AMT POLYAXIAL PEDICLE SCREW

K022768 · Micron Precision Engineering, Inc. · MNI · Nov 13, 2002 · Orthopedic

Device Facts

• Record ID: K022768
• Device Name: AMT POLYAXIAL PEDICLE SCREW
• Applicant: Micron Precision Engineering, Inc.
• Product Code: MNI · Orthopedic
• Decision Date: Nov 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as a pedicle screw fixation system in the non-cervical spine of skeletally mature patients (MNI), The AMT Spinal™ System is intended for immobilization and stabilization of spinal segments 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) severe degenerative spondylolithesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudoarthrosis). The AMT Spinal™ Svstem is intended for skeletally mature patients (MNH): (1) having severe spondylolithesis (Grades 3 and 4) at the L5-S1 vertebral joint; (2) who are receiving fusion by autogenous bone graft only; (3) 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

AMT Spinal™ System is a pedicle screw fixation construct for thoracic, lumbar, and sacral spine immobilization. Components include set screws, hex nuts, hooks, rods, and polyaxial screws. Polyaxial screw features a top-loading rotating head allowing multi-angle insertion and anatomical positioning; eliminates need for rod bending for constructs up to three vertebral levels. Used by surgeons in clinical settings to assist in arthrodesis/fusion. Device provides mechanical stabilization to facilitate bone healing; removed after solid fusion mass development. Components manufactured from Wrought Titanium 6Al4V ELI Alloy.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing (static and fatigue compression, static torsion) performed according to ASTM F1717-96.

Technological Characteristics

Construct system components (screws, rods, hooks, nuts) made of Wrought Titanium 6Al4V ELI Alloy (ASTM F-136). Features top-loading polyaxial head for multi-angle insertion. Supplied non-sterile; intended for steam sterilization. Mechanical fixation principle.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for thoracic, lumbar, and sacral spine conditions including severe degenerative spondylolisthesis with neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and pseudoarthrosis. Specific MNH indications include Grade 3-4 spondylolisthesis at L5-S1 using autogenous bone graft with fixation at 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

• Spine System Evolution (Aesculap)
• Global Spinal Fixation System (Forex)
• Global Spinal Fixation System (U & I Corporation)
• Spiral Radius 90D (Surgical Dynamics)
• Trinity Polyaxial Screw (Corin Spinal Systems)
• AMT Spinal™ System (K002059)

Submission Summary (Full Text)

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# Summary Of Safety And Effectiveness:

This safety and effectiveness summary for the Micron Precision Engineering AMT Spinal™ System is provided as required per Section 513(i)(3) of the Food, Drug, and Cosmetic Act.

#### 1. Submitter: Micron Precision Engineering Inc. 21051 Superior Street Chatsworth, CA 91311

NOV 1 3 2002

2. Mailing Address: 939 Evening Shade Drive San Pedro, CA 90731

### 3. Contact Person:

Mr. Frank E. Bailly Official Correspondent Telephone: [phone] Fax: [phone]

- AMT Spinal™ System 4. Trade Name: Pedicle screw fixation system Common Name: Classification Name: Orthosis, Spondylolisthesis Spinal Fixation (MNH) MNI FDA Product Code:
- Predicate or leqally marketed devices which are substantially equivalent: 5.
- Spine System Evolution Aesculap .
- Global Spinal Fixation System Forex ●

MNH

- Global Spinal Fixation System U & I Corporation .
- . Spiral Radius 90D - Surqical Dynamics
- Trinity Polyaxial Screw Corin Spinal Systems .

There are no significant differences between the Micron Precision Engineering AMT Polyaxial Pedicle Screw and the systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.

Mechanical testing shows the biomechanical performance of the subject device to be similar to the performance of previously cleared spinal systems with similar indications. It is substantially equivalent to these other devices in design, function, material and intended use.

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#### Description of the device: 6.

The AMT Spinal™ System is designed for use as a construct system and consists of set screws, hex nuts, hooks, rods, screws, and cross link assembly (cross link rod and connecting hook) which can be variously assembled to provide immobilization of the thoracic. lumbar, and lumbosacral spine. The system is composed of the following components: right hand set screw, left hand hex nut, pedicle screw, polyaxial screw, rod, cross link assembly (cross link rod and connecting hook). All components are made from Wrought Titanium 6Al4V ELI Alloy (ASTM F-136).

The components under review are the Polvaxial screws. Polyaxial upper body head, and concave compression washer. The AMT Polyaxial Pedicle Screw serves as an additional option to the pedicle screw configurations currently offered in the AMT Spinal™ System (K002059). in a construct system. The AMT Polyaxial Pedicle Screw utilizes the same straight forward simple instruments and is identical to the pedicle screws currently offered in the AMT Spinal™ System in the all areas with the exception of the following:

The top loading polyaxial head allowing for greater positioning abilities.

