(185 days)
Not Found
No
The 510(k) summary describes a calcium phosphate cement for filling bony voids and defects. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses solely on the material properties and intended use of the cement.
Yes
The device is described as a self-setting, calcium phosphate cement intended for use in the repair, augmentation, or restoration of bony defects and voids in the skeletal system. These actions directly address a health condition or restore a biological function, which aligns with the definition of a therapeutic device.
No
The device is a self-setting calcium phosphate cement intended for filling bony voids or gaps, not for diagnosing medical conditions.
No
The device description clearly states it is a "self-setting, calcium phosphate cement," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Description and Intended Use: The description and intended use of the Stryker® Injectable Cement clearly state that it is a self-setting calcium phosphate cement intended for use within the body to fill bony voids or gaps and repair cranial defects. It is a surgical implant/material used directly on the patient's bone.
Therefore, since the device is used in vivo (within the living body) and not for testing samples in vitro, it does not fit the definition of an IVD.
N/A
Intended Use / Indications for Use
Stryker® Injectable Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial shelest of the.
Stryker® Injectable Cement is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, cramofacial; spine, and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The Stryker Injectable Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.
Stryker® Injectable Cement cured in situ provides an open void/gap filler that can augment provisional hardware (e.g., K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary fragments during and is not intended to provide structural support during the healing process.
Stryker® Injectable Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.
Product codes (comma separated list FDA assigned to the subject device)
GXP
Device Description
Stryker® Injectable Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial shelest of the.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects, craniofacial skeleton, skeletal system (i.e. extremities, cramofacial; spine, and pelvis).
Indicated Patient Age Range
Not Found
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)
Not Found
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.
K060061 Stryker® Injectable Cement, K043334 Stryker® HAC Rapid Set Cement
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.
Not Found
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
§ 882.5300 Methyl methacrylate for cranioplasty.
(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).
0
SEP 2 2 2006
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS: Stryker® Injectable Cement
General Information
Proprietary Name: | Stryker® Injectable Cement |
---|---|
Common Name: | Hydroxyapatite Cement |
Proposed Regulatory Class: | Class II |
Device Classification: | GXP (21 CFR 882.5300) Methyl methacrylate for cranioplasty |
Submitter: | Stryker® |
4100 East Milham Avenue | |
Kalamazoo, MI 49001 | |
877-534-2464 x 4226 | |
Submitter's Registration #: | 8010177 |
Manufacturer's Registration #: | 9610726 |
Contact Person: | Wade T. Rutkoskie |
Manager, Regulatory Affairs and Quality Assurance | |
Phone: 877-534-2464 x 4226 | |
Fax: | |
269-323-4215 | |
Summary Preparation Date: | January 4, 2006 |
Intended Use
Stryker® Injectable Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial shelest of the
Substantial Equivalency Information
Stryker® Injectable Cement is substantially equivalent to legally marketed K060061 Stryker® Injectable Cement and K043334 Stryker® HAC Rapid Set Cement.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 2006
Stryker % Mr. Wade Rutkoskie Manager RA/QA 750 Trade Centre Way, Suite 200 Portage, Michigan 49002
Re: K060763
Trade/Device Name: Stryker® Injectable Cement Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: Class II Product Code: GXP Dated: August 22, 2006 Received: August 23, 2006
Dear Mr. Rutkoskie:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Wade Rutkoskie
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w you've ough finding of substantial equivalence of your device to a legally premated notificated.
marketed predicated on a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small odio: Ecturers, International and Consumer Assistance at its toll-free-number (800)-633-2041 วr (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Buechner
Mark N Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(K) Number (if known): K
Device Name: Stryker® Injectable Cement
Indications for Use:
Stryker® Injectable Cement is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, cramofacial; spine, and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The Stryker Injectable Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.
Stryker® Injectable Cement cured in situ provides an open void/gap filler that can augment provisional hardware (e.g., K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary fragments during and is not intended to provide structural support during the healing process.
Stryker® Injectable Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.
Prescription Use (21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Burchum
e of
(Posted November 13, 2003)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K060763