(85 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural integrity of the spinal fixation system components (rods, screws, connectors). There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is described as an "LTD Polyaxial Fixation System" intended to provide "immobilization and stabilization of spinal segments as an adjunct to fusion" for various spinal conditions, indicating a therapeutic purpose.
No
Explanation: The device is described as a fixation system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion. It consists of rods, screws, and connecting components, which are used for surgical implantation, not for diagnosing medical conditions.
No
The device description explicitly states that the system consists of physical components like rods, screws, and connecting components fabricated from medical-grade titanium or titanium alloy. This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests 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 provided text clearly describes the LTD Polyaxial Fixation System as a system of rods, screws, and connecting components intended for the immobilization and stabilization of spinal segments as an adjunct to fusion. This is a surgical implant used within the body, not a device for testing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or diagnostic purposes.
Therefore, based on the provided information, the LTD Polyaxial Fixation System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LTD Polyaxial Fixation System is intended to help provide immobilization 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 lumbarfirst 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 radiosraphic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion.
Product codes
KWQ, KWP, MNH, MNI
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 alloy described by such standards as ASTM F67 or ASTM F136 or ISO 5832-3 or 5832-2
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar and/or sacral spine, non-cervical posterior 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)
The LTD Polyaxial Fixation System was tested for: 1. Static axial testing in a load to failure mode in compression bending, 2. Static torsion testing in a load to failure mode in torsion, and 3. Cyclical axial compression bending testimate the maximum run out load value at 5.0 x 10^6 cycles. The the the protocol followed ASTM Standard F1717-01, "Standard Test Methods for Static and Fatisyer or Spinal Implant Constructs in a Vertebrectomy Model." Results demonstrate that the LTD Polyaxial Fixation System complies with the recognized, voluntary performance standards for spinal implant systems. In addition, test results indicate that the LTD Polyaxial Fixation System is substantially equivalert in staic and fatigue strength to predicate devices previously cleared by FDA.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The Moss Miami system, the Xia Spine System, the Optima Spine System
Reference Device(s)
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
SEP - 8 2004 510(k) Summary
Submitted on behalf of:
U.S. Spinal Technologies, Inc. 3701 FAU Blvd. Ste 210 Boca Raton, FL 33431, USA Telephone: 561-367-7463 Fax: 561-367-9627
by:
Elaine Duncan, M.S.M.E., RAC President, Paladin Medical, Inc. PO Box 560 Stillwater. MN 55082 715-549-6035 715-549-5380
Kot 1225
CONTACT PERSON:
Telephone:
Fax:
DATE PREPARED: June 14, 2004
Elaine Duncan
| TRADE NAME: | LTD Polyaxial Fixation System |
|---|---|
| COMMON NAME: | spinal fixation system |
SUBSTANTIALLY EQUIVALENT TO:
The LTD, the Moss Miami system, the Xia Spine System and the Optima Spine System are all top-loading polyaxial screws with greater than 40° variability and all four systems are made from titanium. All four systems have screws that accept a 6.0mm titanium rod. All four pedicle screws use a threaded Set Screw to lock the rod to the pedicle screw. All four systems are indicated from L5-S1 for 1) Degenerative Disc Disease, 2) Spinal Stenosis, and 3) Spondylolisthesis. [The Moss Miami and the Xia Spine System are also indicated for deformities (kyphosis/scoliosis)]. However, the Moss Miami is assembled in three pieces w screw shank, bushing and head body, where as the LTD and Xia are assembled using two pieces: screw shank and head body.
DESCRIPTION of the DEVICE:
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 alloy described by such standards as ASTM F67 or ASTM F136 or ISO 5832-3 or 5832-2
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) spiral tumor, and/or (5) failed previous fusion (pseudarthrosis).
510(k) Submission
l of i
13
1
510(k) Summary-Continued
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 bark nin 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) turnor resection, and/or (7) failed previous fusion.
SUMMARY of TESTING:
The LTD Polyaxial Fixation System was tested for: 1. Static axial testing in a load to failure mode in compression bending, 2. Static torsion testing in a load to failure mode in torsion, and 3. Cyclical axial compression bending testimate the maximum run out load value at 5.0 x 106 cycles. The the the protocol followed ASTM Standard F1717-01, "Standard Test Methods for Static and Fatisyer or Spinal Implant Constructs in a Vertebrectomy Model." Results demonstrate that the LTD Polyaxial Fixation System complies with the recognized, voluntary performance standards for spinal implant systems. In addition, test results indicate that the LTD Polyaxial Fixation System is substantially equivalert in staic and fatigue strength to predicate devices previously cleared by FDA.
f 7
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 8 2004
U.S. Spinal Technologies, LLC. C/o Ms. Elaine Duncan, M.S.M.E., RAC President Paladin Medical, Inc. PO Box 560 Stillwater, Minnesota 55082
Re: K041625
Trade/Device Name: LTD Polyaxial Fixation System Regulation Number: 21 CFR 888.3050, 21 CFR 888.3060, 21 CFR888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: KWQ, KWP, MNH, MNI Dated: June 14, 2004
Dear Ms. Duncan:
Received: June 15, 2004
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
3
Page 2 -- Ms. Elaine Duncan, M.S.M.E., RAC
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.
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 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 contact the Office of Compliance at (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely, yours,
Mark A. Melkerson
Celia M. Witten, Ph.D., M.D. 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): KO41625
Device Name: LTD Polyaxial Fixation System
INDICATIONS:
The LTD Polyaxial Fixation System is intended to help provide immobilization 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 lumbarfirst 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 radiosraphic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion.
Prescription Use J J J _______________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use .........................................................................................................................................................
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
ﻠﺴﻴﺴﺎﺕ
(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,
Page 1 of 1 and Neurological Devices
510(k) Number K04 1625