(33 days)
K 102429
No
The description focuses on the mechanical components and materials of the plating system and screws, with no mention of AI or ML capabilities.
No.
The device is an orthopedic implant system designed to fix fractures, osteotomies, and non-unions of the distal tibia and fibula, which is a structural and mechanical support, not a therapeutic agent that treats or cures a disease.
No
This device is an orthopedic implant system designed for the fixation of fractures and other bone injuries. It does not perform any diagnostic functions.
No
The device description clearly states the system contains plates, screws, and washers made from titanium alloy, 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 describes the device as being used for the fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device description details plates, screws, and washers made from titanium alloy, designed for surgical implantation to stabilize bone.
- 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) for structural support and fixation.
N/A
Intended Use / Indications for Use
Wright's ORTHOLOC® 3Di Ankle Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as:
- Lateral Malleolar Fractures
- Syndesmosis injuries
- Medial Malleolar Fractures
- Bi-Malleolar Fractures
- Tri-Malleolar Fractures
- Posterior Malleolar Fractures
- Distal Anterior Tibia Fractures
- Vertical Shear Fractures of the Medial Malleolous
- Pilon Fractures
- Distal Tibia Shaft Fractures
- Distal Fibula Shaft Fractures
- Distal Tibia Periarticular Fractures
- Medial Malleolar Avulsion Fractures
- Lateral Malleolar Avulsion Fractures
ORTHOLOC® 3Di Locking Screws:
The ORTHOLOC® 3Di locking screws are intended for use with Wright's ORTHOLOC® 3Di Plating Systems of the same base material.
ORTHOLOC® Bone Screws:
ORTHOLOC® Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Washer
Wright's washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of bone fragments.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The ORTHOLOC® 3Di .Ankle Plating System contains plates belonging to 1 of 2 general categories-distal tibia and fibula-based on the contouring of each plate: All plates feature polyaxial locking screw holes. Some plates have k-wire holes, compression slots, or syndesmosis slots. The plates are made from titanium alloy and accept 2.7mm ORTHOLOC® 3Di locking screws. 2.7mm. 3.5mm and 4.0mm ORTHOLOC® Bone Screws, and 4.0mm Wright™ Compression Screws (cleared under K082320, now branded DART-FIRE®). Washers are also available for use with the ORTHOLOC® Bone Screws.
The design features of the ORTHOLOC® 3Di Ankle Plating System - Line Addition are substantially equivalent to the design features of the predicate ORTHOLOC® 3Di Ankle Plating System
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal tibia and fibula
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)
Non-Clinical Evidence: Through mechanical analysis the new plates do not represent a new worst-case.
Clinical Evidence: N/A
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.
K 102429
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.
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.
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K131093 page 1 of 2
Create Motion.® WRIC
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® 3Di Ankle Plating System.
Wright Medical Technology, Inc. (a)(1). Submitted By: 5677 Airline Road Arlington, TN 38002 April 17, 2013 Date: Ryan Bormann Contact Person: Regulatory Affairs Specialist II Office - (901) 867-4409 Fax - (901) 867-4190 (a)(2). Proprietary Name: ORTHOLOC® 3Di Ankle Plating System Bone Plate System Common Name: 21 CFR 888.3030 - Class II Classification Name and Reference: HRS: Plate, Fixation Bone Device Product Code, Device Panel: (a)(3). Predicate Device: K 102429 ORTHOLOC® 3Di Ankle Plating System
(a)(4). Device Description .
4
The ORTHOLOC® 3Di .Ankle Plating System contains plates belonging to 1 of 2 general categories-distal tibia and fibula-based on the contouring of each plate: All plates feature polyaxial locking screw holes. Some plates have k-wire holes, compression slots, or syndesmosis slots. The plates are made from titanium alloy and accept 2.7mm ORTHOLOC® 3Di locking screws. 2.7mm. 3.5mm and 4.0mm ORTHOLOC® Bone Screws, and 4.0mm Wright™ Compression Screws (cleared under K082320, now branded DART-FIRE®). Washers are also available for use with the ORTHOLOC® Bone Screws.
