Reform Pedicle Screw System

K151422 · Precision Spine, Inc. · NKB · Aug 21, 2015 · Orthopedic

Device Facts

• Record ID: K151422
• Device Name: Reform Pedicle Screw System
• Applicant: Precision Spine, Inc.
• Product Code: NKB · Orthopedic
• Decision Date: Aug 21, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Reform Pedicle Screw System is 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The Reform Pedicle Screw System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The Reform Pedicle Screw System is also intended for non-cervical pedicle screw fixation (T1-S1/ilium) for the following indications: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; kyphosis; and/or lordosis); spinal tumor; degenerative disc disease (DDD); pseudoarthrosis; and failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Reform Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Reform Pedicle Screw System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Story

Top-loading, posterior spinal fixation system; components include pedicle screws, rods, cross-connectors, locking cap screws, hooks, domino connectors, lateral offset connectors. Used by surgeons in clinical settings to provide immobilization and stabilization of spinal segments. Implants attached to thoracic, lumbar, or sacral spine to facilitate fusion. Hydroxyapatite (HA) coating added to pedicle screws to enhance integration. System provides structural support for spinal segments; aids in correction of deformities or stabilization of fractures. Benefits include stabilization of unstable spinal segments, support for bone fusion, and correction of spinal curvatures.

Clinical Evidence

No clinical testing performed on the subject device. Substantial equivalence supported by clinical literature assessment confirming safety and effectiveness of pedicle screw fixation in pediatric patients.

Technological Characteristics

Top-loading posterior spinal fixation system. Materials: medical grade stainless steel, cobalt chromium alloys, titanium, titanium alloy (ASTM F138, ASTM F1537, ISO 5832-12, ASTM F136, ISO 5832-3). Features hydroxyapatite (HA) coated or uncoated pedicle screws. Provided sterile or non-sterile.

Indications for Use

Indicated for skeletally mature patients with acute/chronic spinal instabilities or deformities (thoracic, lumbar, sacral) including degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, tumor, pseudoarthrosis, and failed fusion. Also indicated for severe L5-S1 spondylolisthesis (grades 3-4) and non-cervical (T1-S1/ilium) degenerative disc disease, trauma, stenosis, and curvatures. Indicated for pediatric patients with adolescent idiopathic scoliosis via posterior approach. Used as 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

• PSS System (Reform Pedicle Screw System) (K143248, K131343, K130279, K121172, K092128, K090033, K073240, K071438)
• Polaris Spinal System (K141804, K133746, K131615)

Submission Summary (Full Text)

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August 21, 2015

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

Precision Spine, Incorporated Michael C. Dawson, Esq. Director of Regulatory Affairs/Deputy General Counsel 2050 Executive Drive Pearl, Mississippi 39208

Re: K151422

Trade/Device Name: Reform Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNH, MNI, KWP Dated: August 5, 2015 Received: August 10, 2015

Dear Mr. Dawson:

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 – Michael C. Dawson, Esq.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 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 [phone] or [phone] 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K151422 Device Name Reform Pedicle Screw System

Indications for Use (Describe)

The Reform Pedicle Screw System is 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The Reform Pedicle Screw System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The Reform Pedicle Screw System is also intended for non-cervical pedicle screw fixation (T1-S1/ilium) for the following indications: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; kyphosis; and/or lordosis); spinal tumor; degenerative disc disease (DDD); pseudoarthrosis; and failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Reform Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Reform Pedicle Screw 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)

> Prescription Use (Part 21 CFR 801 Subpart D) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(K) SUMMARY

| Submitter's Name: | Precision Spine, Inc. |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address: | 2050 Executive Drive<br>Pearl, MS 39208 |
| Submitter's Telephone: | 973-455-7150 ext. 128 |
| Contact Person: | Michael C. Dawson |
| Date Summary was Prepared: | May 26, 2015 |
| Trade or Proprietary Name: | Reform Pedicle Screw System |
| Common or Usual Name: | Orthosis, Spinal Pedicle Fixation<br>Orthosis, Spondylolisthesis Spinal Fixation<br>Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease<br>Appliance, Fixation, Spinal Interlaminal |
| Classification: | Class III per 21 CFR §888.3070 and 888.3050 |
| Product Code: | NKB, OSH, MNH, MNI, KWP |
| Classification Panel: | 87 Orthopedic Panel |

# DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Reform System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, locking cap screws, hooks, domino connectors, and lateral offset connectors. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from medical grade stainless steel, cobalt chromium alloys, titanium or titanium alloy described by such standards as ASTM F138, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3. The pedicle screws are included with or without hydroxyapatite (HA) coating.

### Change from Predicate:

The purpose of this submission is to add hydroxyapatite (HA) coated pedicle screws to the PSS System (Reform Pedicle Screw System) cleared in K143248, K131343, K130279, K121172, K092128, K090033, K073240, and K071438.

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### INDICATIONS FOR USE

The Reform Pedicle Screw System is 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (psuedoarthrosis).

The Reform Pedicle Screw System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The Reform Pedicle Screw System is also intended for non-cervical pedicle screw fixation (T1-S1/ilium) for the following indications: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); spinal tumor; degenerative disc disease (DDD); pseudoarthrosis; and failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Reform Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Reform Pedicle Screw System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

# TECHNOLOGICAL CHARACTERISTICS

The intended use and technological features of the modifications/additions to the components of the PSS System (Reform Pedicle Screw System) do not substantially differ from the legally marketed predicate devices, which are the PSS System (Reform Pedicle Screw System, K143248, K131343, K130279, K121172, K092128, K090033, K073240, and K071438) and the Biomet Polaris Spinal System (K141804, K133746, K131615). The predicate devices and the subject addition to the PSS (Reform) system is designed for posterior stabilization to provide immobilization and stabilization of spinal segments as an adjunct to fusion.

Reform Pedicle Screw System is manufactured from medical grade stainless steel, cobalt chromium alloys, titanium or titanium alloy described by such standards as ASTM F138, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3. The pedicle screws are included with or without hydroxyapatite (HA) coating. The implants are provided sterile and non-sterile with instructions for sterilization. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:

- Indications for Use ●
- Materials of manufacture
- Structural support mechanism ●
- Sterilization ●

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| | | Table 5-1 Predicate Devices |
|--|--|-----------------------------|
|--|--|-----------------------------|

| 510k Number | Trade or Proprietary or<br>Model Name | Manufacturer | Primary or<br>Additional |
|----------------------------------------------------------------------------------|---------------------------------------------|---------------------------------|--------------------------|
| K143248, K131343, K130279,<br>K121172, K092128, K090033,<br>K073240, and K071438 | PSS System (Reform<br>Pedicle Screw System) | Precision Spine<br>(Spinal USA) | Primary |
| K143248, K133746, K131615 | Polaris Spinal System | Biomet Spine | Additional |

### PERFORMANCE DATA

Analysis was performed to show that the subject devices are substantially equivalent to the predicate devices and do not require additional mechanical testing. To support substantial equivalence, a clinical literature assessment was conducted using published clinical data for pedicle screw fixation. The assessment concluded that pedicle screw fixation is safe and effective for use in pediatric patients.

#### CONCLUSION

The overall technology characteristics and mechanical engineering analysis lead to the conclusion that the Reform Pedicle Screw System is substantially equivalent to the predicate device.