SFC™ has been designed to be used in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). SFC.10 is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in thoracic and/or lumbar spine such as posterior pedicle screw and rod system, anterior plate systems, and anterior screw and rod systems. The SFCTM may be used with autograft or allograft.

Device Description

The SFCTM acts as an expandable spacer to maintain proper vertebral body spacing and angulation following vertebrectomy. The SFCTM VBR is manufactured from Ti6Al4V.

AI/ML Overview

The provided text describes a medical device submission (K110153) for the Spinal Fusion Carrier (SFC™) VBR. It details the device, its intended use, and its substantial equivalence to predicate devices based on non-clinical testing.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from recognized standards)	Reported Device Performance
ASTM F2077: Standard Test Methods for Intervertebral Body Fusion Devices	All applicable requirements met
ASTM F2267: Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression	All applicable requirements met
Specific mechanical tests mentioned:
- Static axial compression	All applicable requirements met
- Static axial torsion	All applicable requirements met
- Static compression shear	All applicable requirements met
- Dynamic axial compression	All applicable requirements met
- Dynamic axial torsion	All applicable requirements met
- Subsidence	All applicable requirements met
- Expulsion	All applicable requirements met

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

The provided text describes non-clinical in-vitro mechanical testing. This means there was no human "test set" or patient data involved. The tests were performed on the device itself.

Sample size for the test set: Not applicable for patient data. The number of devices tested for each mechanical test is not specified in the summary, but it would typically involve multiple units to ensure statistical robustness according to the ASTM standards.
Data provenance: Not applicable as it's non-clinical in-vitro testing. It would be conducted in a laboratory setting.

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

Not applicable. For non-clinical mechanical testing, "ground truth" is established by the specified parameters and methodologies of the ASTM standards, not by expert interpretation of patient data.

4. Adjudication Method for the Test Set

Not applicable. As non-clinical testing, there's no diagnostic output or interpretation requiring expert adjudication. The "results" are quantitative measurements of mechanical properties compared against standard-defined acceptance criteria.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. This type of study is relevant for diagnostic imaging or AI-assisted diagnostic devices where human readers interpret cases. The SFC™ VBR is a spinal implant, and its evaluation focuses on mechanical performance and biocompatibility, not diagnostic accuracy.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, a standalone study was performed, but it was a standalone non-clinical mechanical study of the device itself, not a standalone algorithm performance study. The tests described (ASTM F2077, ASTM F2267, and various mechanical stress tests) represent the performance of the device without human interaction during the test procedure, demonstrating its physical capabilities.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is defined by:

Performance standards: The quantitative pass/fail criteria and methodologies outlined in the ASTM F2077 and ASTM F2267 standards.
Material properties and design specifications: The inherent characteristics of the device (e.g., manufactured from Ti6Al4V) and its engineering design.
Predicate device performance: The performance characteristics of the previously cleared predicate devices (Innovotec SEC VBR, K091743; Aesculap Hydrolift VBR, K083186; Synthes Synex II, K061891) against which the SFC™ VBR was shown to be substantially equivalent.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical implant, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data-driven model development.

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

Not applicable, as there is no "training set" for this type of device.

Summary

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

K110153 @CT 1 2 2011

510(k) Summary

Manufacturer:	Königsee Implantate GmbHOT Aschau, Am Sand 4,07426 Allendorf - GERMANY
Dated Prepared:	January 10, 2011
Device Trade Name:	Spinal Fusion Carrier (SFCTM) VBR
Contact:	Justin EggletonMusculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Office: 202.552.5800Fax: 202.552.5798
Classification:	21 CFR §888.3060
Class:	II
Product Code:	MQP

Indications For Use:

Device Description:

The SFCTM acts as an expandable spacer to maintain proper vertebral body spacing and angulation following vertebrectomy. The SFCTM VBR is manufactured from Ti6Al4V.

Predicate Device(s):

The SFC™ was shown to be substantially equivalent to previously cleared devices (Innovotec SEC VBR, K091743; Aesculap Hydrolift VBR, K083186; Synthes Synex II, K061891) and has the same indications for use, design, function, and materials used.

Performance:

Testing performed on this device indicates that the SFC™ is substantially equivalent to predicate devices. ASTM F2077 and ASTM F2267 performance standards (static axial compression, static axial torsion, static compression shear, dynamic axial compression,

Page 1 of 2

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

dynamic axial torsion, subsidence, and expulsion) were adhered to and all applicable requirements were met.

Conclusions:

The subject and predicate devices share the same indications for use, design, function, and materials of manufacture. The non-clinical test results demonstrate that any minor differences do not impact device performance as compared to the predicates. The AccuLIF Cage was shown to be substantially equivalent to the cited predicate devices.

Page 2 of 2

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three flowing lines above it, representing health and well-being.

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

OCT 1 2 2011

Konigsee Implantate GmbH % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Justin Eggleton 1331 H Street NW. 12th Floor Washington, District of Columbia 20005

Re: K110153

Trade/Device Name: Konigsee Implantate Spinal Fusion Carrier (SFC") VBR Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: September 26, 2011 Received: September 27, 2011

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) 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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 devine (1 rith 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. Justin Eggleton

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); medical device reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (OS) 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/ReportalProblem/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/Industrv/default.htm.

Sincerely vours.

For

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

Enclosure

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

Indications for Use

510(k) Number (if known): _ k 1/0153

Device Name: Königsee Implantate Spinal Fusion Carrier (SFC™) VBR

SFC 131 has been designed to be used in the thoracolumbar spine (Ti to L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). SFCTM is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in thoracic and/or lumbar spine such as posterior pedicle screw and rod system, anterior plate systems, and anterior screw and rod systems. The SFC™ may be used with autograft or allografi.

ly Prescription Use (Part 29 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (29 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)

(Division Sign-Off) Division of Surgical, Orthopedie, and Restorative Devices

510(k) Number_ KI10153

Regulation Number and Section

N/A