(99 days)
Not Found
No
The device description and intended use clearly define a mechanical spinal fixation system made of rods, screws, and connecting components. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for various conditions like degenerative spondylolisthesis, fracture, tumor, and failed fusions, directly addressing medical conditions.
No
The device description clearly states it is a "Fixation System" consisting of "rods, screws and connecting components" used to "provide immobilization and stabilization of spinal segments as an adjunct to fusion." This indicates its role as a treatment device, not a diagnostic one.
No
The device description explicitly states that the system consists of physical components like rods, screws, and connecting components, fabricated from medical-grade titanium. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion. This is a therapeutic and structural function within the body.
- Device Description: The device consists of physical components like rods, screws, and connectors made from medical-grade titanium. These are physical implants, not reagents or instruments used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The LTD Polyaxial Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the LTD Polyaxial Fixation system is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the LTD Polyaxial Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the LTD Polyaxial Fixation System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
MNH, MNI, KWP, KWQ
Device Description
The LTD Polyaxial Fixation System consists of a variety of shapes and sizes of rods, screws and connecting components, sold with or without the surgical instrument tray. These components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The LTD Polyaxial Fixation System implant components are fabricated from medical grade titanium or titanium allow described by such standards at ASTM F67 or ASTM F136 for ISO 5832-2/3.
This Pre-market Notification adds 5.5mm rods and associated polyaxial screws to the LTD Polyaxial System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
noncervical posterior spine, lumbar and/or sacral spine, fifth lumbar-first sacral (L5-S1) vertebral joint, lumbar and sacral spine (L3 and below)
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)
Biomechanical testing included a static axial compression Performance Data: bending test, static torsion test and dynamic axial compressing bending test. All tests met the acceptance criteria.
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.
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
§ 888.3050 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
510(k) Summary
| Manufacturer: | US Spine
3600 FAU Blvd., Suite 101
Boca Raton, FL 33431 | DEC 26 2006 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Submitted By: | Richard Jansen, Pharm. D.
Silver Pine Consulting
13540 Guild Ave.
Apple Valley, MN 55124
Phone 952-431-5999
Fax 952-432-3245
richj@s-pineconsulting.com | |
| Proprietary Name: | LTD Polyaxial Fixation System | |
| Classification Name: | Appliance, Fixation, Spinal | |
| Common/Usual Name: | Pedicle Screw Spinal System | |
| Classification: | Class II (888.3050, 888.3060, 888.3070) | |
| Product Codes: | MNH, MNI, KWP, KWQ | |
| Predicate Devices: | K980447 - Moss Miami Pedicle Fixation System
K984251 - Stryker Spine Xia Spine System
K031585 - Optima Spine System | |
| Device Description: | The LTD Polyaxial Fixation System consists of a variety of
shapes and sizes of rods, screws and connecting
components, sold with or without the surgical instrument
tray. These components can be rigidly locked into a variety
of configurations, with each construct being tailor-made for
the individual case. The LTD Polyaxial Fixation System
implant components are fabricated from medical grade
titanium or titanium allow described by such standards at
ASTM F67 or ASTM F136 for ISO 5832-2/3.
This Pre-market Notification adds 5.5mm rods and
associated polyaxial screws to the LTD Polyaxial System. | |
| Indications for Use: | The LTD Polyaxial Fixation System is intended to help
provide immobilization and stabilization of spinal segments
as an adjunct to fusion of the lumbar and/or sacral spine, | |
Pg 1 of 2
1
K612785
When used as a pedicle screw fixation system of the noncervical posterior spine in skeletally mature patients, the LTD Polyaxial Fixation system is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the LTD Polyaxial Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the LTD Polyaxial Fixation System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.
Biomechanical testing included a static axial compression Performance Data: bending test, static torsion test and dynamic axial compressing bending test. All tests met the acceptance criteria.
pg 2of2
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
US Spine % Richard Jansen, Pharm. D Silver Pine Consulting 13540 Guild Ave Apple Valley, Minnesota 55124
DEC 26 2006
Re: K062785
Trade/Device Name: LTD 5.5 Polyaxial Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, KWQ, MNI, MNH Dated: November 22, 2006 Received: November 27, 2006
Dear Dr. Jansen:
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 - Dr. Richard Jansen
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 contact the Office 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address .
Sincerely yours.
Barbara Buchmu
Mark N. Melkerson 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: K062785
Device Name: LTD Polyaxial Pedicle Fixation System
Indications for Use:
The LTD Polyaxial Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the LTD Polyaxial Fixation system is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the LTD Polyaxial Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the LTD Polyaxial Fixation System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.
Prescription Use V (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buchud
(Division Sign-Of Division of General, Restarative, and Neurological Devices
510(k) Number K062785