(56 days)
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No
The document describes a mechanical hip implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
This device, a hip stem, is intended to alleviate pain and restore function in total hip arthroplasty, and is used to treat various conditions like degenerative joint disease and rheumatoid arthritis, which are direct therapeutic benefits.
No
The device is a hip stem (total hip replacement prosthesis) intended for surgical implantation to alleviate pain and restore function, not to diagnose a condition.
No
The device description clearly identifies the device as a physical hip stem, which is a hardware component used in surgery. There is no mention of software as the primary or sole component.
No, 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 provided text describes a hip stem, which is an implantable medical device used in surgery to replace part of the hip joint. It is a physical component inserted into the body.
- Intended Use: The intended use clearly states it's for "primary and revision total hip arthroplasty to alleviate pain and restore function." This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The description and intended use are consistent with a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Rejuvenate Monolithic size 4 Hip Stem is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used with any currently available compatible Howmedica Osteonics acetabular components; V40 femoral heads, V40 Alumina Heads, C-Taper Alumina heads when used with the V40/C-Taper Adaptor and the Biolox® Delta Universal Taper Heads and sleeves.
The indications for use of total hip replacement prostheses include:
- Noninflammatory 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 that is unmanageable using other techniques.
- Stryker's Rejuvenate Hip System is intended for cementless use only.
Product codes
MEH, LZO, LPH, JDI, KWY, KWZ, KWL, LWJ
Device Description
The Rejuvenate Monolithic Size 4 Hip stem is part of the previously cleared Rejuvenate Monolithic Hip System. The size 4 monolithic hip stem is intended for cementless. press-fit application. It is designed for use with the available compatible Howmedica Osteonics' femoral heads, bipolars and their compatible acetabular components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hip
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
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K091161 (pg 1/3)
510(k) Summary of Safety and Effectiveness
JUN 1 6 2009
Proprietary Name:
Rejuvenate Monolithic Size 4 Hip Stem
Common Name:
Hip prosthesis
Classification Name and Reference: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis, 21 CFR §888.3353
Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis, 21 CFR 888.3358
Hip joint metal/polymer semi-constrained cemented prosthesis 21 CFR §888.3350
Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis. 21 CFR 888.3390
Hip joint metal/polymer constrained cemented or uncemented prosthesis. 21 CFR §888.3310
Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis. 21 CFR §888.3360
Regulatory Class:
Product Codes:
Class II
87 MEH - prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calciumphosphate
87 LZO - prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
87 LPH - prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
87 JDI - prosthesis, hip, semi-constrained, metal/polymer, cemented
87 KWY - prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
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1
87 KWZ - prosthesis, hip, constrained, cemented or uncemented, metal/polymer
87 KWL - prosthesis, hip, hemi-, femoral, metal
87 LWJ - prosthesis, hip, semi-constrained, metal/polymer, uncemented
For Information contact:
Estela Celi, Regulatory Affairs Associate Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-6461 Fax: (201) 831-3461
Date Prepared:
April 20, 2009
Description:
The Rejuvenate Monolithic Size 4 Hip stem is part of the previously cleared Rejuvenate Monolithic Hip System. The size 4 monolithic hip stem is intended for cementless. press-fit application. It is designed for use with the available compatible Howmedica Osteonics' femoral heads, bipolars and their compatible acetabular components.
Intended Use:
The Rejuvenate Monolithic size 4 Hip Stem is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used with any currently available compatible Howmedica Osteonics acetabular components; V40 femoral heads, V40 Alumina Heads, C-Taper Alumina heads when used with the V40/C-Taper Adaptor and the Biolox® Delta Universal Taper Heads and sleeves.
Indications:
The indications for use of total hip replacement prostheses include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular I) necrosis:
-
- Rheumatoid arthritis;
-
- Correction of functional deformity;
-
- Revision procedures where other treatments or devices have failed: and.
- ર) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques.
- () Stryker's Rejuvenate Hip System is intended for cementless use only.
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7
Substantial Equivalence:
The Rejuvenate Monolithic Hip Size 4 Hip Stem is identical to the stems which are part of the previously submitted Rejuvenate Monolithic Hip System in regard to intended use, design, materials, mechanical testing and operational principles as a hip prosthesis.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 an eagle or bird in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Howmedica Osteonics Corp. % Ms: Estela Celi Regulatory Affairs Associate 325 Corporate Dr. Mahwah, New Jersey 07430
JUN 1 6 2009
Re: K091161
Trade/Device Name: Rejuvenate Monolithic Size 4 Hip Stem Regulation Number: 21 CFR 888,3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: MEH, LZO, LPH, JDI, KWY, KWZ, KWL, LWJ Dated: April 20, 2009 Received: April 21, 2009
Dear Ms. Celi:
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 ucurec 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, Or to 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 I (1 MThe general controls provisions of the Act include requirements for annual registration, l'isting 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 not incum 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. Estela Celi
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Buchus
Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Yogyllel (pq 1/1)
Device Name: Rejuvenate Monolithic Size 4 Hip Stem
Indications for Use:
The indications for use of the total hip replacement prostheses include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular 1) necrosis:
-
- Rheumatoid arthritis
-
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and, 4)
- 5). H Treatment of nonunion, femoral neck and trochanteric fractures of the proximal * femur with head involvement that are unmanageable using other techniques.
- Stryker's Rejuvenate Hip System is intended for cementless use only. ()
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Scuta
B-(Division Sign-Off)
Division of Surgical, Orthopedic
Restorative De
510(k) Number K091161
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