- The rotating head (polyaxial) eliminates the need to bend rods for constructs up to the . three (3) vertebral levels.
- The rotating head (polyaxial) can be rotated allowing the surgeon greater versatility in ● positioning rod and screws to the anatomy.
- Allows anatomical screw placement and easy rod positioning. ●
- This allows the surgeon multi-angle pedicle screw insertion. .
- All components are made from Wrought Titanium 6Al4V ELI Alloy (ASTM F-136). Materials:

Function: The system functions to assist in arthrodesis or fusion of the thoracic, lumbar and lumbosacral spine.

### 7. Intended Use:

When used as a pedicle screw fixation system in the non-cervical spine of skeletally mature patients (MNI), The AMT Spinal™ System is intended for immobilization and stabilization of spinal segments 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) severe degenerative spondylolithesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudoarthrosis).

The AMT Spinal™ Svstem is intended for skeletally mature patients (MNH): (1) having severe spondylolithesis (Grades 3 and 4) at the L5-S1 vertebral joint; (2) who are receiving fusion by autogenous bone graft only; (3) 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.

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#### Comparison of the technological characteristics of the device to predicate and legally 8. marketed devices:

There are no significant differences between the AMT Polyaxial Pedicle Screw and the AMT Spinal™ System currently being marketed which would adversely affect the use of the product. It is substantially equivalent to this device in design, function, material and intended use.

| Parameter | Identical,<br>Similar, or<br>Different | Similarities and Differences |
|--------------------------|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Identical | • Both the predicate and the proposed devices have the same profile and<br>geometry. |
| | Different | • The proposed device has a top loading rotating head to allow greater<br>versatility in positioning rod and screws to the anatomy. |
| Materials | Identical | • Ti-6Al-4V ELI Alloy for both the predicate and the proposed devices. |
| Manufacturing<br>Process | Identical | • Both the predicate and the proposed devices are machined in the same<br>process. |
| | Identical | • Both the predicate and the proposed devices are machined using the material<br>specifications. |
| Biocompatibility | Identical | • The materials used meet or exceed ASTM standards, are common to<br>orthopedic products today, and leave an extensive safe clinical history . |
| Pyrogenicity | Identical | • Neither the predicate nor the proposed devices are labeled as non-pyrogenic.<br>Per USP XXII, NF18 (1995 edition). "These requirements do not apply to<br>orthopedic products." |
| Sterility | Identical | • Both the predicate and the proposed devices will be supplied as a non-sterile<br>implant. |
| | Identical | • Both the predicate and the proposed devices will be steam sterilized. |

#### Non-clinical Performance and Conclusions: 9.

The Food and Drug Administration have established no performance standards applicable to pedicle screw systems. However, static and fatigue compression and static torsion testing of the AMT Polyaxial Pedicle Screw were performed according to ASTM F1717-96. Data regarding the functional performance of the proposed AMT Polyaxial Pedicle Screw has been generated.

### 10. Clinical Performance and Conclusion:

Clinical data and conclusion were not needed for this device

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in a thick, black line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

NOV 13 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Frank E. Bailly Official Correspondent Micron Precision Engineering, Inc. 939 Evening Shade Drive -San Pedro, California 90731

> K022768 Trade Name: AMT Polyaxial Pedicle Screw - AMT Polyaxial Pedicle Screw Regulation Number: 888.3070 Regulation Names: Pedicle Screw Spinal System and Spondylolisthesis Spinal Fixation Device System Regulatory Class: II Product Codes: MNI and MNH Dated: August 12, 2002 Received: August 21, 2002

Dear Mr. Bailly:

Re:

We have reviewed your Section 510(k) premarket 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 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.

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Page 2 - Mr. Frank E. Bailly

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

O. Miah 71 Williams

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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510(k) Number (if known):

### K022768

# Device Name: AMT Spinal™ System

# Indications for Use

When used as a pedicle screw fixation system in the non-cervical spine of skeletally mature patients (MN), The AMT Spinal™ System is intended for immobilization of spinal segments 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) severe degenerative spondylolithesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (6) spinal tumor, and (7) failed previous fusion (pseudoarthrosis).

The AMT Spinal™ System is intended for skeletally mature patients (MNH): (1) having severe spondylolithesis (Grades 3 and 4) at the L5-S1 vertebral joint; (2) who are receiving fusion by autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (1.3 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 IF NEEDED)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Mark H. Milliken

(Division Sign-Off) Division of General, Restorative and Neurological Devic

510(k) Number K022768

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)