(84 days)
No
The description focuses solely on the mechanical design, materials, and intended use of a hip prosthesis, with no mention of software, algorithms, or data processing.
Yes
The device is described as an implant used for the reconstruction of the hip joint due to damage caused by trauma or degenerative disease, which directly addresses a medical condition and aims to restore function, aligning with the definition of a therapeutic device.
No
This device is described as a "Prosthesis" and an "implant" for the reconstruction of the hip joint. It is a physical component intended for surgical placement, not for diagnosing conditions.
No
The device description clearly states it is a metallic femoral stem, which is a physical hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "reconstruction of the hip joint due to damage caused by trauma or degenerative disease and in cases where a previous hip replacement component has failed." This describes a surgical implant used in vivo (within the body) for treatment.
- Device Description: The description details a metallic femoral stem designed to be implanted into the bone and articulate with another component. This is consistent with a surgical implant, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on laboratory tests
- Using reagents or assays
Therefore, the Biomet APF Porous Coated Line Extension Prosthesis is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Biomet's APF Porous Coated Line Extension Prosthesis is intended for use in reconstruction of the hip joint due to damage caused by trauma or degenerative disease and in cases where a previous hip replacement component has failed. The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnosis. The device is a single use implant.
Product codes (comma separated list FDA assigned to the subject device)
LPH, JDI
Device Description
The device is composed of a metallic femoral stem (forged titanium) which is designed to articulate with a commercially available acetabular component.
The APF Porous Coated Line Extension stem geometry is designed for proximal, as well as, distal stability and gradual offloading into the bone along the canal. The proximal portion of the stem incorporates a bi-planar taper to encourage proximal offloading, thus reducing stress shielding. This broad proximal geometry fills a greater portion of the metaphysis, thus providing improved rotational stability. In a cemented application, the increased proximal stress transfer of titanium helps preserve the calcar bone and maintain the integrity of the proximal cement mantle.
The stem has a porous coated collar which is incorporated to provide the component stability and stress transfer. Only the underside of the collar is porous coated to help ensure collar-calcar contact and stress distribution. This also provides additional rotational stability and load transfer.
Distally the stem is cylindrical with an anterior bow for left and right configurations. The distal anterior bow more closely matches the anatomic femur to provide rotational stability. This cylindrical design will also enhance implant stability by providing a potential area of biological fixation in situations of proximal bone deficiencies. The lower modulus of elasticity of a titanium stem will also produce less distal stress offloading and is less likely to fracture the cement mantle.
The APF Porous Coated Line Extension stems will be 75%-100% porous coated to provide maximum proximal and distal fixation through tissue ingrowth in non-cemented applications or cement adherence in cemented applications. This circumferential closedpore porous coating potentially seals the the femur from debris migration. Porous coating on the underside of the collar along with extended proximal to distal porous coating, provide areas of potential tissue ingrowth in crucial regions of cortical bone. The roughened surface of the porous coating will also enhance the hip stem/cement bonding, thus improving the chances of long term success. The portion of the stem that is not porous coated (on the 75% and 80% porous coated components) has a 30 grit corse blast finish or (on the 100% porous coated components) the distal tip of the component has a bead blast finish.
The femoral component utilizes a modular head which is taper-fit onto the stem at the time of surgery (Exhibit I). The modular heads are manufactured from wrought cobalt-chromium-molybdenum conforming to ASTM F-1537. The use of mixed metals in surgery is also addressed in MAF-153 (7/10/92 amendment, pg. 54-105). The stem trunions are identical to Biomet's Type I tapers for the Zirconia Ceramic Heads cleared in 510(k) K905687, K913420, and K925345. There is a 4 degree included angle on the trunion. Refer to Exhibit I for a complete listing of modular heads to be used with this stem. For more information on these modular heads, refer to MAF-442.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint, femoral
Indicated Patient Age Range
skeletally mature individuals
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)
Not Found
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.
K852585, K921225, K971824, K964650, K941942
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.
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
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
2/11/99
K984154 SUMMARY OF SAFETY AND EFFECTIVENESS
Sponsor: Biomet, Inc. Airport Industrial Park Warsaw, Indiana 46580
Device: APF Porous Coated Line Extension
Classification Name: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis (888.3358) and hip joint metal/ceramic/ polymer semiconstrained porous coated cemented prosthesis (888.3350).
