(86 days)
MRS Cemented Stems Howmedica Osteonics, Distal Stem Segments of the Restoration Modular Femoral Stem Howmedica Osteonics
Not Found
No
The device description focuses on the material composition, physical dimensions, and mechanical properties of a modular hip replacement stem. There is no mention of software, algorithms, data processing, or any other elements typically associated with AI/ML. The performance studies mentioned are finite element analyses and testing, which are standard engineering methods, not AI/ML evaluations.
Yes
The device is a component of a total hip arthroplasty system, which is a medical procedure aimed at restoring hip function and alleviating pain due to extensive proximal femoral bone loss. This direct intervention to treat a medical condition categorizes it as a therapeutic device.
No
This device is a surgical implant (femoral stem for hip arthroplasty) intended for treatment, not for diagnosing a condition.
No
The device description clearly details a physical implant made of titanium alloy with coatings, indicating it is a hardware device, not software only.
Based on the provided text, 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 the GMRS Press Fit Stems are implants used in total hip arthroplasty. They are surgically inserted into the proximal femoral segment to replace bone loss. This is an in vivo application (within the living body), not an in vitro application (outside the living body).
The text focuses on the physical characteristics, materials, and surgical application of the device, which are all consistent with a surgical implant and not an IVD.
N/A
Intended Use / Indications for Use
The Global Modular Replacement System (referred to from this point on as the GMRS) Press Fit Stems with PureFix® HA Coating are intended to be used with components of the proximal femoral segment of the Howmedica Modular Replacement System (referred to from this point on as the MRS) in total hip arthroplasty. These devices are intended for use in total hip arthroplasty indicated as a result of extensive proximal femoral bone loss (from trauma, failed previous arthroplasty, or tumor resection). Adequate bone stock must be present to allow the use of the GMRS Press Fit Stems with PureFix® HA Coating.
Product codes (comma separated list FDA assigned to the subject device)
LZO
Device Description
The GMRS Press Fit Stems with PureFix® HA Coating are machined from titanium alloy (Titanium-6Aluminum-4Vanadium) which meets the requirements of ASTM standard F-136. The stems are coated with commercially pure titanium (CP titanium) plasma spray coating that conforms to ASTM specification F-1580. The proximal portion of the stem is also coated with PureFix® HA coating which meets ASTM specification F-1185.
The proximal portion of the stem incorporates a male taper with a taper angle of 2 degrees 52 minutes. This male taper mates with the female taper portion of the head/neck section or body section of the proximal femoral section of the Modular Replacement System.
The GMRS Press Fit Stems with PureFix® HA Coating are available in four styles:
- I Straight Stems: These stems are available in a 125mm length, and diameters from 11mm to 19mm in one millimeter increments. The seat diameter varies from 22 to 36mm, and the seat radius ranges from 8mm to 9.25mm.
- Straight Fluted Stems: These stems are also available in a 125mm length, and diameters from 11mm to 19mm in one millimeter increments. This stem design has four flutes that extend from the seat down 25mm of the length of the stem. These flutes are located 90 degrees apart on the body of the stem. The seat diameter varies from 22mm to 36mm, and the seat radius ranges from 8mm to 9.25mm.
- Curved Stem (150mm): These stems are available in a 150mm length, and diameters from 11mm to 19mm in one millimeter increments. The seat diameter of this stem ranges from 22mm to 36mm, and the seat radius ranges from 7mm to 10.5mm. The radius of the curvature is 45 inches.
- Curved Stem (200mm): These stems are available in a 200mm length, and diameters from 11mm to 19mm in one millimeter increments. The seat diameter of this stem varies from 22mm to 36mm, and the seat radius ranges from 7mm to 10.5mm. The radius of the curvature is 45 inches.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femoral segment
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)
Finite element analyses and testing were present to support a claim of substantial equivalence.
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.
MRS Cemented Stems Howmedica Osteonics, Distal Stem Segments of the Restoration Modular Femoral Stem Howmedica Osteonics
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
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
GMRS Press Fit Stems with PureFix® HA Confidential
510(k) Premarket Notification
OCT 1 7 2002
page 1 of 3
510(k) Summary
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
GMRS Press Fit Stems with PureFix® HA Proprietary Name: Modular Stem Common Name: Classification Name and Reference 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Class II Proposed Regulatory Class: Device Product Code: OR(87) LZO
Intended Use
The Global Modular Replacement System (referred to from this point on as the GMRS) Press Fit Stems with PureFix® HA Coating are intended to be used with components of the proximal femoral segment of the Howmedica Modular Replacement System (referred to from this point on as the MRS) in total hip arthroplasty. These devices are intended for use in total hip arthroplasty indicated as a result of extensive proximal femoral bone loss (from trauma, failed previous arthroplasty, or tumor resection). Adequate bone stock must be present to allow the use of the GMRS Press Fit Stems with PureFix® HA Coating.
