BLACKBIRD SPINAL SYSTEM

K133214 · Choicespine, LP · KWP · Mar 7, 2014 · Orthopedic

Device Facts

• Record ID: K133214
• Device Name: BLACKBIRD SPINAL SYSTEM
• Applicant: Choicespine, LP
• Product Code: KWP · Orthopedic
• Decision Date: Mar 7, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BLACKBIRD™ Spinal System is intended to be used in skeletally mature patients as an adjunct to fusion for stabilization of the cervical spine (C1-T3) for the following conditions: degenerative disc disease (DDD; defined as neck pain of discogenic origin with degeneration of the disk as confirmed by history & radiographic studies) spondylolisthesis trauma fracture / dislocation spinal stenosis atlanto/axial fracture with instability tumor revision of previous cervical spine surgery The use of polyaxial screws is limited to placement in the thoracic spine (T1-T3) "for anchoring the construct only" and is not intended to be placed in the cervical spine. The use of the rods and hook components are intended for use in (C1-T3). This system can be linked to a Ø6.0mm rod system such as the Choice Spine Starfire™ Pedicle Screw System.

Device Story

Posterior spinal fixation system for cervical and upper thoracic spine (C1-T3). Components include polyaxial screws, smooth shaft polyaxial screws, set screws, straight/pre-bent/transition rods, rod-to-rod cross connectors, lateral offset connectors, and hooks. Implanted by surgeons in clinical settings to stabilize spine as adjunct to fusion. Polyaxial screws limited to T1-T3 for construct anchoring. System compatible with Ø6.0mm rod systems (e.g., Starfire™ Pedicle Screw System). Provides mechanical stabilization to treat degenerative disc disease, trauma, stenosis, and tumors; aids in patient recovery by maintaining spinal alignment during fusion.

Clinical Evidence

Bench testing only. Mechanical performance testing conducted per ASTM F1717 (static compression bending, static torsion, dynamic compression bending) and ASTM F1798-97(2008) (torsional/axial gripping capacity, flexion-extension/cantilever bending). Results demonstrate performance equivalent to predicate devices.

Technological Characteristics

Materials: Ti 6Al 4V-ELI alloy or Cobalt-Chromium-Molybdenum (ASTM F1537). Components: polyaxial screws, rods, hooks, connectors. Mechanical fixation principle. Non-active, implantable device. No software or connectivity.

Indications for Use

Indicated for skeletally mature patients requiring cervical spine (C1-T3) stabilization as an adjunct to fusion. Conditions: degenerative disc disease, spondylolisthesis, trauma, fracture/dislocation, spinal stenosis, atlanto/axial fracture with instability, tumor, and revision of previous cervical spine surgery. Polyaxial screws restricted to thoracic (T1-T3) anchoring only; not for cervical placement.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• Aesculap S4 Spinal System (K050979)
• Theken Spine Atoll Cervical-Thoracic System (K070638)
• Alphatec Spine Solanas Spinal Systems (K052201, K071380)

Reference Devices

• Choice Spine Starfire™ Pedicle Screw System

Submission Summary (Full Text)

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

K133214 Page 1 of 2

# MAR 0 7 2014

#### 510(k) Summary

| Date Prepared: | January 24, 2014 |
|---------------------|--------------------------------------------------------------------------------------------------|
| Company: | Choice Spine, LP<br>400 Erin Drive, Knoxville, TN 37919<br>Tel: [phone] Fax: [phone] |
| Regulatory Contact: | Kim Finch, Manager of Regulatory Affairs<br>[e-mail] |
| Trade Name: | BLACKBIRD™ Spinal System |
| Product Class: | Class II |
| Classification: | 888.3050 Spinal Interlaminal Fixation Orthosis |
| Product Codes: | KWP |
| Panel Code: | 87 |

Device Description:

The Choice Spine BLACKBIRD™ Spinal System is a comprehensive system for posterior fixation of the cervical and upper thoracic spine. It is to be implanted posteriorly. The system is composed of polyaxial screws and smooth shaft polyaxial screws in various sizes, set screws, straight rods, pre bent rods, transition rods, rod to rod cross connectors, lateral offset connectors, rod transition connectors. and hooks. All implant components will be made from Ti 6Al 4V-ELI alloy or Cobalt 28- Chromium 6- Molybdenum per ASTM F1537.

#### Indications for Use:

The BLACKBIRD™ Spinal System is intended to be used in skeletally mature patients as an adjunct to fusion for stabilization of the cervical spine (C1-T3) for the following conditions:

- degenerative disc disease (DDD; defined as neck pain of discogenic origin with . degeneration of the disk as confirmed by history & radiographic studies)
- spondylolisthesis ●
- trauma ●
- fracture / dislocation .
- spinal stenosis
- atlanto/axial fracture with instability .
- . tumor
- revision of previous cervical spine surgery .

The use of polyaxial screws is limited to placement in the thoracic spine (T1-T3) "for anchoring the construct only" and is not intended to be placed in the cervical spine. The use of the rods and hook components are intended for use in (C1-T3). This system can be linked to a Ø6.0mm rod system such as the Choice Spine Starfire™ Pedicle Screw System.

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

## Predicate Device(s):

The BLACKBIRD™ Spinal System is substantially equivalent to the previously cleared Aesculap (K050979) S4 Spinal System, Theken Spine (K070638) Atoll Cervical-Thoracic System, and Alphatec Spine (K052201, K071380) Solanas Spinal Systems.

### Performance Standards:

Performance testing was completed by an independent laboratory following ASTM F1717. The tests included static compression bending, static torsion and dynamic compression bending, Additionally Torsional gripping capacity, axial gripping capacity, flexion extension / cantilever bending results were tested per ASTM 1798-97(20008). The performance testing required is the equivalent same for the predicate devices.

#### Substantial Equivalence:

The characteristics of the BLACKBIRD™ Spinal System are similar to the predicate devices Aesculap (K050979) S4 Spinal System, Theken Spine (K070638) Atoll Cervical-Thoracic System, and Alphatec Spine (K052201, K071380) Solanas Spinal Systems. Equivalence is based on the similarities of the intended use, design, physical characteristics when compared to the predicates, and system component materials.

Choice Spine concludes that the BLACKBIRD™ Spinal System is substantially equivalent when compared to the predicate legally marketed devices.

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

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

March 7, 2014

Choice Spine, LP Ms. Kim Finch Manager of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919

Re: K133214

Trade/Device Name: Blackbird Spinal System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: January 23, 2014 Received: January 28, 2014

Dear Ms. Finch:

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 forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

#### Page 2 - Ms. Kim Finch

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,

# Vincent Devlin -S

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

Enclosure

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

#### 7.0 Indications for Use

#### 510(k) Number K133214

#### Device Name: BLACKBIRD™ Spinal System

The BLACKBIRD™ Spinal System is intended to be used in skeletally mature patients as an adjunct to fusion for stabilization of the cervical spine (C1-T3) for the following conditions:

- degenerative disc disease (DDD; defined as neck pain of discogenic origin with . degeneration of the disk as confirmed by history & radiographic studies)
- . spondylolisthesis
- trauma �
- . fracture / dislocation
- � spinal stenosis
- atlanto/axial fracture with instability .
- . tumor
- . revision of previous cervical spine surgery

The use of polyaxial screws is limited to placement In the thoracic spine (T1-T3) "for anchoring the construct only" and is not intended to be placed in the cervices spine. The rods and hook components are intended for use in (C1-T3). This system can be linked to a Ø6.0mm rod system such as the Choice Spine Starfire™ Pedicle Screw System.

Prescription Use_ × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Colin O'Neill

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133214

.

Attachment D