UCR SPINAL SYSTEM

K032739 · Seaspine · MNI · Nov 20, 2003 · Orthopedic

Device Facts

• Record ID: K032739
• Device Name: UCR SPINAL SYSTEM
• Applicant: Seaspine
• Product Code: MNI · Orthopedic
• Decision Date: Nov 20, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 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). The indications for use as a Hook Spinal System 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 consists of variable and fixed cross links, bars, screws, and couplers; titanium alloy construction. Device clamps onto spinal rods to provide immobilization and stabilization of spinal segments; reduces movement to aid fusion. Operated by surgeons in clinical/OR settings; manual 3mm hex driver used to lock device. Output is mechanical stabilization of the spine. Benefits patient by providing structural support during bone graft fusion process. Supplied non-sterile; requires sterilization before use.

Clinical Evidence

Bench testing only. Mechanical strength testing performed to compare subject device to predicate; results demonstrate similar performance.

Technological Characteristics

Titanium alloy cross links (variable and fixed). Variable sizes: 23-75mm; fixed sizes: 20-36mm. Mechanical clamping mechanism using 3mm manual hex driver. Non-sterile; requires sterilization. Standalone mechanical implant.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for severe spondylolisthesis (L5-S1), degenerative spondylolisthesis with neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (pseudarthrosis), spinal stenosis, and degenerative disc disease (hook system only, 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

• UCR Spinal System (K993503)
• UCR Spinal System (K021623)
• UCR Spinal System (K031381)

Submission Summary (Full Text)

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K032739

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#### UCR Spinal System

## SPECIAL 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: | August 18, 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: | Variable and Fixed Cross Link System |
| Device Trade Name: | UCR Spinal System |

The primary device used for comparison in this summary is SeaSpine Inc.'s existing UCR Spinal System cross links (K993503, K021623, and K031381).

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

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### UCR Spinal System

- 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). .

The indications for use as a Hook Spinal System 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 cross links and their components include variable and fixed cross links, fixed cross link bars, link bars, rounded links, screws, coupler, and an instrument. The variable cross links will be available in sizes ranging from 23 to 75mm and the fixed cross links and fixed cross link bars in sizes between 20 and 36mm. The product is supplied "NON-STERILE" and must be sterilized prior to use.

## 3. Technological Characteristics:

The UCR Spinal System variable and fixed cross links have substantially equivalent technological characteristics to the predicate device. 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 fixed and variable cross links and their components is essentially the same as that of the predicate device. See Table 1 bon the following page for a comparison of the fixed and variable cross link system and the predicate device.

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.

| PREDICATE DEVICE COMPARISON SUMMARY TABLE | | | |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|-------------------------------|
| Feature | Variable and Fixed Cross Approved<br>Link System | Cross Link | Substantially<br>Equivalent |
| Intended Use | See Instructions for Use | Identical | Yes |
| Indications for Use | See Instructions for Use | Identical | Yes |
| Design and Scientific<br>Technology | Titanium cross bar which<br>clamps onto spinal rods to<br>reduce the chance of<br>movement to aid fusion.<br>Uses a 3mm manual hex<br>driver to lock the device. | Identical | Yes |
| Sizes | See prints | 60, 70, 80<br>mm | Yes, with<br>additional sizes |
| Material | Titanium alloy | Identical | Yes |
| Sterile | Non-sterile | Identical | Yes |
| Mechanical Strength | See test results | Similar | Yes |

Table 1: Summary of Design Comparison

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

NOV 2 0 2003

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SeaSpine, Incorporated C/o Ms. Diana Smith The Regulatory Affairs Company 727 Park Boulevard San Diego, California 92101

Re: K032739/S1

Trade/Device Name: UCR Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH Dated: October 15, 2003 Received: October 21, 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 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 - Ms. Diana Smith

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,

Miriam C. Provost

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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Indications for Use Statement

K632735 510(k) Number (if known):

Device Name: UCR Spinal System

The intended use of the UCR Spinal System variable and fixed cross links remains the same as that of the existing variable and fixed cross links.

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). ●

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

¥032739 510(k) Numberg Prescription Use V Over=The-Counter-Use · (Per 21 CFR § 801.109)