Intended Use: Biomet's APF Porous Coated Line Extension Prosthesis is intended for use in reconstruction of the hip joint due to damage caused by trauma or degenerative disease and in cases where a previous hip replacement component has failed. The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnosis. The device is a single use implant.
Device Description: The device is composed of a metallic femoral stem (forged titanium) which is designed to articulate with a commercially available acetabular component.
The APF Porous Coated Line Extension stem geometry is designed for proximal, as well as, distal stability and gradual offloading into the bone along the canal. The proximal portion of the stem incorporates a bi-planar taper to encourage proximal offloading, thus reducing stress shielding. This broad proximal geometry fills a greater portion of the metaphysis, thus providing improved rotational stability. In a cemented application, the increased proximal stress transfer of titanium helps preserve the calcar bone and maintain the integrity of the proximal cement mantle.
The stem has a porous coated collar which is incorporated to provide the component stability and stress transfer. Only the underside of the collar is porous coated to help ensure collar-calcar contact and stress distribution. This also provides additional rotational stability and load transfer.
Distally the stem is cylindrical with an anterior bow for left and right configurations. The distal anterior bow more closely matches the anatomic femur to provide rotational stability. This cylindrical design will also enhance implant stability by providing a potential area of biological fixation in situations of proximal bone deficiencies. The lower modulus of elasticity of a titanium stem will also produce less distal stress offloading and is less likely to fracture the cement mantle.
The APF Porous Coated Line Extension stems will be 75%-100% porous coated to provide maximum proximal and distal fixation through tissue ingrowth in non-cemented
1
applications or cement adherence in cemented applications. This circumferential closedpore porous coating potentially seals the the femur from debris migration. Porous coating on the underside of the collar along with extended proximal to distal porous coating, provide areas of potential tissue ingrowth in crucial regions of cortical bone. The roughened surface of the porous coating will also enhance the hip stem/cement bonding, thus improving the chances of long term success. The portion of the stem that is not porous coated (on the 75% and 80% porous coated components) has a 30 grit corse blast finish or (on the 100% porous coated components) the distal tip of the component has a bead blast finish.
The femoral component utilizes a modular head which is taper-fit onto the stem at the time of surgery (Exhibit I). The modular heads are manufactured from wrought cobaltchromium-molybdenum conforming to ASTM F-1537. The use of mixed metals in surgery is also addressed in MAF-153 (7/10/92 amendment, pg. 54-105). The stem trunions are identical to Biomet's Type I tapers for the Zirconia Ceramic Heads cleared in 510(k) K905687, K913420, and K925345. There is a 4 degree included angle on the trunion. Refer to Exhibit I for a complete listing of modular heads to be used with this stem. For more information on these modular heads, refer to MAF-442.
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:
- Reaction to bone cement Fracture of the components Cardiovascular disorders Implant loosening/migration Soft tissue imbalance Deformity of the joint Delayed wound healing Fracture of the cement Dislocation
- Bone fracture Hematoma Blood vessel damage Nerve damage Excessive wear Infection Metal sensitivity Breakdown of porous surface
Substantial Equivalence: In function and overall design the APF Porous Coated Line Extension is equivalent to other commercially available hip stems currently on the market. These devices include:
Porous APF (Biomet, Inc. - 510(k) K852585) Integral Hip Stem (Biomet, Inc. - 510(k) K921225) Reach Femoral Stem (Biomet, Inc. - 510(k) K971824) AML (DePuy - 510(k) K964650) The Solution System (DePuy - 510(k) K941942)
Information on these predicate devices and a table providing comparison is contained in Exhibit IV.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 1999
Mr. Fred McClure Requlatory Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana
Re: K984154 APF Porous Coated Line Extension Trade Name: Regulatory Class: II Product Codes: LPH and JDI Dated: November 17, 1998 Received: November 19, 1998
Dear Mr. McClure:
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 qeneral controls provisions The general controls provisions of the Act 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 Requlations, 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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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 requlations.
3
Page 2 - Mr. Fred McClure
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.
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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
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
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Page_1 of 1
510 (k) Number (if known) : K98 4154
APF Porous Coated Line Extension Device Name:
Indications For Use: Biomet's APF Porous Coated Line Extension Prosthesis is intended for use in reconstruction of the hip joint due to damage caused by trauma or degenerative disease and in cases where a previous hip replacement component has failed. The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnosis. The device is a single use implant.
Prescription use Yes
.
Over the County, Use No
cool
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K784154
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