(33 days)
None of the above predicates have been subject to a design-related recall. No reference device was used in this submission.
No
The 510(k) summary describes a mechanical spine fixation system and does not mention any software, image processing, or AI/ML capabilities. The performance studies are mechanical and biocompatibility testing, not related to algorithmic performance.
Yes.
The device is intended for "immobilization of the posterior, noncervical spine" to treat various medical conditions such as degenerative disc disease, scoliosis, and fractures, which aligns with the definition of a therapeutic device.
No
The Response 5.5 Spine System is an implantable device (rods, hooks, screws, connectors) intended for immobilization and fusion of the spine, not for diagnosing medical conditions.
No
The device description explicitly states it consists of physical components like rods, anchors, connectors, and fasteners, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Response 5.5 Spine System is a surgical implant intended for the immobilization and fusion of the spine. It is a physical device implanted in the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are characteristic of IVDs.
Therefore, the Response 5.5 Spine System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Response 5.5 Spine System is intended for immobilization of the posterior, noncervical spine in skeletally mature patients as an adjunct to the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Response 5.5 Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Response 5.5 Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Product codes (comma separated list FDA assigned to the subject device)
NKB, OSH, KWP, MNH, MNI
Device Description
The Response 5.5 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. No accessories are offered with the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, noncervical spine
Indicated Patient Age Range
skeletally mature patients, pediatric patients (adolescent)
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)
Mechanical Testing:
- Study type: Design verification testing
- Tests completed:
- Axial Grip
- Axial Torsion
- Flexion Extension Static Testing
- Flexion Extension Fatigue
- Construct Static Compression Bending
- Construct Static Torsion
- Construct Compression Bending Fatigue
- Key Results: The subject devices met the pre-determined acceptance criteria for all tests, demonstrating substantial equivalence to predicate devices.
Biocompatibility:
- Study type: Evaluation based on material composition and prior clearances
- Key Results: Implants are comprised of medical grade metals (Titanium Alloy (Ti-6A1-4V-ELI) per ASTM F136, and CoCr (ASTM F1537-08)) with a long history of successful clinical application. Instruments are medical grade stainless Steel. These materials are identical to predicate systems (K150600, K130655). Biocompatibility testing was not required per FDA Guidance #G95-1.
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.
None of the above predicates have been subject to a design-related recall. No reference device was used in this submission.
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
§ 888.3070 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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 23, 2016
OrthoPediatrics Corporation Mr. Mark Fox Vice President, Regulatory Affairs 2850 Frontier Drive Warsaw, Illinois 46582
Re: K160466
Trade/Device Name: Response 5.5 Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, KWP, MNH, MNI Dated: February 18, 2016 Received: February 19, 2016
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
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) K160466
Device Name Response 5.5 Spine System
Indications for Use (Describe)
The Response 5.5 Spine System is intended for immobilization of the posterior, noncervical spine in skeletally mature patients as an adjunct to the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Response 5.5 Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Response 5.5 Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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OrthoPediatrics Corp. Response 5.5 Spine System
510(K) Summary
| I. | Submitter | OrthoPediatrics Corp.
2850 Frontier Drive
Warsaw, IN 46538
(574) 268-6379 |
|------|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact | Mark Fox
Vice President, Regulatory Affairs |
| | Date Prepared | February 18, 2016 |
| II. | Device | |
| | Name of Device | Response 5.5 Spine System |
| | Classification Name | Pedicle screw spinal system and Spinal interlaminal
fixation orthosis (21 CFR 888.3070 and 888.3050) |
| | Classification | Class III; 21 CFR 888.3070 and 21 CFR 888.3050 |
| | Product Codes | NKB, OSH, MNH, MNI, KWP |
| III. | Predicates | K150600 - OrthoPediatrics Response 5.5/6.0 Spine
(PRIMARY)
K130655 – OrthoPediatrics Response 5.5 Spine System
(ADDITIONAL) |
| | | None of the above predicates have been subject to a
design-related recall. No reference device was used in
this submission. |
| IV. | Product Description | The Response 5.5 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.
No accessories are offered with the system.
The purpose of this Pre-Market Notification is to expand the
Indications of Use of the system per product codes NKB, |
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V. Indications For Use
The Response 5.5 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Response 5.5 Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Response 5.5 Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
VI. Comparison of Technological Characteristics
The fundamental scientific principles and technological characteristics, including the intended use, material, general design, and sizes of the device are the same as, or similar to, the predicate devices.
This subject system is an expansion of indications of the previously cleared "Response Spine System" (K130655). At a high level, the subject and predicate devices are based on the following same technological elements:
- Implanted into the patient ●
- Used with rods, hooks, cross-links, and other instrumentation to build a construct
- . The subject devices are intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and /or sacral spine
VII. Performance Data
The following performance data are provided in support of the substantial equivalence determination.
Mechanical Testing
In accordance with, Guidance for Industry and FDA Staff - Spinal System 510(k)'s, OrthoPediatrics Corp. has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices.
5
Design verification testing was completed in accordance with ASTM F1717 -Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, and ASTM F1798 – "Standard Guide to Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. The tests completed were:
- Axial Grip ●
- . - Axial Torsion
-
- Flexion Extension Static Testing
- Flexion Extension Fatigue ●
-
- Construct Static Compression Bending
- . - Construct Static Torsion
- . - Construct Compression Bending Fatigue
The subject devices met the pre-determined acceptance criteria for all tests.
Biocompatibility
Response 5.5 Spine System implants are comprised of medical grade metals (i.e., Titanium Alloy (Ti-6A1-4V-ELI) per ASTM F136, and CoCr (ASTM F1537-08)) and have the same type of body contact as other permanently implantable, (>30 days) contact duration, commercially available spinal system components. Response 5.5 Spine System instruments are comprised of the same material (medical grade stainless Steel) as other commercially available instruments and have patient contact for a transient duration (limited (