Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments

K143320 · Stryker Corp. · HBE · Apr 23, 2015 · Neurology

Device Facts

• Record ID: K143320
• Device Name: Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
• Applicant: Stryker Corp.
• Product Code: HBE · Neurology
• Decision Date: Apr 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Elite and Heavy Duty Attachments are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE) console and electric and pneumatic motors. When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut bone cement in the following manner: drilling, reaming, decorticating, shaping, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose and Throat (ENT)/Otology/Neurotology/Otothinolaryngology; Craniofacial and Maxillofacial; Dental; and Endoscopic applications. The specific applications include Craniectomy, Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS) Spine. Expanded Endonasal (EEA)/Anterior Skull Base/Endoscopic/Transnasal/Transphenoidal, and Orthopedic Spine. When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut teeth in the following manner: sectioning, splitting, fragmenting, extracting, removing, drilling, and reaming. When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices, or the cutting of screws, metal, wires, pins, and other fixation devices in the following manner: sectioning, smoothing or shaping of metal, and removing/rounding sharp edges.

Device Story

Stryker Elite and HD Attachments serve as mechanical interfaces between powered surgical motors (electric/pneumatic) and cutting accessories (burs). Attachments transmit torque from motor to bur to cut bone, bone cement, teeth, or fixation hardware (screws/wires). Used in OR settings by surgeons; attachments provide grip surface for manual control. Features include stainless steel construction, color-coded bands for compatibility identification, and varied lengths (7-20cm). Reusable; requires end-user steam sterilization. Design modifications include sleeker profiles and grooved/knurled textures for improved balance and grip. Output is mechanical cutting action; clinical benefit is precise bone/tissue removal or hardware manipulation during complex surgical procedures.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility (ISO 10993-1) confirmed non-cytotoxic, non-sensitizing, non-toxic, and non-pyrogenic. Functional testing verified 1-year life, locking mechanism reliability, surface temperature limits, bur whip/chatter performance, and package integrity (ASTM D4169).

Technological Characteristics

Materials: Stainless steel. Principle: Rotary torque transmission. Power: Electric/pneumatic motors. Form factor: Straight/angled attachments, 7-20cm lengths. Connectivity: Mechanical interface to CORE console/motors. Sterilization: Steam (moist heat), SAL 10^-6. Standards: ISO 10993-1 (biocompatibility), ASTM D4169 (packaging).

Indications for Use

Indicated for patients requiring bone, bone cement, or tooth cutting (drilling, reaming, decorticating, shaping, smoothing, sectioning, splitting, fragmenting, extracting) or fixation device preparation/cutting in neuro, spine, ENT/otology, craniofacial, maxillofacial, dental, and endoscopic procedures. Includes specific applications: craniectomy, laminotomy/laminectomy, MIS spine, EEA/anterior skull base, and orthopedic spine.

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 Consolidated Operating Room Equipment (CORE) System (K112593)
• Stryker Maestro Pneumatic System (K041754)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three overlapping profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 23, 2015

Stryker Instruments Ms. Brittney M. Larsen, RAC Senior Regulatory Affairs Representative 4100 E. Milham Ave. Kalamazoo, Michigan 49001

Re: K143320 Trade/Device Name: Stryker Elite and Heavy Duty (HD) Attachments Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, and Their Accessories Regulatory Class: Class II Product Code: HBE, HBB, ERL, DZI Dated: March 20, 2015 Received: March 24, 2015

Dear Ms. Larsen,

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K143320

Device Name Stryker Elite and Heavy Duty (HD) Attachments

#### Indications for Use (Describe)

The Elite and Heavy Duty Attachments are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE) console and electric and pneumatic motors. When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut bone cement in the following manner: drilling, reaming, decorticating, shaping, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose and Throat (ENT)/Otology/Neurotology/Otothinolaryngology; Craniofacial and Maxillofacial; Dental; and Endoscopic applications.

The specific applications include Craniectomy, Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS) Spine. Expanded Endonasal (EEA)/Anterior Skull Base/Endoscopic/Transnasal/Transphenoidal, and Orthopedic Spine.

When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut teeth in the following manner: sectioning, splitting, fragmenting, extracting, removing, drilling, and reaming.

When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices, or the cutting of screws, metal, wires, pins, and other fixation devices in the following manner: sectioning, smoothing or shaping of metal, and removing/rounding sharp edges.

