(28 days)
K010378, 023882
K010378, 023882
No
The description focuses on the material properties and intended use of a porous tantalum implant for bone reconstruction, with no mention of AI or ML.
No.
The device is described as a reconstruction system used to reinforce weak or deficient bony tissues, making it a structural implant rather than a device intended to treat or cure a disease or condition.
No
The device is described as a "Reconstruction System" intended for reinforcing weak or deficient bony tissues in orthopedic surgical procedures. Its purpose is structural support, not to diagnose medical conditions or diseases.
No
The device description explicitly states it is manufactured wholly of Hedrocel porous tantalum, which is a physical material used for reconstruction. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for reinforcing bony tissues during surgical procedures. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a physical implant made of porous tantalum, designed to be surgically placed. This is consistent with a surgical implant, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD devices.
Therefore, the Hedrocel Trabecular Metal Reconstruction System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
EZX
Device Description
Hedrocel Trabecular Metal Reconstruction The System ાં તે 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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bony tissues (pelvic, acetabular, femoral, humeral)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Orthopaedic surgical procedures
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 Trabecular Metal Reconstructive System was tested per FDA quidance documents and applicable standards for K010378, as 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K010378, 023882
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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: | July 22, 2003 |
| Device Trade Name: | The Hedrocel Trabecular Metal Reconstructive System |
| Device Common Name: | Surgical Mesh |
| Classification Number | |
| and Name: | 21 CFR § 878.3300 |
| Surgical 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
p. 2/2
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.
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 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.
3
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
4
510(k) Number (if known) :
032282
Device Name:
The Hedrocel Trabecular Metal Reconstruction System
Indications For Use :
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.
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)