(115 days)
Not Found
No
The device description and performance studies focus on mechanical properties and biocompatibility of the implant system, with no mention of AI or ML.
Yes
The device is described as a 'Rib and Pelvic System' that mechanically stabilizes and corrects thoracic deformities to allow the chest and lungs to grow, thereby improving respiration and lung growth in skeletally immature patients with severe spinal deformities and/or Thoracic Insufficiency Syndrome. This direct medical intervention to treat a condition qualifies it as a therapeutic device.
No
Explanation: The device description clearly states its purpose is to "mechanically stabilize and/or correct thoracic deformities" and describes it as an implantable system. This indicates it is a therapeutic device, not a diagnostic one.
No
The device description explicitly details physical components made of titanium and cobalt chromium, including rods, anchors, and surgical instruments, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description: The RESPONSE™ Rib and Pelvic System is a system of implants and instruments designed to mechanically stabilize and correct spinal and thoracic deformities. It is surgically implanted into the patient's body.
- Intended Use: The intended use is to treat severe, progressive spinal deformities and Thoracic Insufficiency Syndrome in skeletally immature patients by providing mechanical support and allowing for growth.
The device is a surgical implant used in vivo (within the body) for structural support and correction, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
N/A
Intended Use / Indications for Use
The RESPONSE™ Rib and Pelvic System is indicated for skeletally immature patients with severe, progressive spinal deformities such as congenital scoliosis, neuromuscular scoliosis, syndromic scoliosis and/or three-dimensional deformity of the thorax associated with or at risk of Thoracic Insufficiency Syndrome (TIS).
Product codes
MDI
Device Description
The RESPONSE™ Rib and Pelvic System consists of longitudinal members (rods), anchors (saddles, hooks, and screws), interconnection components (rod-to-rod and anchor-to-rod connectors) in a variety of sizes to accommodate differing anatomic requirements. The implants in the system can be assembled in a number of different configurations to accommodate the wide variety of anatomical deformities encountered by the clinician. The RESPONSE™ Rib and Pelvic System also includes surgical instruments. All implants and instruments in the system are provided non-sterile. The RESPONSE™ Rib and Pelvic System mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow. The subject devices are attached perpendicularly to the child's rib, thoracic vertebra, sacrum, ilium and pelvis. This mechanically stabilizes the chest wall and spine and enlarges the thorax to improve respiration and lung growth. Once the subject devices are in place, its design allows for expansion, anatomic distraction, and replacement of component parts through less invasive surgery. The components of the RESPONSE™ Rib and Pelvic System are manufactured from titanium alloy per ASTM F136, unalloyed titanium per ASTM F67, or cobalt chromium per ASTM F1537.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
rib, thoracic vertebra, sacrum, ilium and pelvis
Indicated Patient Age Range
skeletally immature patients
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 Biocompatibility assessment and testing for the RESPONSE™ Rib and Pelvic System were performed in conformance with ISO 10993-1.
The implants of RESPONSE™ Rib and Pelvic System were evaluated for use in an MR Environment using ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119, and were determined to be MR Conditional and will be labeled as such.
Mechanical performance evaluations included construct static and dynamic compression testing based on ASTM F1717; axial and torsional grip testing per ASTM F1798; and screw torsional strength, insertion torque, and removal torque testing per ASTM F543; and engineering analysis. Results of the mechanical testing/analysis demonstrate substantially equivalent mechanical performance of the subject device as compared to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
January 20, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
OrthoPediatrics Corp. Yan Li Regulatory Affairs Manager 2850 Frontier Drive Warsaw, Indiana 46582
Re: K233105
Trade/Device Name: RESPONSE™ Rib and Pelvic System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: MDI Dated: December 18, 2023 Received: December 18, 2023
Dear Yan Li:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin O'neill -S
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal 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) K233105
Device Name RESPONSE™ Rib and Pelvic System
Indications for Use (Describe)
The RESPONSE™ Rib and Pelvic System is indicated for skeletally immature patients with severe, progressive spinal deformities such as congenital scoliosis, neuromuscular scoliosis, syndromic scoliosis and/or three-dimensional deformity of the thorax associated with or at risk of Thoracic Insufficiency Syndrome (TIS).
