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K Number
K990657
Device Name
TRIFIX PEDICLE SPINAL SCREW ASSEMBLY
Manufacturer
CORIN U.S.A.
Date Cleared
1999-03-26

(25 days)

Product Code
MNH,KWP,KWQ
Regulation Number
888.3070
Type
Special
Panel
Orthopedic
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  1. The device system consisting screws, washers, spacers, utilizing the anterolateral surgical approach is intended for the following uses:
    (a) anterolateral scrow fixation to the non-cervical spine,
    (b) anterior screw fixation to the cervical spine

The anterolateral/anterior system is intended for use in the following indications:
(a) Degenerative disc disease of the lumbar thoracic and cervical spine relating to discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies.
(b) Spondylolisthesis
(c) Trauma
(d) Spinal Stenosis
(e) Scoliosis
(f) Kyphosis
(g) Tumor
(h) Pseudoarthrosis
(i) Revision of previous surgery
(j) Neoplastia

  1. The device system consisting of hooks, screws, washers, spacers, when utilized as a non-pedicte posterior system has the following intended use:
    hook and sacral/iliac screw fixation to the non-cervical spine

The non-pedicle posterior devices may be used for the following indications:
(a) Degenerative disc discase of the lumbar thoracic and cervical spinc relating to discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies.
(b) Spondy lulisthesis
(c) Trauma
(d) Spinal Sicnosis
(e) Scoliosis
(f) Kyphosis.
(g) Tumor
(h) Pseudoanthrosis
(i) Revision of previous surgery
(j) Neoplastia

  1. The device system consisions of hooks, spacers, sucral/iliae screws and pedicale screws is intended for patients:
    (a) Having a severe spondyloslisthesis (grades 3 and 4) at the I.S-SI joint
    (b) Who ure receiving fusions using autogenous bone graft only
    (c) Who are having the device lixed or auached to the lumbar and sacral spine
    (d) Who are having the device removed after the development of a solid fusion mass

The levels of pedicte screws fixation will be 1.3-S1.

Device Description

The device system consisting screws, washers, spacers, utilizing the anterolateral surgical approach.
The device system consisting of hooks, screws, washers, spacers, when utilized as a non-pedicte posterior system.
The device system consisions of hooks, spacers, sucral/iliae screws and pedicale screws.

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "Trifix Pedicle Spinal Screw Assembly" for use in the Corin Spinal System. It does not contain information about acceptance criteria or a study proving device performance against such criteria.

The letter explicitly states that the FDA reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means the device was cleared based on its similarity to existing devices, not necessarily on a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria.

Therefore, I cannot provide the requested information from this document.

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 1999

Mr. Craig Corrance President Corin USA 10500 University Center Drive, Suite 190 Tampa, Florida 33612

Re : K990657 Trifix Pedicle Spinal Screw Assembly Trade Name: for use in the Corin Spinal System Regulatory Class: II Product Codes: MNH, KWP, and KWQ Dated: February 26, 1999 Received: March 1, 1999

Dear Mr. Corrance:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the qeneral controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Craig Corrance

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Colia M. Witton, Ph.D., M.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INTENDED USE

INDICATIONS FOR USE

  • The device system consisting screws, washers, spacers, utilizing the 1. The device syment occurgical approach is intended for the following uses:
  • (a) anterolateral scrow fixation to the non-cervical spine,
  • (b) anterior screw fixation to the cervical spine

The anterolateral/anterior system is intended for use in the following indications:

  • (a) Degenerative disc disease of the lumbar thoracic and cervical spine relating to discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies.
  • (b) Spondylolisthesis
  • (c) Trauma
  • (d) Spinal Stenosis
  • (e) Scoliosis
  • (f) Kyphosis
  • (g) Tumor
  • (h) Pseudoarthrosis
  • (i) Revision of previous surgery
  • (i) Neoplastia
  1. The device system consisting of hooks, screws, washers, spacers, when utilized as a non-pedicte posterior system has the following intended use:

hook and sacral/iliac screw fixation to the non-cervical spine (3)

The non-pedicle posterior devices may be used for the following indications:

  • Degenerative disc discase of the lumbar thoracic and cervical spinc relating to (દા) discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies.
  • Spondy lulisthesis (b)
  • Trauma (c)
  • Spinal Sicnosis (d)
  • Scoliosis (c)
  • Kyphosis. (1)
  • Tumor ( દ )
  • Pseudoanthrosis (h)
  • Revision of previous surgery (i)
  • Neoplastia (i)

Aoollito

Division S 510(k) Numb

Prescription Use
(Per 21 CFR 801.109)

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  1. The device system consisions of hooks, spacers, sucral/iliae screws and pedicale screws is intended for patients:

(a) Having a severe spondyloslisthesis (grades 3 and 4) at the I.S-SI joint

(b) Who ure receiving fusions using autogenous bone graft only

(c) Who are having the device lixed or auached to the lumbar and sacral spine

(d) Who are having the device removed after the development of a solid fusion mass

The levels of pedicte screws fixation will be 1.3-S1.

Prescription Use
(Per 21 CFR 801.109)

bice fo

(Division Sign-Off)
Division of General Restorative Devices K990657
510(k) Number

N/A