(87 days)
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.
The Endius® TITLE 2™ Polyaxial Spinal System is a system that is intended to be used for posterior lumbar fusion procedures. The system is manufactured from titanium which complies with ASTM F136. The components, which are included as part of the system, include screws, rods, and connection components.
The provided text is a 510(k) summary for the Endius® TITLE 2™ Polyaxial Spinal System, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a study against acceptance criteria for algorithm performance.
Therefore, the requested information regarding acceptance criteria, study details (sample size, provenance, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set), and effect size cannot be extracted from the provided text.
The 510(k) summary outlines the device description, indications for use, and claims substantial equivalence to a previously cleared device (Endius TiTLE Spinal Fixation System: K021881). It does not contain information about clinical performance studies with specific statistical acceptance criteria for a new device's performance against a defined ground truth, nor does it include details on AI/algorithmic performance or human reader studies.
In summary, the provided document is a regulatory submission for device clearance based on substantial equivalence, not a clinical study report of a device's performance against pre-defined acceptance criteria.
{0}------------------------------------------------
OCT 1 - 2004
Section 7 - 510(k) Summary
| 7.1Statement | Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Endius, Inc. isrequired to submit with this Premarket Notification either an "... adequatesummary of any information respecting safety and effectiveness or state thatsuch information will be made available upon request of any person." Endius,Inc. chooses to submit a summary of information respecting safety andeffectiveness. According to §513(i)(3)(B), "Any summary under subparagraph(A) respecting a device shall contain detailed information regarding dataconcerning adverse health effects..."The summary regarding the adverse health effects of the modified device,Endius® TITLE 2™ Polyaxial Spinal System is provided below. |
|---|---|
| 7.2Submitter | Endius, Inc.23 West Bacon StreetPlainville, MA. 02762 |
| 7.3CompanyContact | Christine Kuntz-NassifDirector, Regulatory Affairs508-643-0983 Ext. 114 |
| 7.4DeviceName | Proprietary Name:Endius® TITLE 2™ Polyaxial Spinal SystemCommon Name:Pedicle Screw System , Non-pedicle spinal fixation systemClassification Name:Posterior, Noncervical, Nonpedicle System (KWP)Noncervical, Pedicle System (MNH, MNI, NKB) |
| 7.5PredicateDevice | Endius TiTLE Spinal Fixation System: K021881 |
| 7.6DeviceDescription | The Endius® TITLE 2™ Polyaxial Spinal System is a system that is intended tobe used for posterior lumbar fusion procedures. The system is manufacturedfrom titanium which complies with ASTM F136. The components, which areincluded as part of the system, include screws, rods, and connectioncomponents. |
| 7.7DeviceIndicationsandIntendedUse | The Endius® TITLE 2™ Polyaxial Spinal System is indicated for degenerativedisc disease (defined as discogenic back pain with degeneration of the discconfirmed by history and radiographic studies. Levels of fixation are for thethoracic, lumbar, and sacral spine.The Endius® TITLE 2™Polyaxial Spinal System is a pedicle screw systemintended to provide immobilization and stabilization of spinal segments inskeletally mature patients as an adjunct to fusion in the treatment of thefollowing acute and chronic instabilities or deformities of the thoracic, lumbar,and sacral spine: degenerative spondylolisthesis with objective evidence ofneurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor,and failed previous fusion (pseudoarthrosis).The Endius® TITLE 2™ Polyaxial Spinal System is also indicated for pediclescrew fixation for severe spondylolithesis (grades 3 and 4) at L5-S1, inskeletally mature patients, when autogenous bone graft is used, when affixed tothe posterior lumbosacral spine, and intended to be removed after solid fusion isattained. Levels of fixation are from L3-S1.In addition, the Endius® TITLE 2™ Polyaxial Spinal System, when not usedwith pedicle screws is indicated for hook, wire, and/or sacral screw fixationfrom T1 to the ilium sacrum. The non-pedicle screw indications arespondylolithesis, degenerative disc disease, (defined as discogenic back painwith degeneration of the disc confirmed by history and radiographic studies),deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previousfailed fusion surgery. |
| 7.8SubstantialEquivalence | The proposed Endius TITLE 2 Polyaxial Spinal System is substantiallyequivalent to the Endius TiTLE Spinal Fixation System. |
000104
{1}------------------------------------------------
000105
{2}------------------------------------------------
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.
{3}------------------------------------------------
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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
{4}------------------------------------------------
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
Page 1 of 1
510(k) Number K041808
Page Lof
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
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.(b)
Classification. Class II.