CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON)

K140142 · Choicespine, LP · MAX · Jul 16, 2014 · Orthopedic

Device Facts

• Record ID: K140142
• Device Name: CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON)
• Applicant: Choicespine, LP
• Product Code: MAX · Orthopedic
• Decision Date: Jul 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as an intervertebral body fusion device, Choice Spine Lumbar Spacers are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation (e.g., ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft to facilitate fusion. When used as a vertebral body replacement device, Choice Spine Lumbar Spacers are intended for use in the thoracic and lumbar spine, from T1 to L5, for the replacement of a collapsed or unstable vertebral body resulting from a tumor or traumatic injury. The device system is designed for use with supplemental fixation (e.g., ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft to facilitate fusion.

Device Story

Spinal spacer system (Sabre, Shark, Hornet, Harpoon) provides structural support for intervertebral fusion or vertebral body replacement. Rectangular, hollow-center implants accommodate autograft bone to facilitate fusion. Used in thoracic and lumbar spine; requires supplemental fixation (e.g., ORIA Claris/Spinal Clip). Implanted by surgeons during spinal procedures. Tantalum pins provide radiographic visualization. Benefits include stabilization of collapsed/unstable vertebral bodies or discogenic back pain relief.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical performance evaluated via static axial compression, bending, torsion, and dynamic axial compression/torsion testing per ASTM F2077-11 and ASTM F2267-04 standards.

Technological Characteristics

Materials: PEEK OPTIMA LT1 (ASTM F2026) for spacers; 17-4 Stainless Steel (ASTM F899) for trials. Tantalum marking pins (ASTM F560). Rectangular, hollow-center geometry with varying heights/lengths/lordosis. Non-active, implantable device.

Indications for Use

Indicated for skeletally mature patients requiring lumbar intervertebral fusion (L2-S1) for degenerative disc disease with up to Grade I spondylolisthesis after 6 months of failed non-operative treatment, or for thoracic/lumbar (T1-L5) vertebral body replacement following tumor or trauma.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• K2M, LLC Aleutian Spacer System (K051454, K130699)
• Innovasis, Inc., Box Peek VBR System (K062151)
• Choice Spine Lumbar Spacer System (K073669)

Submission Summary (Full Text)

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K140142 page 1 of 2

## JUL 1 6 2014

510(k) Summary for the 9 mm Wide Choice Spine Lumbar Spacer System

Date Prepared: July 14, 2014

Submitter Contact: Choice Spine, LP. 400 Erin Drive, Knoxville, TN 37919 Tel: [phone] Fax: [phone]

Regulatory Contact: Kim Finch, Manager of Regulatory Affairs [e-mail]

Device Name: Spinal Vertebral Body Replacement Device Intervertebral Fusion Device with Bone Graft, Jumbar

TradeName: Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)

Product Class: Class II

Requlation Number 888.3080 Intervertebral Body Fusion Device

888.3060 Spinal Intervertebral body fixation orthosis

Product Codes: MAX, MQP

Panel Code: 87

Indications for Use:

When used as an intervertebral body fusion device, Choice Spine lumbar Spacers are indicated for intervertebral body fusion of the lumbar spine, from L 2 - S 1 , in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation systems such as (ORIA Claris, ORIA Spinal Clip System, etc.).

When used as a vertebral body replacement device, Choice Spine lumbar Spacers are intended for use in the thoracic and lumbar spine, from T1 to L5 , for the replacement of a collapsed or unstable vertebral body resulting from a turnor or traumatic injury. The device system is designed for use with supplemental fixation (ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft bone to facilitate fusion.

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K140142 page 2 of 2

Device Descriptions:

The 9mm width spacer system (SABRE, SHARK, HORNET, HARPOON) has a rectangular shape, a hollow center for placement of autograft bone, and a smooth anterior surface (nose). It is available in a variety of heights, length, and lordosis combinations with and without medial-lateral curvature to accommodate many different anatomic requirements.

#### Materials:

The 9mm width spacers are manufactured from PEEK OPTIMA LT1(Invibio) per ASTM F2026. The spacer includes tantalum marking pins per ASTM F560 for radiographic assistance. These technological characteristics and materials are identical to the predicate devices.

The 9mm width trials are manufactured from 17-4 Stainless Steel per ASTM F899 and are biocompatible.

### Predicate Device(s):

K2M, LLC Aleutian Spacer System K051454, K130699 Innovasis, Inc., Box Peek VBR System K062151 Choice Spine Lumbar Spacer System, K073669

#### Performance Standards:

Performance testing was completed by an independent laboratory following ASTM F2077-11 and ASTM F2267-04. The tests included static axial compression bending, static torsion, dynamic axial compression bending and dynamic torsion testing. The test methods and results are substantially equivalent to those of the predicate devices.

#### Conclusion:

The 9 mm wide spacer has the same technological characteristics, intended use, comparable performance data, and is manufactured using the same processes as the predicate devices. The sterilization method and parameters remain the same. In conclusion, the 9 mm wide devices are substantially equivalent to the listed predicates and do not raise new questions of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 16, 2014

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

Re: K140142

Trade/Device Name: Choice Spine Lumbar Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: June 13, 2014 Received: June 16, 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

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Page 2 - Ms. Kim Finch

forth in the quality systems (OS) 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/ResourcesforYou/Industrv/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/ReportalProblem/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,

# Ronald P. Jean -S for

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 K140142

The Company's Indications for Use Statement for Choice Spine Lumbar Spacer System is provided.

Indications for Use:

When used as an intervertebral body fusion device, Choice Spine Lumbar Spacers are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation (e.g., ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft to facilitate fusion.

When used as a vertebral body replacement device, Choice Spine Lumbar Spacers are intended for use in the thoracic and lumbar spine, from T1 to L5, for the replacement of a collapsed or unstable vertebral body resulting from a tumor or traumatic injury. The device system is designed for use with supplemental fixation (e.g., ORIA Claris, ORIA Spinal Clip System, etc.) and with autograft to facilitate fusion.

Prescription Use X (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)

n E. Dmitrie Division of

Concurrence of CDRH, Office of Device Evaluation (ODE)