(38 days)
Not Found
No
The 510(k) summary describes a traditional implant system for fracture fixation and does not mention any AI/ML components or functionalities.
Yes
The device is intended for "reconstruction, stabilization and rigid fixation of fractures in the pelvis," which are therapeutic actions.
No
The device is described as an internal fixation system for fractures in the pelvis, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is an "internal fixation device that consists of three different types of plates used with compatible screws," indicating it is a hardware implant system, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "reconstruction, stabilization and rigid fixation of fractures in the pelvis." This describes a surgical implant used in the body to treat a physical condition.
- Device Description: The description details "an internal fixation device that consists of three different types of plates used with compatible screws." This is a description of a physical implant, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The Pelvis II Implant System is a surgical implant used for internal fixation of bone fractures.
N/A
Intended Use / Indications for Use
The Pelvis II Implant System is intended for reconstruction, stabilization and rigid fixation of fractures in the pelvis in adult patients.
Indications for the Pelvis II Implant System will include fractures of the following regions of the pelvis:
- . Anterior Column
- . Anterior Column combined with posterior hemi-transverse
- . Quadrilateral surface
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new Pelvis II Implant System. The Pelvis II Implant System is an internal fixation device that consists of three different types of plates used with compatible screws to fit different types of fractures in the pelvis. The subject components will be available sterile and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvis
Indicated Patient Age Range
adult 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)
Non-Clinical Testing:
Non-clinical laboratory testing was performed for the Pelvis II Implant System components to determine substantial equivalence. Testing demonstrated that the Pelvis II Implant System is substantially equivalent to the predicate device currently cleared for marketing.
The following test was performed:
- Stryker Pelvis II Static and Fatigue Plate Testing .
Clinical Testing:
Clinical testing was not required for this submission:
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
K131132
510(k) Summary
Proprietary Name:
Common Name:
Classification Name and Reference:
Device Class:
Product Code(s):
For Information Contact:
April 22, 2013
Date Prepared:
Description:
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new Pelvis II Implant System. The Pelvis II Implant System is an internal fixation device that consists of three different types of plates used with compatible screws to fit different types of fractures in the pelvis. The subject components will be available sterile and non-sterile.
Intended Use:
The Pelvis II Implant System is intended for reconstruction, stabilization and rigid fixation of fractures in the pelvis in adult patients.
MAY 3 1 2013
Pelvis II Implant System
Bones Screws Bone Plates
Single/multiple component metallic bone fixation appliances and accessories 21 CFR §888.3030
Class II
HRS: Plate, Fixation, Bone HWC: Screw, Fixation, Bone
Elijah N. Wreh Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: 201-831-5691 Fax: 201-831-4691
1
Indications for Use:
Indications for the Pelvis II Implant System will include fractures of the following regions of the pelvis:
- . Anterior Column
- . Anterior Column combined with posterior hemi-transverse
- . Quadrilateral surface
Summary of Technologies:
Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the following device:
K001614 - Stryker Trauma Pelvic Set , .
Non-Clinical Testing:
Non-clinical laboratory testing was performed for the Pelvis II Implant System components to determine substantial equivalence. Testing demonstrated that the Pelvis II Implant System is substantially equivalent to the predicate device currently cleared for marketing.
The following test was performed:
- Stryker Pelvis II Static and Fatigue Plate Testing .
Clinical Testing:
Clinical testing was not required for this submission:
Conclusion:
The Pelvis II Implant System is substantially equivalent to the predicate device identified in this premarket notification.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: May 31, 2013
Stryker Trauma AG % Mr. Elijah Wreh Regulatory Affairs Specialist 325 Corporate Drive Mahwah. New Jersey 07430
Re: K131132
Trade/Device Name: Pelvis II Implant System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS. HWC Dated: May 1, 2013 Received: May 2, 2013
Dear Mr. Wreh:
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-Gosmetic-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 hability w 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 - Mr. Elijah Wreh
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson -S
Mark N. Melkerson_
-Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if Known): K131132
Device Name: Pelvis II implant System
Indications for Use:
Indications for the Pelvis II implant System will include fractures of the following regions of the pelvis ring:
- 하 Anterior Column
- Anterior Column combined with posterior hemi-transverse #
- Quadrilateral surface .
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (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)
ਜ Page 1 of
Elizabeth L. Frank -S
Division of Orthopedic Devices