(202 days)
Not Found
No
The description focuses solely on the mechanical design, materials, and intended use of a physical implant. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
Yes.
The device is a femoral component intended for reconstruction of the hip joint due to trauma or degenerative disease, which falls under the definition of a therapeutic device as something used to treat a disease or condition.
No
Explanation: The provided text describes a "Femoral Component" intended for hip joint reconstruction. This device is an implant designed for treatment, not for diagnosing a condition or disease.
No
The device description clearly details a physical, metallic femoral stem, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The provided text describes a femoral component, which is a metallic implant designed to be surgically inserted into the hip joint to replace damaged bone.
- Intended Use: The intended use is for the reconstruction of the hip joint due to trauma or degenerative disease, and in cases of failed previous hip replacements. This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
The device is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Reach Femoral Component 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 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.
Product codes (comma separated list FDA assigned to the subject device)
LZO, LPH
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 Reach stem geometry is designed for proximal, as well as, distal stability and gradual officading into the bone along the canal. The proximal 100mm of each stern incorporates a bi-planar taper to encourage proximal officading, 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 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-calcar contact and stress distribution. This helps to provide rotational stablity and load transfer. Distally, the stem is cylindrical after 100mm with an anterior bow for left and right specific applications. 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 officading and is less likely to fracture the cement mantle. The Reach temoral stems will be fully coated to provide maximum proximal and distal fixation through bony ingrowth. This circumferential closed-pore porous coating potentially seals 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 distal tip of the stern is a sisal buff or polished finish, to prevent distal offloading 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
Hip joint
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.
P820024000, K933942, K941942, K953703, K921255
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
DEC - 4 1997
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 (888.3358) and hip joint metal/ceramic/polymer semi-constrained porous coated cemented prosthesis (888.3350).
Intended Use: The Reach Femoral Component 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 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.
This 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 Reach stem geometry is designed for proximal, as well as, distal stability and gradual officading into the bone along the canal. The proximal 100mm of each stern incorporates a bi-planar taper to encourage proximal officading, 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 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-calcar contact and stress distribution. This helps to provide rotational stablity and load transfer.
Distally, the stem is cylindrical after 100mm with an anterior bow for left and right specific applications. 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 officading and is less likely to fracture the cement mantle.
1
The Reach temoral stems will be fully coated to provide maximum proximal and distal fixation through bony ingrowth. This circumferential closed-pore porous coating potentially seals 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 distal tip of the stern is a sisal buff or polished finish, to prevent distal offloading 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 are not limited to:
| Reaction to bone cement | Bone fracture |
|---|---|
| Fracture of the components | Hematoma |
| Cardiovascular disorders | Blood vessel damage |
| Implant loosening/migration | Nerve damage |
| Soft tissue imbalance | Excessive wear |
| Deformity of the joint | Infection |
| Tissue growth failure | Dislocation |
| Delayed wound healing | Metal sensitivity |
| Fracture of the cement | Breakdown of porous surface |
Substantial Equivalence: The Reach Femoral Hip Component is substantially equivalent to almost all femoral devices on the market in overall design and intended function. Predicate devices include:
000004 4
AML® (Depuy, Warsaw, IN) PMA# P820024000
్రా
| The Solution System ® (Depuy, Warsaw, IN) | -510(k)# K933942 |
|---|---|
| -510(k)# K941942 | |
| -510(k)# K953703 |
Integral® Total Hip System (Biomet, Inc., Warsaw, IN) -510(k) K921255
2
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States of America. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 4 1997
Deborah M. Matarazzo, R.N., B.S.N. Clinical Research Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana
K971824 Re : Reach Femoral Hip Component Trade Name: Requlatory Class: II Product Codes: LZO and LPH Dated: September 5, 1997 Received: September 8, 1997
Dear Ms. Matarazzo:
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 and the following limitation that the package insert must reflect that the Zirconia Ceramic Femoral Heads are to be used only with forged Ti6A14V alloy hip stems with the Type I taper trunnions.
