The subject Diapason Combo, like the predicate OSS Combination Screw Ring/Blocker, are intended for use only with the components of the commercially available Osteonics "Spinal System/ Diapason System. The Rods from the Xia Spinal System are intended to be used with the components of the Osteonics® Spinal System. The uses for the legally marketed Osteonics® Spinal System/Diapason 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 Description

The design change involves modifying the ring height, blocker height and assembly process of the predicate OSS Combination Screw Ring/Blocker. In addition, the submission covers use of predicate Xia 6 mm diameter Rods with the Osteonics Spinal System. The submission involves no change to the Xia rods themselves.

The subject component, a design modification to the Osteonics® Spinal System Combination Screw Ring/Blocker, is a single-use device which is sold non-sterile and is intended for use only with the other components of the commercially available Osteonics® Spinal System. The Rods from the Xia Spinal System are intended to be used with the components of the Osteonics® Spinal System.

AI/ML Overview

This document describes a Special 510(k) submission for a device modification to the Osteonics® Spinal System, specifically for the Diapason Combo and the use of Xia 6mm diameter rods with the system. The submission does not contain information typically found in studies for AI/ML-based medical devices. Instead, it focuses on the mechanical performance of modified spinal implant components. Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models) are not applicable to this submission.

The "study" referenced in this document is a series of mechanical tests designed to demonstrate the comparable performance of the modified components to their predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Comparable Static Mechanical Properties to predicate OSS Screw Blocker and Cap	Testing demonstrates comparable static mechanical properties of the subject Diapason Combo to the predicate OSS Screw Blocker and Cap.
Comparable Fatigue Mechanical Properties to predicate OSS Screw Blocker and Cap	Testing demonstrates comparable fatigue mechanical properties of the subject Diapason Combo to the predicate OSS Screw Blocker and Cap.
Acceptable Static Mechanical Properties of Xia rods with Osteonics® Spinal System/Diapason System	Testing demonstrates acceptable static mechanical properties of the subject Xia rods with the predicate Osteonics® Spinal System/Diapason System.
Acceptable Fatigue Mechanical Properties of Xia rods with Osteonics® Spinal System/Diapason System	Testing demonstrates acceptable fatigue mechanical properties of the subject Xia rods with the predicate Osteonics® Spinal System/Diapason System.

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated as a number of "cases" or "patients" as this is a mechanical engineering study. The "sample size" would refer to the number of individual test specimens of the device components. This detail is not provided in the summary.
Data Provenance: Not applicable. This is a laboratory study involving physical testing of materials/components, not patient data from a specific country or retrospective/prospective collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" in this context refers to established mechanical engineering standards and measurements, not expert clinical interpretation of medical data. The "experts" would be the engineers and technicians performing and analyzing the mechanical tests, operating under established protocols.

4. Adjudication method for the test set

Not applicable. This is a mechanical testing study, not a clinical study requiring adjudication of expert opinions. The determination of "comparable" or "acceptable" performance would be based on engineering analysis and adherence to pre-defined test protocols and measurable criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

MRMC Study: No.
Effect Size of AI: Not applicable, as this is not an AI-based device.

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

Not applicable, as this is not an AI-based device.

7. The type of ground truth used

The "ground truth" for this engineering study is based on:

Established Mechanical Engineering Principles and Standards: This includes accepted methods for static and fatigue testing of spinal implants.
Performance of Predicate Devices: The key ground truth for comparison is the documented and accepted mechanical performance of the previously cleared Osteonics® Spinal System components (the OSS Screw Blocker and Cap) and the Xia 6mm diameter rods. The goal is to show "comparable" or "acceptable" properties relative to these established devices.

8. The sample size for the training set

Not applicable. This is a mechanical testing study, not a machine learning study that requires a training set.

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

Not applicable, as this is not a machine learning study.

Summary

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FEB 1 4 2002

Special 510(k): Device Modification for the Osteonics® Spinal System Summary of Safety and Effectiveness

Submission Information

Name and Address of the Sponsorof the 510(k) Submission:	Howmedica Osteonics Corp59 Route 17Allendale, NJ 07401-1677
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Contact Person:

Karen Ariemma Regulatory Affairs Specialist

Date of Summary Preparation:

January 25, 2002

Device Identification

Proprietary Name: Common Name: Classification Name and Reference:

Osteonics® Spinal System Spinal Fixation Appliances Spinal Interlaminal Fixation Orthosis 21 CFR 888.3050 Pedicle Screw Spinal System 21 CFR 888.3070

Predicate Device Identification

The features of the subject device are substantially equivalent to features of the Osteonics® Spinal System (OSS) Combination Screw Ring/Blocker which was determined substantially equivalent via 510(k) K990158 and to the OSS Screw Blocker and Cap which were determined substantially equivalent via 510(k) K951725. The modified device shall be referred to here in as the Diapson Combo. The Xia 6 mm diameter rods were determined substantially equivalent via K984251.

Description of Device Modification

Intended Use

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20293 Plz

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:

Static and fatigue testing demonstrates the comparable mechanical properties of the subject Diapason Combo to the predicate OSS Screw Blocker and Cap.

Static and fatigue testing demonstrates the acceptable mechanical properties of the subject Xia rods with the predicate Osteonics® Spinal System/Diapason System.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with its head tilted upwards. The figure is composed of three overlapping profiles, creating a sense of depth and dimension. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2002

Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401

Re: K020293

Trade Name: Osteonics® Spinal System Regulatory Number: 21 CFR 888.3070 and 888.3050 Regulation Name: Pedicle Screw Spinal System, Spondylolisthesis Spinal Fixation Device System, Spinal Interlaminal Fixation Orthosis, Regulatory Class: II Product Code: MNH, MNI, KWP Dated: January 25, 2002 Received: January 28, 2002

Dear Ms. Ariemma:

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 (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. Karen Ariemma

This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to ocgin marketing your device to a legally marketed notification. The PDA inding of substantial equiveland 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 If you desire specific active for your actic devices), please contact the Office of Compliance at additionally 607.10 for in This allegitestions on the promotion and advertising of your device, (201) 594-4639. Rudinonary, 12. quese at (301) 594-4639. Also, please note the regulation prease contact the Office or Comphanes et notification" (21 CFR 807.97). Other general emined, "Misoranuming of relection to permanel from the Act may be obtained from the Division of Small information on your responsionnes and its not no nover (800) 638-2041 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

uriam C. Provost

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

Enclosure

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510(k) Number (if known): Kクスリ29 3

Device Name: Modification to the Osteonics® Spinal System

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.

(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)

Miriam C. Provost

Over-The-Counter Use Division of General, Restorative Division of Golleral, Restorative Format 1-2-96)

K020293 510(k) Number_

Regulation Number and Section

N/A