(55 days)
The OP Spine System is intended for posterior, non-cervical fixation (pedicle screw fixation T1-S2/ilium and hook fixation (T1-L5) in pediatric patients is indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. The device is intended to be used with autograft and/or allograft.
The OP Spine System consists of longitudinal members (rods), anchors (hooks and screws), interconnection components (rod-to-rod and anchor-to-rod connectors) and fasteners in a variety of sizes to accommodate differing anatomic requirements.
This document describes the OrthoPediatrics (OP) Spine System, a spinal fixation device intended for pediatric patients. It's a Special 510(k) submission, which means it's claiming substantial equivalence to a previously cleared predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate device) | Reported Device Performance (OP Spine System) |
|---|---|
| Torsional grip performance (based on ASTM F1798) | Demonstrated equivalence to the predicate device. |
| Dynamic compression bending performance (based on ASTM F1717) | Demonstrated equivalence to the predicate device. |
Note: Since this is a Special 510(k) claiming substantial equivalence to an existing device (OP Spine System [K120291]), the acceptance criteria for the new device are directly tied to demonstrating performance equivalent to the predicate. The document states that the fundamental scientific principles, technological characteristics, intended use, material, general design, and sizes are the same as the predicate device.
2. Sample Size and Data Provenance
The document does not specify the sample size used for the performance tests.
The data provenance is not explicitly stated. However, given that it's a submission to the FDA for a US medical device, the testing would typically be conducted according to internationally recognized standards (ASTM in this case), and the results presented to the FDA. The nature of the tests (mechanical testing) suggests a laboratory setting, not patient data.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This submission concerns mechanical performance testing of a physical device, not an AI or imaging system requiring expert interpretation or ground truth establishment by medical professionals.
4. Adjudication Method
Not applicable. Mechanical testing does not involve adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI-assisted diagnostic or therapeutic device that would involve human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical medical device (spine system), not an algorithm.
7. Type of Ground Truth Used
The "ground truth" in this context refers to the established mechanical testing standards (ASTM F1798 and ASTM F1717) and the performance characteristics of the predicate device. The performance of the new device is compared directly to these established benchmarks.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that involves training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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OrthoPediatrics Spine System: Special 510(k)
K121250 loge 1/
| Attachment 4. | JUN 19 2012 |
|---|---|
| 510(k) Summary | |
| NAME OF FIRM: | OrthoPediatrics, Corp.2850 Frontier DriveWarsaw, IN 46582 |
| DATE PREPARED: | April 24, 2012 |
| 510(K) CONTACT: | Mark FoxVice President, Regulatory AffairsTel: (574) 268-6379 |
| PROPOSED TRADE NAME: | OP Spine System |
| DEVICE CLASSIFICATION: | Class II; 21 CFR 888.3070 and 21 CFR 888.3050 |
| CLASSIFICATION NAME: | Pedicle screw spinal system (bone screws, rods, and hooks);adolescent idiopathic scoliosis orthosis; spinal interlaminal fixationorthosis |
| PRODUCT CODE: | OSH; KWP |
| DEVICE DESCRIPTION: | The OP Spine System consists of longitudinal members (rods),anchors (hooks and screws), interconnection components (rod-to-rod and anchor-to-rod connectors) and fasteners in a variety ofsizes to accommodate differing anatomic requirements. |
| INDICATIONS FOR USE: | The OP Spine System is intended for posterior, non-cervicalfixation (pedicle screw fixation T1-S2/ilium and hook fixation (T1-L5) in pediatric patients is indicated as an adjunct to fusion to treatadolescent idiopathic scollosis. The device is intended to be usedwith autograft and/or allograft. |
| MATERIALS: | Medical grade titanium alloyMedical grade cobalt-chromium-molybdenum |
| PREDICATE DEVICES: | OP Spine System [K120291] |
| TECHNOLOGICCHARACTERISTICS: | The fundamental scientific principles and technologicalcharacteristics, including the intended use, material, and generaldesign, and sizes of the device are the same as the predicatedevice. |
| PERFORMANCE DATA: | Torsional grip (ASTM F1798) and dynamic compression bending,(ASTM F1717) tests demonstrated that the device performance isequivalent to the predicate device. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 27, 2013
OrthoPediatrics, Corp. % Mr. Mark Fox Vice President, Regulatory Affairs 2850 Frontier Drive Warsaw. Indiana 46582
Re: K121250
Trade/Device Name: OrthoPediatrics (OP) Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: OSH. KWP Dated: May 23, 2012 Received: May 24, 2012
Dear Mr. Fox:
This letter corrects our substantially equivalent letter of June 19, 2012.
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
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Page 2 - Mr. Mark Fox
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.
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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Image /page/2/Picture/7 description: The image shows the name "Erin DKeith" in a bold, sans-serif font. The letters in the middle, "D" and "K", have a textured or patterned fill, making them stand out from the rest of the name. The overall appearance is clean and legible, with a focus on the name itself.
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K121250
Device Name: Orthopediatrics (OP) Spine System
Indications For Use:
The OP Spine System is intended for posterior, non-cervical fixation (pedicle screw fixation TI-I ho or opine by kins work (T1-L5)) in pediatric patients indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and/or allograft.
Prescription Use イ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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 (ODE)
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(Divilion Sign-Off) ITi .: on of Surgical, Orthopedic, ain itestorative Devices
KIZIZED 510(k) Number_
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.