Who is the manufacturer of Stryker Footed Attachments and Cutting Accessories?

Stryker Corp. filed the 510(k) submission for Stryker Footed Attachments and Cutting Accessories (K143399).

What is the FDA product code for Stryker Footed Attachments and Cutting Accessories?

HBE. It is classified under 21 CFR 882.4310 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Stryker Footed Attachments and Cutting Accessories?

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

What are the predicate devices for Stryker Footed Attachments and Cutting Accessories?

Stryker® Consolidated Operating Room Equipment (CORE) System (K112593).

Who can help prepare an FDA 510(k) submission like Stryker Footed Attachments and Cutting 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 Footed Attachments and Cutting Accessories

K143399 · Stryker Corp. · HBE · May 8, 2015 · Neurology

Device Facts

Record ID	K143399
Device Name	Stryker Footed Attachments and Cutting Accessories
Applicant	Stryker Corp.
Product Code	HBE · Neurology
Decision Date	May 8, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4310
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Footed Attachments and Cutting Accessories 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 Footed Attachments and Cutting Accessories are intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT) / Otology /Neurotology/Otorhinolaryngology; Craniofacial (bones of the skull and supraorbital region); and Sternotomy. Specific applications include Craniotomy/Craniectomy, Pterional Craniotomy, Sub Occipital/Retro Sigmoid/Posterior Fossa Craniotomy, Sphenoid Wing Dissection, Laminotomy/Laminectomy, and Orthopedic Spine. These devices are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices.

Device Story

Device consists of footed/non-footed attachments and cutting accessories (burs, routers) used with Stryker CORE console and electric/pneumatic motors. Attachments provide interface between motor and cutting accessory; footed versions feature nose-tube foot to protect underlying structures. Cutting accessories are single-use, sterile, with proximal notch and distal cutting head. Used in OR by surgeons for bone cutting, drilling, reaming, shaping, and dissecting in neuro, spine, ENT, and orthopedic procedures. Attachments are non-sterile, steam-sterilized at facility. Output is mechanical bone removal; surgeon controls device manually via motor interface. Benefits include precise bone shaping and preparation for fixation hardware.

Clinical Evidence

No clinical data. Bench testing only: life testing (fluted burs, spiral routers, tapered/straight accessories, diamond burs), temperature testing (bur/router), functional/graphics testing of attachments, and attachment latch testing. Biocompatibility testing per ISO 10993-1:2009/(R)2013 (cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, bacterial endotoxin, colorant leachables) confirms non-cytotoxic, non-sensitizing, non-toxic, and non-pyrogenic status.

Technological Characteristics

Materials: 17-4 Stainless Steel. Energy: Electric or pneumatic motor-driven. Form factor: Footed/non-footed attachments (12-25mm) and various cutting accessories (routers, burs). Sterilization: Steam sterilization at user facility. Connectivity: Mechanical interface with CORE console. Software: None.

Indications for Use

Indicated for patients requiring bone cutting, drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing during neurosurgical, spinal, ENT/otology/neurotology/otorhinolaryngology, craniofacial, and sternotomy procedures, including preparation for fixation device placement.

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)

Reference Devices

Anspach Dissecting Tools (K113476)
Medtronic Footed Attachments and Cutting Tools (K081475)

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Submission Summary (Full Text)

