Long and short curve scoliosis
Vetebral 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 system, the system is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Pedicle screws are not intended for placement in pedicles above L3.

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 bone screws are top loading screws that are threaded distally, have a forked proximal design, and are available in both standard and extended ("extra-long" or "long arm") proximal length configurations. The 5.5mm bone screws will be available in standard and extra-long versions in lengths of 30mm, 35mm, 40mm, and 45mm. The 10.0mm bone screws will be available in one standard version only in lengths from 35mm to 60mm in increments of 5mm.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the Osteonics® Spinal System 5.5mm & 10.0mm Bone Screws, dated September 25, 1998. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth establishment is not present in this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. A 510(k) submission for substantial equivalence primarily relies on comparison to a predicate device, as opposed to demonstrating specific performance against predefined acceptance criteria for novel devices. The "reported device performance" section would typically describe results from clinical trials or specific performance tests with quantitative outcomes, which are absent here.

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

This information is not applicable/not provided in the context of this 510(k) submission. There is no mention of a clinical "test set" in the traditional sense, nor any data provenance (country of origin, retrospective/prospective). The submission uses mechanical testing as supporting evidence for substantial equivalence, but details of the mechanical testing are summarized rather than presented as a full study with sample sizes.

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

This information is not applicable/not provided. There is no clinical "test set" requiring ground truth establishment by experts in this submission.

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

This information is not applicable/not provided. There is no clinical "test set" requiring adjudication in this 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:

This information is not applicable. This document describes a medical device (spinal screws), not an AI-assisted diagnostic or treatment system, so MRMC studies are not relevant.

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

This information is not applicable. This document describes a medical device (spinal screws), not an algorithm.

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

This information is not applicable/not provided. Since there is no clinical "test set" or diagnostic algorithm being evaluated, the concept of ground truth in that context is not relevant. The basis for determining "substantial equivalence" is a comparison of design, materials, and intended use with previously cleared predicate devices, supported by mechanical testing.

8. The sample size for the training set:

This information is not applicable/not provided. There is no "training set" mentioned in this submission, as it relates to a physical device rather than a machine learning model.

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

This information is not applicable/not provided. As there is no training set, this question is not relevant.

Summary of the Study (as described in the 510(k) notification):

The "study" presented here is a demonstration of substantial equivalence to previously cleared predicate devices, rather than a clinical trial proving performance against specific acceptance criteria.

The key points of the "study" are:

Objective: To demonstrate that the Osteonics® Spinal System 5.5mm & 10.0mm Bone Screws are substantially equivalent to:
- Existing bone screws within the Osteonics® Spinal System (cleared via K951725).
- The Danek TSRH Spinal System (for 5.5mm screws).
- AcroMed Titanium Bone Screws (for 5.5mm screws).
Methodology for Substantial Equivalence: Comparison of:
- Intended Uses: Stated to be substantially equivalent.
- Material: Osteonics® system and AcroMed screws are made from ASTM F-136-96 Titanium Alloy (Ti6Al-4V ELI). The Danek TSRH system is made from ASTM F-138-92 Stainless Steel alloy.
- Design: Stated that the design and function remain unchanged and are substantially equivalent.
- Supporting Testing Summary: The document mentions "supporting testing summary" but does not elaborate on the specific tests, methodologies, or quantitative results within the provided text. This typically refers to mechanical bench testing, but details are not included.
Conclusion: Based on the similarities in intended uses, materials (with noted differences that are deemed acceptable), design, and supporting testing summary, the devices are considered substantially equivalent.

Important Note from the FDA Letter:

The FDA's response specifies a limitation on the pedicular use of the device. While the sponsor's intended use listed a broader set of conditions for non-pedicular fixation and then for pedicular fixation, the FDA explicitly restricts pedicular use to severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, with other specific conditions (autogenous bone graft, fixed to lumbar and sacral spine, removed after solid fusion). Any other pedicular use is considered Class III and requires a Premarket Approval (PMA) or an Investigational Device Exemption (IDE). This highlights that while the device was found substantially equivalent, its market clearance came with specific, narrowed indications for pedicular use.

Summary

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SEP 25 1998

Osteonics® Spinal System - 5.5mm & 10mm Bone Screws

510(k) Premarket Notification

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

Osteonics® Spinal System 5.5mm &10.0mm Bone Screws

Submission Information

Name and Address of the Sponsorof the 510(k) Submission:	Osteonics Corporation59 Route 17Allendale, NJ 07401-1677
Contact Person:	Kate SuttonRegulatory Affairs Specialist
Date of Summary Preparation:	August 31, 1998

Device Identification

Osteonics® Spinal System 5.5mm & Proprietary Name: 10.0mm Bone Screws Spinal fixation appliance Common Name: Classification Name and Reference: Spinal Interlaminal Fixation Orthosis 21 CFR §888.3050

Predicate Device Identification

The Osteonics® Spinal System, which includes bone screws, was determined to be substantially equivalent via 510(k) #K951725. The proposed 5.5mm and 10.0mm bone screws of the Osteonics® Spinal System are substantially equivalent to those bone screws in the Osteonics® Spinal System and the 5.5mm bone screws of the following competitive devices, which have previously been determined substantially equivalent by FDA:

. Danek TSRH Spinal System
AcroMed Titanium Bone Screws

Device Description

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Intended Use:

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

For non-pedicular fixation of the T4-S2 spine:

Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis) .
Vetebral fracture or dislocation .
. Spinal stenosis
Spondylolisthesis .
Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the . disc confirmed by patient history and radiographic studies).
Previously failed fusion .
Spinal tumor .

