(242 days)
Not Found
No
The document describes a mechanical plating and screw system for fracture fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
Explanation: The device is indicated for fracture fixation, reconstruction, and arthrodesis, which are direct treatments for medical conditions, classifying it as a therapeutic device.
No
This device is described as a "Pilon Fracture Plating System" designed for "fracture fixation." Its intended use revolves around treating fractures, osteotomies, and non-unions, which falls under therapeutic intervention rather than diagnosis.
No
The device description explicitly states it is a system of titanium alloy plates and screws, 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 describes the device as being used for the surgical fixation of bone fractures and related procedures in the distal tibia and fibula. This is a direct surgical intervention on the patient's body.
- Device Description: The device is described as a system of plates and screws made of titanium alloy, designed to facilitate fracture fixation. These are physical implants used in surgery.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the ORTHOLOC™ 2 system does not involve any such testing of biological samples.
- Performance Studies: The performance studies described are mechanical tests (bend and fatigue) and compatibility tests with a Magnetic Resonance Environment, which are relevant to the physical properties and surgical use of the implants, not to diagnostic testing of biological samples.
Therefore, the ORTHOLOC™ 2 with 3Di Technology Pilon Fracture Plating System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ORTHOLOC™ 2 with 3Di Technology Pilon Fracture Plating System is indicated for complex intra- and extraarticular fractures, osteotomies, and non-unions of the distal tibia, and fracture fixation of the fibula in skeletally mature patients. This includes periarticular stabilization and fixation of fragments in fresh 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, ostectorny, 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.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The subject ORTHOLOC™ 2 with 3Di Technology Pilon Fracture Plating System is designed to facilitate fracture fixation of the fibula and tibia. The system achieves its intended effect through the use of the various titanium alloy (Type II Anodized) straight, anatomical, and contoured plates and both locking and non-locking screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal tibia, fibula
Indicated Patient Age Range
skeletally mature 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)
Comparative, mechanical tested to predicate devices demonstrated substantial equivalence.
Plates were tested per ASTMF382:
. Static Four-Point Bend
. Fatigue Four-Point Bend
Tests Performed per ASTM F2182 to establish compatibility with a Magnetic Resonance
Environment:
RF Heating
Induced Forces .
Induced Torques
. Image Artifact
Engineering Justification for Additional Screw Lengths: by dimensional comparison, the additional screw lengths are substantially equivalent to the predicate screws in ASTM F543
Pyrogencity Analysis: Pyrogen testing was conducted using the bacterial endotoxins test (BET) also known as LAL according to ANSI/AAMI ST72:2011, Bacterial endotoxins – Test methods, routine monitoring and alternatives to batch testing.
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.
K163044, K163039, K082320, K000692, K102429, K120359, K192217
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 8, 2021
Wright Medical Technology, Inc. Anna Hinton Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117
Re: K201259
Trade/Device Name: ORTHOLOC 2 Pilon Fracture 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, HWC Dated: November 23, 2020 Received: November 25, 2020
Dear Anna Hinton:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K201259
Device Name
ORTHOLOC™ 2 with 3Di Technology Pilon Fracture Plating System
Indications for Use (Describe)
The ORTHOLOC™ 2 with 3Di Technology Pilon Fracture Plating System is indicated for complex intra- and extraarticular fractures, osteotomies, and non-unions of the distal tibia, and fracture fixation of the fibula in skeletally mature patients. This includes periarticular stabilization and fixation of fragments in fresh 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, ostectorny, 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.
| 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) |
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Image /page/3/Picture/1 description: The image shows the logo for Wright. The logo consists of two overlapping trapezoids, one red and one orange, followed by the word "WRIGHT" in red, and the words "FOCUSED EXCELLENCE" in gray below. The logo is simple and modern, and the colors are bright and eye-catching.
1023 Cherry Road Memphis, TN 38117 wright.com
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™ 2 with 3Di Technology Pilon Fracture Plating System.
a)(1) MANUFACTURER IDENTIFICATION
| Submitted By: | Wright Medical Technology, Inc.
