PASS SPINAL SYSTEM

K012175 · Encore Orthopedics, Inc. · MNI · Jul 31, 2001 · Orthopedic

Device Facts

• Record ID: K012175
• Device Name: PASS SPINAL SYSTEM
• Applicant: Encore Orthopedics, Inc.
• Product Code: MNI · Orthopedic
• Decision Date: Jul 31, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). As a pedicle screw system, the PASS Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Device Story

The PASS Spinal System is a pedicle screw spinal fixation system consisting of screws, rods, nuts, and crosslink members. The subject device adds a sacral plate component to the existing system. The sacral plate utilizes the same polyaxial mechanism as previously cleared polyaxial screws but attaches via two additional screws rather than directly to the vertebrae. The system is used by surgeons in clinical settings to provide immobilization and stabilization of spinal segments during fusion procedures. By securing the spine, the device facilitates fusion and treats various spinal instabilities and deformities. The system is intended for removal after solid fusion is achieved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Components manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. System includes pedicle screws, rods, nuts, crosslink members, and a sacral plate. Features a polyaxial mechanism for screw/plate attachment. Mechanical fixation device; no software or energy source.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization and stabilization as an adjunct to fusion for thoracic, lumbar, and sacral spine conditions including degenerative spondylolisthesis with neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and pseudarthrosis. Also indicated for severe spondylolisthesis (Grade 3 and 4) at L5-S1 when using autogenous bone graft with implants attached from L3 to sacrum.

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

• PASS Spinal System (K001024)

Submission Summary (Full Text)

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JUL 3 1 2001

Class II

16012175

| (1) | Submitter's name: | Encore Orthopedics, Inc. |
|-----|-----------------------------------|-------------------------------------|
| | Submitter's address: | 9800 Metric Blvd, Austin, TX 78758 |
| | Submitter's telephone number: | [phone] |
| | Contact person: | Joanna Droege |
| | Date summary prepared: | July 10, 2001 |
| (2) | Trade or proprietary device name: | PASS Spinal System |
| | Common or usual name: | Pedicle screw spinal system |

- PASS Spinal System (K001024) Legally marketed predicate device: (3)
#### Subject device description: (4)

Classification name:

The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members. It can be used for single or multiple level fixation. All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

The additional component that is the subject of this Special 510(k) submission is the PASS Spinal System Sacral Plate. It has the same polyaxial mechanism as the polyaxial screws cleared in K001024. The difference is that the plate is attached by two additional screws rather than directly to the vertebrae.

#### Subject device intended use: (5)

The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the PASS Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

#### (6) Performance data:

The Food and Drug Administration have established no performance standards applicable to pedicle screw spinal systems.

#### Basis for substantial equivalence: (7)

The PASS Spinal System Sacral Plate is similar in design, materials and indications to the PASS Spinal System (K001024).

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Image /page/1/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the edge. In the center is an emblem that resembles a stylized bird or eagle with three wing-like extensions above its head. The emblem is black and the background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 1 2001

Ms. Joanna Droege Regulatory/QA Manager Encore Orthopedics, Inc. 9800 Metric Boulevard Austin, Texas 78758

K012175 Re: Trade Name: PASS Spinal System Sacral Plate Regulatory Class: II Product Code: MNI Dated: July 10, 2001 Received: July 12, 2001

Dear Ms. Droege:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have roviewed your betermined 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 encededience 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 ( Fecting 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 Marufacturing 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.

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.

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# Page 2 - Ms. Joanna Droege

If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and If you desire specific advice for your de rice of our accessions of compliance at a additionally 809.10 for in Vito diagnostic as on the promotion and advertising of your device, [phone]. Additionally, for questions on the presence the regulation please contact the Office of Comphanee at (301) 37 - 1 - 1 CFF 807.97). Other general entitled, "Misoranding by releveloc to pearlies Act may be obtained from the Division of Small miormation on your responsionnes ander uner [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 and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K0/2175

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: PASS Spinal System

Indications For Use:

## PASS Spinal System

### Indications For Use

The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members THE PROD Spinal bywenner 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, Spondylonoussis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the PASS Spinal System is intended for the treatment of ris a pource better byth (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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

510(k) Number K012175