Type of Use (Select one or both, as applicable)

| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|

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# 510(k) Summary

| Contact Details | | | |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|------------------------|
| 510(k) Owner | Stryker Instruments<br>4100 E. Milham Avenue<br>Kalamazoo, Michigan 49001 USA<br>Ph: [phone]<br>Fax: [phone] | | |
| FDA Establishment<br>Registration No. | 1811755 | | |
| Contact Person | Brittney M. Larsen, RAC<br>Ph: [phone]<br>Fax: [phone]<br>[e-mail] | | |
| Date Submitted | April 22, 2015 | | |
| Device Name | | | |
| Trade Name | Stryker® Elite and Heavy Duty (HD) Attachments | | |
| Common Name | Surgical Drill Handpieces | | |
| Classification | II | | |
| Primary<br>Classification Name | Drills, Burs, Trephines & Accessories (Simple, Powered)<br>(21 CFR 882.4310, Product code HBE) | | |
| Secondary<br>Classification Name | Drill, Surgical ENT (Electric or Pneumatic) including Handpiece<br>(21 CFR 874.4250, Product code ERL)<br><br>Pneumatic cranial drill motor<br>(21 CFR 882.4370, Product code HBB)<br><br>Drill, Bone, Powered<br>(21 CFR 872.4120, Product code DZI) | | |
| Legally Marketed Predicate Device(s) | | | |
| 510(k) Number | Product Code | Trade Name | Manufacturer |
| Primary Predicate | | | |
| K112593 | ERL (primary)<br>DZI, DZJ, HBE<br>(secondary) | Stryker® Consolidated<br>Operating Room Equipment<br>(CORE) System | Stryker<br>Instruments |
| Secondary Predicate | | | |
| K041754 | HBB (primary)<br>ERL, HBE<br>(secondary) | Stryker Maestro Pneumatic<br>System | Stryker<br>Instruments |

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stryker®

# Purpose of this Traditional 510(k) Premarket Notification

Stryker submits this Traditional 510(k), for the Stryker® Elite and HD Attachments, to request clearance for an expansion of indications and addition of color bands to the predicate devices. The predicate devices are currently cleared for a variety of general indications for use. The subject changes include adding the following specific procedures (hereafter referred to as medical applications): Craniectomy, Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS) Spine, Expanded Endonasal Approach (EEA)/Anterior Skull Base/Transnasal/Transphenoidal, and Orthopedic Spine. This expansion of indications does not change the intended use or the fundamental scientific technology of the predicate devices. The subject modifications of this submission also include the addition of color bands to enhance the distinction of attachment and cutting accessory compatibility.

### Device Description and Intended Use

The Stryker® Elite and HD Attachments are used within a system consisting of a variety of devices, including a console, powered motors, and cutting accessories. The attachments connect to the motors and the cutting accessories to complete the system for physician use. The Stryker® Elite and HD Attachments are offered for prescription use only. The Elite and HD Attachments are intended to serve as interfaces between powered motors and cutting accessories for the purposes of:

- Cutting bone, bone cement, and teeth; ●
- Placing or cutting screws, metal, wires, pins, and other fixation devices; and ●
- Providing a location for the user to hold and grip the device system. ●

The Elite and HD Attachments are provided in straight and angled configurations. The subject Elite Attachments are offered in the following lengths: 7cm, 12cm, 14cm, 17cm, and 20cm. The Stryker® HD Attachments are offered in the following lengths: 9cm and 14cm.

The Elite and HD Attachments are powered by, and compatible with, the Stryker electric and pneumatic motors. The attachments are also used with the cutting accessories (burs). All the attachments demonstrate a rotary mode of action by transmitting torque.

The Elite and HD Attachments are made of stainless steel (SST). The attachments display a color band on the outer surface. The color bands serve to enhance the distinction of attachment and cutting accessory compatibility. The Elite and HD Attachment outer profiles feature a sleeker design. The Elite and HD Attachment outer surface textures include laterally grooved and continuous knurling textures for improved user grip.

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Image /page/5/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase, and there is a registered trademark symbol to the right of the "r". The word is likely a logo for the Stryker Corporation, a medical technology company.

