(90 days)
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 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.
- Stryker's Rejuvenate Hip System is intended for cementless use only.
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.
The provided text describes a 510(k) premarket notification for a medical device, the "Rejuvenate Monolithic Stem" (a hip prosthesis). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with detailed acceptance criteria and performance metrics typically seen in studies designed to prove efficacy or meet specific performance targets.
Therefore, the information required for items 1-9 in your request is not explicitly available in the provided document, as a 510(k) summary for a hip prosthesis does not typically include detailed performance data from clinical trials or standalone algorithm evaluations. Instead, it relies on demonstrating equivalence through design, materials, intended use, and mechanical testing.
However, I can extract information related to the device and its claimed equivalence.
Here's an analysis based on the provided text, addressing your points where possible and noting where information is absent:
Analysis of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria for the Rejuvenate Monolithic Stem
The provided document is a 510(k) Summary of Safety and Effectiveness for the Rejuvenate Monolithic Stem, a hip prosthesis. In the context of a 510(k) submission, "acceptance criteria" are generally tied to demonstrating substantial equivalence to legally marketed predicate devices, rather than predefined clinical performance thresholds. The "study" that proves the device meets these criteria primarily involves mechanical testing and comparison of design, materials, and intended use with the predicate devices.
1. A table of acceptance criteria and the reported device performance
As this is a 510(k) submission, explicit "acceptance criteria" in terms of specific performance metrics (like sensitivity, specificity, accuracy) from a clinical study are not provided. The acceptance criteria for a 510(k) are implicitly focused on demonstrating that the device is as safe and effective as a predicate device and performs similarly. The "reported device performance" in this context refers to the outcomes of the mechanical testing and the assertion of substantial equivalence.
| Acceptance Criterion (Implicit for 510(k)) | Reported Device Performance (as stated in the document) |
|---|---|
| Substantial Equivalence to Predicate Devices | "The Rejuvenate Monolithic Hip Stem is substantially equivalent to other commercially available hip systems in regards to intended use, design, materials, and operational principles as a hip prosthesis." |
| Mechanical Performance | "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." |
| Intended Use | The device is intended for "primary and revision total hip arthroplasty to alleviate pain and restore function," which aligns with the predicate devices. |
| Material Composition | Implied to be equivalent to predicate devices (e.g., Secur-Fit HA Stem and Accolade TMZF HA Stems). |
| Design and Operational Principles | "The basic design... is similar to other total hip systems commercially distributed..." and "substantially equivalent... in regards to... design, materials, and operational principles." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify a "sample size" in the context of a clinical test set. The evaluation was based on mechanical testing, not patient data. Therefore, the concept of a "test set" with patient data (and its provenance, retrospective/prospective nature) is not applicable here.
- Data Provenance: Not applicable as it refers to mechanical testing data, not human patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable to a 510(k) submission for a hip prosthesis that relies on mechanical testing. There was no clinical ground truth established by experts for a test set of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable. No clinical test set requiring expert adjudication was described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This information is not applicable. The device is a hip prosthesis, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. The device is a hip prosthesis, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for demonstrating substantial equivalence for this device would be established by engineering standards and mechanical testing results compared against the known performance characteristics of the predicate devices. There is no biological or clinical "ground truth" as would be established by pathology or outcomes data in this submission.
8. The sample size for the training set
- This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The design and manufacturing processes are likely informed by years of historical engineering data and clinical experience with similar devices, but this is not referred to as a "training set."
9. How the ground truth for the training set was established
- This information is not applicable as there is no training set as defined for AI/machine learning devices.
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| Propritery Name: | Rejuvenate Monolithic Stem | DEC 29 2008 |
|---|---|---|
| Common Name: | Hip prosthesis | |
| Classification Name and Reference: | Hip joint metal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prosthesis, 21CFR §888.3353Hip joint metal/polymer/metal semi-constrainedporous coated uncemented prosthesis, 21 CFR§888.3358Hip joint metal/polymer semi-constrained cementedprosthesis 21 CFR §888.3350Hip joint femoral (hemi-hip) metal/polymer cementedor uncemented prosthesis. 21 CFR §888.3390Hip joint metal/polymer constrained cemented oruncemented prosthesis. 21 CFR §888.3310Hip joint femoral (hemi-hip) metallic cemented oruncemented prosthesis. 21 CFR §888.3360 | |
| Regulatory Class: | Class II | |
| Product Codes: | 87 MEH - prosthesis, hip, semi-constrained,uncemented, metal/polymer, non-porous, calcium-phosphate87 LZO - prosthesis, hip, semi-constrained,metal/ceramic/polymer, cemented or non-porous,uncemented87 LPH - prosthesis, hip, semi-constrained,metal/polymer, porous uncemented87 JDI - prosthesis, hip, semi-constrained,metal/polymer, cemented87 KWY - prosthesis, hip, hemi-, femoral,metal/polymer, cemented or uncemented87 KWZ - prosthesis, hip, constrained, cemented oruncemented, metal/polymer87 KWL - prosthesis, hip, hemi-, femoral, metal |
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:
510(k) Summary of Safety and Effectiveness
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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
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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.
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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)
4
§ 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.