(80 days)
Not Found
No
The summary describes a mechanical implant (femoral stem) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is a femoral stem used in hip surgery to treat various joint diseases and fractures, which are conditions that impair normal bodily function and require treatment for restoration.
No
The device described is a TMZF® Press Fit HA Stem, which is a femoral stem used for reconstruction in hip surgery. It is a surgical implant designed for treatment, not for diagnosing medical conditions.
No
The device description clearly indicates that the device is a physical femoral stem made of TMZF® alloy with coatings, intended for surgical implantation. It is a hardware device, not 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 hip replacement and revision procedures. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant (femoral stem) made of specific materials and coatings, designed to be surgically inserted into the body. This is consistent with a medical device, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or screening
Therefore, the TMZF® Press Fit HA Stem and TMZF® Press Fit Plus HA Stem are medical devices intended for surgical implantation, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The TMZF® Press Fit HA Stem and TMZF® Press Fit Plus HA Stem are indicated for cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity. Additionally, these femoral stems can be used in the treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. These stems are also indicated for use in revision procedures where other treatments or devices have failed.
Product codes (comma separated list FDA assigned to the subject device)
MEH
Device Description
The TMZF® Press Fit HA Stem and TMZF® Press Fit Plus HA Stem are neutral, press fit femoral stems consisting of a variety of lengths. The devices are available in two neck angle options for each corresponding body geometry. These femoral stems contain a symmetric wedge with a groove running along each stem's axis distally up to the mid stem region.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur
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)
Testing indicates that the addition of the HA coating over plasma spray has no detectable effect on the stem fatigue strength.
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.
K972228, K955871, K941366, K921301
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
MAR 1 6 2000
510(k) Summary
Device: TMZF® Press Fit HA Stem and TMZF® Press Fit Plus HA Stem
The TMZF® Press Fit HA Stem and TMZF® Press Fit Plus HA Stem are neutral, press fit femoral stems consisting of a variety of lengths. The devices are available in two neck angle options for each corresponding body geometry. These femoral stems contain a symmetric wedge with a groove running along each stem's axis distally up to the mid stem region.
These stems are intended for the reconstruction of the head and neck of the femoral ioint. The device is intended for primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty. These stems can be used with any currently available Howmedica Osteonics acetabular components and V40™ Femoral Heads that can be mated with a 5° 40' BG taper.
The TMZF® Press Fit HA Stem and TMZF® Press Fit Plus HA Stem will be fabricated from TMZF® alloy. The stems are coated with a CP Titanium plasma spray coating and Pure-Fix™ HA.
The substantial equivalence of the TMZF® Press Fit HA Stem and TMZF® Press Fit Plus HA Stem is based upon equivalence in intended use, materials, design, and operational principles to the Meridian® Titanium Femoral Stem (K972228); the Howmedica® Asymmetric Stem Femoral Component (K955871); the Osteonics® Omnifit® AD-HA Hip Stem Series (K941366); and the Biomet® Taperloc™ Hip System (K921301).
Testing indicates that the addition of the HA coating over plasma spray has no detectable effect on the stem fatigue strength.
| For information contact: | Ms. Nancy J. Rieder
Rutherford Regulatory Affairs
Howmedica Osteonics Corp.
359 Veterans Boulevard
Rutherford, NJ 07070-2584 | |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| | Phone: | (201) 507-7956 |
| | Fax: | (201) 507-6870 |
| | E-mail: | NRieder@HowOst.com |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol resembling an eagle or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 6 2000
Ms. Nancy J. Rieder Rutherford Regulatory Affairs Stryker Howmedica Osteonics Corporation 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
Re: K994366
Trade Name: TMZF® Press Fit HA Stem and TMZF® Press Fit Plus HA Stem Regulatory Class: II Product Code: MEH Dated: December 23, 1999 Received: December 27, 1999
Dear Ms. Rieder:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings forming a shape that resembles human profiles.
Page 2 - Ms. Nancy J. Rieder
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Neil R.P. Ogden
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K994366 510(k) Number (if known):
Device Name: TMZF® Press Fit HA Stem and TMZF® Press Fit Plus HA Stem
Indications for Use:
The TMZF® Press Fit HA Stem and TMZF® Press Fit Plus HA Stem are indicated for cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity. Additionally, these femoral stems can be used in the treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. These stems are also indicated for use in revision procedures where other treatments or devices have failed.
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(Division Sign-Off) (Division Sign Orgin Circulative Devices 994366 510(k) Number -
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Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use X (Per 21 CFR 801.109)
Over-The-Counter Use______________
(Optional Format 1-2-96)