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 spondylolistlisthesis 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 Description

The Osteonics® Spinal System is comprised of single-use, non-sterile devices manufactured from ASTM F-136-96 Titanium Alloy (Ti6Al-4V ELI). The Osteonics® Spinal System consists of rods, hooks, containment rings, bone screws and their accessories (blockers and caps), and transverse links.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Osteonics® Spinal System. It seeks expanded indications for use, particularly concerning pedicle screw applications, due to a recent reclassification of such uses.

However, the document does not contain information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established, which are typically found in clinical trial reports or validation studies.

This document is primarily a regulatory submission for expanding the indications of an already cleared device, asserting substantial equivalence to the previously cleared version of the same device. It focuses on the scope of use rather than proving specific performance metrics through new studies.

Therefore, I cannot populate the requested table or provide details about the study because the provided text does not contain that information. The document explicitly states:

"The Osteonics® Spinal System functions as the subject and predicate device. The components of the Osteonics® Spinal System were determined to be substantially equivalent via 510(k) #K951725."
"The design and function of the Osteonics® Spinal System remains unchanged."
"As a result of the recent downclassification of pedicle screw uses, the indications of the Osteonics® Spinal System will be expanded..."

These statements indicate that the submission is based on regulatory reclassification and previous substantial equivalence determinations, not on new performance studies for the expanded indications.

Summary

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

510(k) Premarket Notification

JAN 28 1999

Devi

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

Osteonics® Spinal System - Expanded Indications

Submission Information

Name and Address of the Sponsorof the 510(k) Submission:	Howmedica Osteonics Corp.59 Route 17Allendale, NJ 07401-1677
Contact Person:	Kate SuttonRegulatory Affairs Specialist
Date of Summary Preparation:	January 20, 1999
Proprietary Name:	Osteonics® Spinal System
Common Name:	Spinal fixation appliance
Classification Name and Reference:	Spinal Interlaminal Fixation Orthosis21 CFR §888.3050Pedicle Screw System21 CFR §888.3070

Predicate Device Identification

The Osteonics® Spinal System functions as the subject and predicate device. The components of the Osteonics® Spinal System were determined to be substantially equivalent via 510(k) #K951725.

Device Description

Intended Use:

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

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

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.

Statement of Technological Comparison:

The Osteonics® Spinal System functions as both the subject and predicate device, as this submission is for expanded indications resulting from the recent downclassification to Class II of indications for use for pedicle screws.

Material:

The Osteonics® Spinal System is manufactured from ASTM F-136-96 titanium alloy (Ti6Al-4V ELI).

Design:

The design and function of the Osteonics® Spinal System remains unchanged.

Summary

As a result of the recent downclassification of pedicle screw uses, the indications of the Osteonics® Spinal System will be expanded to include the following:

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).

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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 features a stylized depiction of an eagle or bird-like figure with outstretched wings. The bird is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 28 1999

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

Re: K990059

Osteonics® Spinal System - expanded uses Regulatory Class: II Product Codes: MNI, MNH and KWP Dated: January 6, 1999 Received: January 8, 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. Kate Sutton

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" (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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

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

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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510(k) Number (if known): K 990059

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 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.

(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 Restorative Devices
510(k) Number	K990059

Prescription Use	X	OR	Over-The-Counter Use _____
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

Regulation Number and Section

N/A