(65 days)
The 130° Modified Integral Femoral Components are intended for use in cases with a diagnosis of:
- a) non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
- b) rheumatoid arthritis
- c) non-union, femoral neck, and trochanteric fractures of the proximal femur with head involvement.
- d) correction of functional deformities
- e) revisions of previously failed surgeries and treatments
The 130° Modified Integral Femoral Component is intended for press-fit or cemented application. The device is a single use implant.
The device is composed of a forged titanium stem, which is designed to articulate with any commercially available acetabular component. The device is a modification of Biomet's standard Integral femoral component in that the trunion has been moved inferiorly, medially and rotated 10°, This results in a 130° neck angle as opposed to the standard 140° neck angle. Advantages of a reduced neck angle include potential increased joint stablity by improving soft tissue tension. The remainder of the stem is identical to that of the Biomet's standard Integral stems. The device features a duck-bill collar to provide implant stablity. The modified device has a reduced proximal profile. The device utilizes a modular head that is taper-fit on to the stem at the time of surgery.
This document (K984408) is a 510(k) premarket notification for a medical device called the "130° Modified Integral Femoral Component." It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study with acceptance criteria and device performance metrics in the way a clinical trial or AI algorithm validation would.
Therefore, many of the requested categories (such as sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, etc.) are not applicable to this type of regulatory submission. This document describes a modification to an existing orthopedic implant, and its clearance is based on comparison to legally marketed predicate devices, not on a performance study against specific acceptance criteria for a new clinical endpoint.
However, I can extract and present the aspects that are relevant from the document:
Acceptance Criteria and Device Performance for Biomet 130° Modified Integral Femoral Component (K984408)
The regulatory submission for the Biomet 130° Modified Integral Femoral Component is a 510(k) premarket notification. For such submissions, the "acceptance criteria" are primarily established through the demonstration of substantial equivalence to existing, legally marketed predicate devices. The "study" proving this generally involves engineering analysis, material testing, and comparison of design features and intended use, rather than clinical efficacy trials with quantitative performance metrics against predefined thresholds.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance/Comparison to Predicate |
|---|---|---|
| Intended Use | Identical or very similar intended use to predicate devices. | The device's intended use is for non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, certain proximal femur fractures, correction of functional deformities, and revisions of failed surgeries. This is consistent with predicate hip prostheses. |
| Technological Characteristics (Materials) | Made of similar materials to predicate devices. | Composed of a forged titanium stem. This is a common material for femoral components and is consistent with predicate devices. |
| Technological Characteristics (Design) | Similar design principles, with minor modifications that do not raise new questions of safety or effectiveness. | The device is a modification of Biomet's standard Integral femoral component. The trunion is moved inferiorly, medially, and rotated 10°, resulting in a 130° neck angle (vs. standard 140°). This modification aims to increase joint stability by improving soft tissue tension without fundamentally altering the implant's function. The remainder of the stem is identical to standard Integral stems, features a duck-bill collar, and a reduced proximal profile. It uses a modular head taper-fit onto the stem. |
| Performance (Bench Testing/Analysis, if applicable) | Demonstration that mechanical properties meet standards and are equivalent to predicate devices, or that modifications do not compromise established performance. | While specific test results are not detailed in this summary, the substantial equivalence assertion implies that any necessary bench testing (e.g., fatigue, static strength) would have demonstrated comparable performance to predicate devices and relevant standards. The document states it is "substantially equivalent to most femoral devices on the market in overall design and intended function." |
| Potential Risks | Similar risk profile to predicate devices. | Potential risks are identified as the same as any joint replacement device, including fracture, loosening, infection, nerve damage, metal sensitivity, etc. This is consistent with the known risks of predicate hip implants. |
2. Sample Size used for the test set and the data provenance:
- Sample Size: Not applicable. This is not a clinical trial evaluating performance against a ground truth dataset in the traditional sense. Substantial equivalence is determined by comparing design, materials, and intended use.
- Data Provenance: Not applicable for a traditional "test set." The "data" involves engineering specifications, material properties, and comparison to existing device designs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the context of clinical endpoints or diagnostic accuracy is not established for this type of submission. Regulatory experts at the FDA (e.g., engineers, medical officers) review the submission against regulatory requirements and predicate device information.
4. Adjudication method for the test set:
- Not applicable. There is no "test set" and no "adjudication" in the sense of expert consensus on outcomes for a patient cohort.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI device, nor is it a diagnostic device where reader performance is evaluated.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical orthopedic implant, not an algorithm.
