(48 days)
Not Found
No
The device description focuses solely on the mechanical design and material properties of a metallic femoral stem for hip replacement, with no mention of software, algorithms, or data processing.
Yes.
The device is a femoral component and stem used for treating various joint diseases and fractures, which falls under the definition of a therapeutic device.
No
Explanation: The device described is a femoral component (implant) used in total hip replacement surgeries. Its "Intended Use / Indications for Use" outlines various conditions for which it can be surgically implanted, such as osteoarthritis or rheumatoid arthritis, and for revision procedures or correction of deformities. It is a treatment device, not a diagnostic one that identifies or characterizes a disease or condition.
No
The device description explicitly states it is composed of a metallic femoral stem (forged titanium) and describes its physical characteristics and materials, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that this device is a "metallic femoral stem" intended for surgical implantation as part of a hip replacement. It is a physical implant, not a device used to analyze biological samples.
- Intended Use: The intended uses listed are all related to treating conditions of the hip joint through surgical intervention (e.g., osteoarthritis, rheumatoid arthritis, fractures, revisions). These are clinical indications for a surgical implant, not for a diagnostic test.
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 Reach Femoral Component is indicated for use in:
- non-inflammatory degenerative joint disease a.
- oseoarthritis b.
- avascular necrosis c.
- d. rheumatoid arthritis
- revisions procedures where other devices or treatments have failed e.
- f. correction of functional deformities
- treatment of non-unions, femoral neck and trochanteric fractures of the g. proximal femur with head involvement.
The Reach Femoral Stems are intended for press-fit application and for single use implants.
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO
Device Description
The device is composed of a metallic femoral stem (forged titanium) which is designed to articulate with any Biomet's acetabular component.
The Reach stem geometry is designed for proximal, as well, distal stability and gradual offloading into the bone along the canal. The proximal 100-mm of each stem incorporates a bi-planer 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.
The stem has a duckbill porous coated collar, which is incorporated to provide component stability and stress transfer. The underside of the collar is porous coated to help ensure collar-clacar contact and stress distribution. This helps to provide rotational stability and load transfer.
Distally, the stem is cylindrical with an anterior bow for left and right specific applications. The distal anterior bow more closely matches the anatomic femur to provide rotational stability. The cylindrical design will also enhance implant stability by providing a potential area of biological fixation in situations of proximal bone deficiencies.
The Reach femoral stems will be fully coated to provide maximum proximal and distal fixation through potential bony ingrowth. This circumferetial closed-pore porous coating potentially seals the femur from debris migration. Porous coating in 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 distal tip of the stem is a polished finish, to prevent distal off loading and fixation of the tip (otherwise known as the "pedestal effect").
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)
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.
K933942, K941942, K953703, K921255, 973302
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
§ 888.3358 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.
0
AUG 2 4 1998
SUMMARY OF SAFETY AND EFFECTIVENESS
| SPONSOR: | Biomet, Inc. |
|---|---|
| Airport Industrial Park | |
| Warsaw, Indiana 46580 |
Reach Femoral Hip Component DEVICE:
CLASSIFICATION NAME: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis,
INTENDED USE: The Reach Femoral Component is indicated for use in:
- non-inflammatory degenerative joint disease a.
- oseoarthritis b.
- avascular necrosis c.
- d. rheumatoid arthritis
- revisions procedures where other devices or treatments have failed e.
- f. correction of functional deformities
- treatment of non-unions, femoral neck and trochanteric fractures of the g. proximal femur with head involvement.
The Reach Femoral Stems are intended for press-fit application and for single use implants.
DEVICE DESCRIPTION: The device is composed of a metallic femoral stem (forged titanium) which is designed to articulate with any Biomet's acetabular component.
The Reach stem geometry is designed for proximal, as well, distal stability and gradual offloading into the bone along the canal. The proximal 100-mm of each stem incorporates a bi-planer 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.
The stem has a duckbill porous coated collar, which is incorporated to provide component stability and stress transfer. The underside of the collar is porous coated to help ensure collar-clacar contact and stress distribution. This helps to provide rotational stability and load transfer.
Distally, the stem is cylindrical with an anterior bow for left and right specific applications. The distal anterior bow more closely matches the anatomic femur to provide rotational stability. The cylindrical design will also enhance implant stability
1
by providing a potential area of biological fixation in situations of proximal bone deficiencies.
The Reach femoral stems will be fully coated to provide maximum proximal and distal fixation through potential bony ingrowth. This circumferetial closed-pore porous coating potentially seals the femur from debris migration. Porous coating in 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 distal tip of the stem is a polished finish, to prevent distal off loading and fixation of the tip (otherwise known as the "pedestal effect").
POTENTIAL RISKS: The potential risks associated with this device are the same as with any joint replacement device. These include, but not limited to:
| Fracture of the component | Bone fracture |
|---|---|
| Cardiovascular disorders | Hematoma |
| Implant loosening/migration | Blood vessel damage |
| Soft tissue imbalance | Nerve damage |
| Deformity of the joint | Excessive wear |
| Tissue growth failure | Infection |
| Delayed wound healing | Dislocation |
| Metal sensitivity | Breakdown of porous surface |
SUBSTANTIAL EQUIVALENCE: The Reach Femoral Hip Component is substantially equivalent to most femoral devices on the market in overall design and intended function. Predicate devices include:
The Solution System® Depuy, Warsaw, IN 510(k) # K933942, K941942, K953703 Integral® Total Hip system, Biomet, Inc., Warsaw, IN 510(K) #K921255 Foundation® Porous Hip Stem. Encore Orthopedics. Austin TX 510(K) 973302
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 three human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 4 1998
Ms. Julie K. Ryan Requlatory Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana
Re : K982367 Reach Femoral Hip Component Regulatory Class: II Product Codes: LPH and LZO Dated: July 6, 1998 Received: July 7, 1998
Dear Ms. Ryan:
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, Druq, 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 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. ದ 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 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 requlations.
3
Page 2 - Ms. Julie K. Ryan
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,
Russell D. Lyon
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
4
510(k) NUMBER (IF KNOWN): K982367
Reach femoral Component DEVICE NAME:
INDICATIONS FOR USE:
The indications for use of the Reach Femoral Component are:
.
. .
a.) non-inflammatory degenerative disease
- osteoarthritis b.)
- C.) avascular necrosis
- rheumatoid arthritis d.)
- e.) revisions of hip replacement components
- treatment of non-union, femoral neck and trochanteric £.) fractures of the proximal femur with head involvement.
The Reach stem is intended for press-fit application and for single use implantation.
(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 | 982367 |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter-Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|
(Division Sign-Off) Division of General Restorative Devices
510(k) Number_