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510(k) Summary AR1721

Summary of 510(k) safety and effectiveness information is being submitted in accordance with
the requirements of 21 CFR § 807.92.

Preparation Date: April 6, 2012

Applicant/Sponsor: Biomet Spine
100 Interpace Parkway
Parsippany, NJ 07054
Contact Person: Vivian Kelly
Phone: 973-299-9300 x2214
Fax: 973-257-0232

Trade name: Nextgen Altius OCT System

Common Name: Occipito-cervico-thoracic spinal fixation system
Product Code & Classification KWP - Spinal interlamninal fixation orthosis
Name: MNI & MNH - Noncervical, pedicle screw spinal system
Device Panel - Regulation No.: Orthopedic -21 CFR 888.3050 and 888.3070

Device Description:
The Nextgen Altius OCT System isan occipito-cervico-thoracic spinal fixation system. This
submission isa line extension to Altius OCT System to add CoCr rods and alternate styles of rods,
and screws, as well as other system components to the system and to update the indications for
use for the systenrias a whole.

indications for Use:

When intended for stabilization as an adjunct to fusion of the cervical spine and occipito-
cervico-thoracic junction (occiput -T3), the Nextgen Altius OCT System isintended for use with
allograft or autograft and indicated for: DDD (neck pain of discogenic origin with degeneration
of the disc as confirmed by patient history and radiographic studies); spondylolisthesis;
deformities or curvatures (i.e., scoliosis, kyphosis and/or lordlosis); pseudloarthrosis; spinal
stenosis; trauma, (i.e., fracture or dislocation); atlanto/axial fracture with instability;
occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.

The occipital bone screws are limited to occipital fixation only.

The use of pedlicle screws is limited to placement in T1-T3 in treating thoracic conditions only.
They are not intended to be placed in or treat conditions involving the cervical spine.

The Nextgen Altius OCT System can also be linked to the Biomet Polaris Systems via transitional
rods or using Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system's
package insert for a list of indications for use for each system.

Summary of Technologies:
Page 34 of 38
The technological characteristics of the new components are the same as, or similar to, the
predicate devices in regards to design, indications for use and operational principle.

Performance Data:
Mechanical testing was conducted in accorda nce with FDA's Guidance for Industry and FDA Staff
- Spinal System 510(k)s dated May 3, 2004. Per the guidance document, the following testing
was conducted: static compression bending, static torsion, torsion fatigue and compression
bending fatigue. Testing was conducted in accordance with ASTM F2706, Standard Test
Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a
Vertebrectomy Model, ASTM F1717, Standard Test Methods for Spinal Implant Constructs in a
Vertebrectomy Model and ASTM F1798, Standard Guide for Evaluating the Static and Fatigue
Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis
Implants. The mechanical testing verifies that the subject components are substantially
equivalent to other spinal systems currently on the market and has met all mechanical test
requirements based on the worst-case construct testing.

Substantial Equivalence:
The subject components in the Nextgen Altius OCT System are substantially equivalent to the
current components in the Altius OaT System (K(043229, K(033961 & K(022048), the Depuy
Mountaineer OCT Spinal System (K(110353, K(103100, K(080828, & K(042508) and the Vertex Maxo
& Select" Reconstruction Systems (1(110522, K(082728, K(090714, 1(083071, & 1(091365). The
Nextgen Altius OCT System is substantially equivalent to these predicate systems with respect to
intended use and indications, technological characteristics, and principles of operation and do
not present any new issues of safety or effectiveness.

Conclusion:
The Nextgen Altius OCT System is substantially equivalent to the predicate systems when used
as an occipito-cervico-thoracic spinal fixation device. The intended use and fundamental
technology of the system remain unchanged. Furthermore, mechanical testing and other
supporting information sufficiently demonstrate the substantial equivalence of the subject
components to the other components in the Altius OCT System. Based on this information, the
subject components do not raise any new issues regarding the safety or efficacy.

Page 35 of 38
0 o

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration

10903 New Hampshire Avenue
Document Control Room -W066-G609
Silver Spring, MD 20993-0002

Bioffet Spine
% Ms. Vivian Kelly
100 Interpace Parkway APR 1 72012
Parsippany, New Jersey 070.54

Re: K1 13593
Trade/Device Name: Nextgen OCT System
Regulation Number: 21 CFR 888.3050
Regulation Name: Spinal interlaminal fixation orthosis
Regulatory Class: 11
Product Code: KWP, MNI, MNH
Dated: April 6, 2012
Received: April 9, 2012

Dear Ms. Kelly:

We have reviewed your Section 5 10(k) premarket notification of intent to market the device
referenced above and have determined the deyice 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: CDRH4 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 I1(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 2 1, 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 (21 CFR Part 820); and if applicable, the electronic
product radiation control provisions (Sections 53 1-542 of the Act); 21 CFR 1000-1050.
Page 2 - Ms. Vivian Kelly

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/CDRICDRHOffice/ucml 15809.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" (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/Safey/ReportaProblem/'default.htm for the CDRH' s Office
of Surveillance and Biomnetrics/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
(800) 638-204] or (301) 796-7100 or at its Internet address
hp://www.fda.Qov[MedicalDevices/ResourcesforYou/Industr/defauli.htm.0
Sincerely yours,

W
p-

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

Enclosure
 Indications for Use

5 10(k) Number (if known): Ki 13593

Device Name: Nextgen OCT System

Indications for Use:

When intended for stabilization as an adjunct to fusi on of the cervical spine and occipito-cervico-
thoracic junction (occiput -T3), the Nexigen Altius OCT System is intended for use with allograft or
autograft and indicated for: ODD (neck pain of discogenic origin with degeneration of the disc as
confirmed by patient history and radiographic studies); spondylolisthesis; deformities or curvatures
(i.e., scoliosis, kyphosis and/or lotdosis); pseudoarthrosis; spinal stenosis; trauma, (i.e., fracture or
dislocation); atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous
cervical spine surgery; and tumors.

The occipital bone screws are limited to occipital fixation only.

The use of pedicle screws, is limited to placement in TI-T3 in treating thoracic conditions only.
They are not intended to be placed in or treat conditions involving the cervical spine.

The Nextgen Altius OCT System can also be linked to the Biomet Polaris Systems via transitional
rods or using Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system's
package insert for a list of indications for use for each system.

Prescription Use X AN/ROver-The-Counter Use ___

(Part 21 CER 801 Subpart D) AN/R(21 CFR 801 Subpart C)

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

Concurrence of CDRI-, Office of Device Evaluation (ODE)

and Restorative Devices

SIo0(k) Number K,'3;q93

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