(60 days)
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. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is intended to alleviate pain and restore function in total hip arthroplasty, which are therapeutic goals.
No
Explanation: The device is described as a "sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function," which indicates it is a therapeutic or reconstructive device, not a diagnostic one.
No
The device description clearly identifies the Rejuvenate™ Modular Hip as a physical implant (a hip prosthesis) intended for surgical use, not a software application.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "primary and revision total hip arthroplasty to alleviate pain and restore function." This describes a surgical implant used in the body, not a device used to examine specimens outside the body for diagnostic purposes.
- Device Description: The description refers to it as a "Modular Hip System" and discusses "combined head/neck length options," which are components of a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), diagnostic testing, or providing information for diagnosis.
IVD devices are used to perform tests on specimens taken from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a surgical implant used to replace a joint.
N/A
Intended Use / Indications for Use
The Rejuvenate™ Modular Hip 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 acctabular 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 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 are unmanageable using other techniques.
This hip is intended for cementless use only.
Product codes
MEH, LZO, LPH, JDI, KWY, KWZ, KWL, LWJ
Device Description
This Special 510(k) submission is a line extension to address modifications to the Rejuvenate™ Modular Hip System. This line extension extends the combined head/neck length options.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
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
OCT 2 0 2009
Summary of Safety and Effectiveness Rejuvenate™ Modular Hip System Line Extension
| Proprietary Name: | Rejuvenate™ Modular Stem |
|---|---|
| Common Name: | Hip prosthesis |
| Classification Name and Reference: | Hip joint metal/ceramic/polymer semiconstrained cemented or |
| nonporous uncemented prosthesis, 21 CFR §888.3353 | |
| Hip joint metal/polymer/metal semiconstrained porous coated | |
| uncemented prosthesis, 21 CFR §888.3358 | |
| Hip joint metal/polymer semiconstrained cemented prosthesis21 | |
| CFR §888.3350 | |
| Hip joint femoral (hemihip) 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 nonporous, 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 | |
| 87 LWJ - prosthesis, hip, semi-constrained, metal/polymer, | |
| uncemented |
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For Information contact:
Estela Celi, Regulatory Affairs Associate Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-6461 Fax: (201) 831-6038
Date Prepared:
August 17, 2009
Description:
This Special 510(k) submission is a line extension to address modifications to the Rejuvenate™ Modular Hip System. This line extension extends the combined head/neck length options.
Intended Use
The Rejuvenate™ Modular Hip 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 acctabular 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; 1)
-
- Rheumatoid arthritis;
- 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 femur with head 5) involvement that are unmanageable using other techniques.
This hip is intended for cementless use only.
Substantial Equivalence:
With the addition of this line extension The Rejuvenate™ Modular Hip System is substantially equivalent to the Stryker Modular Hip cleared under K071082 and Rejuvenate™ Modular Hip System cleared under K081044 in regards to intended use, design, materials, and operational principles as a hip prosthesis.
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2
DEPARTMENT OF HEAL.TH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring. MD 20993-0002
Howmedica Osteonics Corporation % Ms. Estela Celi Regulatory Affairs Associate 325 Corporate Drive Mahwah, New Jersey 07430
OCT 20 2009
Re: K092561
Trade/Device Name: Rejuvenate™ Modular Hip System Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prothesis Regulatory Class: II Product Code: MEH, LZO, LPH, JDI, KWY, KWZ, KWL, LWJ Dated: August 17, 2009 Received: September 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 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
3
Page 2 - Ms. Estela Celi
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K09256
Indications for Use
510(k) Number (if known):
Device Name: Rejuvenate™ Modular Hip System
Indications for Use:
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, 4)
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head ર) involvement that are unmanageable using other techniques.
This hip is intended for cementless use only.
Over-The-Counter Use Prescription 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)
Omettu for MXOL
(Division Sign-Of Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092561
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