(87 days)
No
The device description and intended use focus on mechanical components for spinal fusion and stabilization. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
This device is a pedicle screw system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various spinal conditions, indicating a therapeutic purpose.
No
The device is a spinal system (screws, rods, and connection components) intended for immobilization and stabilization of spinal segments as an adjunct to fusion, not for diagnosing conditions.
No
The device description explicitly states the system is manufactured from titanium and includes physical components like screws, rods, and connection components. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Endius® TITLE 2™ Polyaxial Spinal System is a surgical implant (screws, rods, and connection components) intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion. It is a physical device used in vivo (within the body) during surgery.
- No Mention of Samples or Testing: The description and intended use do not involve analyzing biological samples or performing diagnostic tests. The mention of "radiographic studies" is for confirming the diagnosis of degenerative disc disease, not for the device itself to perform a diagnostic function.
Therefore, the Endius® TITLE 2™ Polyaxial Spinal System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
KWP, MNH, MNI, NKB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine, L5-S1, posterior lumbosacral spine, L3-S1, T1 to the ilium sacrum.
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
OCT 1 - 2004
Section 7 - 510(k) Summary
| 7.1
Statement | Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Endius, Inc. is
required to submit with this Premarket Notification either an "... adequate
summary of any information respecting safety and effectiveness or state that
such information will be made available upon request of any person." Endius,
Inc. chooses to submit a summary of information respecting safety and
effectiveness. According to §513(i)(3)(B), "Any summary under subparagraph
(A) respecting a device shall contain detailed information regarding data
concerning adverse health effects..."
The summary regarding the adverse health effects of the modified device,
Endius® TITLE 2™ Polyaxial Spinal System is provided below. |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7.2
Submitter | Endius, Inc.
23 West Bacon Street
Plainville, MA. 02762 |
| 7.3
Company
Contact | Christine Kuntz-Nassif
Director, Regulatory Affairs
508-643-0983 Ext. 114 |
| 7.4
Device
Name | Proprietary Name:
Endius® TITLE 2™ Polyaxial Spinal System
Common Name:
Pedicle Screw System , Non-pedicle spinal fixation system
Classification Name:
Posterior, Noncervical, Nonpedicle System (KWP)
Noncervical, Pedicle System (MNH, MNI, NKB) |
| 7.5
Predicate
Device | Endius TiTLE Spinal Fixation System: K021881 |
| 7.6
Device
Description | 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. |
| 7.7
Device
Indications
and
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. |
| 7.8
Substantial
Equivalence | The proposed Endius TITLE 2 Polyaxial Spinal System is substantially
equivalent 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
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