(87 days)
No
The document describes a system of bone plates and screws for orthopedic fixation and does not mention any software, algorithms, or AI/ML capabilities.
No.
A therapeutic device is typically one that delivers a substance or energy to treat a disease or condition, or directly restores a function. This device is an implantable plate system designed for stabilization and fixation of bones, which is a structural support and not a direct therapeutic function in the classic sense.
No
The device is an orthopedic implant system (plates and screws) used for stabilization and fixation of bones, not for diagnosing conditions.
No
The device description explicitly states it is a system of 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:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The ORTHOLOC™ 3Di Hallux System is described as a system for stabilization and fixation of bones in the feet and toes. It involves plates and screws used in surgical procedures.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze biological samples or provide diagnostic information about a patient's condition based on such analysis. Its function is purely mechanical support and fixation within the body.
Therefore, the ORTHOLOC™ 3Di Hallux System is a surgical implant/device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ORTHOLOC™ 3Di Hallux System is intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of bones of the feet and toes. Specific examples include:
- First metatarsal osteotomies for hallux valgus correction including:
- Opening base wedge osteotomy
- Closing base wedge osteotomy
- Crescentic osteotomy
- Proximal Chevron osteotomy
- Distal Chevron osteotomy (Austin)
- First metatarsal fracture fixation
- Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
- Arthrodesis of the first metatarsophalangeal joint (MTP) including:
- Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
- Revision MTP Fusion
- Revision of failed first MTP Arthroplasty implant
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
Wright Medical's ORTHOLOC™ 3Di Hallux System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of bones of the feet and toes. The subject plates are modified from the DARCO Locking Bone Plate System (K061808). The system contains 33 plates belonging to 1 of 4 plate styles with various sizes and options, each contoured for specific anatomy and designed for specific procedures. All plates feature polyaxial locking screw holes and k-wire holes, and some plates have nonlocking compression slots. The plates are made from titanium alloy conforming to ASTM F136 or ISO 5832-3 and accept 2.7 mm and 3.5 mm locking and non-locking screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
feet and toes (Specifically, first metatarsal, first metatarsalcuneiform joint, and first metatarsophalangeal joint.)
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing supports the effectiveness of the new locking feature and the new screw and shows that no new worst-case plates (in bending) are introduced in this system. The subject plate locking mechanism evaluated in this testing was found to be acceptable for offaxis mechanical screw locking up to three times as compared to a non-locking screw. Torque testing was performed on the subject 2.7 mm non-locking screw and results exceeded the minimum safety factor. Through mechanically validated FEA analysis, the worst-case subject ORTHOLOC™ 3Di plates were found not to represent a new worst-case in bending for any of the four plate families evaluated.
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.
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
K120359 (pg 1/2)
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
MAY - 3 2012
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 ORTHOLOC™ 3Di Hallux System.
| (a)(1). Submitted By: | Wright Medical Technology, Inc.
5677 Airline Road
Arlington, TN 38002 |
|------------------------------------|-----------------------------------------------------------------------------|
| Date: | February 2, 2012 |
| Contact Person: | Leslie Fitch
Regulatory Affairs Specialist
(901) 867-4120 |
| (a)(2). Proprietary Name: | ORTHOLOC™ 3Di Hallux System |
| Common Name: | Bone Plate System |
| Classification Name and Reference: | 21 CFR 888.3030 - Class II |
| Device Product Code, Device Panel: | HRS: Orthopedic |
| (a)(3). Predicate Device: | K061808 - DARCO Locking Bone Plate
System |
(a)(4). Device Description
Wright Medical's ORTHOLOC™ 3Di Hallux System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of bones of the feet and The subject plates are modified from the DARCO Locking Bone Plate System toes. (K061808). The system contains 33 plates belonging to 1 of 4 plate styles with various sizes and options, each contoured for specific anatomy and designed for specific procedures. All plates feature polyaxial locking screw holes and k-wire holes, and some plates have nonlocking compression slots. The plates are made from titanium alloy conforming to ASTM F136 or ISO 5832-3 and accept 2.7 mm and 3.5 mm locking and non-locking screws.
(a)(5). Intended Use
The ORTHOLOC™ 3Di Hallux System is intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of bones of the feet and toes. Specific examples include:
- First metatarsal osteotomies for hallux valgus correction including: .
