(90 days)
Not in text
Not Found
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 or ML.
Yes
The device is a hip stem intended for use in total hip arthroplasty to alleviate pain and restore function, which directly addresses a medical condition and aims to improve patient health.
No
The device is a prosthetic hip stem intended for surgical implantation to replace a damaged hip joint, not to diagnose a condition.
No
The device description clearly states it is a "monolithic hip prosthesis" and a "monolithic stem," indicating a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Rejuvenate Monolithic Hip Stem is for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This is a surgical procedure performed on a patient's body.
- Device Description: The device is described as a monolithic hip prosthesis intended for cementless, press-fit application. This is a physical implant.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
This device is a surgical implant used directly in the body, not a device used to test samples outside the body.
N/A
Intended Use / Indications for Use
The Rejuvenate Monolithic 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 Howmedica Osteonics acetabular components, V40 femoral 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 the total hip replacement prostheses include:
-
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis:
- Rheumatoid arthritis 2)
- Correction of functional deformity; 3)
- Revision procedures where other treatments or devices have failed; and, 4)
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal 5) femur with head involvement that are unmanageable using other techniques.
- Stryker's Rejuvenate Hip System is intended for cementless use only. 6)
Product codes
87 MEH, 87 LZO, 87 LPH, 87 JDI, 87 KWY, 87 KWZ, 87 KWL, 87 LWJ
Device Description
Howmedica Osteonics is introducing a monolithic hip prosthesis. The basic design of the Rejuvenate Monolithic Hip System is similar to other total hip systems commercially distributed such as the Secur-Fit HA Stem and the Accolade TMZF HA Stems.
The subject hip is composed of a monolithic stem intended for cementless, press-fit application. It is designed for use with currently available Howmedica Osteonics' femoral heads, bipolars and their compatible acetabular components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, femoral
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)
Based upon the mechanical testing, the Rejuvenate Monolithic Hip Stem is substantially equivalent for its intended use to other press-fit femoral hip replacement currently on the market.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Secur-Fit HA Stern, Accolade TMZF HA Stems
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.
0
| Propritery Name: | Rejuvenate Monolithic Stem | DEC 29 2008 |
|---|---|---|
| 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: | Class II | |
| Product Codes: | 87 MEH - prosthesis, hip, semi-constrained, | |
| uncemented, metal/polymer, non-porous, calcium- | ||
| phosphate | ||
| 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 | ||
| 87 KWZ - prosthesis, hip, constrained, cemented or | ||
| uncemented, metal/polymer | ||
| 87 KWL - prosthesis, hip, hemi-, femoral, metal |
:
:
510(k) Summary of Safety and Effectiveness
1
K082892 (pg 2/3)
87 LWJ - prosthesis, hip, semi-constrained, metal/polymer, uncemented
For Information contact:
Denise Daugert, Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-5413 Fax: (201) 831-6038
Date Prepared:
September 29, 2008
Description:
Howmedica Osteonics is introducing a monolithic hip prosthesis. The basic design of the Rejuvenate Monolithic Hip System is similar to other total hip systems commercially distributed such as the Secur-Fit HA Stem and the Accolade TMZF HA Stems.
The subject hip is composed of a monolithic stem intended for cementless, press-fit application. It is designed for use with currently available Howmedica Osteonics' femoral heads, bipolars and their compatible acetabular components.
Intended Use
The Rejuvenate Monolithic 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 Howmedica Osteonics acetabular components, V40 femoral 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 necrosis:
- Rheumatoid arthritis; 2)
- Correction of functional deformity; 3)
-
- Revision procedures where other treatments or devices have failed; and,
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal ર) femur with head involvement that are unmanageable using other techniques.
-
- Stryker's Rejuvenate Hip System is intended for cementless use only.
Substantial Equivalence:
The Rejuvenate Monolithic Hip Stem is substantially equivalent to other commercially
2
available hip systems in regards to intended use, design, materials, and operational principles as a hip prosthesis. The following devices are examples of predicate systems: the Secur-Fit HA Stern and the Accolade TMZF HA Stems. Based upon the mechanical testing, the Rejuvenate Monolithic Hip Stem is substantially equivalent for its intended use to other press-fit femoral hip replacement currently on the market.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The overall design is simple and professional, reflecting the department's role in public health and welfare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 9 2008
Howmedica Osteonics Corp. % Ms. Denise Daugert Regulatory Affairs Specialist 325 Corporate Dr. Mahwah, New Jersey 07430
Re: K082892 Trade/Device Name: Rejuvenate Monolithic Hip System 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: September 29, 2008 Received: September 30, 2008
Dear Ms. Daugert:
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 or any I 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. Denise Daugert
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 the reporting 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 yours,
Mark W. Milliman
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): 4 OP2892 (ps 1/1)
Device Name: Rejuvenate Monolithic Stem
Indications for Use:
The indications for use of the total hip replacement prostheses include:
-
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis:
- Rheumatoid arthritis 2)
- Correction of functional deformity; 3)
- Revision procedures where other treatments or devices have failed; and, 4)
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal 5) femur with head involvement that are unmanageable using other techniques.
- Stryker's Rejuvenate Hip System is intended for cementless use only. 6)
Prescription Use Over-The-Counter Use X 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)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of 1
Number 11072852
510(k)
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