MEDICAL CONCEPTS INTERBODY FUSION SYSTEM

K110659 · Medical Concepts, Inc. · MAX · Sep 13, 2011 · Orthopedic

Device Facts

• Record ID: K110659
• Device Name: MEDICAL CONCEPTS INTERBODY FUSION SYSTEM
• Applicant: Medical Concepts, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Sep 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

When used as a cervical intervertebral body fusion device, the Medical Concepts Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. When used as a lumbar intervertebral body fusion device, the Medical Concepts Interbody Fusion System is 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 or retrolisthesis at the involved level(s). 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 and with autograft to facilitate fusion. When used as a vertebral body replacement device, the Medical Concepts System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The device system is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The device system is intended to be used with autograft or allograft bone.

Device Story

Medical Concepts Interbody Fusion System consists of PEEK Optima LT1 interbody fusion and vertebral body replacement implants; includes tantalum markers for radiographic visualization. Implants configured for various surgical approaches: cervical (anterior), lumbar (PLIF, TLIF, ALIF, DLIF), and thoracic/thoracolumbar (vertebral body replacement). System implanted by surgeons using stainless steel instruments. Devices provide structural support to spinal column; used with supplemental fixation and bone graft (autograft/allograft) to facilitate fusion or restore biomechanical integrity. Benefits include stabilization of spinal segments and restoration of column height in degenerative or traumatic conditions.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F2077-03 (static/dynamic compression and torsion), ASTM F2267-04 (subsidence), and ASTM Draft Standard F-04.25.02.02 (expulsion). No clinical data provided.

Technological Characteristics

Materials: PEEK Optima LT1 (ASTM F2026) and tantalum markers (ASTM F560). Instruments: Stainless steel (ASTM F899). Design: Interbody fusion cages and vertebral body replacement components. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients requiring intervertebral body fusion for cervical DDD (C2-T1, one level, radicular symptoms) or lumbar DDD (L2-S1, one/two levels, Grade I spondylolisthesis/retrolisthesis); or vertebral body replacement (T1-L5) following resection/excision due to tumor or trauma/fracture.

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

• Eminent Spine System (K090064)
• MC+ (K043479)
• MC+ (K091088)

Submission Summary (Full Text)

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# K110659

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# Medical Concepts Interbody Fusion System

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# Premarket Notification

| SUBMITTED BY | Medical Concepts, Inc<br>11467 Huebner Rd<br>Suite 350<br>San Antonio, TX 78230 | SEP 13 2011 |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| ESTABLISHMENT<br>REGISTRATION NUMBER | Pending | |
| OWNER/OPERATOR<br>NUMBER | Pending | |
| CONTACT PERSON | Christopher T. Canis<br>Vice President, Operations<br>Medical Concepts, Inc.<br>Phone: [phone]<br>Fax: [phone] | |
| SUBMISSION PREPARED BY | QA Consulting, Inc.<br>Phone: [phone] | |
| DATE PREPARED | 24 June 2011 | |
| CLASSIFICATION NAME | Intervertebral Fusion Device with Bone Graft, Lumbar (MAX)<br>Intervertebral Fusion Device with Bone Graft, Cervical (ODP)<br>Spinal Intervertebral Body Fixation Orthosis (MQP) | |
| DEVICE CLASS | Class II | |
| REGULATION NUMBER | 888.3080 (Product Code: MAX)<br>888.3080 (Product Code ODP)<br>888.3060 (Product Code MQP) | |
| COMMON NAME | Intervertebral Body Fusion Device (MAX, ODP)<br>Vertebral Body Replacement Device (MQP) | |
| PROPRIETARY NAME | Medical Concepts Interbody Fusion System | |
| IDENTIFICATION OF PREDICATE<br>DEVICE(S) | Predicate devices include various cleared interbody fusion<br>and vertebral body replacement systems:<br>- Eminent Spine System (K090064) | |

- MC+ (K043479, K091088) ।
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#### DEVICE DESCRIPTION

The Medical Concepts Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of:

- 1) Medical Concepts cervical interbody fusion device(s), which may be implanted as a single device via an anterior approach.
- 2) Medical Concepts lumbar interbody fusion device(s), which may be implanted
- bi-laterally via a posterior (PLIF) approach; i
- as a single device via a transforaminal (TLIF) approach; or -
- as as a single device via an anterior/anterolateral (ALIF) or direct lateral (DLIF) approach.
- 3) Medical Concepts vertebral body replacement device(s), which may be implanted in the thoracic and/or thoracolumbar spine (T1-L5).