- Opening base wedge osteotomy .
- Closing base wedge osteotomy .
- Crescentic osteotomy .
- . Proximal Chevron osteotomy
- Distal Chevron osteotomy (Austin) .
- First metatarsal fracture fixation .
1
- Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion) .
- Arthrodesis of the first metatarsophalangeal joint (MTP) including: .
- Primary MTP Fusion due to hallux ridgidus and/or hallux valgus .
- Revision MTP Fusion .
- Revision of failed first MTP Arthroplasty implant .
The indications statement has been tailored to the intended use of the subject device, which has fewer plates than the predicate system. The bones of the hand, wrist, ankles, and fingers included in the predicate indications statement are omitted from the indications for this system, because this system includes only plates designed for hallux procedures. The indications statement has also been modified to include specific procedures for which the system is designed. The addition of these specific examples of osteotomies and arthrodeses does not alter the intended therapeutic effect of the subject device. These specific procedures have been evaluated for safety and effectiveness through a clinical literature review.
(a)(6). Technological Characteristics Comparison
While many of the technological characteristics are the same for the subject device system and the predicate, some design changes have been made. The subject plates have a new polyaxial locking feature that offers locking up to 15° off-axis. The subject's locking feature is similar to the locking feature for ORTHOLOC"™ 3Di Ankle Plating System (K102429), but has been modified for the thinner plates of this system. The subject BOW and 18 Metatarsal plates are made from titanium alloy (TigAlaV), while the corresponding predicate plates are commercially pure titanium. The titanium alloy is a stronger material.
(b)(1). Substantial Equivalence - Non-Clinical Evidence
Performance testing supports the effectiveness of the new locking feature and the new screw and shows that no new worst-case plates (in bending) are introduced in this system. The subject plate locking mechanism evaluated in this testing was found to be acceptable for offaxis mechanical screw locking up to three times as compared to a non-locking screw. Torque testing was performed on the subject 2.7 mm non-locking screw and results exceeded the minimum safety factor. Through mechanically validated FEA analysis, the worst-case subject ORTHOLOC™ 3Di plates were found not to represent a new worst-case in bending for any of the four plate families evaluated.
(b)(2). Substantial Equivalence - Clinical Evidence
N/A
(b)(3). Substantial Equivalence - Conclusions
The new design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. Performance testing supports the effectiveness of the new locking feature and the new screw and shows that no new worst-case plates (in bending) are introduced in this system. From the evidence submitted in this 510(k) the subject device system can be expected to perform at least as well as the predicate system.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is in a sans-serif font. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY - 3 2012
Wright Medical Technology, Inc. % Ms. Leslie Fitch 5677 Airline Rd. Arlington, TN 38002
Received: February 6, 2012
Re: K120359
Trade/Device Name: ORTHOLOC™ 3Di Hallux 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: February 2, 2012
Dear Ms. Fitch:
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 I lease be advisou has i br mination that your device complies with other requirements of the Act that I Dr Has Intatutes and regulations administered by other Federal agencies. You must or any I cacial statutes and equirements, including, but not limited to: registration and listing (21 Comply with an the Fee oreagence of the Part 801); medical device reporting of medical
3
Page 2 - Ms. Leslie Fitch
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de rice-related adverse overal) (2) 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 n you 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 note the regulations 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 Tou may 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Ase Lm^m
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K120359 (pg. 1/1)
Indications for Use Statement
510(k) Number (if known): Not yet assigned.
Device Name: ORTHOLOC™ 3Di Hallux System
Indications for Use:
The ORTHOLOC™ 3Di Hallux System is intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of bones of the feet and toes. Specific examples include:
- First metatarsal osteotomies for hallux valgus correction including:
- Opening base wedge osteotomy O
- Closing base wedge osteotomy 0
- Crescentic osteotomy O
- Proximal Chevron osteotomy o
- Distal Chevron osteotomy (Austin) 0
- First metatarsal fracture fixation
- Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
- Arthrodesis of the first metatarsophalangeal joint (MTP) including:
- · Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
- Revision MTP Fusion O
- Revision of failed first MTP Arthroplasty implant O
X Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Asb
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K120359