The Elite and HD Attachments are reusable, provided non-sterile, and end user sterilized. The attachments may be cleaned by manual or mechanical (automated) cleaning procedures. The attachment end user sterilization method is moist heat (steam) and the sterility assurance level (SAL) is 10-6. The Elite and HD Attachments have an expected life of one (1) year. The attachments are individually packaged in a sealed retention insert. The attachment labels contain a label specified part description, quantity, lot number, and contact information. There are no known contraindications for the Elite and HD Attachments.

# Indications for Use

The Elite and Heavy Duty Attachments are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE®) console and electric and pneumatic motors. When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut bone and bone cement in the following manner: drilling, reaming, decorticating, shaping, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose and Throat (ENT)/Otology/Neurotology/Otorhinolaryngology; Cramiofacial and Maxillofacial; Dental; and Endoscopic applications.

specific applications include Craniotomy/Craniectomy, Laminotomy/ The Laminectomy, Minimally Invasive Surgery (MIS) Spine, Expanded Endonasal Approach (EEA)/Anterior Skull Base/Endoscopic/Transnasal/Transphenoidal, and Orthopedic Spine.

When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut teeth in the following manner: sectioning, segmenting, splitting, fragmenting, extracting, removing, drilling, and reaming.

When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices, or the cutting of screws, metal, wires, pins, and other fixation devices in the following manner: sectioning, deburring, smoothing or shaping of metal, and removing/rounding sharp edges.

