VU APOD INTERVERTABRAL BODY FUSION DEVICE by THEKEN SPINE LLC

The Theken Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft material. The Theken Spine Vu aPOD Intervertebral Body Fusion Device is intended for use with supplemental fixation such as the Coral Spinal System or the BodyForm Thoracolumbar Fixation System.

Degenerative disc disease (DDD) is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment

Device Description

The Vu aPOD Intervertebral Body Fusion Device is comprised of PEEK-OPTIMA® LT cages which can be used in combination with an optional titanium spin plate. The cages include toothed spikes on the top and bottom surfaces to engage with the superior and inferior end plates of neighboring vertebral bodies to resist rotation and migration. The cage shape and open center allow for bony in-growth in and around the implant. A single cage is sufficient to be used at each intervertebral level.

AI/ML Overview

The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the format requested. The document is a 510(k) premarket notification for a medical device (Vu aPOD Intervertebral Body Fusion Device), which focuses on establishing substantial equivalence to predicate devices rather than reporting on specific performance metrics and a study to meet pre-defined acceptance criteria.

Therefore, most of the requested fields cannot be filled from the provided text.

Here's an attempt to answer based on the available information and highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (e.g., Sensitivity, Specificity, Accuracy, Mechanical Strength)	Reported Device Performance
Not specified in the document.	Not specified in the document in terms of quantitative performance against criteria. The document mentions "mechanical testing" was performed to demonstrate substantial equivalence, but no specific criteria or results are detailed.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size (Test Set): Not applicable. This document describes a 510(k) submission based on substantial equivalence, not a clinical trial with a test set of patient data.
Data Provenance: Not applicable. The submission relies on design concept, use of established materials, feature comparisons, and mechanical testing to demonstrate equivalence, rather than patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. Ground truth for a test set of patient data is not relevant to this type of 510(k) submission.

4. Adjudication Method for the Test Set:

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Was an MRMC study done? No.
Effect Size of human readers with vs. without AI assistance: Not applicable.

6. Standalone (Algorithm Only) Performance Study:

Was a standalone study done? No. This device is a physical intervertebral body fusion device, not a software algorithm.

7. Type of Ground Truth Used:

Not applicable in the context of clinical performance metrics. The "ground truth" for this submission is related to demonstrating substantial equivalence for manufacturing, materials, design, and mechanical properties compared to predicate devices. This is typically established through engineering analysis and validated testing against industry standards, rather than clinical outcome data.

8. Sample Size for the Training Set:

Not applicable. This device is a physical implant, not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary of available information related to performance/equivalence:

The submission asserts "sufficient evidence exists to reasonably conclude that the Vu aPOD Intervertebral Body Fusion Device is substantially equivalent to the predicate device...This is based on the design concept, the use of established, known materials, feature comparisons, mechanical testing, indications for use, pre-production quality assurance planning and engineering analysis."
The device similarities to predicate devices include: Indications for use, same basic design, same operating principle, same materials (PEEK-OPTIMA LT, Tantalum, Titanium 6Al-4V ELI as per ASTM standards), used with supplemental fixation, same manufacturing environment, same sterilization process, and same packaging configurations.
The FDA's decision is that the device is "substantially equivalent" for its stated indications for use, implying that it meets the safety and effectiveness profile of its predicate devices without raising new questions of safety or effectiveness.

Summary

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K080822 (pg. 1 of 2)

Theken Spine, LLC Vu aPOD Intervertebral Body Fusion Device

7/01/2008

(21 CFR Part 807.92)

A. Submitter Information	JUL - 2 2008
Submitter's Name:Address:	Theken Spine, LLC1800 Triplett Blvd.Akron, Ohio 44306
Telephone Number:Fax Number:Contact Person:Date Prepared:	330-475-8600330-773-7697Dale Davison7/01/2008
B. Device Information
Trade Name:	Vu aPOD Intervertebral Body Fusion Device
Common Name:	Intervertebral Body Fusion Device
Classification Name:	Spinal Intervertebral Body Fusion Device (per 21 CFR 888.3080)
Device Classification:	Class II (per 21 CFR 888.3080)Panel: Orthopedic, Product Code: MAX
Predicate Device:	Theken Surgical, LLC REVEAL VBR System (K050058)DePuy Acromed Lumbar I/F Cage (P960025)Spinal Elements, Lucent Magnum (K073348)
Material Composition:	Polyetheretherketone (PEEK-OPTIMA LT) per ASTM F-2026Tantalum per ASTM F-560Titanium 6Al-4V ELI per ASTM F-136
Subject Device Description:	The Vu aPOD Intervertebral Body Fusion Device is comprised ofPEEK-OPTIMA® LT cages which can be used in combinationwith an optional titanium spin plate. The cages include toothedspikes on the top and bottom surfaces to engage with the superiorand inferior end plates of neighboring vertebral bodies to resistrotation and migration. The cage shape and open center allow forbony in-growth in and around the implant. A single cage issufficient to be used at each intervertebral level.
Intended Use:	The Theken Spine Vu aPOD Intervertebral Body Fusion Device isindicated for use as an adjunct to fusion in patients withdegenerative disc disease (DDD) at one or two contiguous levelsfrom L2 to S1. These DDD patients may also have up to Grade 1spondylolisthesis at the involved level(s). The interior of thespacer component may be packed with autogenous bone graftmaterial. The Theken Spine Vu aPOD Intervertebral Body FusionDevice is intended for use with supplemental fixation such as theCoral Spinal System or the BodyForm Thoracolumbar FixationSystem.

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K080822 (pg. 2 of 2)

Theken Spine, LLC Vu aPOD Intervertebral Body Fusion Device

C. Substantial Equivalence

The technological characteristics of the Vu aPOD Intervertebral Body Fusion Device are similar to the predicate device REVEAL Vertebral Body Replacement (K050058), Manufactured by Theken Surgical. LLC, the DePuy Acromed Lumbar IF Cage (P960025), and the Spinal Elements Lucent Magnum (K073348)

The subject device similarities include:

Indications for use
The same basic design ●
. The same operating principle
. The same materials
Used in conjunction with supplemental fixation .
The same manufacturing environment ●
The same sterilization process .
The same packaging configurations .

Theken Spine believes that sufficient evidence exists to reasonably conclude that the Vu aPOD Intervertebral Body Fusion Device is substantially equivalent to the predicate device REVEAL Vertebral Body Replacement (K050058), manufactured by Theken Surgical, LLC, the DePuy Acromed Lumbar VF Cage (P960025), and the Spinal Elements Lucent Magnum (K073348). This is based on the design concept, the use of established, known materials, feature comparisons, mechanical testing, indications for use, pre-production quality assurance planning and engineering analysis. All implants represent a basic design concept in terms of safety and effectiveness, and differ only in minor details.

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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 and Human Services. The logo features a stylized image of an eagle or bird with its wings spread, formed by three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Theken Spine, LLC % Mr. Dale Davison 1800 Triplett Boulevard Akron, OH 44306

SEP 12 2011

Re: K080822

Trade/Device Name: Vu a·POD Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: May 15, 2008 Received: June 3, 2008

Dear Mr. Davison:

This letter corrects our substantially equivalent letter of July 2, 2008.

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 (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 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

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limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Mark A. Mulhausen

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

Enclosure

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Indications for Use

510(k) Number (if known):__K080822

Device Name: Vu aPOD Intervertebral Body Fusion Device

Indications For Use:

Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number /Lo 80422

Page 1 of 1

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.