2
1
GMRS Press Fit Stems with PureFix® HA Confidential
Indications
Proximal femoral reconstruction secondary to:
- Trauma
- Failed previous prosthesis .
- Tumor resection .
Contraindications
- Overt infection .
- Rapid disease progression beyond an acceptable margin .
For the use of GMRS Press Fit stems with PureFix® HA Coating, the following additional contraindication should be noted:
- . Inadequate bone stock to allow the use of a press fit stem
Device Description
The GMRS Press Fit Stems with PureFix® HA Coating are machined from titanium alloy (Titanium-6Aluminum-4Vanadium) which meets the requirements of ASTM standard F-136. The stems are coated with commercially pure titanium (CP titanium) plasma spray coating that conforms to ASTM specification F-1580. The proximal portion of the stem is also coated with PureFix® HA coating which meets ASTM specification F-1185.
The proximal portion of the stem incorporates a male taper with a taper angle of 2 degrees 52 minutes. This male taper mates with the female taper portion of the head/neck section or body section of the proximal femoral section of the Modular Replacement System.
The GMRS Press Fit Stems with PureFix® HA Coating are available in four styles:
- I Straight Stems: These stems are available in a 125mm length, and diameters from 11mm to 19mm in one millimeter increments. The seat diameter varies from 22 to 36mm, and the seat radius ranges from 8mm to 9.25mm.
510(k) Premarket Notification
page 2 of 3
2
GMRS Press Fit Stems with PureFix® HA Confidential
-
Straight Fluted Stems: These stems are also available in a 125mm length, and 피 diameters from 11mm to 19mm in one millimeter increments. This stem design has four flutes that extend from the seat down 25mm of the length of the stem. These flutes are located 90 degrees apart on the body of the stem. The seat diameter varies from 22mm to 36mm, and the seat radius ranges from 8mm to 9.25mm.
510(k) Premarket N -
Curved Stem (150mm): These stems are available in a 150mm length, and diameters I from 11mm to 19mm in one millimeter increments. The seat diameter of this stem ranges from 22mm to 36mm, and the seat radius ranges from 7mm to 10.5mm. The radius of the curvature is 45 inches.
-
Curved Stem (200mm): These stems are available in a 200mm length, and diameters . from 11mm to 19mm in one millimeter increments. The seat diameter of this stem varies from 22mm to 36mm, and the seat radius ranges from 7mm to 10.5mm. The radius of the curvature is 45 inches.
Equivalent products include:
- MRS Cemented Stems Howmedica Osteonics 1.
- Distal Stem Segments of the Restoration Modular Femoral Stem Howmedica 2. Osteonics
Finite element analyses and testing were present to support a claim of substantial equivalence.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and head. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
OCT 1 7 2002
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Margaret F. Crowe Regulatory Affairs Consultant Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401
Received: July 23, 2002
Re: K022403
Trade/Device Name: GMRS Press Fit Stems with PureFix® HA Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint/metal/ceramic/polymer/semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Codes: LZO Dated: July 22, 2002
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
4
Page 2 - Ms. Margaret F. Crowe
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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.
Mark A. Milkerson
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
page lofl
510(k) Premarket Notification
GMRS Press Fit Stems with PureFix® HA Confidential
510(k) Number (if known): KOL2403
Device Name: GMRS Press Fit Stems with PureFix® HA
Intended Use
The Global Modular Replacement System (referred to from this point on as the GMRS) Press Fit Stems with PureFix® HA Coating are intended to be used with components of the proximal femoral segment of the Howmedica Modular Replacement System in total hip arthroplasty. These devices are intended for use in total hip arthroplasty indicated as a result of extensive proximal femoral bone loss (from trauma, failed previous arthroplasty, or tumor resection). Adequate bone stock must be present to allow the use of the GMRS Press Fit Stems with PureFix® HA Coating.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-the Counter-Use
801.109)
Mark N Millman
Restorative 2403 510(k) Number