OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM

K991055 · Howmedica Osteonics Corp. · MNH · Aug 27, 1999 · Orthopedic

Device Facts

• Record ID: K991055
• Device Name: OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: MNH · Orthopedic
• Decision Date: Aug 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject components of the Osteonics® Spinal System Rod / Plate are single-use devices which are sold non-sterile, and are intended for use only with other components of the commercially available Osteonics® Spinal System. The components of the Osteonics® Spinal System, including the additional components described herein, are available in either ASTM F-136 Ti6AV ELI Alloy. Ti6Al4V ELI alloy components are intended for use only with other Ti6Al4V ELI alloy components. The specific indications of the Osteonics® Spinal System, including the subject additional components, are as follows: As a non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for: . Long and short curve scoliosis . Vertebral fracture or dislocation . Spondylolisthesis . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). . Previously failed fusion . Spinal tumor For Pedicular Use: . When used as a pedicle screw fixation system of the non-cervical posterior spine in . skeletally mature patients, the Osteonics® Spinal System is indicated for one or more of the degenerative spondylolisthesis with objective evidence of neurological following: impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). . In addition, the Osteonics® Spinal System is indicated for pedicle screw fixation in . skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions 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

Osteonics Spinal System Rod/Plate System (RPS) provides spinal fixation for thoracic and lumbar spine; components include rods, plates, 5.0mm bone screws, threaded caps, and ball rings. Device used by surgeons in clinical settings to stabilize spine segments; components secured via threaded caps and ball rings to bone screws. System utilizes ASTM F-136 Ti6Al4V ELI alloy. RPS provides mechanical stabilization to facilitate fusion; intended for single-use. Surgeon selects appropriate rod/plate configuration based on patient anatomy and pathology; implants remain in situ to support fusion, with potential for removal in specific pedicular applications after solid fusion mass development.

Clinical Evidence

Bench testing only. Fatigue and static testing performed to demonstrate mechanical and endurance properties comparable to predicate devices.

Technological Characteristics

Materials: ASTM F-136 Ti6Al4V ELI alloy. Components: Rods, plates, 5.0mm bone screws, threaded caps, ball rings. Design: Low-profile plate and stiff rod options for one or two-level fixation. Non-sterile, single-use. Mechanical fixation principle.

Indications for Use

Indicated for T4-S2 spinal fixation in patients with scoliosis, vertebral fracture/dislocation, spondylolisthesis, degenerative disc disease, failed fusion, or spinal tumor. Pedicular use indicated for skeletally mature patients with degenerative spondylolisthesis (with neurological impairment), fracture, dislocation, scoliosis, kyphosis, tumor, or failed fusion. Also indicated for severe spondylolisthesis (Grades 3-4) at L5-S1 with autogenous bone graft.

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

• Osteonics® Spinal System Rods and Screws
• VSP® Bone Plates and Bone Screws

Submission Summary (Full Text)

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K991055

Osteonics" Spinal System -Rod / Plate System

510(k) Premarket Notification

# 510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEONICS® SPINAL SYSTEM - Rod / Plate System

## Submission Information

| Name and Address of the Sponsor of the 510(k) Submission: | Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677 201-825-4900 |
|-----------------------------------------------------------|-----------------------------------------------------------------------------|
| Contact Person: | Marybeth Naughton Regulatory Affairs Team Member |
| Date Summary Prepared: | March 24, 1999 |

Device Identification

| Proprietary Name: | Osteonics® Spinal System -Rod / Plate System |
|------------------------------------|-------------------------------------------------------|
| Common Name: | Spinal Fixation Appliances |
| Classification Name and Reference: | Spinal Interlaminal Fixation Orthosis 21 CFR 888.3050 |

## Predicate Device Identification

The Osteonics® Spinal System Rod / Plate System components are substantially equivalent to other legally marketed spinal system components. These predicate components are part of the commercially available spinal systems stated below:

- Osteonics® Spinal System Rods and Screws .
- . VSP® Bone Plates and Bone Screws

# Device Description

The Osteonics® Spinal System Rod / Plate System (RPS) is designed for fixation of one or two levels of the lumbar and thoracic spine. The RPS offers options of both a low-profile plate and a stiff rod. The components which comprise the Osteonics® Spinal System Rod / Plate System are: The Rod / Plate, One-Level, Short, the Rod / Plate, One-Level, Long, the Rod / Plate, Two-Level, Long, the 5.0 mm Bone Screw (25mm to 60mm lengths) which are compatible with the rod / plate bone screw holes, the Threaded Cap (which tightens the 5.0mm bone screw to the Rod / Plate), and the Rod / Plate Ball Ring (pre-assembled to the Two-Level, Long Rod / Plate) in order to secure an Osteonics® Spinal System Bone Screw to the two-level rod / plate assembly.

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K991055

Osteonics" Spinal System -Rod / Plate System

510(k) Premarket Notification

## Intended Use

The subject components of the Osteonics® Spinal System Rod / Plate are single-use devices which are sold non-sterile, and are intended for use only with other components of the commercially available Osteonics® Spinal System. The components of the Osteonics® Spinal System, including the additional components described herein, are available in either ASTM F-136 Ti6AV ELI Alloy. Ti6Al4V ELI alloy components are intended for use only with other Ti6Al4V ELI alloy components.

The specific indications of the Osteonics® Spinal System, including the subject additional components, are as follows:

As a non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:

- . Long and short curve scoliosis
- . Vertebral fracture or dislocation
- . Spondylolisthesis
- . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- . Previously failed fusion
- . Spinal tumor

## For Pedicular Use:

- When used as a pedicle screw fixation system of the non-cervical posterior spine in . skeletally mature patients, the Osteonics® Spinal System is indicated for one or more of the degenerative spondylolisthesis with objective evidence of neurological following: impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
- In addition, the Osteonics® Spinal System is indicated for pedicle screw fixation in . skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions 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.

## Statement of Technological Comparison

The components of the Osteonics® Spinal Rod / Plate System share the same materials. intended uses and basic design concepts as those of the predicate Osteonics® Spinal System devices and VSP® Bone Plates and Bone Screws. Fatigue and static testing demonstrates the comparable mechanical and endurance properties of these components.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

AUG 27 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elizabeth A. Staub Vice President, Quality Assurance/Regulatory Compliance/Clinical Research Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

Re: K991055

Trade Name: Osteonics Spinal System Rod/Plate System Regulatory Class: II Product Code: MNH and KWP Dated: June 24, 1999 Received: June 25, 1999

Dear Ms. Staub:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Ms. Elizabeth A. Staub

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thure U. Jager.

Ja- Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Page 1 of 1

510(k) Number (if Known):

Device Name: Osteonics® Spinal System Rod / Plate System Indications For Use:

14991055

The uses for the legally marketed Osteonics® Spinal System are as follows:

As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:

- Long and short curve scoliosis .
- Vertebral fracture or dislocation .
- . Spondylolisthesis
- . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- . Previously failed fusion
- . Spinal tumor

## Pedicular Use:

- . When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Osteonics® Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudarthrosis).
- In addition, the Osteonics® Spinal system is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the LS-S1 joint, having fusions 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.

(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 | <div style="text-align:center;">X</div> | OR | Over-The-Counter Use (Optional Format 1-2-96) |
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| for | |
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| 510(K) Number | K991055 |