TRIFIX PEDICLE SPINAL SCREW ASSEMBLY

K990657 · Corin USA · MNH · Mar 26, 1999 · Orthopedic

Device Facts

• Record ID: K990657
• Device Name: TRIFIX PEDICLE SPINAL SCREW ASSEMBLY
• Applicant: Corin USA
• Product Code: MNH · Orthopedic
• Decision Date: Mar 26, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device system consisting screws, washers, spacers, utilizing the anterolateral/anterior surgical approach is intended for the following uses: (a) anterolateral screw 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. 2. The device system consisting of hooks, screws, washers, spacers, when utilized as a non-pedicle 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: 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. 3. The device system consisting of hooks, spacers, sacral/iliac screws and pedicle screws is intended for patients: (a) Having a severe spondylolisthesis (grades 3 and 4) at the L5-S1 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 (d) Who are having the device removed after the development of a solid fusion mass. The levels of pedicle screws fixation will be L3-S1.

Device Story

Trifix Pedicle Spinal Screw Assembly; part of Corin Spinal System. System comprises screws, washers, spacers, and hooks. Used for spinal fixation via anterolateral, anterior, or posterior surgical approaches. Provides mechanical stabilization of spine segments to facilitate fusion. Operated by surgeons in clinical/OR settings. Output is rigid internal fixation of spinal vertebrae. Benefits include stabilization of spinal column in patients with degenerative conditions, deformity, or trauma. Device is implanted; provides structural support during bone healing.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use.

Technological Characteristics

Spinal fixation system consisting of metallic screws, washers, spacers, and hooks. Designed for lumbar, thoracic, and cervical spine applications. Mechanical fixation device; no software or electronic components.

Indications for Use

Indicated for patients with degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, scoliosis, kyphosis, tumor, pseudoarthrosis, revision surgery, or neoplasia requiring spinal fixation. Specific pedicle screw indication for severe spondylolisthesis (grades 3-4) at L5-S1, requiring autogenous bone graft, with fixation at L3-S1.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

2. 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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3. 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