EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM

K102870 · Exactech, Inc. · MNH · Jan 21, 2011 · Orthopedic

Device Facts

• Record ID: K102870
• Device Name: EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM
• Applicant: Exactech, Inc.
• Product Code: MNH · Orthopedic
• Decision Date: Jan 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Exactech® Proliant™ Polyaxial Pedicle Screw System is intended to provide 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 including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis). In addition, when used as a pedicle screw fixation system, the Proliant System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft only having the device attached to the lumbar and sacral spine (L3 and below), who are having the device removed after the development of a solid fusion.

Device Story

Top-loading spinal fixation system; comprises polyaxial screws, rigid rods, and cross connectors. Used in open surgical procedures to immobilize and stabilize spinal segments as an adjunct to fusion. Components manufactured from titanium alloy. Provided non-sterile; requires hospital steam sterilization. Surgeon implants components to treat spinal instabilities or deformities. System provides mechanical support to facilitate bone fusion; intended for removal after solid fusion in specific severe spondylolisthesis cases.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including static compression bending, static torsion, and dynamic compression fatigue testing per ASTM F1717, and biomechanical assessment comparing mechanical performance to predicate systems.

Technological Characteristics

Titanium alloy (Ti-6Al-4V ELI per ASTM F136). Polyaxial pedicle screw, rigid rod, and cross-connector design. Non-sterile, single-use, hospital steam sterilized. Mechanical performance tested per ASTM F1717.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for acute/chronic instabilities or deformities of thoracic, lumbar, and sacral spine (e.g., degenerative spondylolisthesis with neurological impairment, fracture, dislocation, scoliosis, spinal tumor, pseudoarthrosis). Specific indication for severe spondylolisthesis (Grades 3-4) 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

• Hydralok System (K051216)
• VSS System (K062670)
• Extended VSS System (K073245)

Submission Summary (Full Text)

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K102870

# Exactech® Proliant™ Polyaxial Pedicle Screw System Traditional 510(k)

# 510(k) Summary

| Company: | Exactech®. Inc<br>JAN 2 1 2011<br>2320 NW 66" Court<br>Gainesville, FL 32653 | |
|-------------------|----------------------------------------------------------------------------------------------------|--|
| Date: | November 22, 2010 | |
| Contact Person: | Vladislava Zaitseva<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] | |
| Proprietary Name: | Exactech® Proliant™ Polyaxial Pedicle Screw System | |
| Common Name: | Pedicle screw spinal system | |

## Classification Name:

21 CFR 888.3070 - Pedicle screw spinal system, Class II

- Product Code: MNI Orthosis, Spinal Pedicle Fixation .
- Product Code: MNH Orthosis, Spondylolisthesis Spinal Fixation .

## Legally Marketed Devices to Which Substantial Equivalence Is Claimed

- t Hydralok" System (K051216)
- VSS System (K062670) and Extended VSS System (K073245) .

### Device Description

This submission proposes a new pedicle screw spinal fixation system. The proposed Proliant Polyaxial Pedicle Screw System is a top-loading spinal fixation system that comprises various sizes of polyaxial screws, rigid rods and cross connectors to provide 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 including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).

Components are manufactured from titanium alloy (Ti-6AI-4V ELI per ASTM F136). The system components are provided clean and non-sterile. The products must be steam sterilized by the hospital prior to use.

The Proliant Polyaxial Pedicle Screw System includes a complete instrumentation system to assist the surgeon in the implantation of each component according to a traditional open surgical procedure.

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K/02 8'70

## Exactech® Proliant™ Polvaxial Pedicle Screw System Traditional 510(k)

### Indications for Use

The Exactech® Proliant™ Polyaxial Pedicle Screw System is intended to provide 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 including degenerative spondy|olisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).

In addition, when used as a pedicle screw fixation system, the Exactech Proliant Polyaxial Pedicle Screw System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft only having the device attached to the lumbar and sacral spine (L3 and below), who are having the device removed after the development of a solid fusion.

### Summary of Technological Characteristics

The rationale for substantial equivalence is based on consideration of the following characteristics:

#### Intended Use/Indications for Use. .

The Proliant Polyaxial Pedicle Screw System has the same indications for use and intended uses as the Hydralok System and similar indications for use and intended uses as VSS/Extended VSS Systems.

#### . Materials

The Proliant Polyaxial Pedicle Screw System and predicates Hydralok System and VSS/Extended VSS Systems are composed of titanium, a biocompatible material conforming to a recognized industry standard for permanent implants.

#### . Design Features

The Proliant Polyaxial Pedicle Screw System and predicates Hydralok System and VSS/Extended VSS Systems have similar design features.

#### . Dimensions

The Proliant Polyaxial Pedicle Screw System and predicates Hydralok System and VSS/Extended VSS Systems are dimensionally comparable.

#### Packaging and Sterilization .

The Proliant Polyaxial Pedicle Screw System and predicates Hydralok System and VSS/Extended VSS Systems are provided non-sterile for single use only. Both proposed and predicate systems will be steam sterilized by the hospital prior to use in the operating room using the same method.

#### Device Shelf Life ●

Neither the Proliant Polyaxial Pedicle Screw System nor identified predicates have shelf-life expiration dating.

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K102870

## Exactech® Proliant™ Polyaxial Pedicle Screw System Traditional 510(k)

#### . Performance specifications

The Proliant Polyaxial Pedicle Screw System and predicate systems withstand clinically relevant biomechanical loads.

### Substantial Equivalence Conclusion

The following mechanical testing and engineering analysis were conducted to demonstrate substantial equivalence of the proposed Proliant Polyaxial Pedicle Screw System to predicates Hydralok System and VSS/Extended VSS Systems:

- Static Compression Bending, Static Torsion, and Dynamic Compression Fatigue . testing per ASTM F1717.
- Biomechanical assessment comparing Proliant Polyaxial Pedicle Screw System . mechanical performance to cited predicate systems.

The results of mechanical testing and engineering analysis demonstrate the proposed devices are substantially equivalent to cited predicates.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Exactech®, Inc. % Ms. Vladislava Zaitseva Regulatory Affairs Specialist 2320 NW 66" Court Gainesville, Florida 32653

JAN 2 1 201

Re: K102870

Trade/Device Name: Exactech® Proliant™ Polyaxial Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: December 22, 2010 Received: December 23, 2010

Dear Ms. Zaitseva:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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Page 2 - Ms. Vladislava Zaitseva

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 100-100.

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/ucm1178017; plcase the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Adonalization note the regulation entitled, "Misbranding by reference to premarket notfication" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (11 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm 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 the [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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Exactech® Proliant™ Polyaxial Pedicle Screw System Traditional 510(k)

## Indications for Use Statement

510(k) Number:

K102870

Device Name: Exactech® Proliant™ Polyaxial Pedicle Screw System

## INDICATIONS FOR USE:

The Exactech® Proliant™ Polyaxial Pedicle Screw System is intended to provide 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 including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).

In addition, when used as a pedicle screw fixation system, the Proliant System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft only having the device attached to the lumbar and sacral spine (L3 and below), who are having the device removed after the development of a solid fusion.

Prescription Use __ X___ Over-The-Counter Use and/or (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

Please do not write below this line - use another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

.
Division Sign Off

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102870