(198 days)
Not Found
No
The summary describes a mechanical hip implant system and does not mention any software, algorithms, or data processing related to AI or ML. The performance studies mentioned are based on finite element analysis and physical testing, not AI/ML model validation.
Yes
The device is a modular hip stem intended for total hip arthroplasty, which is a therapeutic intervention to replace a damaged hip joint.
No
The device is described as a modular hip stem intended for primary or revision total hip arthroplasty, which is a therapeutic intervention, not a diagnostic one.
No
The device is a physical implantable medical device (hip stem components) made of Titanium alloy, not a software-only device.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is a "2 Piece Modular Revision Stem Component" intended for "primary or revision total hip arthroplasty." This is a surgical implant used within the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The 2 Piece Modular Revision Stem Components are intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. The stems are intended to be used with Howmedica Osteonics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the proximal femur.
Product codes
LZO
Device Description
The 2 Piece Modular Hip Stem is a modular system comprised of a proximal body, distal stem, and locking bolt. These three individual components utilizing a modular junction are assembled by the surgeon in the operating room or in situ to allow independent sizing This system is designed so that all proximal of the proximal body and distal stem. components will be able to mate with all distal components, thus affording optimal flexibility.
This system is intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. The stems are intended to be used with Howmedica Osteonics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the proximal femur.
The 2 Piece Modular Hip Stem components will be fabricated from Titanium (Ti6A1-4V) Alloy. The Cone, Broached, and Milled body components as well as the Porous Stems will be offered with plasma spray or plasma spray and hydroxylapatite coatings.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, proximal femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, Operating Room
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)
The fatigue strength of the proximal and distal regions of the bodies and stems was verified using finite element techniques. For the proximal body strength analyses, testing consistent with the applicable ISO standards for neck and stem strength was conducted. The effect of taper length on the stresses in the taper region was investigated using finite element techniques. Further physical testing of the taper was undertaken to confirm strength of the junction in torsion. Additionally, the application of the PureFix® HA coating has no effect on the fatigue strength of the shot peened and plasma sprayed coating on the Ti-6Al-4V ELI Alloy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K983404, K972893, K972228, K993768
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary for the 2 Piece Modular Hip Stem
APR 0 3 2002
KO13106
| Proprietary Name: | 2 Piece Modular Hip Stem |
|---|---|
| Common Name: | Femoral Hip Prosthesis |
| Classification Name and Reference: | 21 CFR 888.3353 |
| Hip joint metal/ceramic/polymer semi-constrained cemented or | |
| nonporous uncemented prosthesis. | |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | OR(87) LZO |
| For Information contact: | Jennifer A. Daudelin |
| Regulatory Affairs Specialist | |
| Howmedica Osteonics Corp. | |
| 59 Route 17 | |
| Allendale, NJ 07401-1677 | |
| (201) 831-5379 | |
| Fax: (201) 760-8435 | |
| Date Summary Prepared: | January 24, 2002 |
Date Summary Prepared:
The 2 Piece Modular Hip Stem is a modular system comprised of a proximal body, distal stem, and locking bolt. These three individual components utilizing a modular junction are assembled by the surgeon in the operating room or in situ to allow independent sizing This system is designed so that all proximal of the proximal body and distal stem. components will be able to mate with all distal components, thus affording optimal flexibility.
This system is intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. The stems are intended to be used with Howmedica Osteonics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the proximal femur.
The 2 Piece Modular Hip Stem components will be fabricated from Titanium (Ti6A1-4V) Alloy. The Cone, Broached, and Milled body components as well as the Porous Stems will be offered with plasma spray or plasma spray and hydroxylapatite coatings.
1
510(k) Summary for the 2 Piece Modular Hip Stem
The fatigue strength of the proximal and distal regions of the bodies and stems was verified using finite element techniques. For the proximal body strength analyses, testing consistent with the applicable ISO standards for neck and stem strength was conducted. The effect of taper length on the stresses in the taper region was investigated using finite element techniques. Further physical testing of the taper was undertaken to confirm strength of the junction in torsion. Additionally, the application of the PureFix® HA coating has no effect on the fatigue strength of the shot peened and plasma sprayed coating on the Ti-6Al-4V ELI Alloy.
The substantial equivalence of the 2 Piece Modular Stem is based upon equivalence in intended use, materials, design, and operational principles to the following Howmedica Osteonics devices: Type 3 Femoral Components (K983404); Partnership Revision Femoral Component (K972893); Meridian Titanium Femoral Stems (K972228); and the Citation TMZF HA Femoral Stem (K993768).
KO13106
2
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 an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 3 2002
Jennifer A. Daudelin Regulatory Affairs Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401-1677
Re: K013106
Trade/Device Name: 2-Piece Modular Hip Stem Regulation Number: 21 CFR §888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or porous uncemented prosthesis
Regulatory Class: Class II Product Code: LZO Dated: January 24, 2002 Received: January 25, 2002
Dear Ms. Daudelin:
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.
3
Page 2 - Ms. Jennifer A. Daudelin
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.
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 yours,
. Mark-A. Millman
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
4
Indications for Use
KO13106 510(k) Number (if known):
Device Name: 2 Piece Modular Hip Stem
Indications for Use:
The 2 Piece Modular Revision Stem Components are intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. The stems are intended to be used with Howmedica Osteonics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the proximal femur.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
for Mark A Millmann
(Division Sign-Off)
Division of General, Restorative and Neur nogical Devices
OR
- (a) Number K013106