ZAVATION IBF SYSTEMS

K112664 · Zavation, LLC · ODP · Dec 23, 2011 · Orthopedic

Device Facts

• Record ID: K112664
• Device Name: ZAVATION IBF SYSTEMS
• Applicant: Zavation, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Dec 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as a cervical intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (definded as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment. When used as a lumbar intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, 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 lumbar device is intended to be used in patients who have had six months of non-operative treatment. For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Spinal System and Zavation Cervical Plate System.

Device Story

Zavation IBF System consists of intervertebral body fusion implants in ALIF, LLIF, TLIF, T-PLIF, PLIF, and CIF configurations. Implants are manufactured from PEEK with embedded tantalum markers for radiographic visualization; machined teeth on ends engage vertebral endplates. Used by surgeons in spinal fusion procedures to treat discogenic pain or degenerative disc disease. Implants provide structural support to the intervertebral space while autogenous bone graft facilitates fusion. Requires supplemental internal fixation (e.g., plates or pedicle screws). Benefits include stabilization of spinal segments and promotion of fusion in patients failing conservative therapy.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F2077 and ASTM F2267, including static and dynamic axial compression, subsidence, and expulsion tests, demonstrated substantial equivalence to predicate devices.

Technological Characteristics

Materials: PEEK (ASTM F2026) and Tantalum alloy markers (ASTM F560). Configurations: ALIF, LLIF, TLIF, T-PLIF, PLIF, CIF. Features: Machined teeth for endplate engagement, lordotic and parallel options. Non-sterile, requires sterilization by user.

Indications for Use

Indicated for skeletally mature patients requiring spinal fusion. Cervical: one level (C2-T1) for discogenic neck pain after 6 weeks of failed non-operative treatment. Lumbar: one or two contiguous levels (L2-S1) for degenerative disc disease with up to Grade I spondylolisthesis after 6 months of failed non-operative treatment. Must be used with autogenous bone graft and supplemental internal fixation.

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

• Lumbar I/F Cage, Depuy Spine (P960025)
• Aleutian IBF System, K2M (K110843)
• LDR Spine Cervical Interbody Fusion System (K091088)
• Spinal Elements, Crystal, Interbody Fusion Device (K073351)
• Synthes Spine, Oracle, OPAL Spacer (K072791)
• Synthes Spine, T-PAL Spacer (K100089)
• Globus Medical, Patriot Spacers (K072970)

Submission Summary (Full Text)

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KII2664

DEC 2 3 2011

# 510K Summary

| Date: | September 12, 2011 |
|----------------------------|-------------------------------------------------------------------------------------------------|
| Submitter: | Zavation LLC<br>501 Avalon Way<br>Brandon, MS 39047<br>Phone: [phone]<br>Fax: [phone] |
| Contact person: | John Walker |
| Type of 510(k) submission: | Traditional |
| Trade name: | Zavation IBF System |
| Common name: | Intervertebral Body Fusion Device |
| Classification regulation: | 888.3080 (MAX, ODP) |
| Device classification: | Class II |
| Classification Panel: | Orthopedic |
| Product code: | MAX, ODP |
| Basis for submission: | New device |

## Device Description:

The Zavation IBF implants offers a variety of heights, widths and lengths. There are six main configurations: ALIF, LLIF, TLIF, T-PLIF, PLIF and CIF. The different configurations allow for multiple surgical technique options. The implants are manufactured from medical grade PEEK (Polyetheretherketone).

The Zavation IBF implants are available in a range of sizes, as well as parallel and lordotic angled · implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the implants as an option to help allow for radiographic visualization. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates.

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#### Intended Use:

When used as a cervical intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (definded as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.

When used as a lumbar intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, 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 lumbar device is intended to be used in patients who have had six months of non-operative treatment.

For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Spinal System and Zavation Cervical Plate System.

#### Materials:

The devices are manufactured from medical grade PEEK Zeniva ZA-500(ASTM F2026) with Tantalum alloy position markers (ASTM F560).

### Predicate Device:

Lumbar I/F Cage, Depuy Spine (P960025) Aleutian IBF System, K2M (K110843) LDR Spine Cervical Interbody Fusion System (K091088) Spinal Elements, Crystal, Interbody Fusion Device (K073351) Synthes Spine, Oracle, OPAL Spacer (K072791) Synthes Spine, T-PAL Spacer (K100089) Globus Medical, Patriot Spacers (K072970)

### Technological Characteristics:

The Zavation IBF System possesses the same technological characteristics as the predicates. These include similar heights, widths, lengths, and intended use.

### Performance Data:

Mechanical test results demonstrated that the Zavation IBF System is substantially equivalent to the predicate devices. Testing was performed in accordance with ASTM F2077 and ASTM F2267. Static and Dynamic axial compression, subsidence and expulsion tests were completed.

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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 eagle or bird-like figure with flowing lines, representing movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.

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

DEC 2 3 2011

Zavation LLC % Mr. John Walker 501 Avalon Way Brandon, Mississippi 39047

Re: K112664

Trade/Device Name: Zavation IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX Dated: December 13, 2011 Received: December 13, 2011

Dear Mr. Walker:

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 - Mr. John Walker

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (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 11 you desire specific advice tor your avrites offices/CDRH/CDRHOffices/ucm115809.htm for go to mtd.io.it www.ida.gover.item.ith's (CDRH's) Office of Compliance. Also, please the Center for Devices and Radionanding by reference to premarket notification" (21CFR Part note the regulations 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 I ou may obtain 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,

For Peter

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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# Indications for Use

510(k) Number: K112664

Device Name: Zavation IBF System

Indications For Use:

When used as a cervical intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (definded as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.

When used as a lumbar intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, 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 lumbar device is intended to be used in patients who have had six months of non-operative treatment.

For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System and Zavation Cervical Plate System.

Prescription Use _ X _________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

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ivision of Surgical, Orthopedic, and Restorative Devices

K112664 510(k) Number ___