UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM

K014302 · Pisharodi Surgicals, Inc. · MNH · Mar 29, 2002 · Orthopedic

Device Facts

• Record ID: K014302
• Device Name: UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM
• Applicant: Pisharodi Surgicals, Inc.
• Product Code: MNH · Orthopedic
• Decision Date: Mar 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Universal MultiAXis (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: (1) Degenerative spondylolisthesis with objective neurological impairment; (2) Fracture; (3) Dislocation; (4) Scoliosis; (5) Kyphosis; (6) Spinal tumor, and (7) Failed previous fusion (psaudoarthrosis). " 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.

Device Story

UNIMAX Pedicle Screw System comprises titanium alloy (Ti-6Al-4V) plates, bolts, and screws; provides spinal construct for immobilization and stabilization during fusion. Used in thoracic, lumbar, and sacral spine; intended for skeletally mature patients. Components provided non-sterile; surgical implantation performed by physicians. System design supports stabilization of acute/chronic instabilities or deformities; facilitates solid fusion mass development. Clinical benefit includes structural support for spinal segments during healing process.

Clinical Evidence

No clinical data. Substantial equivalence supported by biomechanical test results verifying design specifications.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V) per ASTM F-136. Components: Plates, bolts, screws. Form factor: Multi-axis pedicle screw system. Sterilization: Provided non-sterile. Connectivity: None (mechanical device).

Indications for Use

Indicated for skeletally mature patients requiring immobilization/stabilization of non-cervical posterior spinal segments (thoracic, lumbar, sacral) as an adjunct to fusion for degenerative spondylolisthesis with neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, or pseudoarthrosis. Specific pedicle screw fixation indications include severe spondylolisthesis (Grades 3-4) at L5-S1, use with autogenous bone graft, and attachment to lumbar/sacral spine (L3 and below).

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.

Predicate Devices

• DYNA-LOK CLASSIC Spinal System, Medtronic Sofamor Danek USA (K001532)

Submission Summary (Full Text)

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## 510(k) Summary

K014302

[As required by 21 CFR 807.92(c)]

#### Submitter's Name / Contact Person

Pisharodi Surgicals, Inc. 942 Wildrose Lane Brownsville, TX 78520

Contact Person: Madhavan Pisharodi, M.D. Tel: [phone]

#### General Information

| Trade Name | UNIMAX Pedicle Screw System |
|----------------|-----------------------------------------------------------------------------------------------------------------|
| Common Name | Pedicle Screw Spinal System |
| Classification | Class II (Orthopedic Devices Panel -Code 87, Product Code MNI)<br>21 CFR 888.3070 - Pedicle Screw Spinal System |
| Predicate | DYNA-LOK CLASSIC Spinal System, Medtronic Sofamor Danek USA<br>(K001532) |

#### Device Description

The UNIMAX Pedicle Screw System consists of plates, bolts, screws and is used to build a spinal construct. The purpose of the UNIMAX System is to provide stabilization during the development of a solid spinal fusion. The system is available in a variety of sizes. The components and instruments needed for this system are described in the Surgical Technique Manual. The UNIMAX Pedicle Screw System components are made from titanium alloy (Ti-6Al-4V) conforming to ASTM standard F-136. The UNIMAX components will be provided non-sterile.

#### Intended Use / Indications

The Universal MultiAXis (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:

(1) Degenerative spondylolisthesis with objective neurological impairment; (2) Fracture; (3) Dislocation; (4) Scoliosis; (5) Kyphosis; (8) Spinal tumor, and (7) Failed previous fusion (pseudoarthrosis). "

**MAR 2 9 2002**

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Confidential

Pisharodi Surgicals, Inc. 510(k) Pre-Market Notification UNIMAX Pedicle Screw System

K014302

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 indicated for JREFELLify maxare plats (L5-S1) vertebral joint; (b) who are receiving fusions using 4) of the his humber first ly; (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.

### Substantial Equivalence Comparison

The UNIMAX System is substantially equivalent to the following device with respect to intended use/indications, system components and materials:

DYNA-LOK CLASSIC Spinal System, Medtronic Sofamor Danek USA (K001532)

#### Summary of Studies

Biomechanical test results verify the design specifications and support substantial equivalence for the UNIMAX System. Test results support the safety and performance of the UNIMAX System for its intended use.

#### Conclusion

The data and information provided in this submission supports a substantial equivalence determination, and, therefore, 510(k) premarket notification clearance of the Pisharodi Surgicals UNIMAX Pedicle Screw System.

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#### 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 features a stylized image of an eagle with three lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

#### Public Health Service

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Madhavan Pisharodi, MD Pisharodi Surgical, Inc. 942 Wildrose Lane Brownsville, Texas 78520

MAR 2 9 2002

Re: K014302

Trade Name: Universal MultiAXis (UNIMAX) Pedicle Screw System Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation, Orthosis Regulatory Class: II Product Code: MNH, MNI Dated: December 28, 2001 Received: December 31, 2001

Dear Dr. Pisharodi:

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 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 (Premarket Approval), 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 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 action. In addition, FDA may publish further announcements 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 - Madhavan Pisharodi, MD

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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

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Pisharodi Surgicals, Inc 510(k) Pre-Market Notificati UNIMAX Podicle Screw System

# INDICATIONS / INTENDED USE STATEMENT

Page 1 of 1

510(k) Number:

Device Name: UNiversal MultiAXis (UNIMAX) Pedicle Screw System

Indications / Intended Use:

The Universal MultiAXis (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:

(1) Degenerative spondylolisthesis with objective neurological impairment; (2) Fracture; (3) Dislocation; (4) Scoliosis; (5) Kyphosis; (6) Spinal tumor, and (7) Failed previous fusion (psaudoarthrosis). "

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)

(Division Sign-Restorative

510(k) Number K014302

**INDICATIONS / INT**