The Innovasis Box™ peek VBR System is a vertebral body replacement indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during partial and total vertebrectomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

This device is intended to be used with internal supplemental spinal fixation systems such as the Innovasis Excella™ Pedicle Screw System. The interior of the Box™ system can be packed with allograft or autograft. Box™ implants are intended to be used in pairs.

Device Description

The Innovasis Box™ Peek VBR System consists of polyetheretherketone(peek) implants meant to be used only in pairs and with supplemental fixation. The devices are offered in a variety of different shapes (i.e. curved, rectangular) and sizes, in order to better accommodate a patient's anatomy. The implants also feature holes located throughout their geometry in order to accommodate bone graft and maximize bone ingrowth.

Tantalum markers are incorporated into the material to allow for visualization of the implant configuration during and after surgery. The ends of the implants have machined barbs meant to engage the vertebral endplates and prevent expulsion.

AI/ML Overview

The provided text describes a medical device, the Innovasis Box™ Peek VBR System, and its clearance through the FDA 510(k) process. This process focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical studies with acceptance criteria as might be found for a novel drug or a high-risk medical device requiring a PMA.

Therefore, the Acceptance Criteria and associated study details as requested (such as sample size, expert qualifications, adjudication method, MRMC studies, effect size, standalone performance, training set details) are not applicable or not explicitly detailed in this type of submission. The "study" here refers to non-clinical bench testing to demonstrate performance in accordance with its intended use and a comparison to predicate devices, rather than a clinical trial with specific performance metrics against a pre-defined acceptance threshold.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit)	Reported Device Performance
Functional Performance: Capable of performing its intended use as a vertebral body replacement.	"Performance testing indicates that the Box™ Peek VBR System is capable of performing in accordance with its intended use." (This is a general statement, specific quantitative metrics are not provided in this 510(k) summary).
Biocompatibility/Material Safety: Materials meet medical grade standards.	"The implants are machined from Medical Grade peek (Polyetheretherketone) OPTIMA (Invibio™) per ASTM F2026. Marker beads machined from Tantalum per ASTM F560." (Meeting ASTM standards implies adherence to material safety and quality).
Mechanical Strength/Integrity: Capable of withstanding forces in the thoracolumbar spine and preventing expulsion.	"The ends of the implants have machined barbs meant to engage the vertebral endplates and prevent expulsion." "Performance testing indicates that the Box™ Peek VBR System is capable of performing in accordance with its intended use." (Again, general statement. Specific biomechanical tests, e.g., compression, torsion, fatigue, are typically performed but quantitative results are not in this summary).
Visualization: Radiopaque markers for post-operative imaging.	"Tantalum markers are incorporated into the material to allow for visualization of the implant configuration during and after surgery."
Substantial Equivalence: Device is as safe and effective as legally marketed predicate devices with the same indications for use and technological characteristics.	The device was found substantially equivalent to five predicate devices: K043316 (RabeaTM - Signus), K032064 (CPOD/LPODTM VBR System – Theken), K050553 (NovelTM VBR Spinal System - Alphatec), K031757 (Peek TetrisTM - Signus), K050449 (Quantum Vertebral Body Replacement – Quantum Orthopedics). This is the primary "acceptance criterion" for a 510(k) clearance.

2. Sample size used for the test set and the data provenance: Not applicable for this type of submission. The performance testing refers to "non-clinical (bench)" testing, not clinical studies on human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood in AI/diagnostic studies (e.g., expert consensus on medical images) is not relevant for this engineering-based substantial equivalence submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 not an AI-powered diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical bench testing, the "ground truth" would be established engineering standards, material specifications (e.g., ASTM standards), and predefined engineering test protocols to demonstrate mechanical integrity and functional performance. It is not comparable to clinical ground truth.

8. The sample size for the training set: Not applicable. This refers to a medical device's engineering and materials, not an AI model requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

KOO 2151 1 Ok

614 East 3900 South Salt Lake City, UT 84107 801-261-2236 Fax 801-261-0573

DEC	2
2	2006

Box™ Peek VBR System
510(k) SummaryJune 5, 2006
Company:	Innovasis Inc.614 East 390

	Salt Lake City, UT 84107
Contact:	Warren M. DansiePhone: (801)261-2236Fax: (801) 261-0573

Box™ Peek VBR System Trade Name:
Vertebral Body Replacement Common Name:

Classification: Product Code: MQP Regulation Number: 21 CRF 888.3060 Classification Name: Spinal intervertebral body fixation orthosis. Panel code: 87

3900 South

Substantially
Equivalent Devices:

Equivalent Devices:	- K043316 – RabeaTM - Signus
	- K032064 – CPOD/LPODTM VBR System – Theken
	- K050553 – NovelTM VBR Spinal System - Alphatec
	- K031757 – Peek TetrisTM - Signus
	- K050449 – Quantum Vertebral Body Replacement – Quantum Orthopedics

Device Description:

Performance Data:Annual program de collection and collection of the collection of the contribution of the contribution of the contribution of the commend	Non-clinical (Bench):
	Borformanno tacting indicator that the Roy TM Dagk VB

Performance testing indicates that the Box™ Peek VBR System is capable of performing in accordance with its intended use.

Materials: The implants are machined from Medical Grade peek (Polyetheretherketone) OPTIMA (Invibio™) per ASTM F2026. Marker beads machined from Tantalum per ASTM F560.

{1}------------------------------------------------

INNOVASIS. Inc. 614 East 3900 South Salt Lake City, UT 84107 801-261-2236 Fax 801-261-0573

2 af 2

KOG 2151

Intended Use:

Indications for use are as follows:

The Innovasis Box™ peek VBR System is a vertebral body replacement indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body resected or excised during partial and total vertebrectomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

Basis for Substantial Equivalence:

The Box™ Peek VBR System has been subjected to risk analysis and engineering analysis and has been shown to be substantially equivalent to the predicates:

K043316 Rabea™ Signus
K032064 - CPOD/LPOD™ VBR System -- Theken
K050553 Novel™ VBR Spinal System Alphatec
K031757 Peek Tetris™ Signus
K050449 - Quantum Vertebral Body Replacement - Quantum Orthopedics

with regards to indications for use, technology and performance.

Summary of Safety and Effectiveness:

The Innovasis Box™ Peek VBR System is shown to be safe and effective for use as a vertebral body replacement and in the indications associated with device product code MQP.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of four curved lines that resemble a human figure or a flame, representing the department's mission to protect and promote the health and well-being of Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 2006

Innovasis Inc. c/o Mr. Warren Dansie 614 East 3900 South Salt Lake City, UT 84107

Re: K062151

Trade Name: Box™ PEEK VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MOP Dated: December 18, 2006 Received: December 19, 2006

Dear Mr. Dansie:

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.

{3}------------------------------------------------

Page 2 - Mr. Warren Dansie

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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Buchund
for

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

Enclosure

{4}------------------------------------------------

Indications of Use Statement

510(k) Number: K062151

Device Name: Box™ Peek VBR System

Indications for use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (21 CFR 801 Subpart D)

Over-The-Counter-Use (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)

Barbara Buchemi

Division ' General Restorative. and New ological Devices

510(k) Number K062151

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.