PASS SPINAL SYSTEM

K013442 · Encore Orthopedics, Inc. · KWP · Jan 15, 2002 · Orthopedic

Device Facts

• Record ID: K013442
• Device Name: PASS SPINAL SYSTEM
• Applicant: Encore Orthopedics, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Jan 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• 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 spines: spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, 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. When used as a posterior, non-cervical, non-pedicle screw fixation system, the PASS Spinal System is intended for hook fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), deformities (scoliosis, kyphosis), pseudarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.

Device Story

PASS Spinal System is a posterior spinal fixation orthosis comprising pedicle screws, rods, nuts, laminar hooks, and crosslink members. Device provides mechanical stabilization of spinal segments to facilitate fusion. Hooks are inserted under lamina or pedicles; polyaxial components allow for multi-level fixation. System is used by surgeons in clinical/OR settings. Output is physical immobilization of the spine; clinical decision-making relies on surgeon assessment of spinal instability or deformity. Benefits include stabilization of the spine to promote solid fusion in patients with acute/chronic instabilities.

Clinical Evidence

Bench testing only. Performance testing was conducted according to ASTM F1717-96 standards to demonstrate mechanical integrity and equivalence to predicate spinal systems.

Technological Characteristics

Materials: Titanium alloy (ASTM F136). Components: Pedicle screws, rods, nuts, crosslink members, laminar hooks. Design: Polyaxial attachment mechanism. Connectivity: None (mechanical device). Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion. Conditions: spondylolisthesis (including severe Grade 3-4 L5-S1), fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudarthrosis, degenerative disc disease. Used in thoracic, lumbar, and sacral spine (T1 to ilium/sacrum).

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• PASS Spinal System (K001024)
• PASS Spinal System (K012175)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness

| (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: | October 16, 2001 |

Class II

K01342
page lotl

- PASS Spinal System Trade or proprietary device name: (2) Pedicle screw spinal system Common or usual name: Spinal interlaminal fixation orthosis
JAN 1 5 2002

Classification name:

(3)

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

The subjects of this submission of polyaxial crossink components for the PASS Spinal System The subjects of this submission are the adultor of poyaxial orosinisher from the morney to ASTM F136.

The hooks can be used for single or multiple level fixation. The polyaxial hooks have the same attachment The nooks can be used for Single of multiple forer maniforners of any and K012175.
mechanism of the PASS Spinal System polyaxial components cleared in K001024 and K012175.

The laminar hooks are inserted inferior and superior around the looks are available hooks are available in standard and The laminar nooks are inseried the superior and superior the same of a superior with a mandard and inserted interior and superior around the pedicies. "The dodble lamination with a pedicle screw assembly without any problem of superimposition.

The laminar hooks are inserted under the lamina and the polyaxial pooks are inserted under the pedicle The laminar hooks are inserted under the lamina and the poyable from and the world and problem of superimposition.

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

The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized to provide Ine PA55 Spinal System Consists of pedice Sorows, Foatsite as an adjunct to husion in the immobilization and stablication of spirant in thoreculty in thorean , lumbar, and sacral spines treatment of the following acule and circuities of doloriment, 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 spondyloilshesian by arth As a pedicies screw system, the PASS Spiral Oystering fusion by autogenous bone graft (Grade 3 and 4) of the LS-ST vellebrae in skeletaly multile resormly with removal of the implants after the attainment of a solid fusion.

When used as a posterior, non-cervical, non-pedicle screw fixation syste, the PASS Spinal System is intended for When used as a posterior, nor-bediole sorew indications are spondylolistiness, degeneratived by nation hook fixation from 11 to the inun/sacrum. The north heleants on of the disc confirmed by patient disc disease (as uelined by back pan of usoogene onlyn mat asgeneralisms (seudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.

#### Performance data: (6)

The Food and Drug Administration have established no performance standards applicable to performal The Food and Drug Administration have established to performance claims of the PASS Spinal System was performed according to ASTM F1717-96.

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

The PASS Spinal System Hooks are equivalent to the other spinal systems commercially available that incorporate pedicle screws, rods, and crosslinking members.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 1 5 2002

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

Re: K013442

> Trade Name: PASS Spinal System Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedicle Screw Spinal System, Spondylolisthesis Spinal Fixation Device System, Spinal Interlaminal Fixation Orthosis, Regulatory Class: II Product Code: MNH, MNI, KWP

Dated: October 16, 2001 Received: October 17, 2001

Dear Ms. Droege:

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 - Ms. Joanna Droege

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 nontication. The I Driving of Castion 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 CFF Part 801 and If you desire specific active for your astic devices), please contact the Office of Compliance at additionally 607.10 for mi == for questions on the promotion and advertising of your device, [phone]. Fraunicance 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 mormation on your respont its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

L. Mark N. Milliken

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): ____________________

Qevice Name: ____Additional Components to PASS Spinal System

Indications For Use:

KC013442
page 1 of 1

# Additional Components to PASS Spinal System

### Indications For Use

The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized to r r so opinal cyclern continue 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, to hastor in the troutine of the volumity pondy olisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, 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 Spondylollethous 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.

When used as a posterior, non-cervical, non-pedicle screw fixation syste, the PASS Spinal System is intented for hook fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (as defined by back pain of discogenic origin with Spond from of the disc confirmed by patient history and radiographic studies), deformities (scoliosis, degonoration of the dise common of atthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X |
|------------------|--------------------------|
| | OR |
| | (per 21 CFR 801.109) |
| | (Optional Format 1-2-96) |
| (Division | n-Off) |
| Division | General, Restorative |
| | and medical Devices |
| 510(k) Number | K013442 |