{0}------------------------------------------------ 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 that resembles a stylized caduceus or a representation of the human form. The symbol is composed of three wavy lines that converge to form a head-like shape. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 8, 2015 Stryker Instruments Ms. Jeanne S. Warner Regulatory Affairs Manager 4100 E. Milham Ave. Kalamazoo, Michigan 49001 > K143399 Trade/Device Name: Stryker Footed Attachments and Cutting Accessories Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, and Their Accessories Regulatory Class: Class II Product Code: HBE, ERL Dated: April 7, 2015 Received: April 8, 2015 Dear Ms. Warner, Re: 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 {1}------------------------------------------------ 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Carlos L. Pena -50/0 Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K143399 ### Device Name Stryker Footed Attachments and Cutting Accessories ### Indications for Use (Describe) The Footed Attachments and Cutting Accessories 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 Footed Attachments and Cutting Accessories are intended to cut bone in the following manner: drilling, reaming, shaping, dissecting, shaving and smoothing for the following medical applications: Neuro: Spine: Ear, Nose, and Throat (ENT) / Otology /Neurotology/Otorhinolaryngology; Craniofacial (bones of the skull and supraorbital region); and Sternotomy. Specific applications include Craniectomy, Pterional Craniotomy, Sub Occipital/Retro Sigmoid/Posterior Fossa Craniotomy, Sphenoid Wing Dissection, Laminotomy/Laminectomy, and Orthopedic Spine. These devices are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices. Type of Use (Select one or both, as applicable): | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |---------------------------------------------------------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the Stryker logo in black and white. The logo is a stylized wordmark with a distinctive design. The letters are bold and connected, giving the logo a modern and recognizable appearance. ## 510(k) Summary | 510(k) Owner: | Stryker Instruments 4100 E. Milham Avenue Kalamazoo, MI 49001 (p) 269-323-7700 (f) 269-389-5299 | |------------------------------------------------------|-------------------------------------------------------------------------------------------------------------| | Contact Person: | Jeanne S. Warner Regulatory Affairs Manager | | Registration Number: Date Summary Prepared: | 1811755 May 07, 2015 | Trade Name(s): Stryker Footed Attachments and Cutting Accessories Powered simple cranial drills, burrs, trephines, and their accessories. Common Name: | Product Code | Device | Regulation Number | Class | |-------------------------|---------------------------------------------------------------------|----------------------|-------| | HBE (Primary Code) | Drills, burs, trephines, and accessories (simple, powered) | 21 CFR 882.4310 | II | | ERL (Secondary Code) | Drill, Surgical, ENT (Electric or Pneumatic) including | 21 CFR 874.4250 | II | ## Predicate Device: Classification Data: | 510(k) number | Product code | Trade name | Manufacturer | |------------------|-----------------|-----------------------------------------------------------------------|------------------------| | K112593 | ERL | Stryker® Consolidated Operating Room Equipment (CORE) System | Stryker Instruments | {4}------------------------------------------------ ## Reference Device- Anspach: | Trade Name: | Anspach Dissecting Tools | |-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Type: | Reference Device | | 510(k) Number: | K113476 | | Description: | The primary predicate device has successfully addressed decision points 1 to 4 in the 510(k) Decision Making Flowchart as per FDA) Guidance for Industry and FDA Staff, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], dated July 28, 2014. However, the dimensions, material and technological characteristics of 2.3mm and 3.0mm spiral routers are compared to Anspach Dissecting Tools, which are cleared through the 510(k), K113476. | | Reference Device- Medtronic: | Trade Name: | Medtronic Footed Attachments and Cutting Tools | |---------------------------------|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Type: | Reference Device | | | 510(k) Number: | K081475 | | | Description: | Medtronic Cutting Tools have been used as a reference device since these devices have the same intended use and same technological characteristics as the subject device. Moreover, the dimensions, material and technological characteristics of Stryker 1.5mm spiral routers are compared to the 1.5mm spiral router offered by Medtronic. | {5}------------------------------------------------ Stryker® ## Indications for Use: The Footed Attachments and Cutting Accessories 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 Footed Attachments and Cutting Accessories are intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving and shaping for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/Otology/Neurotology/ Otorhinolaryngology; Craniofacial(bones of the skull and supraorbital region); and Sternotomy. Specific applications include Craniotomy/Craniectomy, Pterional Craniotomy, Sub Occipital/Retro Sigmoid/Posterior Fossa Craniotomy, Sphenoid Wing Dissection, Laminotomy / Laminectomy, and Orthopedic Spine. These devices are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices. {6}------------------------------------------------ Image /page/6/Picture/0 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 in black and the background is white. Device Footed Attachments are prescription medical devices that are designed to Description: provide an interface between a cutting accessory and a high speed motor. When used with a motor and a cutting accessory, the Footed Attachments are intended cut, drill, ream, dissect and shape bone in a variety of surgical procedures including the following specialty areas: Neuro, Spine, ENT, Sternotomy and Orthopedics. The Stryker Footed Attachments are available in footed and non-footed configurations. The primary difference is the addition of the foot feature at the end of the nose tube. The footed attachment is offered in two configurations: Fixed Footed Attachments and Rotating Footed Attachments. The primary difference between the Fixed and the Rotating Footed Attachment is the ability to rotate the foot portion of the device independently from the motor. Cutting accessories are single use, sterile devices which have a mount or notch machined at their proximal end and a head with a sharp cutting edge at their distal end. The cutting accessories when used with a high speed drill and Footed Attachments are intended to cut, drill, ream, decorticate, shape, dissect, shave and smooth bone in a variety of surgical procedures. Performance The following verification tests were performed which demonstrate that the Data (Non device meets the performance requirements under its indications for use Clinical Tests): conditions. - Life Testing - Fluted Bur cutting accessories - Life Testing – Spiral Routers - Life Testing – Tapered and Straight cutting accessories - Life testing – Diamond bur cutting accessories - Temperature Testing – Bur Cutting Accessory - Temperature Testing - Router Cutting Accessory - Life, Functional and Graphics Testing of Footed Attachments - Attachment Latch Test Results of these tests demonstrate that the functionality, integrity, and safety and effectiveness of the Stryker Footed Attachments and Cutting Accessories is sufficient for their intended use and support a determination of substantial equivalence. {7}------------------------------------------------ Biocompat-Stryker Footed Attachments and Cutting Accessories are classified as ibility Tests: external communicating devices: tissue/bone/dentin with limited patient contact (< 24 hours). > The biocompatibility evaluation was conducted in accordance with AAMI/ANSI/ISO ISO 10993-1:2009/(R)2013, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, and Guidance for Industry and FDA Staff, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," dated April 23, 2013. Results of testing validate that the subject devices are non-cytotoxic, nonsensitizing, a negligible irritant, non-toxic, and non-pyrogenic. | Tests Performed | Biocompatibility Test | Conclusions | |-----------------------------|------------------------------------------------------|---------------------| | Biocompatibility Testing | Cytotoxicity | Non-cytotoxic | | | Sensitization | Non-sensitizing | | | Irritation | Negligible irritant | | | Acute Systemic Toxicity | Non-toxic | | | Material Mediated Pyrogenicity (Attachments) | Non-pyrogen | | Biocompatibility Testing | Bacterial Endotoxin Testing (Cutting Accessories) | Requirement met | | Biocompatibility Testing | Colorant Leachables | Pass | Table 1: Overview of Biocompatibility Testing No clinical testing was deemed necessary for this 510(k). Clinical Tests: {8}------------------------------------------------ # Table 2: Comparison of Subject, Predicate and Reference Devices | Feature | Subject Device - Stryker® - Footed Attachments and | Predicate Device - Stryker CORE® (Duraguards, Routers | Reference Device - Anspach Dissecting Tools (K113476) | Reference Device - Medtronic Footed Attachments and | Justification | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Cutting Accessories | and Burs) ( K112593) | | Cutting Tools (K081475) | | | Model Name | Footed Attachments | Fixed Duraguards | Not applicable as 510k is for Cutting Accessories only | Footed Attachments | Similar | | | Rotating Footed Attachments | Steering Duraguards | Not applicable as 510k is for Cutting Accessories only | Rotating Footed Attachments | Verification and Validation testing has | | | Non-Footed Attachments; 8cm and 9cm | D-Attachment | Not applicable as 510k is for Cutting Accessories only | Non-Footed Attachments 8-B and 9-M | Validation testing has | | | Tapered, Spiral, Straight routers | Tapered routers | Tapered, Spiral routers | Tapered, Spiral, Straight routers | demonstrated that the subject | | | Match Head