The Hedrocel® Vertebral Body Replacement System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Hedrocel® Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Hedrocel® Vertebral Body Replacement may be used with bone graft.

Device Description

The Hedrocel® Vertebral Body Replacement System is designed to be used as a replacement for a single diseased or damaged vertebral body and the adjacent disc when spinal surgery through an anterior approach is indicated. The Hedrocel® Vertebral Body Replacement (VBR) System is comprised wholly of Hedrocel® Porous Tantalum (tantalum deposited on a vitreous carbon skeleton). The VBR is available to accommodate replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to properly tension the spine. The superior and inferior surfaces of the device have a pattern of ripples to provide increased stability. The Hedrocel® Vertebral Body Replacement implants have an included angle to maintain the natural contour of the lumbar spine. The use of titanium or titanium alloy instrumentation is recommended.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Hedrocel Vertebral Body Replacement System." This is a medical device, and the acceptance criteria mentioned are related to its mechanical performance and biocompatibility, demonstrating substantial equivalence to predicate devices. The document does not describe a study involving human subjects or AI; therefore, many of the requested fields are not applicable.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility	Data provided to support the material's use.
Mechanical Behavior (equivalent to predicates): - Static compression - Dynamic compression - Static torsion - Dynamic torsion - Abrasion	Test data provided regarding these aspects, demonstrating the device will perform as intended and is equivalent to cited predicate devices.

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

The document does not specify sample sizes for mechanical testing. The data provenance is not explicitly stated beyond "Performance Data: The Hedrocel Vertebral Body Replacement System was tested per applicable standards (reference K010378)." This suggests laboratory-based mechanical testing, not clinical data from patients.

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

Not applicable. The ground truth for this device's performance is established through engineering standards and mechanical testing, not expert interpretation of clinical data in the context of AI.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of clinical outcomes or image interpretations.

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

Not applicable. This submission is for a medical implant device, not an AI or diagnostic tool that would typically undergo an MRMC study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The device is a physical implant, not an algorithm. The performance data refers to the mechanical integrity and biocompatibility of the implant itself.

7. Type of Ground Truth Used

The ground truth used for validating the device's performance primarily relied on engineering standards and direct physical measurements obtained through mechanical testing (static and dynamic compression, torsion, abrasion) and biocompatibility assessments. It is compared to the established performance of predicate devices.

8. Sample Size for the Training Set

Not applicable. This is not a study involving machine learning where a "training set" would be used.

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

Not applicable.

Summary

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

JUL 1 7 2002

K02/967
page 1 of 2

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Hedrocel Vertebral Body Replacement System

Submitter NameAnd Address:	Implex Corp.80 Commerce DriveAllendale, New Jersey 07401-1600
Contact Person:	Robert A Poggie, PhD
Phone Number:	(201) 818-1800
Fax Number:	(973) 829-0825
Date Prepared:	June 14, 2002
Device Trade Name:	Hedrocel Vertebral Body Replacement System
Device Common Name:	Vertebral Body Replacement Device
Classification Numberand Name:	21 CFR § 888.3060Spinal Vertebral Body Replacement Device

Substantial The term "substantial equivalence" as used in this 510(k) Equivalence: notification is limited to the definition of substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

The Hedrocel® Vertebral Body Replacement System is designed to Device Description: be used as a replacement for a single diseased or damaged vertebral body and the adjacent disc when spinal surgery through an anterior approach is indicated.
The Hedrocel® Vertebral Body Replacement (VBR) System is comprised wholly of Hedrocel® Porous Tantalum (tantalum deposited on a vitreous carbon skeleton). The VBR is available to accommodate replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to properly tension the spine.

The superior and inferior surfaces of the device have a pattern of ripples to provide increased stability. The Hedrocel® Vertebral Body Replacement implants have an included angle to maintain the natural contour of the lumbar spine.

The use of titanium or titanium alloy instrumentation is recommended.

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

Implex Corp

Hedrocel® Vertebral Body Replacement Special 510(k) Premarket Notification

KO21967
page 2 of 2

510(k) Summary (Continued)

The Hedrocel® Vertebral Body Replacement System is a Indications for Use: vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., The Hedrocel® Vertebral Body Replacement is fracture). intended for use with supplemental internal spinal fixation systems. The Hedrocel® Vertebral Body Replacement may be used with bone graft.

The device is unique in comparison to predicates for this Device Technological indication with regard to porous tantalum material and its Characteristics and Comparison to structure. The material has been used in cited predicates for Predicate Device: other applications.

The Hedrocel Vertebral Body Replacement System was tested Performance Data: per applicable standards (reference K010378). Biocompatibility data was provided to support the material's use. Performance testing was provided to support equivalent mechanical behavior to the predicates. The results demonstrated that the device will perform as intended and is equivalent to the cited predicate devices. Test data was provided regarding:

Static compression, ●
Dynamic compression, .
Static torsion, .
. Dynamic torsion, and
. Abrasion.

Conclusion:

The Implex Hedrocel Vertebral Body Replacement System is substantially equivalent to the following predicate devices identified in this premarket notification:

510(k) #	Product Name	Company
K010378	Hedrocel Vertebral Body Replacement	Implex Corp.
K021025

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

Image /page/2/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 2002

Mr. Robert A. Poggie, PhD Director of Applied Research Implex® Corp. 80 Commerce Drive Allendale, New Jersey 07401-1600

Re: K021967

Trade/Device Name: Hedrocel Vertebral Body Replacement System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: June 14, 2002 Received: June 17, 2002

Dear Dr. Poggie;

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. Robert A. Poggie, PhD

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 (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.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely vours.

for Mark A. Millkens

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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

510(k) Number (if known) :

KO21962

Device Name:

The Implex Hedrocel Vertebral Body Replacement System

Indications For Use:

The Hedrocel® Vertebral Body Replacement System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Hedrocel® Vertebral Body Replacement is intended for use with (from hotel internal spinal fixation systems. The Hedrocel® Vertebral Body Replacement may be used with bone graft.

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

Concurrence of CDRH; Office of Device Evaluation (ODE)

Prescriptio
n Use
(Per 21 CFR 801.109)
OR...
Over-The-
Counter Use

Mach n Milker (Optional Format 1-2-96)

(Division Sign-Off)
Division of General. Restorative
and Neurological De. ices
510(k) Number. K021697

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.