(51 days)
Not Found
No
The 510(k) summary describes a calcium phosphate cement for filling bony voids and explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The cement acts as a temporary support during surgery and fills voids/gaps, but is explicitly stated not to provide structural support during the healing process, nor is it described as actively treating a disease or condition.
No
Explanation: The device is a self-setting calcium phosphate cement used to fill bony voids or gaps. Its function is reconstructive and supportive, not for identifying the presence, nature, or extent of a disease or condition.
No
The device description clearly states it is a "self-setting calcium phosphate cement," which is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Stryker Injectable Cement's Function: The description clearly states that this device is a "self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system." It is a material implanted into the body to provide temporary structural support during surgery and act as a void filler.
- No Specimen Analysis: The device does not involve the analysis of any biological specimens taken from the patient.
Therefore, based on its intended use and function, the Stryker Injectable Cement is a surgical implant/material, not an In Vitro Diagnostic device.
N/A
Intended Use / 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, craniofacial, 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 support media and is not intended to provide structural support during the healing process.
Product codes
MQV, FMF
Device Description
Stryker® Injectable Cement is a self-setting calcium phosphate cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e. extremities, craniofacial, 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
0
Koloobl
2006 MAR I
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: | MQV (21 CFR 888.3045) Filler, bone void, calcium compound |
| FMF (21 CFR 880.5860) Syringe, Piston | |
| Submitter: | Stryker® |
| 750 Trade Centre Way | |
| Suite 200 | |
| Kalamazoo, MI 49002 | |
| 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 indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, craniofacial, 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 support media and is not intended to provide structural support during the healing process.
1
Substantial Equivalency Information
Stryker@ Injectable Cement is substantially equivalent to legally marketed K051603 Stryker@ Stryker@ Injectable Cement Is Substantany oqurralent to regally with Medical MIIG II and K042516 Walter Lorenz Otomimix.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized caduceus, a symbol often associated with healthcare, alongside the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular fashion. The caduceus is depicted with a series of curved lines, representing a staff with intertwined snakes, and the text is in a simple, sans-serif font. The overall design is clean and professional, reflecting the organization's role in public health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR I 2006
Mr. Wade T. Rutkoskie Manager, Regulatory and Quality Affairs Stryker® CMF 750 Trade Centre Way Kalamazoo, Michigan 49001
Re: K060061
Trade/Device Name: Stryker® Injectable Cement Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, FMF Dated: January 4, 2006 Received: January 9, 2006
Dear Mr. Rutkoskie:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bected. Decembed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surfal the encreases of 776, the enactment date of the Medical Device Amendments, or to conninered pror to May 2011/09/2017 11:12 provisions of the Federal Food. Drug. de rices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelore, mains 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 may or babyer it 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
3
Page 2 - Mr. Wade T. Rutkoskie
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. product railation of the only in begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premated predicate device results in 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Heekul Leuer 10
Mark N. Melkerson, M.S. Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510(K) Number (if known): K O60066
Device Name: Stryker® Injectable Cement
Indications for Use:
Stryker® Injectable Cement is a self-setting calcium phosphate cement indicated to fill Stryker@ milecable Oction is a ben bem (i.e. extremities, craniofacial, spine, and pelvis). Don't volus of gaps of the sketcal by created or osseous defects created from traumatic injury r hess dercets may be surgiously or 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 Sugment provisional hardware (e.g., K-Wires, plates, screws) to help support bone aughtent provisional narawal (05) .
fragments during the surgical procedure. The cured cement acts only as a temporary fragments during the surgled provide structural support during the healing process.
AND/OR X Prescription Use (21 CFR 801 Subpart D)
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)
(Posted November 13, 2003)
Page
Herbert Lewis
of
Division of General, Restorative, and Neurological Devices
*10(k) Number_