(49 days)
Not Found
Not Found
No
The summary describes a mechanical orthopedic implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a prosthetic component (proximal femoral component) designed for surgical replacement, not a device that administers therapy.
No
The device description indicates it is a component for femoral replacement, specifically a GMRS™ Proximal Femoral Component, which is a prosthetic implant for surgical use. It does not perform any diagnostic function.
No
The device description clearly details a physical implantable medical device made of cobalt-chromium alloy, with specific dimensions and features for surgical implantation. It does not describe software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing bone in the femur. This is a therapeutic device used in vivo (within the body).
- Device Description: The description details the physical characteristics, materials, and design features of a prosthetic implant.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) to provide information about a patient's health status. IVDs are used for diagnosis, monitoring, or screening, not for direct therapeutic intervention like replacing bone.
Therefore, this device falls under the category of a surgical implant or prosthesis, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This component may also be used with the Distal Femoral segment components of the GMRS™ in total femoral replacement.
The Proximal Femoral Module of the GMRS™ is intended to be used in a cemented or press fit mode.
Product codes (comma separated list FDA assigned to the subject device)
LPH
Device Description
It is the intention of Howmedica Osteonics Corp. to offer GMRS™ Proximal Femoral Components in an anteverted style, so both the standard and trochanteric versions will be available in left and right orientations. These new GMRSTM Proximal Femoral Components offer 15 degrees of anteversion.
The current GMRS™ proximal femoral components have the axis of their femoral neck perpendicular to the center plane of the slot formed by the two anti-rotation tabs when viewed from the distal-to-proximal direction. The subject GMRS™ anteverted proximal femoral components have the axis of their femoral neck at 75 or 105 degrees to the center plane of the slot formed by the two anti-rotation tabs when viewed from the distal-toproximal direction. The difference in the degrees of rotation from the currently available component is 15 degrees, which provides 15 degrees of anteversion (left or right) when implanted with the bowed press-fit stems.
The following design features are common to the new Anteverted Proximal Femoral Components, and the existing GMRS™ Proximal Femoral Components:
- These components are each available in one size.
- These components are fabricated from cast cobalt-chromium alloy that meets the requirements of ASTM standard F-75.
- 5 degree 40 minute taper angle to accept Howmedica Osteonics' modular femoral heads with the same taper
- 70mm replacement length
- porous coating and suture holes in the A-P direction for tissue attachment
- threaded insertion feature on the shoulder to allow for the use of an insertion instrument
- 26mm distal diameter
- 34mm head-neck offset .
The GMRS™ Trochanteric Proximal Femoral Component has increased material in the region of the greater trochanter for surgeons who prefer an anatomically shaped component.
The Standard and Trochanteric Proximal Femoral Components of the GMRS™ may be used with the GMRS™ Connection Pieces, Extension Pieces and the Press Fit Stems with PureFix™ HA Coating in proximal femoral replacement. These products may also be used with the MRS Body components, and modular stems in proximal femoral replacement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral, hip joint
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
Global Modular Replacement System Anteverted Proximal Femoral Component
| Global Modular Replacement System Anteverted Proximal Femoral Component
| 510(k) Premarket Notification | Confidential |
|---|---|
| OCT - 9 2003 | 510(k) Summary K032581 |
| Submission Information | |
| Name and Address of Sponsor: | Howmedica Osteonics Corp. |
| 59 Route 17 | |
| Allendale, NJ 07401 | |
| For Information contact: | Margaret F. Crowe |
| Regulatory Affairs Consultant | |
| Howmedica Osteonics Corp. | |
| 59 Route 17 | |
| Allendale, NJ 07401 | |
| Device Identification | |
| Proprietary Name: | Global Modular Replacement System Anteverted |
| Proximal Femoral Component | |
| Common Name: | Proximal Femoral Replacement |
| Classification Name and Reference: | Prosthesis, Hip, Semi-constrained Metal/Polymer |
| Porous Uncemented | |
| 21 CFR §888.3358 | |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | OR(87) LPH |
Intended Use
Indications
Femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This component may also be used with the Distal Femoral segment components of the GMRS™ in total femoral replacement.
Page 1 of 3
2
1
Contraindications
As Related to Bone Tumors A.
Not all bone tumors may be treated successfully by segmental resection. Any condition that may have already resulted in either local or distant spread of the tumor may be a contraindication. Examples of such conditions include:
- pathological fracture; .
- . overt infection;
- . inopportune placement of biopsy incision; and,
- rapid disease progression beyond a respectable margin. .
- B. As related to Failed Previous Prosthesis and Trauma
- Any active or suspected latent infection in or about the hip joint. .
