The Hedrocel Trabecular Metal Reconstruction System is indicated for use in reinforcing weak and/or deficient bony tissues in orthopaedic surgical procedures, such as pelvic reconstruction, acetabular reconstruction, cement restriction and in long bone procedures such as femoral and humeral reconstruction. When used in long bone procedures, ancillary fixation, such as plates and screws, must be used. The Hedrocel® Trabecular Metal Reconstruction system may be used with bone graft.

Device Description

The Hedrocel Trabecular Metal Reconstructive System is manufactured wholly of Hedrocel porous tantalum, the same material that comprises numerous medical devices intended for use in orthopedic applications. Hedrocel porous tantalum is 80% porous with fully interconnecting pores that are about 0.5mm in diameter. The devices in this line extension are wedge shaped and contoured so as to fit a variety of anatomical bone structures. The devices are available in small, medium and large sizes, with the cross-sectional dimensions being 0.52in x 0.88in for the small size; 0.58in x 0.96in for the medium size, and 0.62in x 1.06in for the large size. Each size consists of varying heights ranging from 2mm - 8mm in 2mm increments. There is a consistent inclination angle of 10 degrees along the length in all size ranges. A secondary inclination angle along the width ranges from 20-35 degrees in 5-degree increments. The resultant geometry is a bi-plane wedge. The devices have a 6mm central hole for optional bone graft placement. A tapered slot is provided for implantation instrumentation.

AI/ML Overview

The provided document is a 510(k) summary for the Hedrocel Trabecular Metal Reconstructive System. It states that the device was deemed "substantially equivalent" to predicate devices without performing new testing on the subject device itself. Therefore, the information requested regarding acceptance criteria and performance studies in the prompt is not available for this specific device.

Instead, the summary refers to performance data for predicate devices (K023882 and K962468) as evidence of the subject device's anticipated performance. This means there are no specific acceptance criteria or a dedicated study described for the Hedrocel Trabecular Metal Reconstructive System in this document.

Here's a breakdown of why I cannot answer the specific questions based on the provided text:

A table of acceptance criteria and the reported device performance: Not available. The document states, "The subject device of the Hedrocel Trabecular Metal Reconstructive System was not tested. Rather previous device testing per FDA guidance documents and applicable standards were performed for the predicate devices described in K023882 and other mechanical testing reported in K962468." Therefore, no acceptance criteria or performance data for this specific device are reported.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available for the subject device. The document explicitly states the subject device was not tested.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. No test set for the subject device was used.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for the subject device was used.
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 device is a surgical mesh, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical mesh, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No specific ground truth was established for the subject device's performance through new testing.
The sample size for the training set: Not applicable. The device is a surgical mesh, not a machine learning model requiring a training set.
How the ground truth for the training set was established: Not applicable. The device is a surgical mesh, not a machine learning model.

In summary, the 510(k) clearance for the Hedrocel Trabecular Metal Reconstructive System was based on demonstrating "substantial equivalence" to previously cleared predicate devices, rather than new performance testing of the subject device itself.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

The Hedrocel Trabecular Metal Reconstructive System

Submitter Name	Implex Corp.
And Address:	80 Commerce Drive, Allendale, New Jersey 07401-1600
Contact Person:	Marci Halevi
Phone Number:	(201) 818 - 1800, X 507
Fax Number:	(973) 829 - 0825
Date Prepared:	September 3, 2003
Device Trade Name:	The Hedrocel Trabecular Metal Reconstructive System
Device Common Name:	Surgical Mesh
Classification Numberand Name:	21 CFR § 878.3300Surgical Mesh

The term "substantial equivalence" as used in this 510(k) Substantial 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.

Trabecular Device Metal Reconstructive The Hedrocel Svstem is Description: manufactured wholly of Hedrocel porous tantalum, the same material that comprises numerous medical devices intended for use in orthopedic applications. Hedrocel porous tantalum is 80% porous with fully interconnecting pores that are about 0.5mm in diameter.

The devices in this line extension are wedge shaped and contoured so as to fit a variety of anatomical bone structures. The devices are available in small, medium and large sizes, with the cross-sectional dimensions being 0.52in x 0.88in for the small size; 0.58in x 0.96in for the medium size, and 0.62in x 1.06in for the large size. Each size consists of varying heights ranging from 2mm - 8mm in 2mm increments. There is a consistent inclination angle of 10 degrees along the length in all size ranges. A secondary inclination angle along the width ranges from 20-35 degrees in 5-degree increments. The resultant geometry is a bi-plane wedge. The devices have a 6mm central hole for optional bone graft placement. A tapered slot is provided for implantation instrumentation.

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510(K) Summary Of Safety And Effectiveness - con't

MATERIALS: Tantalum (Hedrocel porous tantalum)

The Hedrocel Trabecular Metal Reconstruction System is indicated for Indications for Use: use in reinforcing weak and/or deficient bony tissues in orthopaedic surgical procedures, such as pelvic reconstruction, acetabular reconstruction, cement restriction and in long bone procedures such as femoral and humeral reconstruction. When used in long bone procedures, ancillary fixation, such as plates and screws, must be used. The Hedrocel® Trabecular Metal Reconstruction system may be used with bone graft.

Device

Technological Characteristics & Comparison to Predicate Device: A comparison of device technological characteristics and properties demonstrates that the device is substantial equivalent to the cited predicate devices.

Performance The subject device of the Hedrocel Trabecular Metal Reconstructive Data: System was not tested. Rather previous device testing per FDA guidance documents and applicable standards were performed for the predicate devices described in K023882 and other mechanical testing reported in K962468. These results indicate that the subject device will perform as indicated for use in support of weakened and/or deficient bony structures.
Conclusion: The Hedrocel Trabecular Metal Reconstructive System is substantially equivalent to the cited predicate devices identified in this premarket notification.

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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 & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

OCT - 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marci Halevi Manager of Regulatory Affairs Implex Corp. 80 Commerce Drive Allendale, New Jersey 07401-1600

Re: K032344

Trade/Device Name: The Hedrocel Trabecular Metal Reconstruction System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: EZX Dated: September 3, 2003 Received: September 4, 2003

Dear Ms. Halevi:

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.

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.

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Page 2 - Ms. Marci Halevi

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 (301) 594-4659. 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/dsma/dsmamain.html

Sincerely yours,

Mark N Milken

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

Enclosure

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Implex Corp.

510(k) Number (if known) :

K03234

Device Name:

The Hedrocel Trabecular Metal Reconstruction System

Indications For Use:

(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	K03 234410/1/03
	OR... Over-The-Counter Use
escriptio Useer 21 CFR 801.109)

Pre n Us (Pe

(Optional Format 1-2-96)

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.