7. The type of ground truth used:
- Not applicable. For a 510(k) device, the "ground truth" for clearance is essentially demonstration of substantial equivalence to a predicate device and compliance with general controls, indicating that the new device is as safe and effective as existing legally marketed devices. This is established through comparative analysis of technical characteristics, intended use, and materials.
8. The sample size for the training set:
- Not applicable. There is no "training set" for this type of regulatory submission.
9. How the ground truth for the training set was established:
- Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo for Biomet Inc. The logo consists of the word "BIOMET" in a stylized font, with the letters connected and enclosed in a rectangular box. To the right of the word "BIOMET" is the word "INC" written vertically. Below the logo, the words "CORPORATE HEADQUARTERS" are written in a serif font. Above the logo is the number K984408.
SUMMARY OF SAFETY AND EFFECTIVENESS
Biomet. Inc SPONSOR:
130° Integral Modified Femoral Component DEVICE:
CLASSIFICATION NAME:
-
Prosthesis, hip, semi-constrained, metal/polymer, porous, uncemented (888.3558)
-
Prosthesis, hip, semi-constrained, metal/polymer, cemented (888.3350)
INTENDED USE: The 130° Modified Integral Femoral Components are intended for use in cases with a diagnosis of:
- non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis a)
- b) rheumatoid arthritis
- non-union, femoral neck, and trochanteric fractures of the proximal femur with head c) involvement.
- correction of functional deformities d)
- revisions of previously failed surgeries and treatments e)
The 130° Modified Integral Femoral Component is intended for press-fit or cemented application. The device is a single use implant.
DEVICE DESCRIPTION: The device is composed of a forged titanium stem, which is designed to articulate with any commercially available acetabular component. The device is a modification of Biomet's standard Integral femoral component in that the trunion has been moved inferiorly, medially and rotated 10°, This results in a 130° neck angle as opposed to the standard 140° neck angle. Advantages of a reduced neck angle include potential increased joint stablity by improving soft tissue tension. The remainder of the stem is identical to that of the Biomet's standard Integral stems. The device features a duck-bill collar to provide implant stablity. The modified device has a reduced proximal profile. The device utilizes a modular head that is taper-fit on to the stem at the time of surgery.
POTENTIAL RISKS: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:
| Fracture of the component | Deformity of the joint | Bone fracture | Hematoma |
|---|---|---|---|
| Implant loosening/migration | Delayed wound healing | Blood vessel damage | Infection |
| Breakdown of porous surface | Soft tissue imbalance | Metal sensitivity | Nerve damage |
| Cardiovascular disorders | Tissue growth failure | Excessive wear | Dislocation |
SUBSTANTIAL EQUIVALENCE: The 130° Degree Integral Modified Femoral Component is substantially equivalent to most femoral devices on the market in overall design and intended function. Predicate devices include:
| Integral Total Hip System (Biomet, Inc.) | K921225 |
|---|---|
| Omni-Fit (Osteonics) | K940715(?) |
| Natural Hip (Intermedics (Sulzer) Orthopaedics) | K920955 |
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580
1
OFFICE 219.267.6639
FAX 219.267.8137
E-MAIL biomet@biomet.com
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 1999
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana
K984408 Re: 130º Modified Integral Femoral Components Trade Name: Requlatory Class: II Product Codes: LPH and JDI Dated: December 7, 1998 December 9, 1998 Received:
Dear Ms. Beres:
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 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 aqainst 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 In addition, FDA may publish further announcements action. 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.
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Page 2 - Ms. Patricia Sandborn Beres
This letter will allow you to begin marketing your device as described in your 510 k) premarket notification. The FDA described in your sia (i) equivalence of your device to a legally finding of Substancial equitation a classification for your marketed predicate device rusalesice to proceed to the market.
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 victo diagnobels at (301) 594-4659. Additionally, for questions on compriation and advertising of your device, please contact che Dffice of Compliance at (301) 594-4639. Also, please note the orrios or compatied, "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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celta M. Witten, Ph.D., M.D.
Ph.D., M.D. Celra M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: 130° Modified Integral Femoral Components
Indications For Use:
- a) non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
- b) rheumatoid arthritis
- c) non-union, femoral neck, and trochanteric fractures of the proximal femur with head involvement.
- d) correction of functional deformities
- e) revisions of previously failed surgeries and treatments
The 130° Modified Integral Femoral Component is intended for press-fit or cemented application. The device is a single use implant.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K984408
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use No
(Optional Format 1-2-96)
§ 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.