RESPONSE SPINE SYSTEM

K130655 · OrthoPediatrics Corp. · OSH · May 8, 2013 · Orthopedic

Device Facts

• Record ID: K130655
• Device Name: RESPONSE SPINE SYSTEM
• Applicant: OrthoPediatrics Corp.
• Product Code: OSH · Orthopedic
• Decision Date: May 8, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Response 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 scoliosis. The device is intended to be used with autograft and/or allograft.

Device Story

Response Spine System is a posterior spinal fixation system for pediatric patients with adolescent idiopathic scoliosis. Components include longitudinal rods, anchors (hooks and screws), and interconnection hardware. System provides rigid stabilization to facilitate spinal fusion when used with autograft or allograft. Surgeons implant the device in an operating room setting. The system accommodates various patient anatomies through a range of component sizes and the inclusion of fixed-angle screws. It functions as a mechanical construct to support the spine during the fusion process, benefiting patients by correcting deformity and stabilizing the spinal column.

Clinical Evidence

Bench testing only. Static and dynamic compression bending tests and static torsion tests were performed in accordance with ASTM F1717 to demonstrate substantial equivalence.

Technological Characteristics

Materials: Titanium alloy (ASTM F136-08e1) and cobalt-chromium-molybdenum (ASTM F1537-08). Components: Longitudinal rods, hooks, pedicle screws (including fixed-angle), and rod-to-rod/anchor-to-rod connectors. Mechanical fixation system.

Indications for Use

Indicated for pediatric patients with adolescent idiopathic scoliosis requiring posterior, non-cervical spinal fixation (pedicle screw T1-S2/ilium or hook T1-L5) as an adjunct to fusion with autograft/allograft.

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

• OrthoPediatrics' OP Spine System (K120291 and K121250)
• Medtronic CD Horizon (K091445)

Submission Summary (Full Text)

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510(k) -- Section 1: OrthoPediatrics Response Spine System

K130655 Page 1 of 2

### MAY 0 8 2013

| NAME OF FIRM: | OrthoPediatrics, Corp.<br>2850 Frontier Drive<br>Warsaw, IN 46582 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | March 7, 2013 |
| 510(K) CONTACT: | Mark Fox<br>Vice President, Regulatory Affairs<br>Tel: [phone] |
| PROPOSED TRADE<br>NAME: | Response Spine System |
| DEVICE<br>CLASSIFICATION: | Class II; 21 CFR 888.3070 and 21 CFR 888.3050 |
| CLASSIFICATION<br>NAME: | Pedicle screw spinal system , adolescent idiopathic scoliosis<br>orthosis; spinal interlaminal fixation orthosis |
| PRODUCT CODE: | OSH; KWP |
| DEVICE<br>DESCRIPTION: | The Response Spine System consists of longitudinal<br>members (rods), anchors (hooks and screws),<br>interconnection components (rod-to-rod and anchor-to-rod<br>connectors) and fasteners in a variety of sizes, including fixed<br>angled screws, to accommodate differing<br>anatomic<br>requirements. |
| INDICATIONS FOR<br>USE: | The Response Spine System is intended for posterior, non-<br>cervical fixation (pedicle screw fixation T1-S2/ilium and hook<br>fixation (T1-L5)) in pediatric patients is indicated as an<br>adjunct to fusion to treat adolescent idiopathic scoliosis. The<br>device is intended to be used with autograft and/or allograft. |
| MATERIALS: | Medical grade titanium alloy - ASTM F136-08e1<br>Medical grade cobalt-chromium-molybdenum - ASTM<br>F1537-08 |
| PREDICATE DEVICES: | OrthoPediatrics' OP Spine System (K120291 and K121250)<br>Medtronic CD Horizon (K091445) |
| | |
| TECHNOLOGIC<br>CHARACTERISTICS: | The fundamental scientific principles and technological<br>characteristics, including the material, and general design,<br>and sizes of the device are substantially the same as the<br>predicate devices. Fixed angle (non-swivel) screws have<br>been added to the system while the smaller diameter<br>longitudinal rod has been eliminated from the system. |
| PERFORMANCE<br>DATA: | Static and dynamic compression bending tests and static<br>torsion tests, performed according to ASTM F1717,<br>demonstrated the device to be substantially equivalent to the<br>predicate devices. |
| CONCLUSION: | The Response Spine System has the same intended use and<br>technological characteristics as the predicate devices.<br>Therefore the Response Spine System is substantially<br>equivalent for its intended use. |

#### 510(k) Summary

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 8, 2013

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

Re: K130655

Trade/Device Name: Response Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: OSH, KWP Dated: March 20, 2013 Received: March 21, 2013

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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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#### Page 2 - Mr. Mark Fox

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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 Statement

510(k) Number (if known): K130655

#### Device Name: OrthoPediatrics' Response Spine System

#### Indications for Use:

The Response 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 scoliosis. The device is intended to be used with autograft and/or allograft.

Prescription Use ___________ X or Over-The-Counter Use

(21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

## Ronald P. Jean -S

(Division Sign-Off)

Division of Orthopedic Devices

510(k) Number: K130655