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stryker®

#### Table 6-1. Comparison to predicate devices

| Description | Stryker® CORE System<br>(Primary Predicate - K112593) | Stryker Maestro Pneumatic<br>System<br>(Secondary Predicate -<br>K041754) | Stryker® Elite and HD Attachments<br>(Subject) | Explanation<br>of Differences |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II | Class II | Class II | Identical |
| Primary<br>Product Code | ERL<br>Drill, Surgical, ENT (Electric or<br>Pneumatic) including Handpiece | HBB<br>Pneumatic cranial drill motor | HBE<br>Drills, Burs, Trephines & Accessories (Simple,<br>Powered) | Equivalent |
| Primary<br>Regulation | 21 CFR 874.4250<br>Ear, nose, and throat electric or<br>pneumatic surgical drill | 21 CFR 882.4370<br>Pneumatic cranial drill motor | 21 CFR 882.4310<br>Powered simple cranial drills, burrs, trephines, and<br>their accessories. | Equivalent |
| Product<br>Types | Straight and angled attachments | Straight and angled attachments | Straight and angled attachments | Identical |
| Conditions<br>for Use | Reusable | Reusable | Reusable | Identical |
| Mechanism of<br>Action | Powered by electric motors | Powered by pneumatic motors | Powered by electric and pneumatic motors | Equivalent |
| Mode of<br>Action | Rotary (transmits torque) | Rotary (transmits torque) | Rotary (transmits torque) | Identical |
| Expected Life | 1 year | 1 year | 1 year | Identical |
| Type of Use | Prescription use only | Prescription use only | Prescription use only | Identical |
| Intended Use | To serve as an interface between powered motors and cutting<br>accessories for the purposes of:<br>• Cutting bone, bone cement, and teeth;<br>• Placing or cutting screws, metal, wires, pins, and other<br>fixation devices;<br>• Providing a location for the user to hold and grip device<br>system. | To serve as an interface between powered motors and cutting accessories for the purposes of:<br>• Cutting bone, bone cement, and teeth;<br>• Placing or cutting screws, metal, wires, pins, and other fixation devices;<br>• Providing a location for the user to hold and grip device system. | To serve as an interface between powered motors and cutting accessories for the purposes of:<br>• Cutting bone, bone cement, and teeth;<br>• Placing or cutting screws, metal, wires,<br>pins, and other fixation devices:<br>• Providing a location for the user to hold and grip device system. | Identical |
| Descript-<br>ion | Stryker® CORE<br>System<br>(Primary Predicate<br>- K112593) | Stryker Maestro<br>Pneumatic System<br>(Secondary<br>Predicate -<br>K041754) | Stryker® Elite and HD Attachments<br>(Subject) | Explanation of<br>Differences |
| Indications<br>for Use | The Stryker®<br>Consolidated<br>Operating Room<br>Equipment (CORE)<br>System is intended<br>for use in the<br>cutting, drilling,<br>reaming,<br>decorticating,<br>shaping, and<br>smoothing of bone,<br>bone cement and<br>teeth in a variety of<br>surgical procedures,<br>including but not<br>limited to, dental,<br>ENT (ear, nose,<br>throat), neuro, spine,<br>and endoscopic<br>applications. It is<br>also usable in the<br>placement or cutting<br>of screws, metal,<br>wires, pins, and<br>other fixation<br>devices. | The Stryker Maestro<br>Pneumatic system is<br>a pneumatically<br>operated surgical<br>instrument system.<br>The pneumatic<br>motor provides<br>power to operate<br>removable rotating<br>surgical cutting<br>tools and their<br>accessories intended<br>for use in<br>neurosurgery,<br>including<br>craniotomy and<br>spinal surgery; as<br>well as Ear, Nose<br>and Throat (ENT),<br>orthopedic, and<br>general surgical<br>applications<br>including<br>maxillofacial,<br>craniofacial and<br>sternotomy<br>surgeries. | The Elite and Heavy Duty Attachments are intended to be used with<br>the Stryker Consolidated Operating Room Equipment (CORE®)<br>console and electric and pneumatic motors. When used with these<br>motors, the Elite and Heavy Duty Attachments and Cutting<br>Accessories are intended to cut bone and bone cement in the<br>following manner: drilling, reaming, decorticating, shaping, and<br>smoothing for the following medical applications: Neuro; Spine; Ear,<br>Nose and Throat (ENT)/Otology/ Neurotology/Otorhinolaryngology:<br>Craniofacial and Maxillofacial; Dental; and Endoscopic applications.<br>The specific applications include Craniotomy/Craniectomy,<br>Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS)<br>Spine, Expanded Endonasal Approach (EEA)/Anterior Skull<br>Base/Endoscopic/Transnasal/Transphenoidal, and Orthopedic Spine.<br>When used with these motors, the Elite and Heavy Duty Attachments<br>and Cutting Accessories are intended to cut teeth in the following<br>manner: sectioning, segmenting, splitting, fragmenting, extracting,<br>removing, drilling, and reaming.<br>When used with these motors, the Elite and Heavy Duty Attachments<br>and Cutting Accessories are also usable in the preparation for the<br>placement of screws, metal, wires, pins, and other fixation devices, or<br>the cutting of screws, metal, wires, pins, and other fixation devices in<br>the following manner: sectioning, deburring, smoothing or shaping of<br>metal, and removing/rounding sharp edges. | The subject devices add the<br>following indications for<br>use to the existing, cleared<br>indications: Craniectomy,<br>Laminotomy/Laminectomy,<br>Minimally Invasive<br>Surgery (MIS) Spine,<br>Expanded Endonasal<br>Approach (EEA)/Anterior<br>Skull Base/Transnasal/<br>Transphenoidal, and<br>Orthopedic Spine. The<br>subject indications add<br>verbiage that defines<br>cutting for each medium in<br>the variety of surgical<br>procedures listed. The<br>purpose of the changes<br>made to the indications for<br>use is to list the procedures<br>within each general<br>indication as per current<br>standard of care as known<br>by the medical community.<br>Verification and validation<br>testing conducted has<br>demonstrated that the<br>subject devices have a<br>similar safety and<br>effectiveness profile as the<br>legally marketed predicate<br>devices |
| Description | Stryker® CORE System<br>(Primary Predicate - K112593); and<br>Stryker Maestro Pneumatic System<br>(Secondary Predicate - K041754) | Stryker® Elite and HD<br>Attachments<br>(Subject) | Explanation of Differences | |
| Size Information | | | | |
| Straight and Angled<br>Attachment Length<br>Offerings | 7cm, 9cm, 12cm, 14cm, 17cm (straight<br>only), 20cm | 7cm, 9cm, 12cm, 14cm, 17cm,<br>20cm | Added the Elite 14cm Hooded and the Elite 17cm Angled<br>Attachment offerings for marketing of a more competitive product<br>offering. Both of the added attachments are within the cleared<br>length range. The 14cm hooded attachment includes a built in<br>hood. Verification and validation testing conducted<br>has<br>demonstrated that the subject devices have a similar safety and<br>effectiveness profile as the legally marketed predicate devices. | |
| Attachment Rear<br>Housing Outer<br>Diameters | 0.677in (nominal) | 0.677in (nominal) | Identical…