1023 Cherry Road
Memphis, TN 38117 |
|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | December 22, 2020 |
| Contact Person: | Anna Hinton
Regulatory Affairs Specialist
Office: (901)451-6362 |
| (a)(2) SUBJECT DEVICE INFORMATION | |
| Proprietary Name: | ORTHOLOC™ 2 with 3Di Technology Pilon Fracture
Plating System |
| Common Name:
Classification Name & Reference: | Bone Plate
Single/multiple component metallic bone fixation
appliances and accessories
21 CFR 888.3030 (primary) – Class II
Smooth or threaded metallic bone fixation fastener
21 CFR 888.3040 – Class II |
| Device Product Code & Panel: | HRS - Orthopedic
HWC- Orthopedic |
| (a)(3) PREDICATE DEVICE INFORMATION | |
| ORTHOLOC 3Di Ankle Fracture Plating System
ORTHOLOC 3Di Small Bones Forefoot System
DARCO Small Screw
ORTHOLOC 2.0/2.4 Plate System | K163044 (primary)
K163039 (additional)
K082320 (additional)
K000692 (additional) |
K102429 (additional)
ORTHOLOC 3Di Hallux System K120359 (additional) NCB Plating System Distal Femur and Proximal Tibia K192217 (additional)
ORTHOLOC 3Di Ankle Plating System, ORTHOLOC Bone Screw
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(a)(4) DEVICE DESCRIPTON
The subject ORTHOLOC™ 2 with 3Di Technology Pilon Fracture Plating System is designed to facilitate fracture fixation of the fibula and tibia. The system achieves its intended effect through the use of the various titanium alloy (Type II Anodized) straight, anatomical, and contoured plates and both locking and non-locking screws.
(a)(5) INTENDED USE
The ORTHOLOC™ 2 with 3Di Technology Pilon Fracture Plating System is indicated for complex intraand extra-articular fractures, osteotomies, and non-unions of the distal tibia, and fracture fixation of the fibula in skeletally mature patients. This includes periarticular stabilization of fragments in fresh fractures.
ORTHOLOC™ 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 ORTHOLOC™ 2 with 3Di Technology Pilon Fracture Plating System is manufactured from identical materials (i.e Titanium Alloy) and has identical sterilization methods as the legally marketed predicate device. The subject plates of the system are available in straight, anatomical, and contoured plates in the left and right orientations designed to maintain an anatomical fit across the bone, similar to the predicate plates. In order to achieve the intended effect, the subject and predicate plates and screws are both used to provide stabilization and to facilitate bone fusion. The subject plates are technologically substantially equivalent in material, size and bending strength to the predicate plates. The subject screws only vary in length from the predicate screws and the subject washers are unchanged from the predicate washers.
(b)(1) SUBSTANTIAL EQUIVALENCE - NON-CLINICAL EVIDENCE
The following evaluations were conducted to support the safety and efficacy of the ORTHOLOC™ 2 with 3Di Technology Pilon Fracture Plating System:
Comparative, mechanical tested to predicate devices demonstrated substantial equivalence.
- । Plates were tested per ASTMF382:
- . Static Four-Point Bend
- . Fatigue Four-Point Bend
- Tests Performed per ASTM F2182 to establish compatibility with a Magnetic Resonance । Environment:
- RF Heating
- Induced Forces .
- Induced Torques
- . Image Artifact
5
- Engineering Justification for Additional Screw Lengths: by dimensional comparison, the additional screw lengths are substantially equivalent to the predicate screws in ASTM F543
- -Pyrogencity Analysis: Pyrogen testing was conducted using the bacterial endotoxins test (BET) also known as LAL according to ANSI/AAMI ST72:2011, Bacterial endotoxins – Test methods, routine monitoring and alternatives to batch testing.
(b)(2) SUBSTANTIAL EQUIVALENCE - CLINICAL EVIDENCE N/A
(b)(3) SUBSTANTIAL EQUIVALENCE - CONCLUSIONS
The design characteristics of the subject device do not raise any new types of questions of safety or effectiveness and testing shows no new worst case. 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.