(76 days)
Not Found
Not Found
No
The 510(k) summary describes a traditional plating system for bone fixation and does not mention any AI or ML components.
No
The device is an internal fixation system used for reconstruction or arthrodesis of small bones, which is a structural rather than a therapeutic function.
No
Explanation: The device is described as a plating system intended for internal fixation, reconstruction, or arthrodeses of small bones, particularly in the foot and ankle. It is used for surgical procedures like replantation, fracture treatment, and joint fusions. This is a therapeutic device, not one that gathers information for diagnosis.
No
The device description explicitly states it includes "alternate styles of plates and screws including locking plates, bone screws and locking screws," which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "internal fixation, reconstruction or arthrodeses of small bones including the fore, mid- and hind foot and ankle." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as "plates and screws including locking plates, bone screws and locking screws." These are physical implants used in surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological state, health, or disease. This device does not do that.
The Stryker® Foot Plating System is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The Stryker® Foot Plating System is intended for use in internal fixation, reconstruction or arthrodeses of small bones including the fore, mid- and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.
Product codes
87 HRS
Device Description
This submission is a line extension to the Stryker® Plating System to add alternate styles of plates and screws including locking plates, bone screws and locking screws for use in the foot and ankle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot and ankle, fore, mid- and hind foot
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)
Profyle® System, Stryker® Plating System, DARCO Locking Bone Plate System, Synthes LCP Locking Calcaneal Plates and Modular Foot System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary of Safety and Effectiveness Stryker® Foot System
MAR 1 5 2007
| Proprietary Name: | Stryker® Foot Plating System |
|---|---|
| Common Name: | Bone plates and screws |
| Classification Name/Reference: | Single/multiple component metallic bone fixation |
| appliances and accessories, 21 CFR §888.3030 | |
| Device Product Code: | 87 HRS |
| Proposed Regulatory Class: | Class II |
| For Information contact: | Vivian Kelly, Senior Regulatory Affairs Specialist |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-5581 Fax: (201) 831-6038 | |
| Date Summary Prepared: | December 28, 2006 |
Description
This submission is a line extension to the Stryker® Plating System to add alternate styles of plates and screws including locking plates, bone screws and locking screws for use in the foot and ankle.
Indications:
The Stryker® Foot Plating System is intended for use in internal fixation, reconstruction or arthrodeses of small bones including the fore, mid- and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.
Substantial Equivalence:
The subject Stryker® Foot Plating System is substantially equivalent to other plating systems in regards to intended use, design, materials, and operational principles as internal fixation components such as the Profyle® System, Stryker® Plating System, DARCO Locking Bone Plate System, Darco International, Inc. and Synthes LCP Locking Calcaneal Plates and Modular Foot System.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Howmedica Osteonics Corp % Ms. Vivian Kelly Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah, NJ 07430
MAR 1 5 2007
Re: K063875
Trade/Device Name: Stryker Foot Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: December 28, 2006 Received: December 29, 2006
Dear Ms. Kelly:
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.
2
Page 2 - Ms. Vivian Kelly
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/dsma/dsmamain.html
Sincerely yours,
Charbare MuenD
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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Indications for Use
510(k) Number (if known):
Device Name: Stryker® Foot Plating System
Indications for Use:
The Stryker® Foot Plating System is intended for use in internal fixation, reconstruction or arthrodeses of small bones including the fore, mid- and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (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)
Page 1 of 1
Joubare BuemP
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K063875
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