(198 days)
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 is a self-setting calcium phosphate cement.
The provided text is a 510(k) summary for a medical device (Stryker® Injectable Cement) and its FDA clearance letter. It does not contain any information about acceptance criteria, device performance, or human studies for the device itself.
The document primarily focuses on:
- Device Identification: Name, common name, regulatory class, product codes.
- Submitter and Manufacturer Information.
- Date of Summary Preparation.
- Intended Use Statement.
- Substantial Equivalence Information: Listing predicate devices (K043334 BoneSource® HAC Rapid Setting Cement, K041842 Norian SRS® Fast Set Putty, and K024336 Wright Medical MIIG II).
- FDA Clearance Letter: Confirming substantial equivalence to predicate devices and allowing the device to be marketed.
Therefore, I cannot fulfill your request for information regarding acceptance criteria, device performance, sample sizes, expert qualifications, study types (MRMC, standalone), or ground truth establishment based on the provided text. This type of detail is typically found in the full 510(k) submission or associated test reports, which are not included here.
{0}------------------------------------------------
K05/603
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, calciumcompoundFMF (21 CFR 880.5860) Syringe, Piston |
| Submitter: | Stryker®4100 East Milham AvenueKalamazoo, MI 49001877-534-2464 x 4062 |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 9610726 |
| Contact Person: | Wade T. RutkoskieManager, Regulatory Affairs and QualityAssurancePhone: 877-534-2464 x 4226Fax: 269-323-4215 |
| Summary Preparation Date: | June 1, 2005 |
Intended Use
Option A: 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.
Substantial Equivalency Information
Stryker® Injectable Cement is substantially equivalent to legally marketed K043334 BoneSource® HAC Rapid Setting Cement, K041842 Norian SRS® Fast Set Putty, and K024336 Wright Medical MIIG II.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or faces, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 3 0 2005
Mr. Wade T. Rutkoskie Manager, Regulatory Affairs & Quality Assurance Stryker® 750 Trade Centre Way Suite 200 Portage, MI 49002
Re: K051603
Trade/Device Name: Stryker® Injectable Cement Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device; Regulatory Class: II Product Code: MQV, FMF Dated: December 8, 2005 Received: December 13, 2005
Dear Mr. Rutkoskie:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally on the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass stated in the enactment date of the Medical Device Amendments, or to devices that provision in the Fig. 1970, are cordance with the provisions of the Federal Food, Drug, and Cosmetic nate (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 therefore, manier the actives 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 n your de rece to such additional controls. Existing major regulations affecting your device can be may of belofeel de 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 I lease of advised that i Dr. in that your device complies with other requirements of the Act or any I DA has made a decommistered by other Federal agencies. You must comply with all r cacares and reguirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set fabeling (21 CFR are 007), gos 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. Rutkoskie
This letter will allow you to 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 marketed 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,
Muli A. Mulhern
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Page 1 of 1
510(k) Number (if known): K 05 1603
Device Name: Stryker® Injectable Cement
Indications For Use:
Option A: Stryker® Injectable Cement is a self-setting calcium phosphate cement indicated to fill bony Survere infoctable Combine is a ben becamities, craniofacial, spine, and pelvis). These volus or gaps of the skelour system (nor one defects created from traumatic injury to the bone. defects may of surgiouny cromed on icated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.
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)
Mark A. Millman
ivision Siv
Restorative
evices
K051
Page of
(Posted November 13, 2003)
§ 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.