UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS

K031381 · Seaspine · MNI · Jul 30, 2003 · Orthopedic

Device Facts

• Record ID: K031381
• Device Name: UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS
• Applicant: Seaspine
• Product Code: MNI · Orthopedic
• Decision Date: Jul 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the UCR Spinal System hooks and their components is substantially equivalent to the intended use of the predicate devices. The intended use of the UCR Spinal System and hooks is as a temporary or permanent posterior implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The intended use and indications when used as a Spondylolisthesis Spinal Fixation Device System are: The UCR Spinal System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions 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. The intended use and indications when used as a Pedicle Screw Spinal System are: The UCR Spinal System 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 (pseudoarthrosis). Hook Spinal System indications are limited to T1-L5 and are: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history ad radiographic), spinal stenosis, spondylolisthesis, spinal deformities (scoliosis, kyphosis, and/or lordosis), fracture, pseudarthosis, tumor resection, and/or failed previous fusion.

Device Story

UCR Spinal System is a posterior spinal implant system consisting of titanium alloy laminar and pedicle hook assemblies; includes hook body, temporary fixation pin, cap, and set screw. Used by surgeons in clinical settings to provide spinal stabilization and immobilization as an adjunct to fusion. Instruments (hook holder, inserter, pin inserter, power rod gripper, rocker) are fabricated from stainless steel and Radal. System is supplied non-sterile and requires sterilization before use. Implants are attached to the spine to correct disorders and facilitate biological fusion; pedicle screws may be removed after solid fusion. Benefits include stabilization of spinal segments in patients with acute/chronic instabilities or deformities.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Titanium alloy laminar and pedicle hook assemblies; laminar hooks (5.5mm/7.0mm width, 5.0-10.0mm height); pedicle hooks (7.5mm/9.0mm width, 5.0-9.5mm height). Instruments made of stainless steel and Radal. Non-sterile; requires sterilization. Mechanical fixation system.

Indications for Use

Indicated for skeletally mature patients requiring spinal fusion for severe spondylolisthesis (L5-S1), degenerative spondylolisthesis with neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed fusion, degenerative disc disease, or spinal stenosis. Hook system limited to T1-L5.

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

• Synergy™ Posterior Spinal System (Cross Medical Products)
• CD Horizon™ (Medtronic Sofamor Danek)

Submission Summary (Full Text)

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UCR Spinal System

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# 510(K) SUMMARY

Pursuant to 510(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and in accordance with 21 CFR & 807.92.

| Submitter Information: | SeaSpine, Inc.<br>Contact: Kirt Stephenson<br>6276 River Crest Drive, Suite E<br>Riverside, CA 92507-0754<br>Phone: [phone] Fax: [phone] |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Registration Number: | 2032593 |
| Submission Correspondent: | The Regulatory Affairs Company<br>Contact: Diana Smith<br>727 Park Boulevard<br>San Diego, CA 92101<br>Phone: [phone] Fax: [phone] |
| Date Summary Prepared: | April 7, 2003 |
| Classification Name: | Spondylolisthesis Spinal Fixation Device<br>System (Class II) – MNH 888-3070<br>Pedicle Screw Spinal System (Class II) –<br>MNI 888-3070<br>Spinal Interlaminal Fracture Orthosis (Class<br>II) - KWP 88-3050 |
| Common/Usual Name: | Laminar and Pedicle Hook Assemblies and<br>Instruments |
| Device Trade Name: | UCR Spinal System |

The primary devices used for comparison in this summary are Cross Medical Products' Synergy™ Posterior Spinal System and Medtronic Sofamor Danek's CD Horizon™.

1. Intended Use: (The statements of intended use are identical.)

The intended use of the UCR Spinal System hooks and their components is substantially equivalent to the intended use of the predicate devices. The intended use of the UCR Spinal System and hooks is as a temporary or permanent posterior implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.

