatic Surgical Drill. (per 21<br>CFR section 874.4250)<br>Powered Simple Cranial Drill, Burrs, Trephines and their Accessories<br>(per 21 CFR section 882.4310) |
| Equivalent to: | Stryker TPS (Dental-K943540, ENT-K943569, Neuro- 943541), TPS<br>Hermes (991696), Stryker Navigation System (K012380) and Dyonics<br>(K771218). |
| Device Description: | The device description of the Stryker System includes drills, shavers,<br>shields, guards, motors, attachments, saws, wire drivers, collets,<br>console, irrigation pump, cords, footswitch, handswitch, clips, tubing,<br>cutting accessories, and sterilization cases.<br>The scope of this modification is limited to the console of the system. |
| Intended Use: | The Stryker Consolidated Operating Room Equipment (CORE) System<br>is intended for use in the cutting, drilling, reaming, decorticating, and<br>smoothing of bone and bone cement in a variety of surgical<br>procedures, including but not limited to Neuro and Endoscopic. It is<br>also usable in the placement or cutting of screws, metal, wires, pins,<br>and other fixation devices. |
| | The endoscopic applications with CORE include use with the SE5<br>Small Joint Shaver in the wrist for any need for morselization of tissue<br>within the joint. Cutters will be used to debride synovitis, articular<br>cartilage flaps, or torn ligaments when surgeons deem resection<br>appropriate. Burs are indicated for management of osseous lesions<br>such as eburnated articular surfaces or osteophytes. |
| Technological<br>Comparison: | Technological characteristics are the same as previously cleared<br>for the Stryker TPS System (K943540, K943569, K943541, and<br>K991696), Stryker Navigation System (K012380) and Dyonics<br>(K771218). |
| Submitted by: | Jean W. Sheppard<br>Sr. Regulatory Affairs Representative<br>Stryker Instruments<br>July 24, 2003 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/12 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The seal is black and white and has a simple, clean design.
JAN 1 6 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jean W. Sheppard Sr. Regulatory Affairs Representative Stryker Instruments 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K032303
Trade/Device Name: Stryker Consolidated Operating Room Equipment (CORE) Console Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, and their accessories Regulatory Class: II Product Codc: HBE Dated: October 20, 2003 Received: October 21, 2003
Dear Ms. Sheppard:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been worked the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to the enactment date of the Medical Device Amendments, or to conniner of the rial) 2011-11-3) in accordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). alle Costiette Act (71ct) that to hot requestly of the general controls provisions of the Act. The r ou may, merelere, mainer of the Act include requirements for annual registration, listing of general controls provisions of are tice, 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 If your device is classified (500 abor of the existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Court of Counts concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issuated of a basenia.
that FDA has made a determination that your device complies with other requirements of the Act that FDA has made a dolorimiation administered by other Federal agencies. You must or any Federal statutes and regulations and annualing, but not limited to: registration and listing (21 comply with an the Act s requirements, me; good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and 1f applicable, the clectronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Jean W. Sheppard
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneting your antial equivalence of your deversity your develop premarket nothcation. THE PDA Intellig of babbankal via revice 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 If you desire specific atvice for your do rice of the same of the regulation entitled, and comact the Office of Compliance an (21CFR Part 807.97). You may obtain "Whisoranding by relevelee to premail.org.ibilities under the Act from the Division of Small other general informational 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
Colia 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
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## Indications for Use Statement
510(k) Number (if known): K032303
The Stryker Consolidated Operating Room Equipment (CORE) Device Name System
- The Stryker Consolidated Operating Room Equipment (CORE)System is Indications intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and bone cement in a variety of surgical procedures, including but not limited to Neuro and Endoscopic. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.
The endoscopic applications with CORE include use with the SE5 Small Joint Shaver in the wrist for any need for morselization of tissue within the joint. Cutters will be used to debride synovitis, articular cartilage flaps, or torn ligaments when surgeons deem resection appropriate. Burs are indicated for management of osseous lesions such as eburnated articular surfaces or osteophytes.
Prescription Use _ X (Per 21 CFR 801 Subpart D) Over-The-Counter Use _ (21 CFR 807 Subpart C)
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AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
Sivision Sign-Off) Division of General, Restorative and Neurological Devices
K632303 (1) Number ...
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