(161 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML capabilities or data processing.
No
Explanation: This device is used for cutting and shaping bone during surgical procedures, which is an interventional or diagnostic function rather than a therapeutic one designed to treat a disease or condition.
No
The device is described as surgical equipment for cutting bone (drilling, reaming, shaping, dissecting, shaving, smoothing) during various medical procedures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components (Footed Attachments, Cutting Accessories) that interface with hardware (motors, CORE Console) for mechanical actions (cutting, drilling, reaming). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "cut bone" in various surgical procedures. This is an in vivo application (within a living organism), not an in vitro application (outside of a living organism, typically on biological samples).
- Device Description: The description reinforces the intended use by detailing how the device interfaces with motors and cutting accessories to perform surgical procedures on bone.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis based on laboratory tests.
Therefore, the device described is a surgical instrument used for bone cutting during procedures, which falls under the category of a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
HBE, ERL
Device Description
Footed Attachments are prescription medical devices that are designed to 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone (Neuro, Spine, Ear, Nose, and Throat (ENT) / Otology /Neurotology/Otorhinolaryngology, Craniofacial (bones of the skull and supraorbital region), Sternotomy)
Indicated Patient Age Range
General
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data (Non Clinical Tests):
- 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.
Biocompatibility Tests:
- Cytotoxicity: Non-cytotoxic
- Sensitization: Non-sensitizing
- Irritation: Negligible irritant
- Acute Systemic Toxicity: Non-toxic
- Material Mediated Pyrogenicity (Attachments): Non-pyrogen
- Bacterial Endotoxin Testing (Cutting Accessories): Requirement met
- Colorant Leakables: Pass
No clinical testing was deemed necessary for this 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
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.(b)
Classification. Class II (performance standards).
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):
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 ( 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 | 12mm-25mm | 12mm-25mm | Identical |
| Type of Router | Tapered, Straight, Spiral | Taper, Straight | Tapered, Spiral | Tapered, Straight, Spiral | Similar |
| Type of Bur | Match Head, Diamond
Match Head | Match Head,
Diamond Match
Head | None | Match Head, Diamond
Match Head | Identical |
9
10
11
12
Conclusion
The subject Stryker® Footed Attachments and Cutting Accessories have the same fundamental scientific technology, intended use, functional characteristics and applications and therefore have a similar safety and effectiveness profile as the legally marketed predicate devices.