The intended use and indications when used as a Spondylolisthesis Spinal Fixation Device System are:

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### UCR Spinal System

- The UCR Spinal System is a pedicle screw system indicated for the treatment ● of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions 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.
CONFIDENTIAL

The intended use and indications when used as a Pedicle Screw Spinal System are:

- The UCR Spinal System 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 (pseudoarthrosis). ●

Hook Spinal System indications are limited to T1-L5 and are:

- degenerative disc disease (as defined by back pain of discogenic origin with ● degeneration of the disc confirmed by patient history ad radiographic),
- . spinal stenosis.
- . spondylolisthesis,
- . spinal deformities (scoliosis, kyphosis, and/or lordosis),
- fracture,
- pseudarthosis, ●
- tumor resection, and/or ●
- failed previous fusion. .

### 2. Description:

The UCR Spinal System hooks include titanium alloy laminar and pedicle hook assemblies. The laminar hooks will be available in widths of 5.5mm and 7.0mm and in five heights that range from 5.0 to 10.0mm. The pedicle spinal hooks will be available in widths of 7.5mm and 9.0mm and in four heights that range from 5.0 to 9.5mm. The laminar hooks will also be available in offset versions. The hook assembly is comprised of a hook body, temporary fixation pin, cap, and set screw. The hook assembly is designed to be compatible with and work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use

The UCR Spinal System hooks also utilize a variety of instruments to assist in placement of the devices. These instruments include a hook holder, hook inserter,

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#### UCR Spinal System

temporary fixation pin inserter, power rod gripper, and a rocker. The instruments will be fabricated from stainless steel and Radal. The product is supplied "NON-STERILE" and must be sterilized prior to use.

#### 3. Technological Characteristics:

The hook assembly has been designed as an addition to the current UCR Spinal System. The hook system is new to the UCR Spinal System line, but has substantially equivalent technological characteristics to the predicate devices. Refer to Table 1 in the following section, entitled Comparison Analysis, for a summation of technological characteristics such as design, dimensional specifications, and material.

#### 4. Comparison Analysis:

The overall design of the UCR Spinal System hooks and their components are substantially equivalent to the predicate devices. See Table 1 on the following page for a comparison of the UCR Spinal System hooks and the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2003

SeaSpine, Inc. c/o Ms. Diana Smith Principal The Regulatory Affairs Company 727 Park Boulevard San Diego, California 92101

Re: K031381 Trade/Device Name: UCR Spinal System Regulatory Number: 21 CFR 888.3070 (b)(1), 888.3050 Regulation Name: Pedicle screw spinal system, Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: MNI, MNH, KWP Dated: April 16, 2003 Received: May 1, 2003

Dear Ms. Smith:

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

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#### Page 2 - Richard W. Treharne, Ph.D.

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. 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" (21CFR 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,

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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CONFIDENTIAL

#### UCR Spinal System

Indications for Use Statement

16031381

510(k) Number (if known):

Device Name: UCR Spinal System

The intended use of the UCR Spinal System hooks and their components is substantially equivalent to the intended use of the predicate devices. The intended use of the UCR Spinal System and hooks is as a temporary or permanent posterior implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.

The intended use and indications when used as a Spondylolisthesis Spinal Fixation Device System are:

- The UCR Spinal System is a pedicle screw system indicated for the treatment . of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions 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.
The intended use and indications when used as a Pedicle Screw Spinal System are:

- The UCR Spinal System 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 (pseudoarthrosis). ●

Mark N. Milburn
(Division Sign-Off)

Division of Gene al. Restorative and Neurological Devices

510(k) Number__K03/38/

#### (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

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# CONFIDENTIAL

# UCR Spinal System

### Indications for Use Statement continued

Hook Spinal System indications are limited to T1-L5 and are:

- degenerative disc disease (as defined by back pain of discogenic origin with ● degeneration of the disc confirmed by patient history ad radiographic),
- . spinal stenosis,
- spondylolisthesis, .
- spinal deformities (scoliosis, kyphosis, and/or lordosis), .
- . fracture,
- pseudarthosis,
- . tumor resection, and/or
- failed previous 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 _________________________________________________________________________________________________________________________________________________________

21