The BioFlex® is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, failed previous fusion (pseudoarthrosis).

In addition, the BioFlex® is indicated for use in patients:

. Who are receiving fusions with autogenous graft only;
. Who are having the device fixed or attached to the lumbar or sacral spine:
t Who are having the device removed after the development of a solid fusion mass.

Device Description

The BioFlex® is comprised spring-like rods and pedicle screws. All components are manufactured from medical grade titanium alloy (Ti6Al4V).

AI/ML Overview

This is a 510(k) premarket notification for a medical device called BioFlex®, a pedicle screw spinal system. This document package does not contain a study with acceptance criteria or performance data as typically seen in AI/ML performance studies. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on design, function, materials, and intended use.

Therefore, many of the requested sections (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets) are not applicable to the information provided in this 510(k) submission.

Here's the information that can be extracted or deduced from the provided text:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate devices regarding indications for use, design, function, and materials.	"Testing performed indicates the BioFlex® is substantially equivalent to predicate devices."

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

Not Applicable. This submission does not describe a "test set" in the context of an algorithmic performance study. The "testing performed" refers to verification and validation activities (likely mechanical and material testing) to demonstrate substantial equivalence, not a clinical performance validation against a ground truth.

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. No ground truth establishment by experts for a test set is described.

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

Not Applicable. No test set or adjudication method is described.

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 is a hardware device (pedicle screw system), not an AI/ML diagnostic or assistive device. Therefore, no MRMC study comparing human readers with and without AI assistance was performed or is relevant.

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

Not Applicable. This is a hardware device.

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

Not Applicable. For this hardware device submission, "ground truth" isn't established in the context of diagnostic accuracy. Substantial equivalence is established through engineering and material testing, and comparison to legally marketed predicate devices.

8. The sample size for the training set:

Not Applicable. This is a hardware device, not an AI/ML product requiring a training set.

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

Not Applicable. This is a hardware device, not an AI/ML product.

Summary

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K072321

510(k) Summary

MAR 2 5 2008

Contact:	Justin EggletonMusculoskeletal Clinical & Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005202.552.5800
Device Trade Name:	BioFlex®
Manufacturer:	BioSpine Co., Ltd275-4 Sungsoodong-2gaSungdong-gu, Seoul Korea 133-020
Common Name:	Pedicle screw spinal system
Classification:	21 CFR §888.3070
Class:	II
Product Code:	NOP

Indications For Use:

In addition, the BioFlex® is indicated for use in patients:

. Who are receiving fusions with autogenous graft only;
. Who are having the device fixed or attached to the lumbar or sacral spine:
t Who are having the device removed after the development of a solid fusion mass.

Device Description:

The BioFlex® is comprised spring-like rods and pedicle screws. All components are manufactured from medical grade titanium alloy (Ti6Al4V).

Predicate Device(s):

BioFlex® was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials.

Performance Standards:

Testing performed indicates the BioFlex® is substantially equivalent to predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BioSpine Company Limited % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Justin Eggleton Director, Spine Regulatory Affairs 1331 H Street NW, 12th Floor Washington, DC 20005

MAR 2 5 2008

Re: K072321

Trade/Device Name: BioFlex Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: NQP Dated: March 7, 2008 Received: March 10, 2008

Dear Mr. Eggleton:

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

The safety and effectiveness of this device for the indication of spinal stabilization without fusion have not been established.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

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Page 2-Mr. Justin Eggleton

The 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling. 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. 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,

Mark N. Millican

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

510(k) Number (if known):

Device Name: BioFlex®

Indications for Use: The BioFlex® is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, failed previous fusion (pseudoarthrosis).

In addition, the BioFlex® is indicated for use in patients:

. Who are receiving fusions with autogenous graft only;
. Who are having the device fixed or attached to the lumbar or sacral spine;
Who are having the device removed after the development of a solid fusion mass. .

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark M. Millken

Division of General, Restorative, and Neurological Devices

(k) Number K072321

510(k) Number_

Regulation Number and Section

N/A