(142 days)
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No
The 510(k) summary describes a mechanical fixation system for ACL reconstruction and does not mention any software, algorithms, or AI/ML capabilities. The performance studies focus on mechanical properties.
Yes
The device is used for fixation of tendons and ligaments during orthopedic reconstruction procedures, which aligns with the definition of a therapeutic device as it treats a medical condition (ACL deficiency).
No
The device is described as a fixation system for orthopedic reconstruction procedures, specifically ACL reconstruction, and does not mention any diagnostic functions.
No
The device description clearly outlines physical components made of PEEK Optima and titanium alloy, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is described as a "two part fixation system for anchoring soft tissue grafts in ACL deficient patients," consisting of screws, sleeves, and a titanium alloy implant. These are physical implants used within the body.
- 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 on samples.
The information provided clearly indicates this is a surgical implant used for structural support within the body, not a diagnostic device that analyzes biological samples.
N/A
Intended Use / Indications for Use
The OrthoPediatrics ACL Reconstruction System is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
Product codes
MBI
Device Description
The OrthoPediatrics ACL Reconstruction System is a two part fixation system for anchoring soft tissue grafts in ACL deficient patients. It is available in diameters of 6mm, 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, & 10mm in order to accommodate differing anatomic requirements. The first system is a screw designed to work in conjunction with a sleeve that has been fitted into the graft tunnel within the bone. Both screw and sleeve components are made entirely of PEEK Optima. The second system consists of a titanium alloy implant intended to hook onto the looped portion of the soft tissue graft and then rest onto the cortex at the end of the graft tunnel.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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DESCRIPTION OF THE TEST SET, SAMPLE SIZE, DATA SOURCE, AND ANNOTATION PROTOCOL
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Static pull out testing as well as dynamic cyclic loading were utilized in order to characterize the mechanical properties of the OrthoPediatrics ACL Reconstruction System. The results demonstrated that the OrthoPediatrics ACL Reconstruction System is substantially equivalent to predicate device performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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
NAME OF FIRM: OrthoPediatrics, Corp. 2850 Frontier Drive Warsaw. IN 46582
DATE PREPARED: June 10, 2013
510(K) CONTACT: Mark Fox Vice President, Regulatory Affairs Tel: (574) 268-6379 ·
MBI
PROPOSED TRADE NAME:
OrthoPediatrics ACL Reconstruction System
Fastner, Fixation, Nondegradable, Soft Tissue
DEVICE CLASSIFICATION:
Class II: 21 CFR 888.3040
CLASSIFICATION NAME: PRODUCT CODE:
DEVICE DESCRIPTION: The OrthoPediatrics ACL Reconstruction System is a two part fixation system for anchoring soft tissue grafts in ACL deficient patients. It is available in diameters of 6mm, 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, & 10mm in order to accommodate differing anatomic requirements. The first system is a screw designed to work in conjunction with a sleeve that has been fitted into the graft tunnel within the bone. Both screw and sleeve components are made entirely of PEEK Optima. The second system consists of a titanium alloy implant intended to hook onto the looped portion of the soft tissue graft and then rest onto the cortex at the end of the graft tunnel.
The OrthoPediatrics ACL Reconstruction System is intended for fixation of tendons and ligaments during orthopedic
INDICATIONS FOR USE: .
MATERIALS:
Titanium Allov per ASTM F136 PEEK Optima per ASTM F2026
Ligament (ACL) Reconstruction.
PREDICATE DEVICES:
EndoButton CL Ultra (Smith & Nephew, K980155) for the loop fixation implant. Arthrex Sheathed Cannulated Interference Screw (Arthrex, K062466) for the screw & sleeve construct.
reconstruction procedures such as Anterior Cruciate
TECHNOLOGIC The fundamental scientific principles and technological CHARACTERISTICS: characteristics, including the intended use, material, and
1
general design, and sizes of the device are the same as, or similar to, the predicate devices. The OrthoPediatrics ACL Reconstruction System possesses a modified technological characteristic in that the femoral component utilizes a sleeve construct in order to prevent off axis screw tracking.
PERFORMANCE DATA:
Static pull out testing as well as dynamic cyclic loading were utilized in order to characterize the mechanical properties of the OrthoPediatrics ACL Reconstruction System. The results demonstrated that the OrthoPediatrics ACL Reconstruction System is substantially equivalent to predicate device performance.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 20, 2013
OrthoPediatrics, Corporation % Mr. Mark Fox Vice President, Regulatory Affairs 2850 Frontier Drive Warsaw. Indiana 46582
Re: K130217
Trade/Device Name: OrthoPediatrics ACL Reconstruction System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: May 15, 2013 Received: May 16, 2013
Dear Mr. Fox:
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
3
Page 2 - Mr. Mark Fox
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/McdicalDevices/Safety/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincercly yours,
Erin I. Keith
For
Mark Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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7 Indications for Use Statement
510(k) Number: K130217
Device Name: OrthoPediatrics ACL Reconstruction System
Indications for Use:
The OrthoPediatrics ACL Reconstruction System is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
Prescription Use______________________________________________________________________________________________________________________________________________________________
AND/OR
Over-the-Counter Use_
(21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices