MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM by IMPLEX CORP.

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 also be used with bone graft.

Device Description

Hedrocel Trabecular Metal Reconstruction The System is manufactured wholly of Hedrocel porous tantalum. Hedrocel porous tantalum is 80% porous with fully interconnecting pores that are about 0.5mm in diameter. This line extension adds components with a variety of cross-sections and heights to the Hedrocel Trabecular Metal Reconstruction System.

AI/ML Overview

Here's an analysis of the provided text regarding the Hedrocel Trabecular Metal Reconstructive System:

Summary of Acceptance Criteria and Study Details:

Based on the provided 510(k) summary, the device is a surgical mesh (The Hedrocel Trabecular Metal Reconstructive System) made of Hedrocel porous tantalum. The core of the submission relies on demonstrating substantial equivalence to existing predicate devices, rather than establishing specific performance acceptance criteria for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Material: Same as predicate device (Tantalum/Hedrocel porous Tantalum)	Manufactured wholly of Hedrocel porous tantalum.
Indications for Use: Same as predicate device (Reinforcing weak/deficient bony tissues in orthopaedic procedures)	Indicated for: pelvic, acetabular, femoral, humeral reconstruction, cement restriction, and use with bone graft.
Technological Characteristics: Similar to predicate device	Addition of components with a variety of cross-sections and heights to the existing system.
Performance (Mechanical Strength): Sufficient strength for indicated use.	Tested per FDA guidance for K010378 and 023882. Mechanical test data in MAF #920 indicates "sufficient strength."

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

Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of clinical trials or algorithm validation. The "testing" refers to mechanical performance tests of the material itself. The document mentions "mechanical test data found in MAF #920," implying laboratory-based material characterization, not patient data.
Data Provenance: Not applicable in the context of clinical data. The mechanical test data would be lab-generated.

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

Not Applicable. This submission focuses on demonstrating substantial equivalence through material properties and mechanical testing, not through expert-verified clinical outcomes or diagnostic accuracy.

4. Adjudication Method for the Test Set:

Not Applicable. There is no mention of adjudication, as this wasn't a clinical performance study requiring expert consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This type of study is not mentioned. The submission is for a medical device (surgical mesh) and its mechanical performance, not an AI or imaging diagnostic tool that would typically involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No. This is not an AI algorithm.

7. The type of ground truth used:

The "ground truth" for the material's performance is derived from laboratory mechanical testing that quantifies properties like strength, and comparison to existing standards and predicate device performance. It is not based on expert consensus, pathology, or outcomes data in a clinical trial setting.

8. The Sample Size for the Training Set:

Not Applicable. There is no "training set" as this is not an AI/machine learning device. The material properties are inherent to the manufacturing process and material composition.

9. How the ground truth for the training set was established:

Not Applicable. See point 8.

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 DriveAllendale, New Jersey 07401-1600
Contact Person:	Marci Halevi
Phone Number:	(201) 818 - 1800, X 507
Fax Number:	(973) 829 - 0825
Date Prepared:	July 22, 2003
Device Trade Name:	The Hedrocel Trabecular Metal Reconstructive System
Device Common Name:	Surgical Mesh
Classification Numberand Name:	21 CFR § 878.3300Surgical Mesh

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.

Device Hedrocel Trabecular Metal Reconstruction The System ાં તે Description: manufactured wholly of Hedrocel porous tantalum. Hedrocel porous tantalum is 80% porous with fully interconnecting pores that are about 0.5mm in diameter. This line extension adds components with a variety of cross-sections and heights to the Hedrocel Trabecular Metal Reconstruction System.

MATERIALS: Tantalum (Hedrocel porous tantalum)

Indications for The Hedrocel Trabecular Metal Reconstruction System is indicated for use in reinforcing weak and/or deficient bony tissues in orthopaedic Use: 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 also be used with bone graft.

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032282

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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.

The Hedrocel Trabecular Metal Reconstructive System was tested per Performance FDA quidance documents and applicable standards for K010378, as Data: referenced in the predicate 023882. In addition, mechanical test data found in MAF #920 indicate the Hedrocel porous tantalum possesses sufficient strength for the indicated use. These results indicate that the subject device will perform as indicated for use in support of weakened bony structures.

The Hedrocel Trabecular Metal Reconstructive System is substantially Conclusion: equivalent to the cited predicate devices identified in this premarket notification.

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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 emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with outstretched wings, rendered in a simple, bold design.

AUG 2 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K032282

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: July 23, 2003 Received: July 24, 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,

sincerely yours,

Mark M Millenn

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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510(k) Number (if known) :

032282

Device Name:

The Hedrocel Trabecular Metal Reconstruction System

Indications For Use :

Mark n Milken

(Division Sign-C Division of Ge I, Restorative and Neurologi

510(k) Number.

) Number K032282

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

Concurrence of CDRH; Office of Device Evaluation (ODE)

Prescripti on Use (Per 21 CFR 801.109) OR . . .

Over - The -Counter Use

(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.