(27 days)
Not Found
Not Found
No
The device description and intended use are for a physical implant (acetabular revision shell) and do not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is an implantable acetabular shell used for hip joint reconstruction, which is a surgical device, not a therapeutic device in the sense of delivering therapy.
No
Explanation:
The device described is a medical implant (Trabecular Metal Acetabular Revision Shell) used for hip reconstructive procedures. Its purpose is to treat painful joint disease or revise previous unsuccessful procedures, not to diagnose a condition.
No
The device description clearly indicates it is a physical implantable device made of Trabecular Metal porous tantalum and Ti-6A1-4V, intended for surgical implantation in the hip. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Trabecular Metal Acetabular Revision Shell is a "modular acetabular reconstructive device" intended for surgical implantation in the hip.
- Intended Use: The intended use describes its application in treating painful hip joint diseases and for revision procedures, all of which involve surgical intervention and implantation within the body.
The device is a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Indications for Use of the Trabecular Metal Acetabular Revision Shells are:
- For cemented or cementless use. .
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problem where arthrodesis or . alternative reconstruction techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for 1 reconstructive techniques as indicated by other deficiencies of the acetabulum.
Product codes (comma separated list FDA assigned to the subject device)
LPH, JDI
Device Description
The Trabecular Metal Acetabular Revision Shell is a modular acetabular reconstructive device (polyethylene liner is cemented to shell) intended for use in primary or revision reconstructive procedures of the acetabulum. The subject Trabecular Metal Acetabular Revision Shell is manufactured from Trabecular Metal porous tantalum. The TM Revision Shell has a Ti-6A1-4V instrument interface ring (ASTM F-136) along its outer perimeter that provides a rigid contact area for the impaction instrument used to implant the device. The Revision Shells are intended for either cementless or cemented fixation to the acetabulum with that allow for optional ancillary fixation to the acetebulum. The screwholes mate with commercially available Zimmer 6.5mm titanium allov bone screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
acetabulum, hip
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 (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
K050937
page 1 of 2
The Trabecular Metal Acetabular Revision Shells
| Submitter Name: | Zimmer Trabecular Metal Technology, Inc. |
|---|---|
| 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: | April 11, 2005 |
| Device Trade Name: | The Trabecular Metal Acetabular Revision Shell |
| Device Common Name: | Acetabular revision shells or cages |
| Classification Number: | 21 CFR § 888.3358 and 21 CFR § 888.3350 |
The term "substantial equivalence" as used in this 510(k) Substantial notification is limited to the definition of substantial equivalence 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 equivalency reclassification. 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.
- The Trabecular Metal Acetabular Revision Shell is a modular Device Description: acetabular reconstructive device (polyethylene liner is cemented to shell) intended for use in primary or revision reconstructive procedures of the acetabulum. The subject Trabecular Metal Acetabular Revision Shell is manufactured from Trabecular Metal porous tantalum. The TM Revision Shell has a Ti-6A1-4V instrument interface ring (ASTM F-136) along its outer perimeter that provides a rigid contact area for the impaction instrument used to implant the device. The Revision Shells are intended for either cementless or cemented fixation to the acetabulum with that allow for optional ancillary fixation to the acetebulum. The screwholes mate with commercially available Zimmer 6.5mm titanium allov bone screws.
1
510(k) Summary (Continued)
The Indications for Use of the Trabecular Metal Acetabular Indications for Use: Revision Shells are:
- For cemented or cementless use. .
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problem where arthrodesis or . alternative reconstruction techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for 1 reconstructive techniques as indicated by other deficiencies of the acetabulum.
The Trabecular Metal Acetabular Revision Shells are Conclusion: substantially equivalent to the identified predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem of three stylized lines, resembling a bird in flight, which is the department's symbol.
Public Health Service
MAY 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marci Halevi Manager of Regulatory Affairs Zimmer Trabecular Metal Technology 80 Commerce Drive Allendale, New Jersey 07401-1600
Re: K050937
Trade/Device Name: Trabecular Metal Acetabular Revision Shells Regulation Number: 21 CFR 888.3358, 888.3350 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented I up Joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: LPH, JDI Dated: April 11, 2005 Received: April 14, 2005
Dear Ms. Halevi:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your section 910(t) production is substantially equivalent (for the indications for referenced above and nave decommised are as a seed predicate devices marketed in interstate commerce use stated in the encrosure/ to regary into of the Medical Device Amendments, or to devices that prior io May 26, 1770, the chaomistic and the provisions of the Federal Food, Drug, and Cosmetic liave been reclassified in accordines was a premarket approval application (PMA). You may, Act (Act) that do not require approval othe general controls provisions of the Act. The general therefore, market the device, subject to an igent of annual registration, listing of devices, good controls provisions of alleling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Sec ao ve) into existing major regulations affecting your device can be illiay be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may publish found in the South ents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I Dri-s issualled of a with other requirements of the Act of that FDA made a decemination that your ceviler Federal agencies. You must comply with any Federal Statutes and regulations administration of to: registration and listing (21 CFR Part 807); all the Act s requirements, including, but novine weeks as set forth in the quality labeling (21 CFR Part 0017, good manager, and if applicable, the electronic product radiation systems (QB) regalates (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) This letter while anow you to begin matical equivalence of your device to a legally premarket notification. The PDA mining or castimation 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 If you desire specific at not 2017 - 1 240) 276-0120. Also, please note the regulation entitled, Contact the Office of Commarket notification" (21CFR Part 807.97) you may obtain. Misoranting by reference to premarismonsibilities under the Act may be obtained from the Oiler general mionmation on your resmational 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/industry/support/index.html
Sincerely yours,
Stupt Rhodes
Miriam Provost, Ph.D.
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Zimmer Trabecular Metal Technology, Inc.
510(k) Number (if known):
K05-0937
Device Name:
Trabecular Metal Acetabular Revision Shells
Indications For Use:
The Indications for Use of the Trabecular Metal Acetabular Revision Shells are:
- For cemented or cementless use. .
- For Cemented of Cementioso aco:
Painful, disabling joint disease of the hip resulting from: degenerative arthritis, a rheumatoid arthritis or late stage avascular necrosis. - medifiation of previous unsuccessful femoral head replacement, cup arthroplasty . or other procedure.
- of other procedure. " techniques are less likely to achieve satisfactory results. Where bone stock is of poor quality or is inadequate for other Where "bons" econniques as indicated by deficiencies of the acetabulum.
Prescription
Use
(Per 21 CFR 801 Subpart D)
AND/OR. . .
Over - The -Counter Use
No
(21 CFR 801 Subpart C) (Optional Format 09-2004)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Htyt Edwards
ral. Restorative. and Neurologic
510(k) N