UCR SPINAL SYSTEM

K043232 · Seaspine · NKB · Dec 21, 2004 · Orthopedic

Device Facts

• Record ID: K043232
• Device Name: UCR SPINAL SYSTEM
• Applicant: Seaspine
• Product Code: NKB · Orthopedic
• Decision Date: Dec 21, 2004
• 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, polyaxial screws, polyaxial reduction screws, cross links, crossbars, rods, caps, set screws, and components, is substantially equivalent to the intended use of the predicate device. The intended use of the UCR Spinal System is as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The intended use of the UCR Spinal System, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is 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. The intended use and indications of the UCR Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T-L-S and are as follows:

Device Story

UCR Spinal System is a posterior, non-cervical spinal fixation system; includes polyaxial screws, polyaxial reduction screws, cross links, crossbars, rods, and caps. Components are manufactured from titanium alloy; instruments utilize stainless steel, aluminum, Radel, and silicone. System is supplied non-sterile; requires high-temperature steam sterilization before use. Intended for surgical implantation by physicians to stabilize thoracic, lumbar, and sacral spinal segments to facilitate fusion. Provides mechanical immobilization for patients with spinal instabilities or deformities. Benefits include structural support during biological fusion process; implants may be removed after solid fusion is achieved in specific spondylolisthesis cases.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical strength testing performed to demonstrate equivalence to predicate components.

Technological Characteristics

Titanium alloy implants; stainless steel, aluminum, Radel, and silicone instruments. Polyaxial screw/rod fixation system. Non-sterile; requires high-temperature steam sterilization. Mechanical stabilization principle. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for: degenerative disc disease (DDD), spondylolisthesis (including severe Grades 3-4 at L5-S1), trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), spinal tumor, pseudoarthrosis, and failed previous fusion. Contraindications include cervical spine use.

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 (K032739/S1)

Submission Summary (Full Text)

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### UCR Spinal System

### 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: Diana Smith<br>2302 La Mirada Drive<br>Vista, CA 92081-7862<br>Phone: [phone] Fax: [phone] |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Registration Number: | 2032593 |
| Submission Correspondent: | SeaSpine, Inc.<br>Contact: Diana Smith, Manager of<br>Regulatory Affairs and Quality Assurance<br>2302 La Mirada Drive<br>Vista, CA 92081-7862<br>Phone: [phone] Fax: [phone] |
| Date Summary Prepared: | November 19, 2004 |
| Classification Name: | Pedicle Screw Spinal System<br>MNH (Class II) - 888.3070(b)(1)<br>MNI (Class II) - 888.3070(b)(1)<br>NKB (Class III) – 888.3070(b)(2)<br>Spinal Interlaminal Fixation Orthosis<br>KWP (Class II) – 888.3050 |
| Common/Usual Name: | Polyaxial Screws, Polyaxial Reduction<br>Screws, Cross Links, Crossbars, Rods, Caps,<br>Components, and Instruments |
| Device Trade Name: | UCR Spinal System |

The primary device used for comparison in this summary is SeaSpine Inc.'s existing UCR Spinal System (K993503, K021623, and K032739/S1).

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

The intended use of the UCR Spinal System, polyaxial screws, polyaxial reduction screws, cross links, crossbars, rods, caps, set screws, and components, is substantially equivalent to the intended use of the prodicate device. The intended use of the UCR Spinal System is as a temporary or permanent posterior, non-cervical implant to

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### UCR Spinal System

correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.

The intended use of the UCR Spinal System, when used as a Pedicic Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is 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. The indications for use are as follows:

- . degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
- severe spondylolisthesis (Grades 3 and 4) of the US-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 (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
- . spondylolisthesis,
- . trauma (i.e., fracture or dislocation),
- . spinal stenosis,
- . deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- . spinal tumor.
- pseudoarthrosis, and/or ◆
- . failed previous fusion.

The intended use and indications of the UCR Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to TI-I.S. and are as follows:

- degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies,
- spondylolisthesis .
- trauma (i.e., fracture or dislocation), .
- . spinal stenosis.
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), �
- . tumor,
- pseudarthosis, and/or
- failed previous fusion. �

### 2. Description:

The UCR Spinal System includes titanium alloy polyaxial and polyaxial reduction screw assemblics. Both screw types will be offered in numerous widths and lengths. The screw assembly is comprised of a screw body, washer, and housines. Both! screws are designed to be compatible with and work in conjunction with the components w

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### UCR Spinal System

the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.

