(133 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical instruments, with no mention of AI or ML.
No
The device is a surgical plating system for bone fixation, rehabilitation, or replacement, which are considered restorative rather than therapeutic.
No
The device is a surgical plating system used for bone fixation and fusion, not for diagnosing medical conditions.
No
The device description explicitly states that the system consists of bone plates, screws, and manual surgical instruments, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "revision procedures and joint fusion in the small bones of the foot." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device consists of "bone plates, screws and manual, orthopedic, surgical instruments." These are physical implants and tools used in surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
The information provided clearly indicates this is a surgical implant system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Contours Lapidus Plating System is intended for revision procedures and joint fusion in the small bones of the foot.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Contours Lapidus Plating System consists of bone plates, screws and manual, orthopedic, surgical instruments. The plates (left and right versions) are low-profile and anatomically contoured for the 1st metatarsal and cuneiform. Each plate has a trapezoidal screw hole geometry with three angled, threaded holes at both the distal and proximal ends as well as a compression hole for intraoperative compression across the joint. The Contours Lapidus plate and bone screws are made from titanium alloy conforming to ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones of the foot (1st metatarsal and cuneiform bones)
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)
Biomechanical Testing: In order to demonstrate that the Contours Lapidus Plating System has the mechanical properties necessary to perform its intended use and to perform as well as the predicate device, Orthofix has conducted mechanical and functional testing of the Contours Lapidus Plating System. This testing includes bending strength, bending stiffness, fatigue life, screw torque and cadaveric functional testing. The results of the testing demonstrated the Contours Lapidus Plating System to meet or exceed all testing requirements and to perform as well as the predicate device.
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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510(k) SUMMARY
DEC 1 5 2010
| Summary Date: | December 4, 2010 |
|---|---|
| Submitter Data: | Orthofix Inc. |
| 1720 Bray Central Drive | |
| McKinney, TX 75609 | |
| 214-937-2000 | |
| 214-937-2736 (fax) | |
| Primary Contact: | Darla Chew |
| darlachew@orthofix.com | |
| Device Trade Name: | Contours Lapidus Plating System |
| Common Name: | bone plate |
| Classification Name: | Single/multiple component metallic bone fixation appliances and |
| accessories. (21 CFR Parts 888.3030 | |
| Product Code: | HRS |
| Legally Marketed | |
| Predicate Device: | Darco ® Locking Plate System: K061808 / August 17, 2006 |
| Device Description: | The Contours Lapidus Plating System consists of bone plates, |
| screws and manual, orthopedic, surgical instruments. The plates | |
| (left and right versions) are low-profile and anatomically contoured | |
| for the 1st metatarsal and cuneiform. Each plate has a trapezoidal | |
| screw hole geometry with three angled, threaded holes at both the | |
| distal and proximal ends as well as a compression hole for | |
| intraoperative compression across the joint. The Contours Lapidus | |
| plate and bone screws are made from titanium alloy conforming to | |
| ASTM F136. | |
| Indications for Use: | The Contours Lapidus Plating System is intended for revision |
| procedures and joint fusion in the small bones of the foot. | |
| Biomechanical | |
| Testing: | In order to demonstrate that the Contours Lapidus Plating System |
| has the mechanical properties necessary to perform its intended | |
| use and to perform as well as the predicate device, Orthofix has | |
| conducted mechanical and functional testing of the Contours | |
| Lapidus Plating System. This testing includes bending strength, | |
| bending stiffness, fatigue life, screw torque and cadaveric | |
| functional testing. The results of the testing demonstrated the | |
| Contours Lapidus Plating System to meet or exceed all testing | |
| requirements and to perform as well as the predicate device. |
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Technological Characteristics:
The Contours Lapidus Plating System is considered to be substantially equivalent in design, intended use and material to the predicate device. However, there are certain design differences, but these do not raise new questions regarding safety and effectiveness. Refer to the Table of Technological Characteristics for a summary.
| Features | Contours Lapidus Plating System |
|---|---|
| Indications for Use | The Contours Lapidus Plating System is indicated for revision |
| procedures and joint fusion in the small bones of the foot. | |
| Plate/Screw Material | Implant grade Titanium (Ti6A14V ELI) |
| Plate Size | 50mm x 16mm x 2mm |
| (left and right versions) | |
| Plate Geometry | Low-profile, anatomically shaped for 1st metatarsal and cuneiform |
| bones. | |
| Fixation Method, | |
| Screw Holes | Trapezoidal screw hole placement. Three in proximal end, three in |
| distal end plus compression hole. | |
| Screw Type | Low profile, locking, non-locking and compression |
| Screw Length | Locking and non-locking screws: 12mm to 32mm lengths (in 2mm |
| increments); compression screws are offered in sizes ranging from | |
| 16mm to 20mm lengths (in 2mm increments), 25mm to 40mm lengths | |
| in 5mm increments, and 42mm to 50mm lengths (in 2 mm increments) |
Sterilization:
The Contours Lapidus Plating System components are supplied NON-STERILE and require sterilization prior to use.
Substantial Equivalence:
Substantial equivalence is based upon design, dimension, material characterization, and biomechanical testing of thre device in companson to the predicate. The Contours Lapidus Plating System is substantially equivalent in design and function to the Darco Locking Plate System which was cleared under K061808 / August 17, 2006.
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Image /page/2/Picture/1 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 fashion around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 1 5 2010
Orthofix, Inc. % Ms. Mary E. Biggers, RAC Regulatory Affairs Consultant 1720 Bray Central Drive McKinney, Texas 75069
Re: K102201
Trade/Device Name: Contours Lapidus Plating System (bone plate) 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: December 4, 2010 Received: December 8, 2010
Dear Ms. Biggers:
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
3
Page 2 - Ms. Mary E. Biggers, RAC
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.
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/ucm11.5809.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,
Ais B. Rto
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use Statement
Page ___ of
510(k) Number (if known):
Device Name:
Contours Lapidus Plating System (bone plate)
Indications for Use:
The Contours Lapidus Plating System is intended for revision procedures and joint fusion in the small bones of the foot.
Prescription Use: (Per 21 CFR 801.109)
Over-The-Counter (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Or
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) for M. Mellekson
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102201