(30 days)
Not Found
No
The document describes a mechanical hip stem and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a hip stem intended for total hip arthroplasty to treat various degenerative joint diseases and fractures, which falls under the definition of a therapeutic device designed to alleviate or cure a medical condition.
No.
The device description indicates it is a "hip stem," which is an implant used in total hip arthroplasty, not a tool for diagnosing medical conditions.
No
The device description clearly states it is a physical hip stem manufactured from titanium alloy, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "total hip arthroplasty," which is a surgical procedure to replace the hip joint. IVDs are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical implantable device (a hip stem) made of titanium alloy. IVDs are typically reagents, instruments, or systems used to perform tests on specimens.
- Anatomical Site: The anatomical site is the "Hip joint," which is where the device is implanted. IVDs are used to analyze specimens from the body, not implanted in the body.
The information provided describes a surgical implant, not a diagnostic test performed on a specimen.
N/A
Intended Use / Indications for Use
The HIPSTAR hip stem is a sterile, single-use device intended for total hip arthroplasty.
Indications
- noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis;
- rheumatoid arthritis (excepting the Osteolock™ HA Acetabular Cup and Peri-Apatite coated prostheses);
- correction of functional deformity; .
- correction or adures where other treatments or devices have failed; and, ●
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal . treatment of head involvement that are unmanageable using other techniques
- intended for cementless fixation. .
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO, MEH
Device Description
The Hipstar Femoral Stem is a straight hip stem manufactured from titanium alloy, The Hipstar Temoral Stein is a Statight any varies a flare for rotational stability, with a TMZF - - The Fripstal Inp realersbility. The body of the stem, with the exception of the narrow unstal stem for implain cases arrit blasted for increased bone to implant interface. The subject hip stem has a 127° neck angle.
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
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.
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
510(k) Summary of Safety and Effectiveness for the HIPSTAR Femoral Stem
JAN 2 5 2007
Proprietary Name:
Common Name:
Classification Name and Reference
Regulatory Class:
Device Product Code:
For Information contact:
Date Summary Prepared:
HIPSTAR Femoral Stem
Total Hip Joint Replacement Prosthesis
Hip joint, metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prostheses, 21 CFR §888.3353
Hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis 21 CFR §888.3358
Class II
87 MEH - prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calcium-phosphate
87 LZO - prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or nonporous, uncemented
87 LPH - prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Tiffani Rogers Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07432 Phone: (201) 831-5612 Fax: (201) 831-6038 E-Mail: Tiffani.Rogers@stryker.com
January 25, 2007
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Device Description
The Hipstar Femoral Stem is a straight hip stem manufactured from titanium alloy, The Hipstar Temoral Stein is a Statight any varies a flare for rotational stability, with a TMZF - - The Fripstal Inp realersbility. The body of the stem, with the exception of the narrow unstal stem for implain cases arrit blasted for increased bone to implant interface. The subject hip stem has a 127° neck angle.
Intended Use:
The HIPSTAR hip stem is a sterile, single-use device intended for total hip arthroplasty.
Indications
- noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis;
- necrosis;
rheumatoid arthritis (excepting the Osteolock™ HA Acetabular Cup and Peri-● Apatite coated prostheses); - correction of functional deformity; .
- correction or adures where other treatments or devices have failed; and, ●
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal . treatment of head involvement that are unmanageable using other techniques
- intended for cementless fixation. .
Substantial Equivalence:
The subject Hipstar femoral stem is a modification to the Hipstar stem cleared in The Subject Hipstar relination of the substantial equivalence of the Hipstar hip stem is based on its similarities in intended use, design and sterilization to the previously cleared Hipstar femoral hip stem (K051223 cleared March 06, 2006).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three figures representing people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circle around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stryker Howmedica Osteonics Corporation % Ms. Tiffani Rogers Regulatory Affairs Specialist Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07430
JAN 2 5 2007
Re: K063822
Trade/Device Name: HIPSTAR Femoral Stem Regulation Number: 21 CFR 888.3358, 21 CFR 888.3353 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, LZO, MEH Dated: December 21, 2006 Received: December 22, 2007
Dear Ms. Rogers:
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
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Page 2 - Ms. Tiffani Rogers
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), please contact the Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ______________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications
- noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis;
- rheumatoid arthritis (excepting the Osteolock™ HA Acetabular Cup and Peri-Apatite . coated prostheses);
- 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 that are unmanageable using other techniques.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X
OR (Per 21 CFR 801.109)
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division of Gene
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