(80 days)
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.
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 provided text is a 510(k) Summary for a medical device called the "TMZF® Press Fit HA Stem and TMZF® Press Fit Plus HA Stem." This type of document is for regulatory clearance and focuses on substantial equivalence to previously approved devices, rather than a detailed study proving performance against specific acceptance criteria like those found in clinical trials for diagnostic algorithms or new therapies.
Therefore, many of the requested categories (1-7, and 9 for the training set ground truth) are not applicable to this document as it describes a predicate-based approval for an orthopedic implant, not a study evaluating device performance against pre-defined metrics.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. This document establishes substantial equivalence to predicate devices, rather than proving performance against specific, quantifiable acceptance criteria. The focus is on comparing the new device's intended use, materials, design, and operational principles to existing cleared devices. The closest statement to "reported performance" is that "Testing indicates that the addition of the HA coating over plasma spray has no detectable effect on the stem fatigue strength." This isn't a performance metric against an acceptance criterion but rather a statement confirming that a change (HA coating) did not negatively impact a critical property.
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable. This document does not describe a "test set" in the context of evaluating a diagnostic algorithm or a similar device. The testing mentioned appears to be mechanical testing (fatigue strength), not an evaluation using patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not Applicable. This document pertains to the regulatory clearance of an orthopedic implant based on substantial equivalence. Establishing "ground truth" with experts as would be done for a diagnostic device (e.g., radiologists interpreting images) is not relevant here.
4. Adjudication Method for the Test Set
Not Applicable. There is no "test set" or adjudication process described in the context of expert review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
Not Applicable. MRMC studies are typically used to evaluate the performance of diagnostic devices or assays, often comparing human readers with and without AI assistance. This document describes an orthopedic implant, for which an MRMC study is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not Applicable. This device is a physical orthopedic implant, not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.
7. The Type of Ground Truth Used
Not Applicable. For orthopedic implants, "ground truth" typically refers to long-term clinical outcomes, revision rates, or pathology results from removed implants, which are typically gathered retrospectively after a device has been on the market for some time, or in pre-market clinical trials (which this 510(k) summary does not describe). The information presented here focuses on mechanical testing.
8. The Sample Size for the Training Set
Not Applicable. This document does not describe a "training set" in the context of machine learning or algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no "training set" in the context of machine learning described, the method for establishing its ground truth is also not applicable.
{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. RiederRutherford Regulatory AffairsHowmedica Osteonics Corp.359 Veterans BoulevardRutherford, 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.
| 11 | 1 |
|---|---|
(Division Sign-Off) (Division Sign Orgin Circulative Devices 994366 510(k) Number -
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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)
§ 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.