(151 days)
The Perfix™ Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletallymature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:
- · Spondylolisthesis (Grade 3 and 4)
- · Degenerative spondylolisthesis with objective evidence of neurological impairment
- · Trauma (i.e., fracture or dislocation)
- · Spinal stenosis
- · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- · Tumor
- · Pseudoarthrosis
- · Failed previous fusion
The Perfix™ Spinal System is manufactured by U&I corporation. The Perfix™ is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism. The Perfix™ Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Penfix™ implant system components are supplied non-sterile, single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136.
This document describes a spinal fixation system, not an AI/ML powered device. As such, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable to the "Perfix™ Spinal System".
The provided text details the device's classification, intended use, and substantial equivalence to a predicate device, which are standard components of a 510(k) submission for a traditional medical device. It does not contain any information about software, algorithms, or AI/ML components.
Therefore, I cannot provide the requested information.
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NOV - 9 2009
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5. 510(k) Summary
| Manufacturer: | U & I Corporation529-1, Yonghyun-dong, UijungbuKyunggi-Do, Korea 480-050Sung-Youn Cho, Regulatory Affairs Manager |
|---|---|
| Sponsor: | U & I Corporation529-1, Yonghyun-dong, UijungbuKyunggi-Do, Korea 480-050 |
| Sponsor Contact : | Sung-Youn Cho, Regulatory Affairs Manager |
| Date Prepared: | June 4, 2009 |
| Device Name: | Trade Name: Perfix™ Spinal System |
| Common Name: | Spinal Fixation System |
| Classification Name: | Orthosis, Spondylolisthesis Spinal Fixation (MNH), per 21 CFR 888.3070Orthosis, Spinal Pedicle Fixation (MNI), per 21 CFR 888.3070Spinal Interlaminal Fixation Fixation Orthosis (KWP), per 21 CFR 888.3050 |
| Product Code: | MNH, MNI, KWP |
| Predicate Devices: | OPTIMA™ Spinal System (K024096) |
Description of Device:
The Perfix™ Spinal System is manufactured by U&I corporation. The Perfix™ is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism. The Perfix™ Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Penfix™ implant system components are supplied non-sterile, single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136.
U&i CORPORATION
Perfix™ Spinal System
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Intended Use:
The Perfix™ Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletallymature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:
- · Spondylolisthesis (Grade 3 and 4)
- · Degenerative spondylolisthesis with objective evidence of neurological impairment
- · Trauma (i.e., fracture or dislocation)
- · Spinal stenosis
- · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
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- · Tumor
- · Pseudoarthrosis
- · Failed previous fusion
Substantial Equivalence:
The Perfix™ Spinal System is substantially equivalent to the pedicle screws of the OPTIMA™ Spinal System in design, materials, function and intended use.
U&i CORPORATION
Perfix™ Spinal System
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
U & I Corporation % Sung-Youn Cho Regulatory Affairs Manager 529-1, Yonghyun-dong, Uijungbu Kyunggi-Do, Korea 480-050
NOV - 9 2009
Re: K091725
Trade/Device Name: Perfix™ Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: September 23, 2009 Received: September 25, 2009
Dear Sung-Youn Cho:
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 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
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Page 2 -- Sung-Youn Cho
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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Miller
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K091725
Device Name: Perfix™ Spinal System
Indications for Use:
The Perfix™ Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletallymature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:
- · Spondylolisthesis (Grade 3 and 4)
- · Degenerative spondylolisthesis with objective evidence of neurological impairment
- · Trauma (i.e., fracture or dislocation)
- · Spinal stenosis
- · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- · Tumor
- · Pseudoarthrosis
- · Failed previous fusion
Prescription Use __________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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 Surgicial. Orthopedic, and Restorative Levices
Perfix™ Spinal System
Perfix™ Spinal System 510(k) Number __________________________________________________________________________________________________________________________________________
U&i CORPORATION
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