(87 days)
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No
The description focuses solely on the material, dimensions, and mechanical design of a hip stem prosthesis. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device, a Cemented Calcar Hip Stem, is a total hip replacement prosthesis intended to treat various degenerative joint diseases and fractures, which directly ameliorates a diseased or injured condition in the body.
No
This device is a Cemented Calcar Hip Stem, which is an implant used in total hip replacement surgery for treatment of various degenerative joint diseases and fractures. It is a prosthetic device, not a diagnostic one.
No
The device description clearly states it is a physical hip stem fabricated from titanium alloy, which is a hardware component.
Based on the provided text, 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 is a "Cemented Calcar Hip System," a "total hip replacement prosthesis," and a "Cemented Calcar Hip Stem." These are implantable devices used in surgical procedures.
- Intended Use: The intended use describes the conditions for which the hip replacement is used (degenerative joint disease, rheumatoid arthritis, etc.) and its surgical application ("total hip replacement prosthesis," "revision procedures," "treatment of nonunion, femoral neck and trochanteric fractures").
There is no mention of testing samples from the body or providing diagnostic information based on such tests. The device is a physical implant for surgical reconstruction.
N/A
Intended Use / Indications for Use
The indications for use of the Cemented Calcar Hip System in total hip replacement prosthesis include: degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. The Cemented Calcar Hip Stem is intended for use with bone cement.
Product codes
LPH
Device Description
The Cemented Calcar Hip Stem is fabricated from wrought titaniumaluminum-vanadium alloy (Ti-6Al-4V) conforming to ASTM F136. The Cemented Calcar Hip Stem is available in sizes 12-16, which have diameters from 10-14mm and lengths of 18-20cm. The proximal body is polished and designed with filleted holes for cerclage cables. The distal and lateral portions of the stem are gritblasted. The Cemented Calcar Hip Stem is designed with a 1320 neck angle and a Morse taper to accept the femoral head. The distal portion of the stem tapers to accept a distal centralizer.
The Cemented Calcar Hip Stem is to be implanted either with or without a collar. The modular collar is available in a +15 and +30mm height for each size stem. The collar is attached to the stem using an attachment screw. The modular collars are fabricated from wrought titanium-aluminum-vanadium alloy (Ti-6Al-4V) conforming to ASTM F136.
The attachment screw is used to attach the collar to the Cemented Calcar hip stem. The attachment screw is fabricated from wrought titanium-aluminum-vanadium alloy (Ti-6Al-4V) conforming to ASTM F136.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hip, proximal femur
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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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
Summary of Safety and Effectiveness
Encore Orthopedics®, Inc. 9800 Metric Blvd Austin, TX 78758 512-832-9500
JAN 1 7 2002
Trade Name: Cemented Calcar Hip System
Common Name: Cementless hip stem
Classification Name: Hip joint metal/polymer semi-constrained cemented prosthesis
Description: The Cemented Calcar Hip Stem is fabricated from wrought titaniumaluminum-vanadium alloy (Ti-6Al-4V) conforming to ASTM F136. The Cemented Calcar Hip Stem is available in sizes 12-16, which have diameters from 10-14mm and lengths of 18-20cm. The proximal body is polished and designed with filleted holes for cerclage cables. The distal and lateral portions of the stem are gritblasted. The Cemented Calcar Hip Stem is designed with a 1320 neck angle and a Morse taper to accept the femoral head. The distal portion of the stem tapers to accept a distal centralizer.
The Cemented Calcar Hip Stem is to be implanted either with or without a collar. The modular collar is available in a +15 and +30mm height for each size stem. The collar is attached to the stem using an attachment screw. The modular collars are fabricated from wrought titanium-aluminum-vanadium alloy (Ti-6Al-4V) conforming to ASTM F136.
The attachment screw is used to attach the collar to the Cemented Calcar hip stem. The attachment screw is fabricated from wrought titanium-aluminum-vanadium alloy (Ti-6Al-4V) conforming to ASTM F136.
Intended Use: The indications for use of the Cemented Calcar Hip System in total hip replacement prosthesis include: degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. The Cemented Calcar Hip Stem is intended for use with bone cement.
Comparable Features to Predicate Device(s): Features comparable to predicate devices include same materials, design and indications.
1
Image /page/1/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 a stylized image of an eagle with three wavy lines representing its wings.
Public Health Service
JAN 1 7 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Joanna Droege Regulatory/QA Engineer Encore Orthopedics, Inc. 9800 Metric Boulevard Austin, Texas 78758
Re: K013490
Trade/Device Name: Cemented Calcar Hip System Regulation Number: 888.3358 Regulation Name: Hip Joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: October 18, 2001 Received: October 22, 2001
Dear Ms. Droege:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Joanna Droege
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Mark N. Millhurs
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: ___ Cemented Calcar Hip System__________________________________________________________________________________________________________________________________
Indications For Use:
Cemented Calcar Hip System Indications For Use
The indications for use of the total hip replacement prosthers include: The Indications for disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision frecrosis, Theatmator artifical ts or devices have failed; and treatment of procedures where other trochanteric fractures of the proximal femur with head. honomion, temoral heck and trochante in other techniques. This stem is to be used with bone cement.
(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)
Mark N. Millhussen
(Division Sign-Off) Division of General, Restorative and Neurological Devices KO13490
510(k) Number -
SK25