ISSYS PEDICLE SCREW SYSTEM

K043522 · Custom Spine, Inc. · KWP · Jan 14, 2005 · Orthopedic

Device Facts

• Record ID: K043522
• Device Name: ISSYS PEDICLE SCREW SYSTEM
• Applicant: Custom Spine, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Jan 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Custom Spine Issys Pedicle Screw System is used for the following human spine pathologies: - Deformity - Trauma & Tumor When used as pedicle screw fixation system of the non cervical posterior spine (T1-S1) in skeletally mature patients, these systems are indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). In addition these systems are indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (grade 3 and 4) at the L5-S1 joint having fusion with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass

Device Story

The Issys Pedicle Screw System is an implantable spinal fixation construct used to stabilize the thoracic, lumbar, and sacral spine to promote fusion. The system comprises bone screws, polyaxial screw heads, saddle pins, spinal rods, and blocker screws. It is used by surgeons in a clinical/surgical setting to treat spinal pathologies including deformities, trauma, and tumors. The device is assembled intraoperatively to create a rigid construct. Instruments are provided for the application and removal of the implants. The system provides mechanical stabilization, which facilitates the biological process of spinal fusion, potentially reducing pain and correcting spinal alignment in patients.

Clinical Evidence

Bench testing only. Testing was conducted in accordance with ASTM F1717 to demonstrate substantial equivalence to the Moss-Miami, Universal, and Optima Spinal Systems.

Technological Characteristics

System components include bone screws, polyaxial screw heads, saddle pins, spinal rods, and blocker screws. Materials include medical grade stainless steel. Bench testing performed per ASTM F1717. The device is a mechanical fixation system; no software or energy source is utilized.

Indications for Use

Indicated for skeletally mature patients requiring non-cervical posterior spinal fixation (T1-S1) for deformity, trauma, tumor, degenerative spondylolisthesis with neurological impairment, fracture, dislocation, scoliosis, kyphosis, or pseudarthrosis. Also indicated for severe spondylolisthesis (grade 3-4) at L5-S1 with autogenous bone graft, with implants removed after fusion.

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

• Moss-Miami Spinal System
• Universal Spinal System
• XIA Spinal System
• Optima Spinal System

Submission Summary (Full Text)

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December 29, 2004

K043522

JAN 1 4 2005

Custom Spine 601 Jefferson Road Suite 208 Parsippany, NJ 07054

## 510(k) Summary of Safety and Effectiveness Custom Spine Issys Pedicle Screw System December 29, 2004

- Sponsor Name 】. Custom Spine 601 Jefferson Road, Suite 208 Parsippany, NJ 07054 (877) 770-SPINE (7746)
- 2. Device Name Proprietary Name: Issys Pedicle Screw

Common Name: Pedicle Screw System

| Classification Name and Reference: | 21CFR 888.3070<br>Pedicle Screw Spinal System<br>21 CFR 888.3050<br>Spinal interlaminal fixation orthosis |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Device Product Code: | MNI: Orthosis, Spinal, Pedicle Fixation<br>MNH: Orthosis, spondylolisthesis spinal fixation<br>KWP: Appliance, fixation, spinal interlaminal |

## 3. Device Description

The Custom Spine Issys Pedicle Screw System is comprised of various types and sizes of implantable components that are assembled to create a rigid spinal construct to provide stabilization and promote spinal fusion. It is used as an as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The system consists of bone screws, a polyaxial screw head, saddle pin, spinal rods, and blocker screws

Page 1 of 2

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and is designed to facilitate optimal screw and rod placement. Instruments made and is doble grade stainless steel are also provided which provide for the application and removal of the implant.

4. Intended use:

ndow ace:
Custom Spine Issys Pedicle Screw System is used for the following human spine pathologies:

- . Deformity
- Trauma & Tumor ●

When used as pedicle screw fixation system of the non cervical posterior spine (T1-S1) in skeletally mature patients, these systems are indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

In addition these systems are indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (grade 3 and 4) at the L5-S1 joint having fusion with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass

- 5. Identification of Legally Marketed Device
Equivalency of the Custom Spine Pedicle Screw system is based on the predicate device Moss- Miami Spinal System, Universal Spinal System, XIA Spinal System, and Optima Spinal System.

- 6. Comparison of Technological Characteristics
The Issys Pedicle Screw is substantially equivalent in design, materials, construction and intended use as those of the predicates identified above. Since the Issys Pedicle Screw is the same in intended use and technological characteristics as the predicate devices, the Issys Pedicle Screw does not raise any new safety and efficacy concerns when compared to these similar legally marketed devices.

- 7. Performance Testing
Bench testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalency to the Moss Miami Spinal System, Universal Spinal System, and Optima Spinal System.

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Image /page/2/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 that resembles an eagle or a stylized human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 2005

Custom Spine, Inc. C/o Ms. Debbie Iampietro QRC Associates PO Box 1070 Conway, New Hampshire 03818

Re: K043522

Ro-19322
Trade/Device Name: Custom Spine ISYSS Pedicle Screw System Regulation Number: 21 CFR 888.3050, 888.3070 Regulation Namber 21 Crice Coolinal fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: KWP, MNH, MNI Dated: December 17, 2004 Received: December 21, 2004

Dear Ms. Iampietro:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have leviewed your beculor 910(t) prehistantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, enciosure) to tegany marketed products as a concess that have been reclassified in the enability the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require accordance will the provisions of also Posts (PMA). You may, therefore, market the device, subject to approval of a promation upprovial approvial controls provisions of the Act include the general controls provisions of also reens 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 If your device is classified (see above) into i major regulations affecting your device can be found in the Subject to such additions, 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 FIEASE be advised mar 1271 o tobailed us a device complies with other requirements of the Act or any FDA has made a decemination max your cod by other Federal agencies. You must comply with all the Federal statutes and regulations administration and listing (21 CFR Part 807); labeling (21 ACF S requirements, merading, our novactice requirements as set forth in the quality systems (QS) CFK Fart 8017, good manufacturing practicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms.Iampietro

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 ate of Comment notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Jour vole Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Mulkern

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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Custom Spine Issys Pedicle Screw System December 29, 2004 ંવપુર 822

## Indications for Use

510(k) Number (if known):_Unknown

Device Name: Custom Spine Issys Pedicle Screw System

Indications For Use:

Custom Spine Issys Pedicle Screw System is used for the following human spine pathologies:

- Deformity .
- Trauma & Tumor .

When used as pedicle screw fixation system of the non cervical posterior spine (TI-S1) in skeletally mature patients, these systems are indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of of the following: degener, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

In addition these systems are indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (grade 3 and 4) at the L5-S1 joint having fusion with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with the rainowal of the implants after the development of a solid fusion mass

Prescription Use _X_

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K043522