(24 days)
Not Found
Not Found
No
The device description and intended use focus on a physical implant (acetabular augment) and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
This device is a prosthetic alternative used to address segmental acetabular deficiencies, making it a therapeutic device designed to treat a medical condition.
No
Explanation: The device is described as an acetabular augment system, which is a prosthetic alternative for segmental acetabular deficiencies. This indicates a therapeutic or reconstructive purpose rather than a diagnostic one.
No
The device description clearly describes a physical implant (truncated hemispherical geometry, OD sizes, thicknesses, portals for screws) made of Trabecular Metal Technology, indicating it is a hardware device, not software.
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 description clearly states that this device is an "Acetabular Augment System" intended to be a "prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies." This means it's a physical implant used within the body during surgery to address a structural issue in the hip socket (acetabulum).
- No Specimen Analysis: There is no mention of analyzing any biological specimens from the patient.
Therefore, based on the provided information, this device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Trabecular Metal Technology 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 (comma separated list FDA assigned to the subject device)
LPH
Device Description
The TMT Acetabular Augment possesses a truncated hemispherical geometry with an inner diameter 3mm larger than the major diameter of the corresponding acetabular cup. The TMT Augment is available in OD sizes 40 to 70 mm in 2 mm increments, and each size is offered in various thicknesses, 5mm to 30mm in 5 mm increments. The TMT Acetabular Augment includes portals that allow the use of Continuum Bone Screws, 5mm and 6.5mm, and Zimmer Trilogy and HGP II 6.5 mm bone screws for adjunct fixation. In addition, the portals also provide a containment system for bone graft in cementless applications.
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): 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.
Not Found
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.
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: | Implex Corp. |
|---|---|
| Submitter Address: | 80 Commerce Drive |
| Allendale, New Jersey 07401-1600 | |
| Contact Person: | Robert A. Poggie, Ph.D. |
| Phone Number: | (201) 818-1800 |
| Fax Number: | (201) 995-9722 |
| Date Prepared: | August 2, 2001 |
| Device Trade Name: | The Trabecular Metal Technology Acetabular Augment |
| System | |
| Device Common | |
| Name: | Acetabular augmentation devices for total hip replacement |
| acetabular components | |
| Classification Number: | 21 CFR § 888.3358 |
The term "substantial equivalence" as used in this Substantial 510(k) notification is limited to the definition of Equivalence: 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 A determination of substantial reclassification. 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 aqainst interest under the US Patent Laws or their application by the courts.
The TMT Acetabular Augment possesses a truncated Device Description: hemispherical geometry with an inner diameter 3mm larger than the major diameter of the corresponding acetabular cup. The TMT Augment is available in OD sizes 40 to 70 mm in 2 mm increments, and each size is offered in various thicknesses, 5mm to 30mm in 5 mm The TMT Acetabular Augment includes increments. portals that allow the use of Continuum Bone Screws, 5mm and 6.5mm, and Zimmer Trilogy and HGP II 6.5 mm bone screws for adjunct fixation. In addition, the portals also provide a containment system for bone graft in cementless applications.
1
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|--------------------------------------------------------|-----------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of General, Restorative and Neurological Devices |
| 510(k) Number | K012507 |
| Prescription Use (Per 21 CFR 801.109) | Over-The-Counter Use |
| | (Optional Format 1-2-96) |