(248 days)
No
The device description and performance studies focus on mechanical properties and surgical implantation, with no mention of AI or ML.
Yes
The device is described as an implant system for the immobilization and stabilization of the spine, intended as an adjunct to fusion for a variety of medical conditions. This direct involvement in treating and stabilizing a bodily function classifies it as a therapeutic device.
No.
This device is a spinal implant system intended for immobilization and stabilization of the spine as an adjunct to fusion; it does not collect or analyze medical data to diagnose a condition.
No
The device description explicitly details physical hardware components (screws, rods, connectors) made of titanium alloy, cobalt chrome, and commercially pure titanium, and describes mechanical performance testing.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for stabilizing the spine. This is a medical device used in vivo (within the body), not in vitro (outside the body) for diagnostic purposes.
- Device Description: The description details physical components like screws, rods, and connectors made of materials like titanium alloy. These are physical implants, not reagents, instruments, or software used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on laboratory tests.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
· The RESPONSE 4.5/5.0 and 5.5/6.0 Spine Systems and the RESPONSE 5.5/6.0 Cannulated Screw System are 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 dicogenic 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), turnor, pseudarthrosis, and/or failed previous fusion. · When used for posterior non-cervical pedicle screw fixation in pediatric patients, the RESPONSE 4.5/6.0 Spine System and the RESPONSE 5.5/6.0 Cannulated Screw System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis, neuromuscular scoliosis, and congental scoliosis. The RESPONSE 4.5/5.0 Spine Systems and the RESPONSE 5.5/6.0 Cannulated Screw System are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Product codes
NKB, KWP
Device Description
The RESPONSE 5.5/6.0 Cannulated Screw System is a cannulated screw spinal implant system consisting of anchors (screws) that attach to the longitudinal members (rods) and interconnection components (connectors) previously cleared in the RESPONSE 5.5/6.0 Spine System see K193100.
Pedicle screws are placed in the spine that attach to rods that allow immobilization and stabilization of the spine. The RESPONSE 5.5/6.0 Cannulated Screws are cannulated screws that are passed over a guidewire to achieve insertion. The RESPONSE 5.5/6.0 Cannulated Screws are available in a 6mm to 9mm diameter range by 40mm to 100mm lengths.
All implant components are manufactured from titanium alloy, cobalt chrome, and commercially pure titanium.
All components are supplied non-sterile.
The screws, which have a Ø1.750 mm cannulation, are available in the following diameters and lengths:
Ø6.0 - 40-80mm
Ø6.5 - 40-90mm
Ø7.0 - 40-100mm
Ø8.0 - 40-100mm
Ø9.0 - 40-100mm
All screws are double lead with a 2.750 mm thread pitch which is identical to the predicate screws.
For the subject screws, the minor diameter, neck diameter and thread runout length were increased and the hexalobe feature and root radius were modified from the predicate pedicle screw design to accommodate the cannulation.
The subject drivers are cannulated with features to interface with the screw hexalobe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical spine, thoracolumbosacral 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)
The following performance data were provided in support of the substantial equivalence determination:
- dynamic compression bend testing per ASTM F1717-21, ●
- static compression bend testing per ASTM F1717-21, ●
- static and dynamic flexion/extension testing per ASTM F1798-21, ●
- screw pullout strength via ASTM F543-17,
- user validation studies,
- functional relationship analysis,
● MR compatibility per ASTM F2052-21, ASTM F2119-07, ASTM F2182-19 and ASTM F2213-17.
Information submitted under K193100 was leveraged to support the following:
- axial and rotational grip per ASTM F1798-21, ●
- sterilization per AAMI ST79:17, ●
- biocompatibility per ISO 10993-1.
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
March 23, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
OrthoPediatrics Corp. Jennifer Gregory 2850 Frontier Drive Warsaw, Indiana 46582
Re: K222105
Trade/Device Name: RESPONSE 5.5/6.0 Cannulated Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP Dated: March 9, 2023 Received: March 10, 2023
Dear Jennifer Gregory:
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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/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.
