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 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.

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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Osteonics® Combination Screw Ring/Blocker. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with pre-defined acceptance criteria and performance metrics in the same way a PMA (Premarket Approval) submission would.

Therefore, the document does not contain explicit "acceptance criteria" for device performance in the traditional sense (e.g., sensitivity, specificity, accuracy thresholds) or a "study" that directly proves the device meets such criteria based on a clinical outcome.

Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence in terms of intended use, material, and design, and confirming that the device functions identically to the predicate device. The "study" in this context is the comparison and analysis of the proposed device against the predicate devices.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit)	Reported Device Performance (Demonstrated Substantial Equivalence)
Intended Use: Identical to predicate devices.	The intended uses of the subject device (Osteonics® Combination Screw Ring/Blocker) are identical to the predicate Osteonics® Spinal System.
Material: Identical to predicate devices.	All components are manufactured from ASTM F-136-96 titanium alloy (Ti6Al-4V ELI), identical to the predicate devices.
Design/Function: Functionally identical to predicate devices when assembled. Changes should not raise new questions of safety or effectiveness.	The Combination Screw Ring/Blocker incorporates the blocker into the containment ring as a single, preassembled component via a snap-fit process. The design modifications (proximal circular "lip" on blocker, parallel bars on containment ring) allow for this preassembly. The locking mechanism and function are explicitly stated to be identical to that employed by the predicate Long Arm Containment Ring and Screw Blocker used together.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable. This submission is based on a comparison to predicate devices, not on a clinical test set. No human or animal samples were used for testing in the provided summary.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There was no "test set" requiring expert-established ground truth in this submission. The demonstration of substantial equivalence relies on engineering and design comparisons and functional identity to predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there was no test set or expert adjudication process for performance in this 510(k) submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a mechanical spinal implant component, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" in this context is the established safety and effectiveness of the predicate devices based on their prior marketing authorization. The new device demonstrates "substantial equivalence" to this established ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

Summary

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

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

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

Osteonics® Combination Ring/Blocker

510(k) Premarket Notification

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).

{2}------------------------------------------------

Osteonics® Combination Ring/Blocker

510(k) Premarket Notification

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.

{4}------------------------------------------------

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 (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,

Stupt Rhodes

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
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Prescription Use X	OR	Over-The-Counter Use
---------------------------------------------------------------------	----	------------------------------------------------------------------------

(Per 21 CFR 801.109)	(Optional Format 1-2-96)
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Styph Plevels for CMU

Regulation Number and Section

N/A