FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY

K100044 · Blackstone · NKB · Feb 4, 2010 · Orthopedic

Device Facts

• Record ID: K100044
• Device Name: FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY
• Applicant: Blackstone
• Product Code: NKB · Orthopedic
• Decision Date: Feb 4, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications: 1) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) 2) spondylolisthesis, 3) trauma (i.e., fracture or dislocation), 4) spinal stenosis, 5) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), 6) tumor. 7) pseudoarthrosis, and 8) failed previous fusion The Firebird Spinal Fixation Screw System components are used with certain components of the Blackstone SFS system, including rods, rod connectors and cross-connectors.

Device Story

Temporary, non-sterile, single-use spinal implant system; titanium alloy components; includes screws, rods, rod connectors, and cross-connectors. Surgeon attaches screws to vertebral body in non-cervical spine; connects screws with rods to build spinal construct. Used in clinical/OR settings by orthopedic surgeons. Provides mechanical stabilization of spine to facilitate fusion. Modification adds side-loading body component to existing system. Output is physical stabilization of spinal segments; aids clinical decision-making by providing structural support for fusion. Benefits patient through stabilization of diseased/injured spinal segments.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM standards to demonstrate substantial equivalence to predicate systems.

Technological Characteristics

Temporary, non-sterile, single-use, multiple-component system. Materials: titanium alloy and cobalt chrome. Principle: pedicle screw fixation with rod-screw construct. Form factor: spinal implant components (screws, rods, connectors). Connectivity: N/A. Sterilization: non-sterile (requires sterilization by user).

Indications for Use

Indicated for skeletally mature patients requiring posterior, non-cervical pedicle fixation as an adjunct to fusion (autograft/allograft) for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, and failed previous fusion.

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

• Blackstone Pedicle Screw System (K081684)
• Blackstone Pedicle Screw System, 4.0 mm Screws (K082797)
• Firebird Spinal Fixation System, Cobalt-Chrome Rods (K092624)
• Blackstone Spinal Fixation System (K080407)
• Synthes Universal Spine System (USS) (K082572)

Submission Summary (Full Text)

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# FEB - 4 2010

Premarket Notification 510(k) Blackstone Medical, Inc. Firebird Spinal Fixation System Modification

## 510(k) SUMMARY

.

## Spinal Fixation System Modification - Side-loading Body

| Sponsor: | Blackstone Medical, Inc.<br>1211 Hamburg Turnpike<br>Suite 300<br>Wayne, NJ 07470 |
|---------------------------|-----------------------------------------------------------------------------------|
| Registration Number: | 3004606875 |
| Contact Person: | Whitney G. Törning, Senior Director of Regulatory Affairs<br>& Quality Assurance |
| Telephone Number: | 973.406.2838 |
| Fax Number: | 973.406.2938 |
| Email: | [e-mail] |
| Submitter: | Martin G. Sprunck.<br>Regulatory Affairs Manager |
| Manufacturer: | Orthofix, Inc.<br>1720 Bray Central Dr.<br>McKinney, TX 75069 |
| Registration Number: | 2183449 |
| Contract Manufacturer: | Structure Medical, Inc.<br>2975 S. Horseshoe Drive<br>Naples, Florida 34104 |
| System Name: | Firebird Spinal Fixation System |
| Trade Name (Component): | Firebird Side-loading Body |
| Common Name (System): | Posterior Thoracolumbar System |
| Product Code: | NKB - Orthosis, Spinal Pedicle Fixation, for Degenerative<br>Disc Disease |
| Subsequent Product Codes: | MNI - Orthosis, Spinal Pedicle Fixation |

Firebird Spinal Fixation System Modification - 510(k) Summary

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Premarket Notification 510(k) Blackstone Medical, Inc. Firebird Spinal Fixation System Modification

| Regulatory Classifications: | Class III Preamendment Device, 888.3070 - Pedicle Screw<br>Spinal System - *Class III Summary and Certification<br>Required<br>Class II – 888.3070 - Pedicle Screw Spinal System |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Review Panel: | Orthopedic Device Panel |
| Predicate Devices: | Blackstone Pedicle Screw System (K081684 SE 9/15/08)<br>Blackstone Pedicle Screw System, 4.0 mm Screws<br>(K082797 SE 10/17/08)<br>Firebird Spinal Fixation System, Cobalt-Chrome Rods<br>(K092624 SE 9/25/09)<br>Blackstone Spinal Fixation System (K080407 SE 3-13-08)<br>Synthes Universal Spine System (USS) (K082572 SE 11-<br>24-08) |

### Intended Use / Indications for Use

The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications:

- I ) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- 2) spondylolisthesis,
- 3) trauma (i.e., fracture or dislocation),
- 4) spinal stenosis,
- 5) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- 6) tumor.
- 7) pseudoarthrosis, and
- 8) failed previous fusion

The Firebird Spinal Fixation Screw System components are used with certain components of the Blackstone SFS system, including rods, rod connectors and cross-connectors.

#### Technological Characteristics

The Firebird Spinal Fixation System is a temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws to the non-cervical spine. The spinal construct is completed by connecting the screws with titanium alloy or cobalt chrome rods.

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Premarket Notification 510(k) Blackstone Medical, Inc. Firebird Spinal Fixation System Modification

#### Performance Data

Mechanical testing of the Firebird Spinal Fixation system with the Side-loading Body was conducted in accord with ASTM standards, and demonstrates that the system is substantially equivalent to predicate systems. The additional component does not change the intended use, indications, technological characteristics or principles of operation of the Firebird Spinal Fixation System.

### Basis of Substantial Equivalence

Mechanical testing was conducted to demonstrate that the Firebird Spinal Fixation System with the addition of the Side-loading Body is substantially equivalent to the current Firebird Spinal Fixation System, (K081684 SE 9/15/08, K082797 SE 10/17/08 and K092624 SE 9/25/09), which has been cleared by FDA for the purpose of building a spinal implant construct in the non-cervical spine.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird-like figure, which is the department's symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

FEB - 4 2010

Blackstone Medical, Inc. % Ms. Whitney G. Törning Senior Director of Regulatory Affairs and Quality Assurance 1211 Hamburg Turnpike, Suite 300 Wayne, New Jersey 07470

Re: K100044

Trade/Device Name: Firebird Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: January 07, 2010 Received: January 08, 2010

Dear Ms. Törning:

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 agamst 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

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Page 2 - Ms. Whitney G. Törning

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 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/CDRH/CDRHOffices/ucr 1 1 800 .jpht 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" (21168 Production 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 tollofire number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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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Premarket Notification 510(k) Blackstone Medical, Inc. Firebird Spinal Fixation System Modification

#### Indications for Use Statement

510(k) Number (if known):

System Name: Firebird Spinal Fixation System Device Name: Firebird Side-loading Body

Indications for Use:

The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications:

- l ) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- 2) spondylolisthesis,
- 3) trauma (i.e., fracture or dislocation),
- 4) spinal stenosis,
- 5) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- 6) tumor.
- 7) pseudoarthrosis, and
- 8) failed previous fusion

The Firebird Spinal Fixation System components are used with certain components of the Blackstone SFS system, including rods, rod connectors and cross-connectors.

AND/OR

Prescription Use X (Part 21 C.F.R. 801 Subpart D)

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division Sign Off

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K100044 510(k) Number