| 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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510(k) Summary
I. Submitter
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Applicant: | OrthoPediatrics Corp. |
| Applicant Address: | 2850 Frontier Drive, Warsaw, IN 46582 |
| Establishment Registration Number: | 3006460162 |
| Contact: | Yan Li |
| Contact Phone: | (574) 267-0864 |
| Date Prepared: | September 26, 2023 |
II. Device
| Device Trade Name: | RESPONSE™ Rib and Pelvic System |
|---|---|
| Device Classification: | II |
| Classification Panel: | Orthopedic |
| Regulation Number: | 21 CFR 888.3070 Thoracolumbosacral Pedicle Screw System |
| Classification Product Code: | MDI |
| Device Classification Name: | Prosthesis, Rib Replacement |
| Common Name: | Prosthesis, Rib Replacement |
III. Predicate Device and Reference Device
Substantial equivalence is claimed to the following predicate device:
Primary Predicate Device:
- . Vertical Expandable Prosthetic Titanium Rib (K142587*, Depuy Synthes Spine, Inc.) *The HDE H030009 is superseded by the 510(k) K142587
Additional Predicate Device:
- . Polaris Spinal Growth System (K180227, Zimmer Biomet Spine, Inc.)
4
IV. Device Description
The RESPONSE™ Rib and Pelvic System consists of longitudinal members (rods), anchors (saddles, hooks, and screws), interconnection components (rod-to-rod and anchor-to-rod connectors) in a variety of sizes to accommodate differing anatomic requirements. The implants in the system can be assembled in a number of different configurations to accommodate the wide variety of anatomical deformities encountered by the clinician. The RESPONSE™ Rib and Pelvic System also includes surgical instruments. All implants and instruments in the system are provided non-sterile. The RESPONSE™ Rib and Pelvic System mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow. The subject devices are attached perpendicularly to the child's rib, thoracic vertebra, sacrum, ilium and pelvis. This mechanically stabilizes the chest wall and spine and enlarges the thorax to improve respiration and lung growth. Once the subject devices are in place, its design allows for expansion, anatomic distraction, and replacement of component parts through less invasive surgery. The components of the RESPONSE™ Rib and Pelvic System are manufactured from titanium alloy per ASTM F136, unalloyed titanium per ASTM F67, or cobalt chromium per ASTM F1537.
V. Indications for Use
The RESPONSE™ Rib and Pelvic System is indicated for skeletally immature patients with severe, progressive spinal deformities such as congenital scoliosis, neuromuscular scoliosis, idiopathic scoliosis, syndromic scoliosis and/or three-dimensional deformity of the thorax associated with or at risk of Thoracic Insufficiency Syndrome (TIS).
Comparison of Technological Characteristics VI.
The subject device RESPONSE™ Rib and Pelvic System and the previously cleared predicate device Vertical Expandable Prosthetic Titanium Rib (K142587) are substantially equivalent in that these devices share the same intended use, principles of operation, same patient population and many fundamental technological characteristics. There are some differences between the predicate and subject devices in terms of design features and materials. The successful testing data provided in this submission supported that the differences between the subject and predicate devices do not raise new questions for safety and effectiveness.
VII. Performance Data
The Biocompatibility assessment and testing for the RESPONSE™ Rib and Pelvic System were performed in conformance with ISO 10993-1.
The implants of RESPONSE™ Rib and Pelvic System were evaluated for use in an MR Environment using ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119, and were determined to be MR Conditional and will be labeled as such.
5
Mechanical performance evaluations included construct static and dynamic compression testing based on ASTM F1717; axial and torsional grip testing per ASTM F1798; and screw torsional strength, insertion torque, and removal torque testing per ASTM F543; and engineering analysis. Results of the mechanical testing/analysis demonstrate substantially equivalent mechanical performance of the subject device as compared to the predicate.
VIII. Conclusion
The information provided above supports that the RESPONSE™ Rib and Pelvic System is as safe and effective as the predicate device. Information and data provided within the submission support the differences between the subject and predicate devices. Therefore, it is concluded that the RESPONSE™ Rib and Pelvic System is substantially equivalent to the predicate device.