Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System

K181390 · OrthoPediatrics Corp. · NKB · Sep 18, 2018 · Orthopedic

Device Facts

• Record ID: K181390
• Device Name: Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System
• Applicant: OrthoPediatrics Corp.
• Product Code: NKB · Orthopedic
• Decision Date: Sep 18, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Response Spine System (Response 4.5/4.0 & Response 5.5/6.0 Spine Systems) 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, pseudoarthrosis, and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Response Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Response Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Story

Response Spine System is a pedicle screw spinal implant system; consists of longitudinal rods, anchors (hooks/screws), interconnection components, and fasteners. Used by surgeons in clinical settings to provide immobilization and stabilization of the posterior, non-cervical spine. Acts as an adjunct to fusion for various spinal pathologies in skeletally mature and pediatric (adolescent idiopathic scoliosis) patients. Implants are used with autograft/allograft to facilitate fusion. System provides mechanical support to the spine; helps maintain alignment during healing process. Benefits include stabilization of spinal segments, correction of deformities, and support for fusion procedures.

Clinical Evidence

No clinical data was required or provided. Substantial equivalence established via mechanical bench testing (static and dynamic compression bending, static torsion) comparing worst-case line extensions to predicate systems.

Technological Characteristics

Pedicle screw spinal system; components include rods, hooks, screws, and connectors. Materials, design, and principle of operation are identical to predicate. Sterilization method is consistent with predicate. System is a mechanical implant; no software or energy source.

Indications for Use

Indicated for immobilization and stabilization of posterior, non-cervical spine in skeletally mature patients as adjunct to fusion for degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, and failed fusion. Also indicated for pediatric patients with adolescent idiopathic scoliosis via posterior approach pedicle screw fixation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Response 5.5/6.0 Spine System (K150600)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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.

September 18, 2018

OrthoPediatrics, Corp. Mr. Mark Fox Vice President of Regulatory Affairs 2850 Frontier Drive Warsaw, Indiana 46582

Re: K181390

Trade/Device Name: Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP Dated: August 22, 2018 Received: August 27, 2018

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. 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/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.

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

{1}------------------------------------------------

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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Ronald P. Jean -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K181390

#### Device Name

Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System

#### Indications for Use (Describe)

The Response Spine System (Response 4.5/4.0 & Response 5.5/6.0 Spine Systems) 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, pseudoarthrosis, and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Response Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Response 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) | |
|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-size: 10pt;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

#### 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 [e-mail]

"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}------------------------------------------------

# 510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the OrthoPediatrics Response Spine System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.

| Sponsor: | OrthoPediatrics, Corp.<br>2850 Frontier Drive<br>Warsaw, IN 46582<br>Establishment Registration Number: 3006460162 |
|-----------------|--------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mark Fox<br>V.P. Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] |
| Date: | May 25, 2018 |
| Subject Device: | |
| | Trade Name: Response Spine System<br>Response 5.5/6.0 Spine System<br>Response 4.5/5.0 Spine System |
| | Common Name: Pedicle Screw Spinal System |
| | Classification Name: |
| | NKB 21 CFR 888.3070:<br>Thoracolumbosacral Pedicle Screw System |
| | KWP 21 CFR 888.3050: Spinal Interlaminal Fixation<br>Orthosis |

# Legally marketed devices to which substantial equivalence is claimed:

- Response 5.5/6.0 Spine System (K150600)
#### Device Description:

The Response Spine System is a pedical screw spinal implant system consisting of longitudinal members (rods), anchors (hooks and screws), interconnection components (rod-to-rod and anchorto-rod connectors) and fasteners in a variety of sizes to accommodate differing anatomic requirements.

{4}------------------------------------------------

# Indications for Use:

The Response Spine System (Response 5.5/6.0 and Response 4.5/5.0 Spine Systems) 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., facture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Response Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Response Spine System is intended to be used with autograft. Pediatric pediale screw fixation is limited to a posterior approach.

# Summary of Technological Characteristics:

The intended use, indications for use, materials, sterilization methods, device design, and principle of operation of the subject device are the same as the predicate device. Differences in device sizes do not introduce any new risks of safety and efficacy. The Response Spine System including the 4.5/5.0 size offerings is substantially equivalent to the Response 5.5/6.0 Spine System for the primary intended use as an adjunct to fusion as described in the device labeling.

# Summary of Performance Data (Mechanical Testing - Bench):

Static and dynamic compression bending, and static torsion tests were used to characterize the mechanical properties of the worst case line extension Response 4.5/5.0 Spinal System pedicle screw constructs.

The static results show the Response 4.5/5.0 Spinal System has static yield and stiffness, and dynamic compression bending runout properties comparable to cleared, predicate systems. Overall, the results show the Response 4.5/5.0 Spinal System to have properties comparable to or better than other commercially available, adult-indicated posterior pedicle screw devices.

# Clinical Tests:

Clinical data was not required to establish substantial equivalence between the subject device and the predicate device.

# Substantial Equivalence Conclusion

Based on identical design technology, materials, intended use, and indications for use, the subject device is similar to the predicate device and does not introduce any new risks of safety or efficacy. Therefore, Orthopediatrics, Corp concludes that the Response Spine System is substantially equivalent to the predicate device.