(30 days)
Not Found
No
The summary describes a physical implant device made of porous tantalum for vertebral body replacement. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies focus on mechanical properties and biocompatibility.
Yes
The Hedrocel® Vertebral Body Replacement System is a device designed to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma, which is a therapeutic intervention.
No
The device is a vertebral body replacement system, an implant used in surgery to replace a diseased or damaged vertebral body, not to diagnose a condition.
No
The device description clearly states it is comprised wholly of Hedrocel® Porous Tantalum, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The Hedrocel® Vertebral Body Replacement System is a physical implant designed to replace a damaged vertebral body in the spine. It is surgically implanted into the body.
- Lack of Specimen Analysis: The description and intended use do not involve the analysis of any biological specimens taken from the patient.
Therefore, this device falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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., 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.
Product codes (comma separated list FDA assigned to the subject device)
MQP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Thoracolumbar spine (T1 - L5)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Hedrocel Vertebral Body Replacement System was tested 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
JUL 1 7 2002
K02/967
page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Hedrocel Vertebral Body Replacement System
| Submitter Name
And Address: | Implex Corp.
80 Commerce Drive
Allendale, 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 Number
and Name: | 21 CFR § 888.3060
Spinal 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