The Medical Concepts Interbody Fusion System implant components are made of polyether ether ketone (PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

The Medical Concepts Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.

#### INDICATIONS

When used as a cervical intervertebral body fusion device, the Medical Concepts Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

When used as a lumbar intervertebral body fusion device, the Medical Concepts Interbody Fusion System is 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 or retrolisthesis at the involved level(s). 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 and with autograft to facilitate fusion.

When used as a vertebral body replacement device, the Medical Concepts System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectorny) due to tumor or traumaffracture. The device system is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The device system is intended to be used with autograft or allograft bone.

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## SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The purpose of this premarket notification is to obtain clearance to market the Medical Concepts Interbody Fusion System. The Medical Concepts Interbody Fusion System is comprised of various device configurations designed to accommodate patient anatomy and provide the surgeon with different surgical approach options.

The Medical Concepts Interbody Fusion System implant components are made of polyether ether ketone (PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

The subject system has similar technological characteristics as the predicate devices identified above. Specifically, the following characteristics support this conclusion:

- Intended for use at either one level or two contiguous levels from L2-S1 for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
- Intended for use at one level from the C2-C3 disc to the C7-TI disc for the treatment of degenerative disc disease (DDD) of the cervical spine with accompanying radicular svmptoms.
- Intended for use as a vertebral body replacement device (partial vertebrectomy) due to tumor or trauma/fracture.
- Substantially equivalent results of non-clinical testing relative to static and dynamic testing -(per ASTM F2077-03), subsidence (per ASTM F2267-04), and expulsion (per ASTM Draft Standard F-04.25.02.02)

### DISCUSSION OF NON-CLINICAL TESTING

The following non-clinical tests were conducted:

- Static and dynamic compression testing, conducted in accordance with ASTM F2077-03 -
- -Static and dynamic torsion testing, conducted in accordance with ASTM F2077-03
- Subsidence testing, conducted in accordance with ASTM F2267-04 -
- -Expulsion testing, conducted in accordance with ASTM Draft Standard F-04.25.02.02

#### CONCLUSIONS

The subject and predicate device(s) share the same intended use, primary implant design and equivalent material of manufacture. The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the Medical Concepts Interbody Fusion System is substantially equivalent to the predicate device.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Medical Concepts, Inc. % Mr. Christopher T. Canis 11467 Huebner Road. Suite 350 San Antonio, Texas 78230

SEP 13 2011

Re: K110659

Trade/Device Name: Medical Concepts Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP, MQP Dated: September 01, 2011 Received: September 02, 2011

Dear Mr. Canis:

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. Iisting 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

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Page 2 - Mr. Christopher T. Canis

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 331-542 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/wcm115809.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/MedicalDevices/Safetv/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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely vours Mark N. Melker

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

Enclosure

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## INDICATIONS FOR USE

## 510(k) Number (if known): K110659

Medical Concepts Interbody Fusion System Device Name:

Indications for Use:

When used as a cervical intervertebral body fusion device, the Medical Concepts Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degeneralive disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

When used as a lumbar intervertebral body fusion device, the Medical Concepts Interbody Fusion System is 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 or retrolisthesis at the involved level(s). 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 and with autograft to facilitate fusion.

When used as a vertebral body replacement device, the Medical Concepts System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The device system is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The device system is intended to be used with autograft or allograft bone.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number_K 110659

The Forum 8000 IH-10 West, Suite 1140 San Antonio, TX 78230

Phone: [phone] Fax: [phone]

Medical Concepts