(23 days)
No
The summary describes a mechanical hip implant and its modifications compared to a predicate device. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
No
The device is an orthopedic implant (Modular Reach Hip) used for conditions like osteoarthritis, avascular necrosis, and fractures, which restore function but are not considered therapeutic in the sense of delivering therapy.
No
This device is a hip implant, specifically an orthopedic prosthetic for joint replacement and fracture treatment, not a device for diagnosing medical conditions.
No
The device description clearly describes a physical implantable hip prosthesis made of Ti-6Al-4V, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses describe the treatment of various conditions affecting the hip joint and proximal femur through surgical implantation. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a hip implant system designed for surgical implantation to replace or repair parts of the hip joint. This is consistent with a surgical implant, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatment or devices have failed; 5) treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
Product codes
87LPH
Device Description
The predicate to the Modular Reach Hip - the Mallory-Head Modular Hip - was previously cleared in K921274. The proximal portion of the predicate has been modified by removing A/P and lateral fins and adding an optional proximal collar. The modified and predicate devices are made of the same material (Ti-6Al-4V), both are porous coated, and intended for noncemented use.
The modified device, the Modular Reach Hip, can be used with any Biomet modular distal component. As with the predicate, the proximal body and the distal stem are joined by means of a Morse locking taper. Additional fixation is achieved through a locking screw inserted through the driving platform and engaging with the stem taper.
The predicate and the Modular Reach Hip utilize Biomet Type I taper modular heads which are taper-fit on to the stem at the time of surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K994038
DEC 22 1999
SUMMARY OF SAFETY AND EFFECTIVENESS
Sponsor: Biomet. Inc.
Manufacturer: Biomet Manufacturing. Inc. Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581-0587
Proprietary Name: Modular Reach Hip
Common or Usual Name: Modular metallic total hip system
Classification Name: Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (888.3358)
Device Classification: Class II
Device Product Code: 87LPH
Device Description: The predicate to the Modular Reach Hip - the Mallory-Head Modular Hip - was previously cleared in K921274. The proximal portion of the predicate has been modified by removing A/P and lateral fins and adding an optional proximal collar. The modified and predicate devices are made of the same material (Ti-6Al-4V), both are porous coated, and intended for noncemented use.
The modified device, the Modular Reach Hip, can be used with any Biomet modular distal component. As with the predicate, the proximal body and the distal stem are joined by means of a Morse locking taper. Additional fixation is achieved through a locking screw inserted through the driving platform and engaging with the stem taper.
The predicate and the Modular Reach Hip utilize Biomet Type I taper modular heads which are taper-fit on to the stem at the time of surgery.
Indications For Use: : 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatment or devices have failed; 5) treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
Potential Risks:
-
- Major surgical risks associated with anesthetic including: brain damage, pneumonia, blood clots, heart attach, and death.
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- Cardiovascular disorders including venous thrombosism pulmonary embolism, and myocardial infarction.
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- A sudden drop in blood pressure intraoperatively due to the use of bone cement.
1
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- Damage to blood vessels, hematoma, delayed wound healing and/or infection.
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- Temporary or permanent nerve damage may result in pain and numbness.
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- Material sensitivity reactions. Implantation of foreign material in tissues can result in histological reactions involving various sizes of macrophages and fibroblasts. The clinical significance of this effect is uncertain, as similar changes may occur as a precursor to or during the healing process. Particulate wear debris and discoloration from metallic and polyethylene components of joint implants may be present in adjacent tissue or fluid. It has been reported that wear debris may initiate cellular response resulting in osteolysis or osteolysis may be a result of loosening of the implant.
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- Early or late postoperative, infection, and allergic reaction.
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- Intraoperative bone perforation or fracture may occur, particularly in the presence of poor bone stock caused by osteoporosis, bone defects from previous surgery, bone resorption, or while inserting the device.
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- Loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.
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- Periarticular calcification or osseification, with or without impediment of joint mobility.
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- Inadequate range of motion due to improper selection or positioning of components.
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- Undesirable shortening of limb.
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- Dislocation and subluxation due to inadequate fixation and improper positioning. Muscle and fibrous tissue laxity can also contribute to these conditions.
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- Fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalionment, trauma, non-union, or excessive weight.
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- Fretting and crevice corrosion can occur at interfaces between components.
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- Wear and/or deformation of articulating surfaces.
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- Trochanteric avulsion or non-union as a result of excess muscular tension, early weight bearing or inadequate reattachment.
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- Problems of the knee or ankle of the affected limb or contralateral limb aggravated by leg length discrepancy, too much femoral medialization or muscle deficiencies.
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- Postoperative bone fracture and pain.
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines representing movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 1999
Mr. Fred McClure Regulatory Specialist Biomet Inc. Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581
Re: K994038 Trade Name: Modular Reach Hip Regulatory Class: II Product Code: LPH Dated: November 15, 1999 Received: November 29, 1999
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 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. 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.
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Page 2 - Mr. Fred McClure
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,
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510 (k) Number (if known) :
Modular Reach Femoral Device Name:
Indications For Use: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatment or devices have failed; 5) treatment of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
NRO for JZD
(Division Sign-Off)
Division of General Restorative Devices K994038
510(k) Number
465 Prescription Use . (Per 21 CFR 801.109)
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