(185 days)
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.
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.
This 510(k) premarket notification for the Stryker® Injectable Cement does not contain information about acceptance criteria or a study proving that the device meets those criteria.
The provided document is a 510(k) summary and the FDA's clearance letter for the Stryker® Injectable Cement. It focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety and effectiveness.
Here's a breakdown of why the requested information is not present in the provided text:
- Acceptance Criteria and Device Performance Table: This type of information (specific performance metrics, thresholds, and reported results) is typically found in a detailed study report that would be part of the full 510(k) submission, but not in the summary or clearance letter. The summary states that the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance is considered acceptable based on that comparison, but it doesn't quantify or define specific performance criteria.
- Sample size, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, and ground truth for training set: These items relate to the methodology and results of specific clinical or performance studies. The provided 510(k) summary of safety and effectiveness, while mentioning "Substantial Equivalency Information," does not include details of any primary studies conducted for this particular premarket notification. It references predicate devices (K060061 Stryker® Injectable Cement and K043334 Stryker® HAC Rapid Set Cement) as the basis for substantial equivalence, implying that their existing data or established safety and efficacy profiles are being leveraged.
In summary, the provided text is a regulatory clearance document, not a detailed technical report of a study designed to establish and meet specific acceptance criteria. Such studies would have been part of the broader submission that led to this clearance, but the details are not included in the publicly available summary or the FDA letter.
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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 AvenueKalamazoo, MI 49001877-534-2464 x 4226 |
| Submitter's Registration #: | 8010177 |
| Manufacturer's Registration #: | 9610726 |
| Contact Person: | Wade T. RutkoskieManager, Regulatory Affairs and Quality AssurancePhone: 877-534-2464 x 4226Fax: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.
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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.
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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
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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
§ 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).