OSTEONICS COMBINATION SCREW RING/BLOCKER

K990158 · Osteonics Corp. · MNI · Feb 1, 1999 · Orthopedic

Device Facts

• Record ID: K990158
• Device Name: OSTEONICS COMBINATION SCREW RING/BLOCKER
• Applicant: Osteonics Corp.
• Product Code: MNI · Orthopedic
• Decision Date: Feb 1, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 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® Combination Screw Ring/Blocker is a spinal fixation component; integrates containment ring and screw blocker into single preassembled unit. Factory-assembled via snap-fit; blocker features proximal circular lip; containment ring features two parallel bars that expand/retract to secure lip. Device placed over screw arms; tightening blocker expands proximal screw portion to create friction-fit lock between screw and ring; screw arms broken off post-fixation. Used by surgeons in spinal fusion procedures to stabilize vertebrae. Benefits include simplified surgical assembly and secure fixation of spinal implants.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: ASTM F-136-96 titanium alloy (Ti6Al-4V ELI). Design: Single-piece preassembled containment ring and blocker. Mechanism: Snap-fit assembly with friction-fit locking. Connectivity: None (mechanical implant).

Indications for Use

Indicated for skeletally mature patients requiring spinal fixation for scoliosis, vertebral fracture/dislocation, spondylolisthesis, degenerative disc disease, failed fusion, kyphosis, or spinal tumor. Pedicular use indicated for non-cervical posterior spine; specific use 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® Long Arm Containment Ring (K981452)
• Osteonics® Spinal System Screw Blocker (K951725)

Submission Summary (Full Text)

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Osteonics® Combination Ring/Blocker

510(k) Premarket Notification

то

FEB 1 . 1999

# 510(k) Premarket Notification Summary of Safety and Effectiveness for the

1990158

Osteonics® Combination Screw Ring/Blocker (A Component of the Osteonics® Spinal System)

### Submission Information

Name and Address of the Sponsor of the 510(k) Submission:

Contact Person:

Date of Summary Preparation:

Device Identification

Proprietary Name:

Common Name:

Classification Name and Reference:

Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677

Marybeth Naughton Regulatory Affairs Team Member

January 20, 1999

Osteonics® Combination Screw Ring/Blocker

Spinal fixation appliance

Spinal Interlaminal Fixation Orthosis 21 CFR §888.3050 Pedicle Screw System 21 CFR 8888.3070

#### Predicate Device Identification

The Osteonics® Long Arm Containment Ring, a component of the Osteonics® Spinal System, was determined to be substantially equivalent via 5109k) #K981452. The Osteonics® Spinal System Screw Blocker was determined to be substantially equivalent via 5109k) #K951725. The proposed Osteonics® Combination Screw Ring/Blocker is substantially equivalent to the Osteonics® Long Arm Containment Ring and Osteonics® Spinal System Screw Blocker.

### Device Description

The Combination Screw Ring/Blocker incorporates the blocker into the design of the containment ring, resulting in a single, preassembled component. The blocker portion of the Combination Screw Ring/Blocker is preassembled in the factory to the containment ring via a snap-fit assembly process. The proximal portion of the existing Screw Blocker has been modified to include a proximal circular "lip". Two bars on the proximal side of the containment ring expand and retract to allow the snap-fit insertion of the proximal lip of the blocker component.

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Osteonics® Combination Ring/Blocker

510(k) Premarket Notification

TO

The locking mechanism and function of the Combination Screw Ring/Blocker is identical to that currently employed by the Long Arm Containment Ring and the Screw Blocker. The Combination Screw Ring Blocker is placed over the screw arms. The blocker is then tightened, which expands the proximal portion of the screw creating a friction-fit lock between the proximal screw and the containment ring portion of the Combination Screw Ring/Blocker. The screw arms are then broken off.

## Intended Use:

·

The following are specific indications for the Osteonics® Spinal System.

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 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 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.

#### Statement of Technological Comparison:

- The substantial equivalence of the Osteonics® Combination Screw Ring/Blocker, the predicate Long Arm Containment Ring and Screw Blocker of the Osteonics® Spinal System, in terms of intended use and design features is based on the following:
## Intended Uses:

The intended uses of the subject and predicate devices are identical.

#### Material:

All components of the Osteonics® Spinal System are manufactured from ASTM F-136-96 titanium alloy (Ti6Al-4V ELI).

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#### Osteonics® Combination Ring/Blocker

#### 510(k) Premarket Notification

TO

#### Design:

The subject Combination Screw Ring/Blocker incorporates the blocker into the design of the containment ring, resulting in a single, preassembled component. The blocker portion of the Combination Screw Ring/Blocker is preassembled in the factory to the containment ring via a snap-fit assembly process. The proximal portion of the predicate Screw Blocker has been modified to include a proximal circular "lip". Two parallel bars have been added to the proximal side of the predicate Long Arm Containment Ring. The bars expand and retract to allow the snap-fit insertion of the proximal lip of the blocker component. The function of the Combination Scrow Ring/Blocker is identical to that of the predicate Long Arm Containment Ring and Screw Blocker when used together.

#### Summary

Based on the similarities presented above and the supporting analyses, the substantial equivalence of the subject Combination Screw Ring/Blocker to the predicate Long Arm Containment Ring and Screw Blocker of the legally marketed Osteonics® Spinal System is demonstrated.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol representing the human form, depicted as three overlapping profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1999

Ms. Marybeth Naughton Regulatory Affairs Specialist Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

Re: K990158

> Osteonics® Spinal System - Combination Screw Ring/Blocker Regulatory Class: II Product Codes: MNI, MNH, and KWP Dated: January 12, 1999 Received: January 19, 1999

Dear Ms. Sutton:

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 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). 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 (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 requirements, 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.

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## Page 2 - Ms. Marybeth Naughton

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.

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" (21CFR 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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Stupt Rhodes

An

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): K990158

Device Name: Osteonics® Spinal System

Indications For Use:

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 .
- 1 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 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) |
|-----------------------------------------|
| Division of General Restorative Devices |

| 510(k) Number | K990158 |
|---------------|---------|
|---------------|---------|

| Prescription Use <span style="text-decoration: underline;">X</span> | OR | Over-The-Counter Use <span style="text-decoration: underline;"></span> |
|---------------------------------------------------------------------|----|------------------------------------------------------------------------|
|---------------------------------------------------------------------|----|------------------------------------------------------------------------|

| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
|----------------------|--------------------------|
|----------------------|--------------------------|

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