(64 days)
Not Found
No
The description focuses on the material properties and physical components of the resorbable fixation system, with no mention of AI or ML capabilities.
No.
The device is intended for the fixation of bones, which is a structural support function, not a therapeutic treatment of a disease or condition.
No
Explanation: The device is a resorbable fixation system used for the physical fixation of bones in the craniofacial and midfacial skeleton, which is a therapeutic function, not a diagnostic one. It does not identify or detect medical conditions.
No
The device description explicitly states it consists of "resorbable bone fixation plates, meshes and screws made of a copolymer of poly lactide and poly glycolide," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details resorbable bone fixation plates, meshes, and screws made of a copolymer. This is a physical implant material, not a reagent or instrument used to test samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.), providing diagnostic information, or being used in a laboratory setting.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a surgical implant used for structural support and fixation within the body.
N/A
Intended Use / Indications for Use
The Stryker Resorbable Fixation System is intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures.
Product codes (comma separated list FDA assigned to the subject device)
HRS, MAI, EZX, DZJ and HWC
Device Description
The Stryker Delta Resorbable Fixation System is a cranio-maxillofacial plating system, intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in mandible and/or full load bearing procedures. It consists of resorbable bone fixation plates, meshes and screws made of a copolymer of poly lactide and poly glycolide. The copolymer degrades and resorbs in vivo by hydrolysis into lactic and glycolic acid which are metabolized in the body to water (H₂O) and carbon dioxide (CO₂). The Delta Resorbable Fixation System is color coded and currently offered in two diameters, 1.7 mm and 2.2 mm with an emergency screw option of 2.6 mm. As the resorbable bone fixation plates and other devices already cleared in the earlier submission have not been modified, they are not described in this Special 510(k).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones of the craniofacial and midfacial skeleton
Indicated Patient Age Range
adult and pediatric patients
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.
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K 113109
Page 1/3
DEC 2 3 2011
Special 510/k)
stryker®
Craniomaxillofacial
510(k) Summary of Safety and Effectiveness:
Stryker Resorbable Fixation System
Proprietary Name:
Common Name:
Classification Name and Reference:
Proposed Regulatory Class:
Product Codes:
Predicate Device:
Stryker Resorbable Fixation System
Resorbable Bone Plating System
Sec. 888.3030 - Single/multiple component metallic bone fixation appliance and accessories
Class II
HRS, MAI, EZX, DZJ and HWC
• Stryker Leibinger Resorbable Fixation
System - K993061
• Lactosorb 1.5mm Implants – Mesh Panels
· Stryker Neuro II 0.3mm Titanium Mesh
Page 8 of 53
750 Trade Centre Way Suite 200 Portage, MI 49002 t: 269 324 5346 f: 877 648 7114 www.stryker.com
Stryker Resorbable Fixation System
1
Stryker Resorbable Fixation System
Page 2/3
Special 510(k)
For Information contact:
Manish Patel Regulatory Compliance Analyst Stryker Craniomaxillofacial 750 Trade Centre Way, Suite 200 Portage, MI 49002 Phone: (269) 389-4261 manish.patel@stryker.com
Date Prepared:
10/18/2011
Description:
This Special 510(k) is being submitted to the U.S. FDA to provide authorization to market modifications to the Stryker Leibinger Resorbable Fixation System cleared under K993061.
Proposed Modification:
The subject Stryker Resorbable Fixation System has the same intended use and indications for use, is constructed from the same material, and has the same fundamental scientific technology as the previously cleared Leibinger Resorbable Fixation System under K993061.
The only changes are below
-
- Addition of a 0.5 mm Low Profile Mesh to an already existing 0.7 mm size range
-
- Increase in thread pitch of screws
-
- Increase in thread pitch of standard and self-drilling taps
2
K113109 Page 3/3
Stryker Resorbable Fixation System
Special 510(k)
Device Description:
The Stryker Delta Resorbable Fixation System is a cranio-maxillofacial plating system, intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in mandible and/or full load bearing procedures. It consists of resorbable bone fixation plates, meshes and screws made of a copolymer of poly lactide and poly glycolide. The copolymer degrades and resorbs in vivo by hydrolysis into lactic and glycolic acid which are metabolized in the body to water (Η₂Ο) and carbon dioxide (CO₂). The Delta Resorbable Fixation System is color coded and currently offered in two diameters, 1.7 mm and 2.2 mm with an emergency screw option of 2.6 mm. As the resorbable bone fixation plates and other devices already cleared in the earlier submission have not been modified, they are not described in this Special 510(k).
Intended Use / Indications for Use:
The Stryker Resorbable Fixation System is intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures.
.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 2 3 2011
Stryker % Manish Patel Regulatory Compliance Analyst 750 Trace Centre Way, Suite 200 Portage. Michigan 49002
Re: K113109 Trade/Device Name: Stryker Resorbable Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, MAI, EZX, DZJ, HWC Dated: December 2, 2011 Received: December 5, 2011
Dear Manish Patel:
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
4
Page 2 - Manish Patel
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours
ely yours,
For Mitter
Def. D.K.
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (If known): K113109
Device Name: Stryker Resorbable Fixation System
Indications for Use:
The Stryker Resorbable Fixation System is intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kurek Mxim
Division Sign Off
Division Sig Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K113109