- Any mental or neuromuscular disorder which would create an unacceptable risk of . prosthesis instability, prosthesis fixation failure, or complication in postoperative care.
- . Bone stock compromised by disease, infection, or prior implantation that cannot provide adequate support and fixation of the prosthesis.
The Proximal Femoral Module of the GMRS™ is intended to be used in a cemented or press fit mode.
Device Description
It is the intention of Howmedica Osteonics Corp. to offer GMRS™ Proximal Femoral Components in an anteverted style, so both the standard and trochanteric versions will be available in left and right orientations. These new GMRSTM Proximal Femoral Components offer 15 degrees of anteversion.
The current GMRS™ proximal femoral components have the axis of their femoral neck perpendicular to the center plane of the slot formed by the two anti-rotation tabs when viewed from the distal-to-proximal direction. The subject GMRS™ anteverted proximal femoral components have the axis of their femoral neck at 75 or 105 degrees to the center
page 1 of 3
2
Global Modular Replacement System Anteverted Proximal Femoral Component 510(k) Premarket Notification Confidential
plane of the slot formed by the two anti-rotation tabs when viewed from the distal-toproximal direction. The difference in the degrees of rotation from the currently available component is 15 degrees, which provides 15 degrees of anteversion (left or right) when implanted with the bowed press-fit stems.
The following design features are common to the new Anteverted Proximal Femoral Components, and the existing GMRS™ Proximal Femoral Components:
- . These components are each available in one size.
- These components are fabricated from cast cobalt-chromium alloy that meets the . requirements of ASTM standard F-75.
- 5 degree 40 minute taper angle to accept Howmedica Osteonics' modular femoral . heads with the same taper
- . 70mm replacement length
- . porous coating and suture holes in the A-P direction for tissue attachment
- . threaded insertion feature on the shoulder to allow for the use of an insertion instrument
- . 26mm distal diameter
- 34mm head-neck offset .
The GMRS™ Trochanteric Proximal Femoral Component has increased material in the region of the greater trochanter for surgeons who prefer an anatomically shaped component.
The Standard and Trochanteric Proximal Femoral Components of the GMRS™ may be used with the GMRS™ Connection Pieces, Extension Pieces and the Press Fit Stems with PureFix™ HA Coating in proximal femoral replacement. These products may also be used with the MRS Body components, and modular stems in proximal femoral replacement.
Page 3 of 3
4
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 9 2003
Ms. Margaret F. Crowe Regulatory Affairs Consultant Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677
Re: K032581
Trade/Device Name: GMRS™ Anteverted Proximal Femoral Component 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: August 18, 2003 Received: August 21, 2003
Dear Ms. Crowe:
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.
4
Page 2 - Ms. Margaret F. Crowe
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 vours.
R. Mark A. Milkman
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
5
510(k) Number (if known): K03258 | ___________________________________________________________________________________________________________________________________________
Device Name: GMRS™ Anteverted Proximal Femoral Component
It is the intention of Howmedica Osteonics Corp. to introduce an additional style of GMRS™ Proximal Femoral Component – this new style of GMRS™ Proximal Femoral Component is anteverted, and as such is available in left and right orientations. This additional style of Proximal Femoral Component is similar in design to the existing GMRS™ Proximal Femoral Components, except for 15 degrees of anteversion. Indications and contraindications for this additional style of GMRS™ Proximal Femoral Component are listed below:
Indications
Femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This component may also be used with the Distal Femoral segment components of the GMRS™ in total femoral replacement.
Contraindications
As Related to Bone Tumors A.
Not all bone tumors may be treated successfully by segmental resection. Any condition that may have already resulted in either local or distant spread of the tumor may be a contraindication.
Examples of such conditions include:
- pathological fracture; .
- . overt infection;
- . inopportune placement of biopsy incision; and,
- rapid disease progression beyond a respectable margin. .
for Mark N Milhum
(Division Sign-Off)
J. Restorative
510(k) Number K032581
10F2
- As related to Failed Previous Prosthesis and Trauma B.
- . Any active or suspected latent infection in or about the hip joint.
- Any mental or neuromuscular disorder which would create an unacceptable risk of ● prosthesis instability, prosthesis fixation failure, or complication in postoperative care.
6
- Bone stock compromised by disease, infection, or prior implantation that cannot provide . adequate support and fixation of the prosthesis.
The Proximal Femoral Module of the GMRS™ is intended to be used in a cemented or press fit mode.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Prescription Use
Over-The-Counter Use ___(Per 21 CFR 801.109) (Optional Format 1-2-96)
for: Mark N. Millhum
(Division Sign-Off)
on of General, Restorative and Neurological Devices
510(k) Number K032581
f 2