(87 days)
Not Found
No
The description focuses on the mechanical components and materials of a bone plating system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is intended for the fixation of fractures, osteotomies, and non-unions, which are therapeutic interventions.
No
This device is an ankle fracture plating system, which is a surgical implant used for the fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula. It is a treatment device, not a diagnostic one.
No
The device description clearly states it consists of physical plates and screws made from titanium alloy, which are 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 that the device is for the "fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula." This describes a surgical implant used to stabilize bones.
- Device Description: The description details plates, screws, and washers made from titanium alloy, which are components of a surgical implant system.
- 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) 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® 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 Malleolus
- · 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 are intended for use with Wright's ORTHOLOC® 3Di Plating Systems of the same base material.
ORTHOLOC™ Bone Screws are indicated for use in bone reconstruction, orthrodesis, joint fusion, fracture repar, and fracture fixation, appropriate for the size of the device.
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, HWC
Device Description
The ORTHOLOC® 3Di Ankle Plating System consists of plates belonging to 1 of 2 general categories-distal tibia and fibula-based on the contouring of each plate. All plates feature poly-axial locking screw holes while some plates feature compression slots. The plates are made from titanium alloy and are compatible with 2.7mm and 3.5mm ORTHOLOC® 3Di locking screws, 3.5mm and 4.0mm ORTHOLOC® Bone Screws, and 4.0mm Wright Compression Screws.
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)
Performance testing, engineering analysis and rationale was performed to demonstrate substantial equivalence in static and fatigue bending strength. An engineering analysis was performed for the subject device screws to demonstrate substantial equivalence with respect to insertion/removal torque, pull-out strength and torsional strength, and bending strength.
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.
K131093, K102429, K073460, K000684
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure embracing a bird, which is a symbol of care and protection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Janaury 26, 2017
Wright Medical Technology, Inc. Val Myles Regulatory Affairs Specialist 1023 Cherry Road Memphis. TN 38117
Re: K163044 Trade/Device Name: ORTHOLOC® 3Di Ankle Fracture 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: October 21, 2016 Received: October 31, 2016
Dear Ms. Val Myles:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
ORTHOLOC® 3Di Ankle Fracture Plating System
Indications for Use (Describe)
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 Malleolus
- · 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 are intended for use with Wright's ORTHOLOC® 3Di Plating Systems of the same base material.
ORTHOLOC™ Bone Screws are indicated for use in bone reconstruction, orthrodesis, joint fusion, fracture repar, and fracture fixation, appropriate for the size of the device.
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
|× 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
901 867 9971 mt.com
K163044
510(K) SUMMARY
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 Fracture Plating System.
Wright Medical Technology, Inc. (a)(1). Submitted By:
| | 1023 Cherry Road
Memphis, TN 38117 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Date: | October 21, 2016 |
| Contact Person: | Val Myles
Regulatory Affairs Specialist
Office - (901) 290-5162
Fax - (901) 867-4190 |
| (a)(2). Proprietary Name: | ORTHOLOC® 3Di Ankle Fracture Plating System |
| Common Name: | Plate, Fixation, Bone
Screw, Fixation, Bone |
| Classification Name and Reference: | 21 CFR 888.3030 - Class II
21 CFR 888.3040 - Class II |
| Device Product Code, Device Panel: | HRS - Orthopedic
HWC - Orthopedic |
| (a)(3). Predicate Device: | ORTHOLOC® 3Di Ankle Fracture: K131093
K102429
Synthes LCP Distal Fibula Plates: K073460
Synthes Small Fragment DCL: K000684 |
(a)(4). Device Description
The ORTHOLOC® 3Di Ankle Plating System consists of plates belonging to 1 of 2 general categories-distal tibia and fibula-based on the contouring of each plate. All plates feature poly-axial locking screw holes while some plates feature compression slots. The plates are made from titanium alloy and are compatible with 2.7mm and 3.5mm ORTHOLOC® 3Di locking screws, 3.5mm and 4.0mm ORTHOLOC® Bone Screws, and 4.0mm Wright Compression Screws.
4
K163044
(a)(5). INTENDED USE
Wright's ORTHOLOC® 3Di Ankle Fracture 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 Malleolus
- 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 are intended for use with Wright's ORTHOLOC® 3Di Plating Systems of the same base material.
ORTHOLOC™ Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
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 subject devices included in ORTHOLOC® 3Di Ankle Fracture Plating System are technologically substantially equivalent to predicate devices in material, size, and bending strength.
(b)(1). Substantial Equivalence - Non-Clinical Evidence
Performance testing, engineering analysis and rationale was performed to demonstrate substantial equivalence in static and fatigue bending strength. An engineering analysis was performed for the subject device screws to demonstrate substantial equivalence with respect to insertion/removal torque, pull-out strength and torsional strength, and bending strength.
(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 devices can be expected to perform at least as well as the predicate devices.