(17 days)
Not Found
No
The 510(k) summary describes a system of bone plates and screws for fracture fixation. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The performance studies focus on mechanical properties and equivalence to predicate devices.
No
The device is described as an ankle plating system and screws intended for fixation of fractures, osteotomies, and non-unions, which are used to stabilize and repair bone, not to provide therapy.
No
The device is an ankle plating system and associated screws intended for 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 explicitly states that the device includes physical components (screws) manufactured from titanium alloy, which are hardware.
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 is a surgical implant used in vivo (within the body) for structural support and repair.
- Device Description: The device is described as screws and plates manufactured from titanium alloy, intended for single use. This aligns with the description of a surgical implant.
- 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. IVDs are typically reagents, instruments, or systems used for testing these types of samples.
Therefore, the Wright's ORTHOLOC™ 3Di Ankle Plating System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Ankle Plates:
Wright's ORTHOLOC™ 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 ORTHOLOCTM 3Di Plating Systems of the same base material.
ORTHOLOCTM 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)
HWC, HRS
Device Description
The ORTHOLOC™ 3Di Locking Screws subject to this premarket notification include the 2.7mm diameter-26, 28, and 30mm length locking screws. The ORTHOLOC™ Bone Screws subject to this premarket notification include the non-locking 2.7mm low profile bone screws. All screws are manufactured from titanium alloy and have a solid core. The implants are single use only devices.
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)
Substantial equivalence is shown through comparison of design characteristics, materials information, worst-case analyses, and ultimate, insertion, and removal torque testing. The results show that the subject screws can be expected to perform at least as well as the legally marketed predicate screws.
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.
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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K 120802 (113) APR - 2 2012
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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 URTHOLOC™ 3Di Locking Screws and ORTHOLOCTM Bone Screws.
A.1. Submitted By:
Date:
Contact Person:
Wright Medical Technology, Inc. 5677 Airline Rd Arlington, TN 38002
March 15, 2012
Sarah Holtgrewe Regulatory Affairs Project Specialist (901) 867-4476
A.2. Proprietary Name:
Common Name:
Device Classification Regulation:
Device Product Code & Panel:
A.3. Predicate Devices:
ORTHOLOC™ 3Di Locking Screws & ORTHOLOCTM Bone Screws
Locking Plate Screw & Bone Screw
21 CFR 888.3040-Class II
HWC: Screw, Fixation Bone HRS: Plate, Fixation, Bone 87 Orthopedics
K102429—ORTHOLOC™ 3Di Ankle Plating and ORTHOLOCTM System Bone Screws K112772—ORTHOLOC™ Bone Screws --Modification
A.4. Device Description
The ORTHOLOC™ 3Di Locking Screws subject to this premarket notification include the 2.7mm diameter-26, 28, and 30mm length locking screws. The ORTHOLOC™ Bone Screws subject to this premarket notification include the non-locking 2.7mm low profile bone screws. All screws are manufactured from titanium alloy and have a solid core. The implants are single use only devices.
1
K120802(2/3)
Image /page/1/Picture/1 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a stylized graphic that appears to be a stylized letter "W". The graphic is composed of two thick, horizontal lines that converge towards the center, creating a sense of depth and movement. The overall design is clean and modern, with a focus on simplicity and visual impact.
A.5. Intended Use
Ankle Plates:
Wright's ORTHOLOC™ 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™ 3D iLocking Screws:
The ORTHOLOC™ 3Di locking screws are intended for use with Wright's ORTHOLOCTM 3Di Plating Systems of the same base material.
ORTHOLOCTM 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 subject 2.7mm locking screws are identical to the predicate 2.7mm locking screws with the exception of screw length. The subject 2.7mm bone/non-locking screws have an identical low-profile head and neck as the predicate 3.5 mm low-profile non-locking bone screws and identical thread form as the predicate 2.7mm locking screw.
B.1. Substantial Equivalence - Non-Clinical Evidence
Substantial equivalence is shown through comparison of design characteristics, materials information, worst-case analyses, and ultimate, insertion, and removal torque testing. The
headquarters Wright Medical Technology, Inc
Arlington, TN 38002
2
Image /page/2/Picture/1 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a stylized design that appears to be two horizontal lines that are angled slightly upwards. The design is black and white, and the word "WRIGHT." is also black and white.
results show that the subject screws can be expected to perform at least as well as the legally marketed predicate screws.
B.2. Substantial Equivalence - Clinical Evidence
N/A-clinical evidence not required
B.3. Substantial Equivalence - Conclusions
Substantial equivalence is shown through design characteristics, materials information, worst-case analysis, and ultimate, insertion, and removal torque testing, The subject locking screws are identical in indication for use, and all dimensional characteristics except screw length. The subject bone screws have an identical low-profile head and neck as the predicate 3.5 mm low-profile non-locking bone screws and identical thread form as the predicate 2.7mm locking screws. No new types of safety and effectiveness questions can be expected. From the evidence given in the Premarket Notification, the subject devices can be expected to perform at least as well as the predicate devices.
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Image /page/3/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Incorporated % Ms. Sarah Holtgrewe Regulatory Affairs Project Specialist 5677 Airline Road Arlington, Tennessee 38002
APR - 2 2012
Re: K120802
Trade/Device Name: ORTHOLOC™ 3Di Locking Screws & ORTHOLOC™ Bone Screws Regulation Number: 21 CFR 888.3040
Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HRS, HWC
Dated: March 15, 2012
Received: March 16, 2012
Dear Ms. Holtgrewe:
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 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.
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Page 2 – Ms. Sarah Holtgrewe
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Mark N. Melkerson
for Peter
Dan Cur
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K120802
Device Name: ORTHOLOC™ 3Di Locking Screws & ORTHOLOC™ Bone Screws
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
The 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.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
D. Ovens
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120802
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