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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,
Image /page/1/Picture/5 description: The image shows a digital signature for Eileen Cadel -S. The signature indicates that the document was digitally signed by Eileen Cadel -S on March 23, 2023. The timestamp of the signature is 10:04:20 -04'00'. The signature is likely used to verify the authenticity and integrity of the document.
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) K222105
Device Name RESPONSE 5.5/6.0 Cannulated Screw System
Indications for Use (Describe)
· The RESPONSE 4.5/5.0 and 5.5/6.0 Spine Systems and the RESPONSE 5.5/6.0 Cannulated Screw System are 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 dicogenic 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), turnor, pseudarthrosis, and/or failed previous fusion. · When used for posterior non-cervical pedicle screw fixation in pediatric patients, the RESPONSE 4.5/6.0 Spine System and the RESPONSE 5.5/6.0 Cannulated Screw System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis, neuromuscular scoliosis, and congental scoliosis. The RESPONSE 4.5/5.0 Spine Systems and the RESPONSE 5.5/6.0 Cannulated Screw System are 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image shows a logo for OrthoPediatrics. The logo includes a cartoon drawing of a child with a smiling face, blue hair, and a green body. The text "OrthoPediatrics" is written in a playful font, with "Ortho" in blue and "Pediatrics" in red. The image also includes the text "K222105 Page 1 of 4".
510(k) Summary
I. Submitter
| Submission: | Special 510(k) Premarket Notification |
|---|---|
| Applicant: | OrthoPediatrics Corp. |
| Applicant Address: | 2850 Frontier Drive, Warsaw, IN 46582 |
| Establishment Registration Number: | 3006460162 |
| Submitter: | Natalie Heck |
| Submitter Phone: | (574) 268-6379 |
| Contact: | Jennifer Gregory |
| Contact Phone: | 574-267-0880 |
| Date Prepared: | March 21, 2023 |
| II. Device | |
| Device Trade Name: | RESPONSE 5.5/6.0 Cannulated Screw System |
| Regulation Number: | 21 CFR 888.3070, 21 CFR 888.3050 |
| Product Code and Common Name: | NKB Thoracolumbosacral Pedicle Screw System |
| KWP Appliance, Fixation, Spinal Interlaminal | |
| Device Classification: | II |
Classification Panel:
Orthopedic
III. Predicate Device
Substantial equivalence is claimed to the following predicate devices:
Primary Predicate: RESPONSE 5.5/6.0 Spine System, K193100, OrthoPediatrics Corp.
IV. Submission Purpose: The addition of cannulated screws and associated instruments to the RESPONSE 5.5/6.0 Spine System
V. Device Description
The RESPONSE 5.5/6.0 Cannulated Screw System is a cannulated screw spinal implant system consisting of anchors (screws) that attach to the longitudinal members (rods) and interconnection components (connectors) previously cleared in the RESPONSE 5.5/6.0 Spine System see K193100.
4
Image /page/4/Picture/1 description: The image shows the logo for OrthoPediatrics. The logo includes a cartoon drawing of a child with a large head and a smiling face. The text "OrthoPediatrics" is written in a stylized font, with the "Ortho" in blue and the "Pediatrics" in red. Above the logo is the text "K222105" and "Page 2 of 4".
Pedicle screws are placed in the spine that attach to rods that allow immobilization and stabilization of the spine. The RESPONSE 5.5/6.0 Cannulated Screws are cannulated screws that are passed over a guidewire to achieve insertion. The RESPONSE 5.5/6.0 Cannulated Screws are available in a 6mm to 9mm diameter range by 40mm to 100mm lengths.
All implant components are manufactured from titanium alloy, cobalt chrome, and commercially pure titanium. See table below for associated material standards:
| Material | Applicable Standard |
|---|---|
| Implants | N/A |
| Ti-6Al-4V | ASTM F136 |
| Co28Cr6Mo | ASTM F1537 |
| CP Titanium | ASMT F67 |
All components are supplied non-sterile.