The UCR Spinal System will also include titanium alloy cross links, crossbars, rods, and caps. The cross links will come in one size, the crossbars in five sizes, the rods in two diameters, and the caps in two sizes. The cross link assemblies are comprised of a nut and hook while the crossbar assemblies are made up of two bars, two locking screws, a coupler, and a pin. All of these devices are 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 will offer a wide variety of instruments that range from insitu rod benders to modular taps. These various instruments will be made primarily from various grades of stainless steel with a fcw components made from aluminum, titanium alloy, Radel, and silicone. These items are supplied "NON-STERILE" and must be sterilized prior to use.

#### 3. Technological Characteristics:

The polyaxial screws, polyaxial reduction screws, cross links, crossbars, rods, caps, and components in this submission have been designed as an addition to the current UCR Spinal System. The devices being added to the UCR Spinal System have substantially equivalent technological characteristics to the predicate devices and are designed to be compatible with and work in conjunction with the current components in the UCR Spinal System. 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 designs of the UCR Spinal System polyaxial screws, polyaxial reduction screws, cross links, crossbars, rods, caps, and components are substantially equivalent to the predicate devices. See Table 1 on the following page for a companison of the UCR Spinal System polyaxial screws, polyaxial reduction screws, cross links, crossbars, rods, caps, and components to the predicate devices.

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# Ko43232

# UCR Spinal System

| Feature | UCR Spinal System<br>(new components) | UCR Spinal System<br>(current) | Substantially<br>Equivalent |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|-----------------------------|
| Intended Use | The intended use of the UCR Spinal System<br>is as a temporary or permanent posterior,<br>non-cervical implant to correct spinal<br>disorders and provide stabilization of the<br>spine to permit the biological process of<br>spinal fusions to occur. | Similar | Yes |
| Indications for Use | • Degenerative disc disease (DDD) as<br>defined by back pain of discogenic origin<br>with degeneration of the disc confirmed by<br>patient history and radiographic studies,<br>• spondylolisthesis,<br>• trauma (i.e., fracture or dislocation),<br>• spinal stenosis,<br>• deformities or curvatures (i.e., scoliosis,<br>kyphosis, and/or lordosis).<br>• tumor,<br>• pseudarthosis, and/or<br>• failed previous fusion. | Similar | Yes |
| Design | Polyaxial screws, polyaxial reduction<br>screws, cross links, crossbars, rods, caps,<br>and components | Similar | Yes |
| Screw Sizes | See prints | Similar | Yes |
| Cross Links | See prints | Similar | Yes |
| Crossbars | See prints | Similar | Yes |
| Rods | See prints | Similar | Yes |
| Caps | See prints | Similar | Yes |
| Material | Titanium alloy | Similar | Yes |
| Sterile | Non-sterile | Similar | Yes |
| Method of<br>Sterilization | High-temperature steam | Similar | Yes |
| Mechanical Strength | See test results | Similar | Yes |

Table 1: Summary of Design Comparison

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Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized symbol that resembles an abstract bird or human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2004

Ms. Diana Smith Manager of Regulatory Affairs and Quality Assurance SeaSpine, Inc. 2302 La Miranda Drive Vista, California 92081

Re: K043232

Trade/Device Name: UCR Spinal System Regulation Number: 21 CFR 888.3050, 21 CFR 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Pedicle screw spinal system Regulatory Class: III Product Code: NKB, KWP, MNH, MNI Dated: November 17, 2004 Received: November 22, 2004

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,

Lila witte

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

510(k) Number (if known): K043232

Device Name: UCR Spinal System

Indications for Use:

The intended use of the UCR Spinal System, polyaxial screws, polyaxial reduction screws, cross links, crossbars, rods, caps, set screws, and components, is substantially equivalent to the intended use of the predicate device. The intended use of the UCR Spinal System is as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.

The intended use of the UCR Spinal System, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is 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. The indications for use are as follows:

- degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies,
- 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 (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
- spondylolisthesis, .
- trauma (i.e., fracture or dislocation), ●
- spinal stenosis, .

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter-Use (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, Restoration and Neurological Devices

| 510(k) Number | K043232 |
|---------------|---------|
|---------------|---------|

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## Indications for Use Statement continued

The intended use and indications of the UCR Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T L J and are as follows:

- degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies,
- spondylolisthesis .
- trauma (i.e., fracture or dislocation), .
- . spinal stenosis.
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), .
- . tumor.
- pseudarthosis, and/or .
- failed previous fusion.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

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