K Number

Validate with FDA (Live)

Device Name

OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY

Manufacturer

OSTEONICS CORP.

Date Cleared

1999-04-30

(144 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

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

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

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.

Device Description

The Osteonics® Spinal System is comprised of single use, non-sterile devices manufactured from ASTM F-136-96 Titanium alloy (Ti6A1-4V ELI). The Osteonics® Spinal System Sacral Offset Connector Assembly may be used in any application where supplemental sacral screw placement is desired by the surgeon. This assembly allows a sacral connector with supplemental sacral screw to the joined to the spinal rod in the sacral offset blocker secures the sacral screw to the connector assembly. The Clamping Screw is used with the Sacral Offset Connector to provide a stable lock on the longitudinal spinal rod.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device, specifically the Osteonics® Spinal System - Sacral Offset Connector Assembly. The submission focuses on demonstrating substantial equivalence to predicate devices through material, design, and intended use comparison.

However, the provided text does not contain information about acceptance criteria for device performance or a study proving that the device meets such criteria.

The document primarily covers:

Submission Information: Sponsor, contact, date, device identification (proprietary name, common name, classification name).
Predicate Device Identification: Listing similar commercially available spinal systems.
Device Description: Materials, intended use (sacral screw placement, connecting to spinal rod, clamping screw for stable lock).
Intended Use/Indications For Use: Detailed list of spinal conditions for which the system is indicated, both as a non-pedicle screw system and as a pedicle screw fixation system.
Statement of Technological Comparison: Asserts substantial equivalence based on materials, intended uses, and basic design concepts, and mentions that "Fatigue and static testing demonstrates the mechanical and endurance properties of these components."

Missing Information:

The document explicitly states that "Fatigue and static testing demonstrates the mechanical and endurance properties of these components" under the "Statement of Technological Comparison." This indicates that some form of testing was performed. However, the details required to directly answer your request are not present in the provided text.

Specifically, the following information is not provided:

A table of acceptance criteria and the reported device performance: While testing is mentioned, no specific criteria (e.g., maximum load, cycles to failure) or numerical results are given.
Sample size used for the test set and the data provenance: No information on the number of devices tested or if the data was retrospective/prospective, or country of origin.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is a mechanical device, so expert review of "ground truth" in clinical image interpretation or diagnosis would not be applicable in this context.
Adjudication method for the test set: Not applicable for mechanical testing.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is a mechanical spinal fixation device, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a mechanical device.
The type of ground truth used: For mechanical testing, the "ground truth" would be the measured physical properties or failure points under specified conditions, defined by engineering standards. The document only states "Fatigue and static testing," but no specific standards or detailed methodology.
The sample size for the training set: Not applicable, as this is a mechanical device, not an AI alogorithm that uses training data.
How the ground truth for the training set was established: Not applicable.

To answer your request thoroughly, additional documentation regarding the specific fatigue and static testing performed on the Osteonics® Spinal System Sacral Offset Connector Assembly would be required. This would typically be found in engineering reports or test summaries that are part of the full 510(k) submission, but are not included in this excerpt.

Summary

{0}------------------------------------------------

4/30/99

K984/375

510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEONICS® SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY

Submission Information

Name and Address of the Sponsorof the 510(k) Submission:	Osteonics Corporation59 Route 17Allendale, NJ 07401-1677201-825-4900
Contact Person:	Marybeth NaughtonRegulatory Affairs Team Member
Date Summary Prepared:	December 4, 1998
Device Identification
Proprietary Name:	Osteonics® Spinal System -Sacral OffsetConnector Assembly
Common Name:	Spinal Fixation Appliances
Classification Name and Reference:	Spinal Interlaminal Fixation Orthosis21 CFR §888.3050Pedicle Screw System21 CFR §888.0370

Predicate Device Identification

The Osteonics® Spinal System Sacral Offset Connector Assembly components are substantially equivalent to other legally marketed spinal system sacral offset components. These predicate components are part of the commercially available spinal systems stated below:

Tacoma™ Sacral Plate System: Sofamor Danek .
Saddle with Anchor™ Fixation System: Advanced Spine Fixation Systems, Inc. .

Device Description

{1}------------------------------------------------

Intended Use

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

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

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 components of the Osteonics® Spinal System Sacral Offset Connector Assembly share the same materials, intended uses and basic design concepts as that of the predicate devices. Fatigue and static testing demonstrates the mechanical and endurance properties of these components.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 1999

Ms. Marybeth Naughton Regulatory Affairs Team Member Stryker Osteonics 59 Route 17 Allendale, New Jersey 07401-1677

Re: K984375

Trade Name: Osteonics® Spinal System Sacral Offset Connector Assembly Regulatory Class: II Product Codes: KWP, MNH and MNI Dated: February 24, 1999 Received: February 25, 1999

Dear Ms. Naughton:

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 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 requirement, as set forth in the Quality System Regulation (OS) 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.

{3}------------------------------------------------

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

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

Enclosure

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510(k) Number (if known): K984375

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
. 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 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 LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (OD

e Evaluation (ODE)

Division Sign-Off

(Division Division of General Rest 510(k) Number

Prescription Usex

Over-The-Counter Use

(Optional Format 1-2-96)

(Per 21 CFR 801.109)

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.