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. ਜੋ 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
3
Page 2 - Deborah M. Matarazzo, R.N., B.S.N.
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.
Under Section 522(a) of the act, manufacturers of certain types of devices identified by the Act or designated by FDA are required to conduct postmarket surveillance studies. FDA has identified under Section 522(a) (1) (C) the device cleared for marketing by this letter as requiring postmarket surveillance. The rationale for this decision is contained in the enclosed attachment.
Within thirty (30) days of first introduction or delivery for introduction of this device into interstate commerce you are required to submit to FDA certification of the date of introduction into interstate commerce, a detailed protocol which describes the postmarket surveillance study, and a detailed profile of the study's principal investigator that clearly establishes the qualifications and experience of the individual to conduct the proposed study. For your information, general guidance on preparing a protocol for a postmarket surveillance study is attached.
Submit five (5) copies to:
Center for Devices and Radiological Health Postmarket Surveillance Studies Document Center Room 3083 (HFZ-544) 1350 Piccard Drive Rockville, Maryland 20850
Within sixty (60) days of receipt of your protocol, FDA will either approve or disapprove it and notify you of the Agency's action in writing. You should not begin your postmarket surveillance study of this device until the protocol has been Data generated under an unapproved protocol may not approved. satisfy your obligation under section 522. Please note that you must continue to collect and report data needed to maintain compliance with Medical Device Reporting regulations (21 CFR 803).
Failure to certify accurately the date of initial introduction of your device into interstate commerce, to submit timely an acceptable protocol, or to undertake and complete an FDA approved postmarket surveillance study consistent with the protocol will be considered violations of section 522. In accordance with the Medical Device Amendments of 1992, failure
4
Page 3 - Deborah M. Matarazzo, R.N., B.S.N.
of a manufacturer to meet its obligations under section 522 is a prohibited act under section 301 (q) (1) (C) of the Act (21 U.S.C. 331 (q) (1) (C). Further, under section 502 (t) (3) of the act (21 U.S.C. 352(t)(3)), a device is misbranded if there is a failure or refusal to comply with any requirement under section 522 of the act. Violations of sections 301 or 502 may lead to regulatory actions including seizure of your product, injunction, prosecution, or civil money penalties.
If you have questions concerning postmarket surveillance study requirements, contact the Postmarket Surveillance Studies Branch at (301) 594-0639.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D.
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
5
DEC - 4 1997
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 (888.3358) and hip joint metal/ceramic/polymer semi-constrained porous coated cemented prosthesis (888.3350).
Intended Use: The Reach Femoral Component 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 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.
This 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 Reach stem geometry is designed for proximal, as well as, distal stability and gradual officading into the bone along the canal. The proximal 100mm of each stern incorporates a bi-planar taper to encourage proximal officading, 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 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-calcar contact and stress distribution. This helps to provide rotational stablity and load transfer.
Distally, the stem is cylindrical after 100mm with an anterior bow for left and right specific applications. 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 officading and is less likely to fracture the cement mantle.
