PASSMED SPINAL SYSTEM

K032094 · Medicrea · KWP · Nov 14, 2003 · Orthopedic

Device Facts

• Record ID: K032094
• Device Name: PASSMED SPINAL SYSTEM
• Applicant: Medicrea
• Product Code: KWP · Orthopedic
• Decision Date: Nov 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PASSmed is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). As a pedicle screw system PASSmed is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S1 vertebra 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. It also includes hooks and a sacral plate indicated for degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

Device Story

PASSmed is a posterior pedicle screw and spinal fixation system; includes polyaxial screws, rods (Ø6mm), sacral plates, and hooks. Used for thoracic, lumbar, and sacral spinal stabilization; provides immobilization as an adjunct to fusion. Components connect via polyaxial attachment mechanisms or clamps; sacral plates attach to sacrum with screws. Operated by surgeons in clinical/OR settings. Provides mechanical stabilization to spinal segments; facilitates fusion; intended for removal after solid fusion achieved. Benefits patients by addressing spinal instabilities and deformities.

Clinical Evidence

Bench testing only. Mechanical testing performed according to ASTM F1717 indicates the PASSmed system is as mechanically sound as other commercially available spinal fixation devices.

Technological Characteristics

System includes polyaxial screws, Ø6mm rods, sacral plates, and laminar/pedicle hooks. Polyaxial attachment mechanism used for screws and rod-plates. Materials and design are identical to predicate devices. Testing conducted per ASTM F1717.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion. Conditions include degenerative spondylolisthesis, severe spondylolisthesis (Grades 3-4, L5-S1), degenerative disc disease, trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), spinal tumors, and pseudarthrosis.

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

• K001024
• K012175
• K013191
• K013431
• K013442
• K020236

Submission Summary (Full Text)

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510(k) Summary

Date November 11, 2003

NOV 1 4 2003

## Submitter

Medicrea Z.I. Chef de Baic 17000 LaRochelle, FRANCE

## Contact person

J.I). Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199

## Common name

Posterior pedicle screw system Hooks Sacral plate

## Classification name

Spondylolisthesis Spinal Fixation Device System per MNH 888.3070 Pedicle Screw Spinal System per MNI 888.3070 Spinal Interlaminal Fixation Orthosis per KWP 888.3050

#### Equivalent Device

The components covered by this submission are exactly the same as those cleared in K001024, K012175, K013191, K013431, K013442 and K020236. These devices were all submitted by Encore Orthopedics. All of the cleared devices were designed, manufactured and packaged by Medicrea.

#### Device Description

The PASSmed system includes pedicies include polyasial screws in a various lengths and diameters. Standard and offist height seres are available, with the offset used in cases of severe spondylolisticsis. Standard and realignment clamps are used to connect the screw and rods. Rods are Ø6mm in lengths ranging from 50mm. It also includes sacral plates and serens. The sacral plate takes the place of pedicle screw in connecting the rod to the sacrum. The place is attached to the sarum with two serews. The polyasial attachment mechanism to the same as the pedicle screws. The plates come in right and left configuration. The rod-plates are similar to the consist of a short rod segment that has enarged portions at the ends with holes to attach directly to screw with hemispherical nuts rather than connecting to the rod was a clamp. The rods attach to the hooks and can be used for single or multiple level lisations. They have the same rod attachment mechanism as the polyasial serews. The laminar hooks are inserted inferior around the lamina, pediele hooks are inserted inferior and superior around the pedicles.

## Intended Use

The PASSmed is a pediele serew system intended to provide immobilization of spinal segments in skelctally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: degencive spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system PASSmed is indicated for the treament of severe spondylolisthesis (Grades 3 and 4) of the L2-51 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacra spine (L 3 to sacrum) with removal of the implants after the attainment of a solid fusion.

I also includes hooks and a sacral plate indicated for degenerative disc disease (ddd) defined as back pain of discogence origin with degeneration of the disc confirmed by history and radiographic studies, trauma (i.e., fracture or dislocation), spinal stenosis, deformities (i.e., scolosis, kyphosis, and/or lordosis), tumor, pseudoat(trosis and failed previous fusion.

#### Summary Nonclinical Tests

Testing performed according to ASTM F1717 indicate that the PASSmed system is as mechanically sound as other devices commercially available.

K032094
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle with its wings spread.

Public Health Service

NOV 1 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medicrea C/o Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K032094 Trade/Device Name: PASSmed Spinal System Regulation Number: 21 CFR 888.3050, 21 CFR 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: KWP, MNH, MNI Dated: October 10, 2003 Received: October 14, 2003

Dear Mr. Webb:

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.

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. J.D. Webb

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

to Mark A. Millers

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): K032094

Device Name: PASSmed Spinal System

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Indications for Use:

# PASSmed Spinal System Indications for Use

The PASSmed is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system PASSmed is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S1 vertebra 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.

It also includes hooks and a sacral plate indicated for degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

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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)

)

Mark N Mulkerson

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

510(k) Number K032049

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