For pedicular use:

Additionally, when used as a pedicle screw system, the system is intended for patients: (a) . having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Pedicle screws are not intended for placement in pedicles above L3.

Statement of Technological Comparison:

The substantial equivalence of the Osteonics® Spinal System 5.5mm and 10.0mm bone screws to the predicate bone screws in the Osteonics® Spinal System, and for the 5.5mm bone screws, the Danek TSRH Spinal System and AcroMed Titanium Bone Screws, in terms of intended use and design features, is based on the following:

Intended Uses:

The intended uses of the subject devices are substantially equivalent to those of the predicate devices.

Material:

The Osteonics® Spinal System and the AcroMed Titanium Bone Screws are manufactured from ASTM F-136-96 titanium alloy (Ti6Al-4V ELI). The Danek TSRH Spinal System is manufactured from ASTM F-138-92 Stainless Steel alloy.

Design:

The design and function of the subject spinal system bone screws remains unchanged and is substantially equivalent to that of the predicate bone screws.

Summary

Based on the similarities presented above and the supporting testing summary, the substantial equivalence of the Osteonics® Spinal System to the bone screws of the legally marketed Osteonics® Spinal System, Danek TSHR Spinal System, and AcroMed Titanium Bone Screws is demonstrated.

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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized depiction of three human profiles facing right, arranged in a row. The profiles are black and have a flowing, abstract design. The seal is surrounded by the text "DEPARTMENT OF HEALTH & HUM. SERVICES • USA" in a circular arrangement.

SEP 2 5 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re : K983152 5.5mm and 10.0mm Bone Screws to be used with the Osteonics® Spinal System Requlatory Class: II Product Codes: MNH and KWP Dated: September 1, 1998 Received: September 9, 1998

Dear Ms. Sutton:

We have reviewed your Section 510 (k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal, Food, Drug, and Cosmetic Act (Act). This decision is based on your device system being found equivalent only to similar device systems labeled and intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. You may, therefore, market your device system subject to the general controls provisions of the Act and the limitations identified below.

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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment for indications other than severe spondylolisthesis, as described above, would cause the device system to be adulterated under 501(f) (1) of the Act.

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Page 2 - Ms. Kate Sutton

This device system, when intended for pedicular screw fixation/attachment to the spine for indications other than severe spondylolisthesis, as described above, is a class III device under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval. (PMA) application prior to marketing. Accordinqly:

All labeling for this device, including the package 1. label, must state that there are labeling limitations. The package insert must prominently state that the device system using pedicle screws is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
1. You may not label or in anyway promote this device system for pedicular, screw fixation/attachment to the cervical, thoracic or lumbar vertebral column for intended uses other than severe spondylolisthesis, as described above. The package insert must include the following statements:

WARNINGS :

. When used as a pedicle screw system, this device system is intended only for grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral (L5-S1) vertebral joint.
The screws of this device system are not intended for insertion into the pedicles to facilitate spinal fusions above the L5-S1 vertebral joint.
. Benefit of spinal fusions utilizing any pedicle screw fixation system has not been adequately established in patients with stable spines.
Potential risks identified with the use of this ● device system, which may require additional surgery, include:

device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury.

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See Warnings, Precautions, and Potential Adverse Events sections of the package insert for a complete list of potential risks.

1. Any pedicular screw fixation/attachment for intended uses other than severe spondylolisthesis, as described by item 1, for this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) requlations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment for intended uses other than severe spondylolisthesis, as described above, must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.
1. Any previous warning statements identified as part of previous 510(k) clearances or required by OC/Labeling and Promotion which stated that a component/system was not approved for screw fixation into the pedicles of the spine must be replaced by the warnings of items 1 and 2 above.

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 Requlations, 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 General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Druq 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.

FDA advises that the use of your device system with any other device components but those identified in this 510(k) would require submission of a new 510(k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system ________________________________________________________________________________________________________________________________________ consisting of the subject device components and other device components, whether yours or those of other manufacturers, may also be required.

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Page 4 - Ms. Kate Sutton

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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. 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 983152

Device Name: Osteonics® Spinal System 5.5mm & 10.0mm Bone Screws

Indications For Use:

The uses for the Osteonics® Spinal System 5.5mm & 10.0mm Bone Screws, as part of the legally marketed Osteonics® Spinal System, are as follows:

Non-Pedicular Use; fixation of the T4-S2 spine:

Long and short curve scoliosis .
. Vetebral fracture or dislocation
t Spondylolisthesis
Degenerative disc disease (defined as back pain of discogenic origin with degeneration of . the disc confirmed by history and radiographic studies).
D Previously failed fusion
Spinal tumor

Pedicular Use:

の When used as a pedicle screw system, the system is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Pedicle screws are not intended for placement in pedicles above L3.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General Restorative Devices 510(k) Number K983/So

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

N/A