ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM

K041808 · Endius, Inc. · KWP · Oct 1, 2004 · Orthopedic

Device Facts

• Record ID: K041808
• Device Name: ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
• Applicant: Endius, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Oct 1, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Endius® TITLE 2™ Polyaxial Spinal System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Levels of fixation are for the thoracic, lumbar, and sacral spine. The Endius® TITLE 2™Polyaxial Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The Endius® TITLE 2™ Polyaxial Spinal System is also indicated for pedicle screw fixation for severe spondylolithesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1. In addition, the Endius® TITLE 2™ Polyaxial Spinal System, when not used with pedicle screws is indicated for hook, wire, and/or sacral screw fixation from T1 to the ilium sacrum. The non-pedicle screw indications are spondylolithesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previous failed fusion surgery.

Device Story

Polyaxial spinal fixation system; components include screws, rods, and connection components; manufactured from titanium (ASTM F136). Used in posterior lumbar fusion procedures; provides immobilization and stabilization of spinal segments. Operated by surgeons in clinical settings. Output is mechanical fixation of spinal segments to facilitate fusion; benefits include stabilization of acute/chronic spinal instabilities or deformities.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Polyaxial spinal fixation system; materials: titanium (ASTM F136); components: screws, rods, connection components; mechanical fixation; non-active device.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion. Conditions: degenerative disc disease, degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis, and severe spondylolisthesis (grades 3-4 at L5-S1). Levels: T1 to sacrum (pedicle screws L3-S1).

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

• Endius TiTLE Spinal Fixation System (K021881)

Submission Summary (Full Text)

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OCT 1 - 2004

K041808

## Section 7 - 510(k) Summary

| 7.1<br>Statement | Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Endius, Inc. is<br>required to submit with this Premarket Notification either an "... adequate<br>summary of any information respecting safety and effectiveness or state that<br>such information will be made available upon request of any person." Endius,<br>Inc. chooses to submit a summary of information respecting safety and<br>effectiveness. According to §513(i)(3)(B), "Any summary under subparagraph<br>(A) respecting a device shall contain detailed information regarding data<br>concerning adverse health effects..."<br>The summary regarding the adverse health effects of the modified device,<br>Endius® TITLE 2™ Polyaxial Spinal System is provided below. |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7.2<br>Submitter | Endius, Inc.<br>23 West Bacon Street<br>Plainville, MA. 02762 |
| 7.3<br>Company<br>Contact | Christine Kuntz-Nassif<br>Director, Regulatory Affairs<br>508-643-0983 Ext. 114 |
| 7.4<br>Device<br>Name | Proprietary Name:<br>Endius® TITLE 2™ Polyaxial Spinal System<br>Common Name:<br>Pedicle Screw System , Non-pedicle spinal fixation system<br>Classification Name:<br>Posterior, Noncervical, Nonpedicle System (KWP)<br>Noncervical, Pedicle System (MNH, MNI, NKB) |
| 7.5<br>Predicate<br>Device | Endius TiTLE Spinal Fixation System: K021881 |
| 7.6<br>Device<br>Description | The Endius® TITLE 2™ Polyaxial Spinal System is a system that is intended to<br>be used for posterior lumbar fusion procedures. The system is manufactured<br>from titanium which complies with ASTM F136. The components, which are<br>included as part of the system, include screws, rods, and connection<br>components. |
| 7.7<br>Device<br>Indications<br>and<br>Intended<br>Use | The Endius® TITLE 2™ Polyaxial Spinal System is indicated for degenerative<br>disc disease (defined as discogenic back pain with degeneration of the disc<br>confirmed by history and radiographic studies. Levels of fixation are for the<br>thoracic, lumbar, and sacral spine.<br><br>The Endius® TITLE 2™Polyaxial Spinal System is a pedicle screw system<br>intended to provide immobilization and stabilization of spinal segments in<br>skeletally mature patients as an adjunct to fusion in the treatment of the<br>following acute and chronic instabilities or deformities of the thoracic, lumbar,<br>and sacral spine: degenerative spondylolisthesis with objective evidence of<br>neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor,<br>and failed previous fusion (pseudoarthrosis).<br><br>The Endius® TITLE 2™ Polyaxial Spinal System is also indicated for pedicle<br>screw fixation for severe spondylolithesis (grades 3 and 4) at L5-S1, in<br>skeletally mature patients, when autogenous bone graft is used, when affixed to<br>the posterior lumbosacral spine, and intended to be removed after solid fusion is<br>attained. Levels of fixation are from L3-S1.<br><br>In addition, the Endius® TITLE 2™ Polyaxial Spinal System, when not used<br>with pedicle screws is indicated for hook, wire, and/or sacral screw fixation<br>from T1 to the ilium sacrum. The non-pedicle screw indications are<br>spondylolithesis, degenerative disc disease, (defined as discogenic back pain<br>with degeneration of the disc confirmed by history and radiographic studies),<br>deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previous<br>failed fusion surgery. |
| 7.8<br>Substantial<br>Equivalence | The proposed Endius TITLE 2 Polyaxial Spinal System is substantially<br>equivalent to the Endius TiTLE Spinal Fixation System. |

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 - 2004

Christine Kuntz-Nassif Director, Regulatory Affairs Endius. Inc. 23 West Bacon Street Plainville, Massachusetts 02762

Re: K041808

Trade/Device Name: Endius® TiTLE 2™ Polyaxial Spinal System Regulation Number: 21 CFR 888.3050, 21 CFR 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Pedicle screw spinal system Regulatory Class: III Product Code: KWP, MNH, MNI, NKB Dated: September 8, 2004 Received: September 9, 2004

Dear Ms. Kuntz-Nassif:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 – Ms. Christine Kuntz-Nassif

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo lotet notification. The FDA finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please in you attine of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other gottoral miconnational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson

Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Endius® TITLE 2™ Polyaxial Spinal System Device Name:

Indications For Use:

The Endius® TITLE 2™ Polyaxial Spinal System is indicated for degenerative discase The Endius - ITTLE 2 - Folyandi Opinal Opinal of the disc confirmed by history and cosers spine (delined as thisogestic back pain fixation are for the thoracic, lumbar, and sacral spine.

The Endius® TITLE 2™ Polyaxial Spinal System is a pedicle screw system intended to provide The Endius "TTLE Z" Folyanal Spinal System of System of Schents as an adjunct to
immobilization and stabilization of spinal segments in skeletally mature of the immobilization and stabilization of spinal organic instabilities or deformities of the this on the treatment of the following as and as a spondylolisthesis with objective evidence of thoracic, fullibal, and sacral spine. Gogeneral ro speally.
newologic impairment, fracture, dislocation, scoliosis, spinal turnor, and failed previous fusion (pseudoarthrosis).

The Endius® TITLE 2™ Polyaxial Spinal System is also indicated for pedicle screw fixation for I he Endults - I T LL 2 - F orfaxtur Spinal DJ 8.5 I, in skeletally mature patients, when autogenous severe spondytonthlesss (grades 3 and 1) as a lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.

In addition, the Endius® TITLE 2™ Polyaxial Spinal System, when not used with pedicle screws is indicated for hook, wire, and/or sacral screw fixation from T1 to the ilium sacrum. The non-IS marcatur indications are spondylolithesis, degenerative disc disease, (defined as discogenic pedicte sciew indication of the disc confirmed by history and radiographic studies), back pain will degenciation of the asso cosis), tumor, fracture, and previous failed fusion surgery.

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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
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510(k) Number K041808
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