(60 days)
Not Found
No
The summary describes a mechanical orthopedic implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is intended for stabilization and fixation of bones, including joint fusion (Arthrodesis), which are therapeutic interventions.
No
The device is described as a system for stabilization and fixation of bones, particularly for arthrodesis, which is a surgical procedure, not a diagnostic one.
No
The device description explicitly states the system uses "plates of various designs and both locking and non-locking screw configurations," 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 states the device is for "stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of bones of the feet and toes." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details the use of "plates of various designs and both locking and non-locking screw configurations," which are components of a surgical fixation system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (in glass, or outside the body) to analyze biological samples. This device is used in vivo (in the living body) for surgical fixation.
N/A
Intended Use / Indications for Use
The ORTHOLOC™ 2 Lapidus with Rotation 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: Arthrodesis of the first metatarsal-cuneiform joint (Lapidus Fusion).
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The ORTHOLOC™ 2 Lapidus with Rotation System is designed to facilitate arthrodesis of the first metatarsal-cuneiform joint, or Lapidus fusion. The system achieves its intended effect through the use of plates of various designs and both locking and non-locking screw configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones of the feet and toes; first metatarsal-cuneiform joint
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)
The following evaluations were conducted to support the safety and efficacy of the ORTHOLOC™ 2 Lapidus with Rotation System
- Static Four-Point Bend Testing per ASTM F382 l
- Pyrogencity Analysis per ANSI/AAMI ST72:2011
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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Image /page/0/Picture/0 description: The image shows the date May 14, 2019. The month is spelled out, followed by the day and year. The text is in a clear, sans-serif font and is easy to read. The date is likely extracted from a document or image.
FDA U.S. FOOD & DRUG
ADMINISTRATION
Wright Medical Technology, Inc. Alayne Melancon Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117
Re: K190670
Trade/Device Name: ORTHOLOC 2 Lapidus with Rotation 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: March 11, 2019 Received: March 15, 2019
Dear Alayne Melancon:
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.
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Assistant Director THT6C2: Fracture Fixation and Stereotaxic Devices Team DHT6C: Division of Stereotaxic. Trauma and Restorative Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K190670
Device Name ORTHOLOC™ 2 Lapidus with Rotation System
Indications for Use (Describe)
The ORTHOLOC™ 2 Lapidus with Rotation 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: Arthrodesis of the first metatarsal-cuneiform joint (Lapidus Fusion).
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 Wright logo. The logo consists of two overlapping trapezoids, one red and one orange, on the left side. To the right of the trapezoids is the word "WRIGHT" in red, with a small trademark symbol next to it. Below the word "WRIGHT" is the phrase "FOCUSED EXCELLENCE" in a smaller, gray font.
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 Lapidus with Rotation System.
(a)(1) MANUFACTURER IDENTIFICATION
| Submitted By: | Wright Medical Technology, Inc.
1023 Cherry Road
Memphis, TN 38117 |
|-----------------|-------------------------------------------------------------------------------------------------|
| Date: | May 13, 2019 |
| Contact Person: | Alayne Melancon
Regulatory Affairs Specialist
Office: (901)290-5986
Fax: (901)867-4190 |
(a)(2) SUBJECT DEVICE INFORMATION
| Proprietary Name: | ORTHOLOC™ 2 Lapidus with Rotation System |
|---|---|
| Common Name: | Bone Plate |
| Classification Name & Reference: | Single/multiple component metallic bone fixation |
| appliances and accessories - 21 CFR 888.3030 – Class II | |
| Device Product Code & Panel: | HRS - Orthopedic |
(a)(3) PREDICATE DEVICE INFORMATION
ORTHOLOC™ 3Di Hallux System K120359
(a)(4) DEVICE DESCRIPTON
The ORTHOLOC™ 2 Lapidus with Rotation System is designed to facilitate arthrodesis of the first metatarsal-cuneiform joint, or Lapidus fusion. The system achieves its intended effect through the use of plates of various designs and both locking and non-locking screw configurations.
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(a)(5) INTENDED USE
The ORTHOLOC™ 2 Lapidus with Rotation 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: Arthrodesis of the first metatarsal-cuneiform joint (Lapidus Fusion).
(a)(6) TECHNOLOGICAL CHARACTERISTICS COMPARISON
The ORTHOLOC™ 2 Lapidus with Rotation 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 both large and standard, left and right orientations, and are designed with plantar steps to maintain an anatomical fit across the joint for varying amounts of correction.
(b)(1) SUBSTANTIAL EQUIVALENCE - NON-CLINICAL EVIDENCE
The following evaluations were conducted to support the safety and efficacy of the ORTHOLOC™ 2 Lapidus with Rotation System
- Static Four-Point Bend Testing per ASTM F382 l
- -Pyrogencity Analysis per ANSI/AAMI ST72:2011
(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.