(112 days)
MAF #920
No
The device description and intended use focus on the material properties and physical design of the implant, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies rely on predicate device testing, not algorithmic performance metrics.
Yes
The device is indicated for use in reinforcing weak and/or deficient bony tissues in orthopedic surgical procedures such as pelvic and acetabular reconstruction, which aims to treat or alleviate a medical condition.
No
The device is described as a "reconstruction system" indicated for "reinforcing weak and/or deficient bony tissues in orthopaedic surgical procedures." This function is therapeutic/reconstructive rather than diagnostic.
No
The device description explicitly states it is manufactured wholly of Trabecular Metal porous tantalum and describes physical components (wedge-shaped components), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "reinforcing weak and/or deficient bony tissues in orthopaedic surgical procedures." This is a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description details a physical implant made of porous tantalum, designed to be placed within bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is an orthopedic implant used in vivo.
N/A
Intended Use / Indications for Use
The 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. TThe Trabecular Metal Reconstruction system may be used with bone graft.
Product codes
FTM, EZX
Device Description
The Trabecular Metal Reconstructive System is manufactured wholly of Trabecular Metal porous tantalum, the same material that comprises numerous medical devices intended for use in orthopedic applications. Trabecular Metal porous tantalum is 80% porous with fully interconnecting pores that are about 0.5mm in diameter.
The components of this line extension are wedge-shaped components, similar to the cleared wedge-shapes (K032344). The smallest size wedge is 19mm height with a 5° angle and the largest size wedge is 28mm height with a 30° angle. The angles run in increments of 5 degrees and there are 6 heights for each range of angles. One 'arm' is longer than the other, with the shorter 'arm' contoured along its length and slightly wider than the longer 'arm'. The base of the wedge is contoured. The relief allows biological fixation to occur along both the outer and inner segments of the device.
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
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
The subject devices of the Trabecular Metal Reconstructive System were not tested. Rather previous device testing per FDA guidance documents and applicable standards were performed for the predicate devices described in K02388, Master File MAF #920, 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
MAF #920
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
K046756.51 1/2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS JUL 1 4 2004
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: | March 19, 2004 |
| Device Trade Name: | The 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 The Trabecular Metal Reconstructive System is manufactured wholly of Description: Trabecular Metal porous tantalum, the same material that comprises numerous medical devices intended for use in orthopedic applications. Trabecular Metal porous tantalum is 80% porous with fully interconnecting pores that are about 0.5mm in diameter.
The components of this line extension are wedge-shaped components, similar to the cleared wedge-shapes (K032344). The smallest size wedge is 19mm height with a 5° angle and the largest size wedge is 28mm height with a 30° angle. The angles run in increments of 5 degrees and there are 6 heights for each range of angles. One 'arm' is longer than the other, with the shorter 'arm' contoured along its length and slightly wider than the longer 'arm'. The base of the wedge is contoured. The relief allows biological fixation to occur along both the outer and inner segments of the device.
1
Image /page/1/Picture/0 description: The image contains a sequence of handwritten characters. The characters appear to be 'Kr40756'. The writing style is cursive, with some characters connected to each other. The overall impression is that of a handwritten code or identifier.
510(K) Summary Of Safety And Effectiveness - con't
MATERIALS: Tantalum (Hedrocel porous tantalum)
The Trabecular Metal Reconstruction System is indicated for use in Indications for Use: 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. TThe 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
Data: | The subject devices of the Trabecular Metal Reconstructive System
were not tested. Rather previous device testing per FDA guidance
documents and applicable standards were performed for the predicate
devices described in K02388, Master File MAF #920, 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 Trabecular Metal Reconstructive System is substantially equivalent
to the cited predicate devices identified in this premarket notification. |
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 4 2004
Marci Halevi Manager of Regulatory Affairs Implex Corp. 80 Commerce Drive Allendale, New Jersey
Re: K040756
Trade/Device Name: Trabecular Metal Reconstruction System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTM, EZX Dated: March 23, 2004 Received: March 24, 2004
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 - 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 A. Milliman
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) :
040756 -51
Device Name:
The Trabecular Metal Reconstruction System
Indications For Use:
The 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 Trabecular Metal Reconstruction System may also be used with bone graft
Mark A. Milburn
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K040756
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR. . .
Over-The-Counter Use
(Optional Format 1-2-96)