The screws, which have a Ø1.750 mm cannulation, are available in the following diameters and lengths:
Ø6.0 - 40-80mm Ø6.5 - 40-90mm Ø7.0 - 40-100mm Ø8.0 - 40-100mm Ø9.0 - 40-100mm
All screws are double lead with a 2.750 mm thread pitch which is identical to the predicate screws.
For the subject screws, the minor diameter, neck diameter and thread runout length were increased and the hexalobe feature and root radius were modified from the predicate pedicle screw design to accommodate the cannulation.
The subject drivers are cannulated with features to interface with the screw hexalobe.
VI. Intended Use
The RESPONSE 5.5/6.0 Cannulated Screws are intended to be used for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion and as an adjunct to fusion to treat scoliosis in pediatric patients in combination with the RESPONSE 5.5/6.0 Spine System. Pediatric cannulated spine screw fixation is limited to a posterior approach.
5
Image /page/5/Picture/1 description: The image shows the OrthoPediatrics logo. The logo features a smiling face with a green body and the words "OrthoPediatrics" in blue and red. The image also contains the text "K222105 Page 3 of 4" at the top.
Cannulated pedicle screws are intended to be used in the thoracolumbosacral spine in skeletally mature and pediatric patients; as such, they are provided in a 6mm to 9mm diameter range.
VII. Indications for Use
The RESPONSE 4.5/5.0 and 5.5/6.0 Spine Systems and the Response 5.5/6.0 Cannulated Screw System are 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 4.5/5.0 and 5.5/6.0 Spine System and the Response 5.5/6.0 Cannulated Screw System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. The RESPONSE 4.5/5.0 and 5.5/6.0 Spine Systems and the Response 5.5/6.0 Cannulated Screw System are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
VIII. Comparison of Technological Characteristics
The RESPONSE 5.5/6.0 Cannulated Screws and predicate implant and instruments are used to correct spinal deformities in skeletally mature and pediatric patients. The construct provides immobilization and stabilization of spinal segments as an adjunct to fusion of the non-cervical spine. The construct, which is implanted into the patient, consists of rods, anchors (hooks and screws), and connectors.
The RESPONSE 5.5/6.0 Cannulated Screws and the predicate devices share the same materials of construction, body contact and duration of contact, principle of operation, and similar design features for implant and instruments, and component types.
The RESPONSE 5.5/6.0 Cannulated Screws have the same intended use as the predicate device.
Components introduced in this submission include screws that fall within the length and diameter combinations of the previously cleared RESPONSE Spine System components and instruments with the same mating geometries and materials as existing system components. With the exception of the cannulation, these components are similar to devices in the previously cleared RESPONSE Spine Systems.
These technological differences do not raise different questions of safety and effectiveness and are addressed by the testing provided within the submission.
IX. Performance Data
6
Image /page/6/Picture/1 description: The image shows a logo for OrthoPediatrics. The logo includes a cartoon drawing of a child with a smiling face, and the text "OrthoPediatrics" written in a playful font. The text "K222105 Page 4 of 4" is located in the upper right corner of the image.
The following performance data were provided in support of the substantial equivalence determination:
- dynamic compression bend testing per ASTM F1717-21, ●
- static compression bend testing per ASTM F1717-21, ●
- static and dynamic flexion/extension testing per ASTM F1798-21, ●
- screw pullout strength via ASTM F543-17,
- user validation studies,
- functional relationship analysis,
● MR compatibility per ASTM F2052-21, ASTM F2119-07, ASTM F2182-19 and ASTM F2213-17.
Information submitted under K193100 was leveraged to support the following:
- axial and rotational grip per ASTM F1798-21, ●
- sterilization per AAMI ST79:17, ●
- biocompatibility per ISO 10993-1.
X. Conclusion
The information supplied above supports that the RESPONSE 5.5/6.0 Cannulated Screw System is equivalent to the predicate device. Information provided within the submission support the differences between the subject and predicate devices. Therefore, it is concluded that the RESPONSE 5.5/6.0 Cannulated Screw System is substantially equivalent to the predicate device.