6
The Reach temoral stems will be fully coated to provide maximum proximal and distal fixation through bony ingrowth. This circumferential closed-pore porous coating potentially seals 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 distal tip of the stern is a sisal buff or polished finish, to prevent distal offloading 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 are not limited to:
| Reaction to bone cement | Bone fracture |
|---|---|
| Fracture of the components | Hematoma |
| Cardiovascular disorders | Blood vessel damage |
| Implant loosening/migration | Nerve damage |
| Soft tissue imbalance | Excessive wear |
| Deformity of the joint | Infection |
| Tissue growth failure | Dislocation |
| Delayed wound healing | Metal sensitivity |
| Fracture of the cement | Breakdown of porous surface |
Substantial Equivalence: The Reach Femoral Hip Component is substantially equivalent to almost all femoral devices on the market in overall design and intended function. Predicate devices include:
000004 4
AML® (Depuy, Warsaw, IN) PMA# P820024000
్రా
| The Solution System® (Depuy, Warsaw, IN) | -510(k)# K933942 |
|---|---|
| -510(k)# K941942 | |
| -510(k)# K953703 |
Integral® Total Hip System (Biomet, Inc., Warsaw, IN) -510(k) K921255
7
Image /page/7/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States of America. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 4 1997
Deborah M. Matarazzo, R.N., B.S.N. Clinical Research Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana
K971824 Re : Reach Femoral Hip Component Trade Name: Requlatory Class: II Product Codes: LZO and LPH Dated: September 5, 1997 Received: September 8, 1997
Dear Ms. Matarazzo:
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 and the following limitation that the package insert must reflect that the Zirconia Ceramic Femoral Heads are to be used only with forged Ti6A14V alloy hip stems with the Type I taper trunnions.
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. ਜੋ 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
8
Page 2 - Deborah M. Matarazzo, R.N., B.S.N.
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.
Under Section 522(a) of the act, manufacturers of certain types of devices identified by the Act or designated by FDA are required to conduct postmarket surveillance studies. FDA has identified under Section 522(a) (1) (C) the device cleared for marketing by this letter as requiring postmarket surveillance. The rationale for this decision is contained in the enclosed attachment.
Within thirty (30) days of first introduction or delivery for introduction of this device into interstate commerce you are required to submit to FDA certification of the date of introduction into interstate commerce, a detailed protocol which describes the postmarket surveillance study, and a detailed profile of the study's principal investigator that clearly establishes the qualifications and experience of the individual to conduct the proposed study. For your information, general guidance on preparing a protocol for a postmarket surveillance study is attached.
Submit five (5) copies to:
Center for Devices and Radiological Health Postmarket Surveillance Studies Document Center Room 3083 (HFZ-544) 1350 Piccard Drive Rockville, Maryland 20850
Within sixty (60) days of receipt of your protocol, FDA will either approve or disapprove it and notify you of the Agency's action in writing. You should not begin your postmarket surveillance study of this device until the protocol has been Data generated under an unapproved protocol may not approved. satisfy your obligation under section 522. Please note that you must continue to collect and report data needed to maintain compliance with Medical Device Reporting regulations (21 CFR 803).
Failure to certify accurately the date of initial introduction of your device into interstate commerce, to submit timely an acceptable protocol, or to undertake and complete an FDA approved postmarket surveillance study consistent with the protocol will be considered violations of section 522. In accordance with the Medical Device Amendments of 1992, failure
9
Page 3 - Deborah M. Matarazzo, R.N., B.S.N.
of a manufacturer to meet its obligations under section 522 is a prohibited act under section 301 (q) (1) (C) of the Act (21 U.S.C. 331 (q) (1) (C). Further, under section 502 (t) (3) of the act (21 U.S.C. 352(t)(3)), a device is misbranded if there is a failure or refusal to comply with any requirement under section 522 of the act. Violations of sections 301 or 502 may lead to regulatory actions including seizure of your product, injunction, prosecution, or civil money penalties.
If you have questions concerning postmarket surveillance study requirements, contact the Postmarket Surveillance Studies Branch at (301) 594-0639.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Whitten, Ph.D.
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
10
Page 1 of _1
510(k) Number (if known): K971824
Device Name: Reach Femoral Component
Indications For Use:
The Reach Femoral Component is intended for use in reconstruction of the hip joint due to damage caused by trauma or degenerative disease and in cases where previous hip replacement component failed. The device is intended for cemented application for general use and non-cemented application in skeletally mature approduction artinary surgery for rehabilitating hip joints damaged as
individuals undergoing primary surgery for rehabilitat ing hip internet of its comments of comments of Modular Head component or Metallic Modular Head component with appropriate matching Type I Taper.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Divisio Division of General Resto 510(k) Number