(248 days)
No
The summary describes a mechanical pedicle screw system and its components, with no mention of software, algorithms, or any technology related to AI or ML.
Yes.
The device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various spinal instabilities or deformities, which is a therapeutic purpose.
No
Explanation: The UNIMAX Pedicle Screw System is described as a medical device intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion. Its purpose is therapeutic (to treat instabilities or deformities), not diagnostic (to identify or determine the nature of a disease or condition). The device components are hardware (screws, washers, plates) used in surgical procedures.
No
The device description explicitly states that the system consists of physical components such as pedicle screws, washers, nuts, and plates, all manufactured from titanium alloy. This indicates it is a hardware-based medical device, not software-only.
Based on the provided text, the UNIMAX Pedicle Screw System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as a surgical implant used to provide immobilization and stabilization of spinal segments in vivo (within the body) as an adjunct to fusion. It treats structural problems of the spine.
- Device Description: The device description details physical components like screws, washers, nuts, and plates made from titanium alloy, which are typical of surgical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
Therefore, the UNIMAX Pedicle Screw System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The UNIMAX Pedicle Screw 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 thoracic, lumbar or sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusions.
As a pedicle screw system the UNMAX Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
Product codes
MNI, MNH
Device Description
The UNIMAX Pedicle Screw System intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of thoracic, lumbar or sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusions.
As a pedicle screw system the UNMAX Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The UNIMAX Pedicle Screw System consists of pedicle screws (K014302) vertical, washers, nuts and horizontal plates. It can be used for single or multiple level fixation. .
All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.
The additional component that is the subject of this Special 510(k) submission is the Offset Horizontal Plate. Its purpose is to provide rigidity to the spinal construct similar to the horizontal plate cleared on K014302.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar or sacral spine
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)
Nonclinical Tests: Analysis indicates that the offset horizontal plate is as strong as the predicate device.
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
510(k) Summary
AUG 2 9 2003
K024313
page 1 of 2
Date May 6, 2003
Submitter Pisharodi Surgicals, Inc.
942 Wildrose Lane Brownsville, TX 78520
Contact person J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199
Trade name UNIMAX Pedicle Screw System Horizontal Offset Plate
Common name Posterior spine system
Classification name Spondylolisthesis Spinal Fixation Device System - class II Pedicle Screw Spinal System - class II 888.3070 (per 21 CFR section)
Indications for Use
The UNIMAX Pedicle Screw 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 thoracic, lumbar or sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusions.
As a pedicle screw system the UNMAX Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
Equivalent Device
This additional component is equivalent to the previous horizontal plate for the UNIMAX Pedicle Screw System in indications, usage and materials.
Device Description
The UNIMAX Pedicle Screw System intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of thoracic, lumbar or sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusions.
As a pedicle screw system the UNMAX Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The UNIMAX Pedicle Screw System consists of pedicle screws (K014302) vertical, washers, nuts and horizontal plates. It can be used for single or multiple level fixation. .
1
All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.
The additional component that is the subject of this Special 510(k) submission is the Offset Horizontal Plate. Its purpose is to provide rigidity to the spinal construct similar to the horizontal plate cleared on K014302.
1
age of
Summary Nonclinical Tests
Analysis indicates that the offset horizontal plate is as strong as the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem of three stylized lines that resemble an eagle or bird in flight. The logo is black and white.
AUG 2 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pisharodi Surgicals, Inc. c/o Mr. J.D. Webb The Orthomedix Group, Inc. 1001 Oakwood Boulevard Round Rock, TX 78681
Re: K024313
Trade/Device Name: UNiversal MultiAXis (UNIMAX) Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH Dated: July 31, 20003 Received: August 1, 2003
Dear Mr. Webb:
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 - Mr. J.D. Webb
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 (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/dsmaldsmamain.html
Sincerely yours,
Sincerely yours,
Mark A. Millican
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
Confidential
page 1 of 1
INDICATIONS / INTENDED USE STATEMENT
024313
510(k) Number: K014302 (Regulatory Number: 21 CFR 888.3070)
Device Name: UNiversal MultiAXis (UNIMAX) Pedicle Screw System
Indications / Intended Use:
The Pisharodi Surgicals, Inc. UNIMAX Pedicle Screw System is intended to provide immobilization and stabilization of non-cervical posterior 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,
When used as a pedicle screw fixation system of the non-cervical spine in skeletally mature patients, the UNIMAX Pedicle Screw System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).
When used as a pedicle screw fixation system the UNIMAX Pedicle Screw 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 (4) who are having the device removed after the development of a solid fusion mass.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milliken
Division Sign-Off
- Restorative
510(k) Number K024313