(102 days)
Not Found
Not Found
No
The summary describes a mechanical fixation system (plates and screws) and mentions only biomechanical testing, with no indication of software, image processing, or AI/ML components.
Yes
The device is described as a "fixation system" used to treat various spinal instabilities and deformities, indicating it provides a therapeutic intervention rather than just diagnosis or monitoring.
No
The device is a fixation system consisting of plates and screws intended to stabilize the spine, not to diagnose medical conditions.
No
The device description explicitly states that the system consists of "a variety of plates and screws," which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical fixation system for treating spine instability. This is a therapeutic device used in vivo (within the body) during surgery.
- Device Description: The device consists of plates and screws, which are implants used to stabilize the spine. This aligns with a surgical device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide diagnostic information about a patient's condition. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, the Life Spine Anterior Lumbar Fixation System (Presidio) is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Life Spine Anterior Lumbar Fixation System (Presidio) is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Life Spine Anterior Lumbar Fixation System (Presidio) consists of a variety of plates and screws. Implant components can be rigidly locked to suit the individual pathology and anatomical conditions of the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Thoracic and thoracolumbar (T1-L5) spine, lumbar and lumbosacral (L1-S1) spine
Indicated Patient Age Range
Not Found
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)
Biomechanical testing in accordance with appropriate ASTM standards was conducted to demonstrate substantial equivalence to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
| Submitted By: | Life Spine, Inc.
2401 W. Hassell Road, Suite 1535
Hoffman Estates, IL 60169
Telephone: 847-884-6117
Fax: 847-884-6118 | JAN 1 9 2010 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| 510(k) Contact: | Charles P. Gill
Life Spine, Inc.
2401 W. Hassell Road, Suite 1535
Hoffman Estates, IL 60169
Telephone: 847-884-6117
Fax: 847-884-6118 | |
| Date Prepared: | October 6, 2009 | |
| Trade Name: | Life Spine Anterior Lumbar Fixation System (Presidio) | |
| Common Name: | Spinal Fixation System | |
| Classification: | KWQ, 21 CFR 888.3060, Class II | |
510(k) Summary Life Spine Anterior Lumbar Fixation System (Presidio™)
Device Description:
The Life Spine Anterior Lumbar Fixation System (Presidio) consists of a variety of plates and screws. Implant components can be rigidly locked to suit the individual pathology and anatomical conditions of the patient.
Intended Use of the Device:
The Life Spine Anterior Lumbar Fixation System (Presidio) is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.
Performance Data:
Biomechanical testing in accordance with appropriate ASTM standards was conducted to demonstrate substantial equivalence to the predicate devices.
Substantial Equivalence:
The Life Spine Anterior Lumbar Fixation System (Presidio) was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an emblem of a stylized bird with outstretched wings, symbolizing protection and care.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
JAN 1 9 2010
Life Spine % Mr. Charles P. Gill Director Regulatory Affairs/ Quality Assurance Manager 2401 W. Hassell Road - Suite 1535 Hoffman Estates, Illinois 60169
Re: K093200
Trade/Device Name: Life Spine Anterior Lumbar Fixation System (Presidio ") Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: January 04, 2010 Received: January 05, 2010
Dear Mr. Gill:
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. Iisting 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 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
2
Page 2 - Mr. Charles P. Gill
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.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" (21CFR 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/Safety/ReportalProblem/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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Kailara buelum
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
. Indications for Use
510(k) Number (if known):
Device Name: Life Spine Anterior Lumbar Fixation System (Presidio™)
Indications for Use: The Life Spine Anterior Lumbar Fixation System (Presidio) is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
K093200 510(k) Number_
4
| Sponsor: | Nexxt Medical, Inc.
10142 Brooks School Road
Fishers, IN 46037
Phone (317) 436.7801
Fax (317) 245.2518 | JAN 1 9 2010 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Andy Elsbury, President | |
| Proposed Trade Name: | Blade™ Anterior Cervical Plate System | |
| Device Classification | Class II | |
| Classification Name: | Appliance, fixation, spinal intervertebral body | |
| Regulation: | 888.3060 | |
| Device Product Code: | KWQ | |
| Device Description: | The Blade™ Anterior Cervical Plate System consists of and screws and
plates in a variety of sizes. One-, two- and three-level plates are offered.
Screws are available in two diameters in both self-tapping and self-drilling
versions. The Blade™ Anterior Cervical Plate System components are
manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM
F136 or titanium (Grade 2 or 4) as described by ASTM F67. | |
| Intended Use: | The Blade™ Anterior Cervical Plate System is intended for anterior screw
fixation of the cervical spine. These implants have been designed to provide
stabilization as an adjunct to cervical fusion. Indications for the use of this
implant system include degenerative disc disease (defined as neck pain of
discogenic origin with the degeneration of the disc confirmed by history and
radiographic studies), spondylolisthesis, trauma (i.e., fractures or
dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or
scoliosis), tumor, pseudarthrosis or failed previous fusion.
WARNING: The Blade™ Anterior Cervical Plate System is not intended
for screw attachment or fixation to the posterior elements (pedicles) of the
cervical, thoracic or lumbar spine. | |
| Substantial
Equivalence: | Documentation was provided which demonstrated the Blade™ Anterior
Cervical Plate System to be substantially equivalent to previously cleared
devices: The substantial equivalence is based upon equivalence in basic
design, intended use, indications, anatomic sites and mechanical
performance. | |
.
- September 19.
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8. 510(k) Summary
.