(17 days)
No
The 510(k) summary describes a mechanical plating system for bone stabilization and does not mention any AI/ML components or capabilities.
Yes
The device is used for stabilization of fractures, joint fusion, and bone reconstruction, which are therapeutic interventions.
No
The device is a plating system used for the stabilization of fractures and reconstruction of bones, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components like plates and screws, indicating it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the stabilization of bone fractures, joint fusion, and reconstruction in the feet and ankles. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of plates and screws, which are implants used in surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
Wright's ORTHOLOC® Calcaneal Plating System is intended for use in stabilization of fresh fractures, jount fusion and reconstruction of bones in the feet and ankles. The system can be used in both adult and pediatric patients.
Product codes
HRS
Device Description
The ORTHOLOC® Calcaneal Plating System consists of 2 styles of plates (Tab and Perimeter) and features 3.5mm diameter locking and non-locking screws that range from 10-60mm each. The Tab plates are offered in three different sizes: small, medium, and large, and feature multiple tabs that can be manipulated or cut to accommodate for various patient anatomy. The Perimeter plates come in two sizes: small and large and also feature removable sections. The ORTHOLOC® hole design on the plates allow for the screws to be inserted from either side. This allows each plate to be used in either a right or a left orientation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
feet and ankles
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
Prescription Use
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
Mechanical testing, including Static Bend Testing and Screw through Plate testing, has shown that the performance of the subject plating system is statistically equivalent or greater than the predicate plating system.
Key Metrics
Not Found
Predicate Device(s)
K061808 DARCO® Locking Bone Plate System, K091243 ORTHOLOC® Ankle Plating 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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure. The symbol is composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2014
Wright Medical Technology, Inc. Ms. Jeanine Redden Director, Regulatory Affairs 1023 Cherry Road Memphis, Tennessee 38117
Re: K142121 Trade/Device Name: ORTHOLOC® Calcaneal Plating 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 Dated: July 31, 2014 Received: August 4, 2014
Dear Ms. Jeanine Redden:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Jeanine Redden
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
umber (if known)
510(k) Number (if known)
Device Name
ORTHOLOC® Calcaneal Plating System
Indications for Use (Describe)
Wright's ORTHOLOC® Calcaneal Plating System is intended for use in stabilization of fresh fractures, jount fusion and reconstruction of bones in the feet and ankles. The system can be used in both adult and pediatric patients.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
Headquarters Wright Medical Technology, Inc.
1023 Cherry Road Memphis, TN 38117
01 867.9971 vmt.com
Image /page/3/Picture/3 description: The image shows the Wright logo. The logo consists of two overlapping trapezoids, one red and one orange, to the left of the word "WRIGHT" in red. Below the word "WRIGHT" is the phrase "FOCUSED EXCELLENCE" in a smaller, lighter font. The logo is clean and modern, with a focus on the company name.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the ORTHOLOC® Calcaneal Plating System.
| 1. | Submitted By: | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 | |
|---|---|---|---|
| Date: | August 12, 2014 | ||
| Contact Person: | Jeanine Redden Director, Regulatory Affairs Phone: 901.867.4255 Fax: 901.687.4190 | ||
| 2. | Proprietary Name: | ORTHOLOC® Calcaneal Plating System | |
| Common Name: | Plate, Fixation, Bone | ||
| Classification Name and Reference: | 21 CFR 888.3030- Class II, Single/multiple component metallic bone fixation appliances and accessories | ||
| Device Product Code, Device Panel: | HRS - Orthopedic | ||
| 3. | Predicate Device: | K061808 DARCO® Locking Bone Plate System K091243 ORTHOLOC® Ankle Plating System |
4. Device Description
The ORTHOLOC® Calcaneal Plating System consists of 2 styles of plates (Tab and Perimeter) and features 3.5mm diameter locking and non-locking screws that range from 10-60mm each. The Tab plates are offered in three different sizes: small, medium, and large, and feature multiple tabs that can be manipulated or cut to accommodate for various patient anatomy. The Perimeter plates come in two sizes: small and large and also feature removable sections. The ORTHOLOC® hole design on the plates allow for the screws to be inserted from either side. This allows each plate to be used in either a right or a left orientation.
4
5. Intended Use
Wright's ORTHOLOC® Calcaneal Plating System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of bones in the feet and ankles. The system can be used in both adult and pediatric patients.
6. Technological Characteristics Comparison
The ORTHOLOC® Calcaneal Plating System compared the legally marketed predicate device has limited indications, utilizes similar instrumentation, is made of stronger material, and has identical sterilization methods.
7. Substantial Equivalence- Non-Clinical Evidence
Mechanical testing, including Static Bend Testing and Screw through Plate testing, has shown that the performance of the subject plating system is statistically equivalent or greater than the predicate plating system.
8. Substantial Equivalence- Clinical Evidence
N/A
9. Substantial Equivalence- Conclusions
The design characteristics of the subject devices do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate systems and are substantially equivalent.