KRD1 PEDICLE SCREW SYSTEM

K092420 · Spinefrontier, Inc. · MNI · Nov 19, 2009 · Orthopedic

Device Facts

• Record ID: K092420
• Device Name: KRD1 PEDICLE SCREW SYSTEM
• Applicant: Spinefrontier, Inc.
• Product Code: MNI · Orthopedic
• Decision Date: Nov 19, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KRD1™ 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 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). In addition, the KRD1™ Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft.

Device Story

System consists of polyaxial pedicle screws, longitudinal rods, and transverse connectors; facilitates spinal immobilization and stabilization. Screws feature tulip and washer assembly allowing polyaxial rotation; locking cap secures rod position. Components installed by surgeons in clinical/OR settings to provide rigid fixation as adjunct to fusion. Device provides mechanical support to spinal segments; helps restore alignment; promotes fusion. No electronic or software components.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: medical grade titanium alloy (ASTM F-136). Components: polyaxial pedicle screws, longitudinal rods (5.5mm diameter), transverse connectors. Mechanical fixation system; no energy source or software.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for thoracic, lumbar, and sacral spine conditions: degenerative spondylolisthesis with neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed fusion (pseudoarthrosis), and severe spondylolisthesis (Grade 3-4) at L5-S1.

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

• Syneray Posterior Spinal System (K950099)
• Synthes USS Click-X Variable Axis System (K992739)
• Synthes Pangea System (K052123)

Submission Summary (Full Text)

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#### 5.0 510(k) Summary

### 1. Sponsor

SpineFrontier, Inc. 500 Cummings Center Suite 3500 Beverly, MA 01915

NOV 1 9 2009

Primary Contact: John Sullivan 1- 978-232-3990 Telephone:

November 12, 2009 Date Prepared:

## 2. Device Name and Classification:

KRD1™ Pedicle Screw System " Proprietary Names:

Common/Usual Name: Spine Fixation System

Classification Name: Orthosis, Spondylolisthesis Spinal Fixation Orthosis, Spinal Pedicle Fixation (21 CFR 888.3070(b)(1)), Class II

MNH, MNI Product Code:

### 3. Predicate Devices

K950099 - Syneray Posterior Spinal System K992739 - Synthes USS Click-X Variable Axis System K052123 - Synthes Pangea System

### 4. Device Description

The KRD1™ Pedicle Screw System consists of longitudinal rods, polyaxial screws, transverse connectors, and instrumentation to facilitate installation of this system.

The KRD11M Pedicle Screw is offered in multiple screw diameters, with multiple lengths to accommodate individual patient needs. KRD1™ Pedicle Screw assemblies consist of the screw, a tulip, and a washer that secures the tulip to the screw and also serves as the saddle for the longitudinal rod. The

SpineFrontier, Inc. KRD1 Pedicle Screw System - Supplement to 510(k) Premarket Notification K092420 November 12, 2009

Company Confidential

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tulip and screw designs allow the screw to have a polyaxial rotation relative to the tulip. A locking cap is placed on top of the pedicle screw assembly to secure the position of the implant and to retain the longitudinal rod.

The KRD1™ Pedicle Screw assembly serves as the central fixation device to which various rods and cross connectors are secured to provide desired fixation.

Longitudinal rods are provided in two configurations, straight and lordotic, have a fixed diameter (5.5mm), and vary by length.

Cross connector assemblies are provided in multiple configurations, varying by length. Cross connectors are used to provide additional fixation support.

The KRD1™ Pedicle Screw System components are fabricated from medical grade titanium alloy conforming to ASTM F-136 specifications.

#### 5. Intended Use

The KRD1™ 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondvlolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudoarthrosis).

In addition, the KRD1™ Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft.

### 6. Technological Characteristics & Substantial Equivalence Determination

The SpineFrontier KRD1™ Pedicle Screw System was shown to be substantially equivalent to predicate devices through comparison of indications for use, function, operating principles, and materials.

The KRD1 The Pedicle Screw System has been shown to be substantially equivalent to predicate devices in terms of performance (mechanical testing). Clinical data was not required for this device.

Company Confidential

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

# NOV 1 9 2009

SpineFrontier, Inc. % Mr. John Sullivan Director, QA and Regulatory Compliance 500 Cummings Center, Suite 3500 Beverly, Massachusetts 01915

Re: K092420

Trade/Device Name: KRD1™ Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: October 20, 2009 Received: October 20, 2009

Dear Mr. Sullivan:

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.

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

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Page 2 - Mr. John Sullivan

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Joneta J

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

Enclosure

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#### 4.0 Indications for Use Statement

510(k) Number (if Known): K092420

Indications For Use:

The KRD1™ 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 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).

In addition, the KRD1™ Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone.

Prescription Use: _X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use: (Part 21 CFR 807 Subpart C)

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Division Size 80

(Division Sign Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092420

SpineFrontier, Inc. KRD1 " Pedicle Screw System - Supplement to 510(k) Premarket Notification K092420 November 12, 2009

Company Confidential

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