The Small Stature Spacers are indicated for use in the thoracolumbar spine (i.e., T1 to L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Small Stature Spacers are also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The Small Stature Spacers are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

Device Description

The Small Stature Spacers are comprised of polyetheretherketone (PEEK) and are similar in design to the EBI ESL PEEK-OPTIMA® Spine System cleared in K061016.

AI/ML Overview

The provided 510(k) summary for the "Small Stature Spacers" does not include acceptance criteria or a study that proves the device meets such criteria. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing.

Here's a breakdown based on the information provided:

Table of Acceptance Criteria and Reported Device Performance: This information is not available in the provided text. The submission states, "Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use." This is a general statement and does not present specific quantitative acceptance criteria or performance metrics.
Sample size used for the test set and the data provenance: Not applicable, as no clinical or specific non-clinical test set with a sample size is described beyond a general statement about "non-clinical laboratory testing."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth establishment by experts is mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no test set requiring adjudication is described.
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 physical spinal implant, not an AI-assisted diagnostic or therapeutic tool for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as detailed ground truth is not discussed for non-clinical testing. The "ground truth" for substantial equivalence of a physical implant is typically established by demonstrating that its material properties, mechanical performance, and design characteristics are comparable to a predicate device, as confirmed through laboratory testing.
The sample size for the training set: Not applicable, as no training set (in the context of AI/machine learning) is mentioned for this physical device.
How the ground truth for the training set was established: Not applicable, as no training set is discussed.

Summary of the 510(k) Approach:

The submission for the "Small Stature Spacers" follows a traditional 510(k) pathway for medical devices that are substantially equivalent to existing, legally marketed devices. The "study" proving the device meets criteria is primarily non-clinical laboratory testing aimed at demonstrating that its technological characteristics, materials (PEEK), and design are similar to the predicate device (ESL® PEEK-OPTIMA® Spine System K061016) and that it is "functional within its intended use."

The key phrase is: "Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use."

And specifically: "Clinical Testing: Clinical testing was not required for the predicate device. Therefore, this submission contains no clinical testing."

This means the acceptance criteria were likely based on established engineering standards and performance benchmarks for spinal implants, and the non-clinical tests (e.g., mechanical strength, fatigue, material characterization) confirmed the device met these standards, thereby demonstrating substantial equivalence to the predicate. Specific numerical criteria and results are not detailed in this summary.

Summary

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K063393

510(k) Summary

Preparation Date: November 8, 2006 JUN 2 5 2007

Applicant/Sponsor: Biomet Spine

Contact Person: Debra L. Bing

Proprietary Name: Small Stature Spacers

Common Name: Vertebral Body Replacement Device

Classification Code/Name: Spinal Intervertebral Fixation Orthosis, 21 CFR 8888.3060

Product Code: MOP

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

ESL® PEEK-OPTIMA® Spine System K061016 .

Device Description:

The Small Stature Spacers are comprised of polyetheretherketone (PEEK) and are similar in design to the EBI ESL PEEK-OPTIMA® Spine System cleared in K061016.

Indications for Use:

Summary of Technologies: The technological characteristics of the Small Stature Spacers are the same as, or similar to, the predicate device.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use.

Clinical Testing: Clinical testing was not required for the predicate device. Therefore, this submission contains no clinical testing.

All trademarks are property of Biomet, Inc., except PEEK-OPTIMA®, which is the property of Invibio Biomaterial Solutions.

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Image /page/1/Picture/12 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

JUN 2 5 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Spine % Biomet Manufacturing Corporation Ms. Susan Alexander Regulatory Specialist P.O. Box 587 Warsaw. Indiana 46581-0587

Re: K063393

Trade/Device Name: Small Stature Spacers Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: May 18, 2007 Received: May 21, 2007

Dear Ms. Alexander:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Susan Alexander

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Harbazo Muchup

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K063393 510(k) Number (if known):

Device Name: Small Stature Spacers

Indications For Use:

Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qabare Buerup

(Division Sign-Of Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number K063393

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.