(87 days)
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No
The summary describes a physical implant made of porous tantalum and its mechanical properties and clinical performance. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The Trabecular Metal Osteonecrosis Intervention Implant is a device intended to treat osteonecrosis of the femoral head, which is a medical condition, by providing physical support to weakened bone. This therapeutic intended use qualifies it as a therapeutic device.
No
The device is described as an "Osteonecrosis Intervention Implant" used for treatment, not diagnosis. Its function involves providing structural support to weakened bone, not detecting or identifying medical conditions.
No
The device description clearly states it is a physical implant fabricated from porous tantalum, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text describes a physical implant (Trabecular Metal Osteonecrosis Intervention Implant) that is surgically placed into the femoral head to treat osteonecrosis. It is a therapeutic device, not a diagnostic one that analyzes samples.
The information provided clearly indicates a device used in vivo (within the body) for treatment, not in vitro (in a lab) for diagnosis.
N/A
Intended Use / Indications for Use
The Trabecular Metal Osteonecrosis Intervention Implant is indicated for use in patients with Stage I or Stage II osteonecrosis of the femoral head (Steinberg/UPenn System) and who would qualify for core decompression based upon physical and radiographic examination and medical history. The Trabecular Metal Osteonecrosis Intervention Implant may be used with or without bone graft.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Trabecular Metal Osteonecrosis Intervention Implant is fabricated from Trabecular MetalTM porous tantalum. The implant is cylindrical in shape with a 10 mm diameter and length options from 70 to 130 mm in 5 mm increments.
The Trabecular Metal Osteonecrosis Intervention Implant possesses distal threads for engagement of bone. The threaded portion is 25 mm in length and the outer diameter is 14 mm, the inner diameter is 10 mm. Slots within the lateral most aspect of the implant interface with the driving instrument.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Femoral Head
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Trabecular Metal Osteonecrosis Intervention Implant was characterized per modified ASTM testing standards for THR devices, mechanical test methods that simulated bone deficiencies caused by early stage femoral head osteonecrosis, and finite element modeling of the device. The results of these tests showed that the subject device safely supports weakened bone associated with early stage osteonecrosis of the femoral head. The clinical data collected under IDE G990234 show the device to perform safely and efficaciously per the indications for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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Zimmer Trabecular Metal Technology, Inc.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
APR 1 5 2005 The Trabecular Metal Osteonecrosis Intervention Implant
| Submitter Name | Zimmer Trabecular Metal Technology, Inc. |
|---|---|
| And Address: | 80 Commerce Drive |
| Allendale, New Jersey 07401-1600 | |
| Contact Person: | Robert A Poggie, PhD |
| Phone Number: | (201) 818 - 1800, X 519 |
| Fax Number: | (973) 829 - 0825 |
| Date Prepared: | April 12, 2005 |
| Device Trade Name: | Trabecular Metal Osteonecrosis Intervention Implant |
| Device Common Name: | Porous metal rod |
| Classification Number | |
| and Name: | 21 CFR § 888.3030; product code HRS - Single/multiple |
| component metallic bone fixation appliances and accessories | |
| Substantial | |
| Equivalence: | The term "substantial equivalence" as used in this 510(k) |
| 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 | |
| Description: | The Trabecular Metal Osteonecrosis Intervention Implant is |
| fabricated from Trabecular MetalTM porous tantalum. The implant is | |
| cylindrical in shape with a 10 mm diameter and length options from 70 | |
| to 130 mm in 5 mm increments. |
The Trabecular Metal Osteonecrosis Intervention Implant
possesses distal threads for engagement of bone. The threaded
portion is 25 mm in length and the outer diameter is 14 mm, the inner
diameter is 10 mm. Slots within the lateral most aspect of the implant
interface with the driving instrument. |
1
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Zimmer Trabecular Metal Technology, Inc.
Trabecular Metal Osteonecrosis Intervention Implant 510(k) Premarket Notification ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Summary Continued ...
Indications for The Trabecular Metal Osteonecrosis Intervention Implant is indicated Use: for use in patients with Stage I or Stage II osteonecrosis of the femoral head (Steinberg/UPenn System) and who would qualify for core decompression based upon physical and radiographic examination and medical history. The Trabecular Metal Osteonecrosis Intervention Implant may be used with or without 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 Trabecular Metal Osteonecrosis Intervention Implant was Data: characterized per modified ASTM testing standards for THR devices, mechanical test methods that simulated bone deficiencies caused by early stage femoral head osteonecrosis, and finite element modeling of the device. The results of these tests showed that the subject device safely supports weakened bone associated with early stage osteonecrosis of the femoral head. The clinical data collected under IDE G990234 show the device to perform safely and efficaciously per the indications for use.
- Conclusion: The Trabecular Metal Osteonecrosis Intervention Implant is substantially equivalent to the cited predicate devices identified in this premarket notification.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
APR 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Robert A. Poggie, Ph.D. Zimmer Trabecular Metal Technology, Inc. 80 Commerce Drive Allendale, New Jersey 07401-1600
Re: K050101
Trade/Device Name: The Trabecular Metal Osteonecrosis Intervention Implant Regulation Number: 21 CFR 888.3030 Regulation Name: Single/ multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: January 17, 2005 Received: January 18, 2005
Dear Dr. Poggie:
We have reviewed your Section 510(k) premarket notification of intent to market the device w f nave a nowe 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 docs 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 - Robert A. Poggie, Ph.D.
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 (240) 276-0120 . 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/cdrl/industry/support/index.html.
Sincerely yours,
Stypk Rlurde
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ко50101 510(k) Number (if known) :
The Trabecular Metal Osteonecrosis Intervention Implant
Device Name:
Indications For Use:
The Trabecular Metal Osteonecrosis Intervention Implant is indicated for use in patients with Stage I or Stage II osteonecrosis of the femoral head (Steinberg/UPerin System) and who would qualify for core decompression based upon physical and radiographic examination and medical history. The Trabecular Metal Osteonecrosis Intervention Implant may be used with or without bone graft.
X Prescription Use
AND/OR. . .
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Stupk Rlvdu
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