and Diamond Match Head cutting accessories | None | Not applicable for these cutting accessory head types | Match Head and Diamond Match Head cutting accessories | devices have a similar safety and effectiveness profile as the legally marketed predicate devices. | | Patient Population | General | General | General | General | Identical | | Contra- indications | None | None | None | None | Identical | | Feature | Subject Device - Stryker® – Footed Attachments and Cutting Accessories | Predicate Device – Stryker CORE® (Duraguards, Routers and Burs) (K112593) | Reference Device - Anspach Dissecting Tools (K113476) | Reference Device - Medtronic Footed Attachments and Cutting Tools (K081475) | Justification | | Indications for Use statement | The Footed Attachments and Cutting Accessories 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 Footed Attachments and Cutting Accessories are intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT) / Otology /Neurotology/Otorhinolaryngology; Craniofacial (bones of the skull and supraorbital region); and Sternotomy. Specific applications include Craniotomy/Craniectomy, Pterional Craniotomy, Sub Occipital/Retro Sigmoid/Posterior Fossa Craniotomy, Sphenoid Wing Dissection, Laminotomy/Laminectomy, and Orthopedic Spine. These devices are also usable in the preparation for the placement of screws, metal, wires, pins, and | The Stryker® Consolidated Operating Room Equipment (CORE) System is intended for use in the cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to dental, ENT (ear, nose, throat), neuro, spine, and endoscopic applications. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices. | Dissection tools are intended for cutting and shaping bone including spine and cranium. 7 | The Electric Drill System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in the following applications: • Neurosurgical (Cranial, Craniofacial), • Spinal • Arthroscopic • Orthopedic • Sternotomy • General Surgical Procedures | Similar. The intended use of all the devices identical; to cut bone. The specific indications that are being proposed for addition are a subset of already cleared indications for the predicate devices. Verification and Validation testing has demonstrated that the subject devices have a similar safety and effectiveness profile as the legally marketed predicate devices. | | Feature | Subject Device - Stryker® - Footed Attachments and Cutting Accessories | Predicate Device - – Stryker CORE® (Duraguards, Routers and Burs) ( K112593) | Reference Device - Anspach Dissecting Tools (K113476) | Reference Device - Medtronic Footed Attachments and Cutting Tools (K081475) | Justification | | Attachment Material | 17-4 Stainless Steel (SST) | 17-4 Stainless Steel (SST) and 13-8 MO Stainless Steel (SST) | N/A – Attachments not referenced | 17-4 Stainless Steel (SST) | Identical | | Attachment Packaging | Packaged in a sealed Korrvu retention insert | Packaged in a sealed Korrvu retention insert | Not applicable as 510k is for Cutting Accessories only | Wrapped in a Low Density Polyethylene bag and placed in a One Piece Folder E-flute corrugated carton | Similar | | Sterilization Method | Supplied non-sterile. Sterilized at the user facility by steam sterilization. | Supplied non- sterile. Sterilized at the user facility by steam sterilization. | N/A – Attachments not referenced | Supplied non-sterile. Sterilized at the user facility by steam sterilization. | Identical | | Model Name | Footed Attachments | Fixed Duraguards | N/A – Attachments not referenced | Footed Attachments | Similar | | | Rotating Footed Attachments | Steering Duraguards | N/A – Attachments not referenced | Rotating Footed Attachments | Similar | | | Non-Footed Attachments (8cm and 9cm) | D-Attachment | N/A – Attachments not referenced | Non-Footed Attachments (8-B and 9-M) | Similar | | | Tapered, Spiral, Straight Routers | Tapered, Straight Routers | Fluted Spiral, Fluted | Tapered, Spiral, Straight Routers | Identical | | | Match Head and Diamond Match Head cutting accessories | Match Head and Diamond Match Head cutting accessories | None | Match Head and Diamond Match Head cutting accessories | Identical | | Feature | Subject Device - Stryker® - Footed Attachments and Cutting Accessories | Predicate Device – Stryker CORE® (Duraguards, Routers and Burs) (K112593) | Reference Device - Anspach Dissecting Tools (K113476) | Reference Device - Medtronic Footed Attachments and Cutting Tools (K081475) | Justification | | Attachment configuration | • Fixed Footed • Non-Footed • Rotating Footed | • Fixed • Footed • Non-Footed • Rotating • Footed | Not applicable as 510k is for Cutting Accessories only | • Fixed Footed • Non-Footed • Rotating Footed | Identical | | Knurling on the surface of the Attachment | Yes | No | Not applicable as 510k is for Cutting Accessories only | Yes | Similar to predicate. Identical to reference. Verification and Validation testing has demonstrated that the subject devices have a similar safety and effectiveness profile as the legally marketed predicate devices. | | Footed Attachment Size | 12mm-25mm | 12mm-25mm…