(64 days)
Not Found
Not Found
No
The summary describes a physical implant (acetabular augment) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a prosthetic alternative used in orthopedic surgery to reconstruct acetabular defects, which directly addresses a medical condition or injury.
No.
The device description indicates it is a prosthetic implant (acetabular augment system) used for reconstruction in cases of acetabular deficiencies, not for diagnosing conditions.
No
The device description clearly describes a physical implant made of Trabecular Metal, intended for surgical implantation. It is not a software-only device.
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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that the Trabecular Metal Acetabular Augment System is a prosthetic alternative intended to be implanted into the body to address acetabular deficiencies. It is a physical implant, not a device that analyzes biological samples.
- Intended Use: The intended use is to provide a prosthetic alternative for orthopedic surgeons in cases of segmental acetabular deficiencies. This is a surgical intervention, not a diagnostic test performed on a sample.
The information provided describes a surgical implant, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The Trabecular Metal Acetabular Augment System is intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.
Product codes
LPH
Device Description
The Trabecular Metal Acetabular Augments provides an alternative to structural allograft for augmenting moderate to large-sized segmental acetabular defects encountered in acetabular reconstruction. The Trabecular Metal Acetabular Augments possesses a truncated hemispherical geometry. The device is available in OD sizes 50 to 74 mm in 4 mm increments, and each size is offered in thicknesses from 5mm to 30mm in 5mm increments, aside from the 74mm implant which is available only in thicknesses of 10mm, 20mm and 30mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Acetabular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Orthopedic surgeon
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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)
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The Trabecular Metal Technology Acetabular Augment System
| Submitter Name: | Zimmer Trabecular Metal Technology |
|---|---|
| Submitter Address: | 80 Commerce Drive |
| Allendale, New Jersey 07401-1600 | |
| Contact Person: | Marci Halevi |
| Phone Number: | (201) 818-1800 ext. 507 |
| Fax Number: | (973) 879-0825 |
| Date Prepared: | October 8, 2004 |
| Device Trade Name: | The Trabecular Metal Acetabular Augments |
| Device Common | |
| Name: | Acetabular augmentation devices for total hip replacement |
| acetabular components | |
| Classification Number: | 21 CFR § 888.3358 |
Substantial The term "substantial equivalence" as used in this Equivalence: 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 Acetabular Augments provides an alternative to structural allograft for augmenting moderate to large-sized segmental acetabular defects encountered in acetabular reconstruction. The Trabecular Metal Acetabular Augments possesses a truncated hemispherical geometry. The device is available in OD sizes 50 to 74 mm in 4 mm increments, and each size is offered in thicknesses from 5mm to 30mm in 5mm increments, aside from the 74mm implant which is available only in thicknesses of 10mm, 20mm and 30mm.
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510(k) Summary (Continued)
Indications for Use: The Trabecular Metal Acetabular Augment System is intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.
The Trabecular Metal Acetabular Augment System is Conclusion: substantially equivalent to the identified predicate devices.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human services, featuring three angled bars or lines.
Public Health Service
DFC 21 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marci Halevi Manager of Regulatory Affairs Zimmer Trabecular Metal Technology Zimmer, Inc. 80 Commerce Drive Allendale, New Jersey 07401-1600
Re: K042871
Trade Name: Trabecular Metal Acetabular Augments Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH
Dated: October 15, 2004 Received: October 18, 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.
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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,
Willy Witherspoon
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) :
Device Name:
Trabecular Metal Acetabular Augments
Indications For Use:
Trabecular Metal Acetabular Augments are intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR. . .
Over - The -Counter Use
(21 CFR 801 Subpart C) (Optional Format 09-2004)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of
Concurrence of CDRH; Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Research and Nearologic
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