The design features of the ORTHOLOC® 3Di Ankle Plating System - Line Addition are substantially equivalent to the design features of the predicate ORTHOLOC® 3Di Ankle Plating System
(a)(5). INTENDED USE
Ankle Plates:
Wright's ORTHOLOC® 3Di Ankle Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as:
| headquarters | ||
|---|---|---|
| Wright Medical Technology, Inc. | 5677 Airline Road | wmt.com |
で、この上、このことになっていました。 この日には、このため、この時には、このため、この時には、この時には、この時には、いつでも、このと、あり、このことになるので、
A | - |
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K131093 page 2 of 2
- Lateral Malleolar Fractures
- Syndesmosis injuries .
- Medial Malleolar Fractures ●
- Bi-Malleolar Fractures .
- Tri-Malleolar Fractures ●
- Posterior Malleolar Fractures �
- Distal Anterior Tibia Fractures ●
- Vertical Shear Fractures of the Medial Malleolous .
- Pilon Fractures .
- Distal Tibia Shaft Fractures �
- Distal Fibula Shaft Fractures .
- Distal Tibia Periarticular Fractures .
- Medial Malleolar Avulsion Fractures
- Lateral Malleolar Avulsion Fractures ●
ORTHOLOC® 3Di Locking Screws:
The ORTHOLOC® 3Di locking screws are intended for use with Wright's ORTHOLOC® 3Di Plating Systems of the same base material.
ORTHOLOC® Bone Screws:
ORTHOLOC® Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Washer
Wright's washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of bone fragments.
(a)(6). Technological Characteristics Comparison
The ORTHOLOC® 3Di Ankle Plating System - Line Addition and the legally marketed predicate ORTHOLOC® 3Di Ankle Plating System have identical indications, utilize the same instrumentation, and are identical in material, sterilization methods, and selection.
(b)(1). Substantial Equivalence - Non-Clinical Evidence
Through mechanical analysis the new plates do not represent a new worst-case. ●
(b)(2). Substantial Equivalence - Clinical Evidence
N/A
(b)(3). Substantial Equivalence - Conclusions
The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject line addition can be expected to perform at least as well as the predicate systems.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms. The logo is printed in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 21, 2013
Wright Medical Technology, Incorporated % Mr. Ryan Bormann Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002
Re: K131093
Trade/Device Name: ORTHOLOC® 3Di APS - Straight Tubular Plates 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: April 17, 2013 Received: April 23, 2013
Dear Mr. Bormann:
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 ffor 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
3
Page 2 - Mr. Ryan Bormann
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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/3/Picture/8 description: The image shows the name "Erin D. Keith" in a stylized font. The first name, "Erin," is in a simple, bold typeface. The middle initial "D" is enclosed in a decorative, geometric shape. The last name, "Keith," is also in a bold font, with some decorative elements.
For
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): K131093
page 1 of 2 ·
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Device Name: ORTHOLOC® 3Di APS - Straight Tubular Plates
Indications For Use:
Wright's ORTHOLOC® 3Di Ankle Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as:
- . Lateral Malleolar Fractures
- Syndesmosis injuries .
- Medial Malleolar Fractures �
- Bi-Malleolar Fractures .
- Tri-Malleolar Fractures .
- Posterior Malleolar Fractures .
- Distal Anterior Tibia Fractures ●
- Vertical Shear Fractures of the Medial Malleolous .
- . Pilon Fractures
- Distal Tibia Shaft Fractures .
- Distal Fibula Shaft Fractures .
- Distal Tibia Periarticular Fractures .
- Medial Malleolar Avulsion Fractures .
- . Lateral Malleolar Avusion Fractures
ORTHOLOC® 3Di Locking Screws:
The ORTHOLOC® 3Di locking screws are intended for use with Wright's ORTHOLOC® 3Di Plating Systems of the same base material.
ORTHOLOC® Bone Screws:
ORTHOLOC® Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Washer
Wright's washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of bone fragments.
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K131093 page 2 of 2
Prescription Use _ xxx (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 IF NEEDED) . . · ·
Elizabet标订%Erank -S
Division of Orthopedic Devices
Concurrence of CDRH, Office of Device Evaluation (ODE) 1 of 1
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