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 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.

AI/ML Overview

The provided 510(k) Premarket Notification for the Osteonics® Spinal System - Rod / Plate System (K991055) primarily focuses on demonstrating substantial equivalence to predicate devices based on mechanical properties and intended use. It does not describe a study involving human or image-based performance for an AI/CAD/Software device, but rather a mechanical device.

Therefore, most of the requested information regarding acceptance criteria for device performance in a clinical/diagnostic context, sample sizes for test/training sets, expert qualifications, and ground truth establishment is not applicable to this submission.

However, I can extract the relevant information regarding the performance claims and the study type conducted.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance	Substantially equivalent mechanical and endurance properties to predicate devices.	"Fatigue and static testing demonstrates the comparable mechanical and endurance properties of these components."
Material	Same materials as predicate devices (ASTM F-136 Ti6AV ELI Alloy).	"The components... share the same materials," specifically ASTM F-136 Ti6AV ELI Alloy.
Intended Use	Same intended uses as predicate devices.	"The components... share the same... intended uses."
Basic Design Concepts	Similar basic design concepts as predicate devices.	"The components... share the same... basic design concepts."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable. The "test set" in this context refers to the samples of the device components (rods, plates, screws) that were subjected to mechanical testing. The specific number of physical components tested is not provided in this document.
Data Provenance: Not applicable in the context of clinical data. The "data" refers to the results of the mechanical (fatigue and static) testing of the Osteonics® Spinal System Rod / Plate System components. This testing would have been conducted in a laboratory setting by Howmedica Osteonics Corp.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. The "ground truth" for this device is established through engineering and materials science principles, verified by mechanical testing, not by expert clinical consensus.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically used for disagreements in human expert interpretations of data (e.g., medical images). For mechanical testing, the "adjudication" is based on established engineering standards and whether the physical samples meet those standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the clinical performance of diagnostic or AI-assisted devices where human readers are involved. The K991055 submission is for a mechanical implantable device.

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

Not applicable. This device is a physical spinal implant system, not an algorithm or software. Its performance is evaluated through mechanical testing, not standalone algorithmic performance.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on engineering standards for mechanical strength, durability (fatigue), and material properties. The performance of the device components (rods, plates, screws) under static and dynamic loads is compared against established benchmarks and the performance of predicate devices.

8. The Sample Size for the Training Set

Not applicable. As this is a physical medical device, not an AI/ML algorithm, there is no "training set" in the computational sense. The design and manufacturing processes are informed by established engineering principles and prior device experience, but not through a "training set" of data.

9. How the Ground Truth for the Training Set was Established

Not applicable. See point 8. The "ground truth" for the device's design and manufacturing is derived from validated engineering specifications, material science, and regulatory requirements, not from a dataset with established ground truth labels for training.

Summary

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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

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K991055

Osteonics" Spinal System -Rod / Plate System

510(k) Premarket Notification

Intended Use

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 (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,

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	X	OR	Over-The-Counter Use (Optional Format 1-2-96)
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for
510(K) Number	K991055

Regulation Number and Section

N/A