(50 days)
The Stryker 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 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.
This hip is intended for cementless use only.
This Special 510(k) submission is a line extension to address modifications to the Stryker Modular Hip System. This line extension extends the combined head/neck length options.
This document describes a Special 510(k) submission for a line extension to the Stryker Modular Hip System, specifically addressing modifications to extend combined head/neck length options for the Rejuvenate Modular Hip System.
This submission is primarily concerned with demonstrating substantial equivalence to a previously cleared predicate device (Stryker Modular Hip cleared under K07182). Therefore, the provided text does not contain typical "acceptance criteria" based on quantitative performance metrics, nor does it detail a study proving device performance against such criteria in the way a diagnostic AI device would. Instead, the "acceptance criteria" here inherently relate to meeting the requirements for substantial equivalence, meaning the modifications do not raise new questions of safety and effectiveness.
Here's an analysis based on the provided information, addressing your requested points where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, there are no explicit quantitative "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a medical device like a hip implant line extension in this type of submission. The "acceptance criteria" are the regulatory requirements for demonstrating substantial equivalence. The "reported device performance" is the assertion of equivalence to the predicate.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as stated in submission) |
|---|---|
| Maintain intended use | "The Rejuvenate Modular Hip System is substantially equivalent to the Stryker Modular Hip cleared under K07182 in regards to intended use..." |
| Maintain design principles/features | "...design..." |
| Maintain material properties | "...materials..." |
| Maintain operational principles | "...and operational principles as a hip prosthesis." |
| No new questions of safety or effectiveness raised by modifications (line extension for head/neck length options) | Implicitly met by the FDA's clearance of substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a submission for a mechanical device (hip implant line extension), not a diagnostic device involving a test set of data. The "test" is an engineering and regulatory assessment, not a clinical data-based evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth as typically understood for diagnostic AI (e.g., expert consensus on medical images) is not relevant for this type of medical device submission. The "ground truth" here is regulatory compliance and engineering principles.
4. Adjudication Method for the Test Set
Not applicable for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for diagnostic imaging or AI performance with human readers. This is a mechanical implant device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This is not an algorithmic or AI device.
7. The Type of Ground Truth Used
Not applicable in the context of diagnostic AI. For this device, the "ground truth" for regulatory assessment is based on:
- Engineering design specifications and analysis.
- Material testing.
- Comparison to the predicate device's established safety and effectiveness.
- Compliance with relevant standards (though not explicitly detailed in the provided excerpt).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of the Study Proving the Device Meets Acceptance Criteria
The "study" in this context is the Special 510(k) submission process itself, where the manufacturer (Howmedica Osteonics Corp.) demonstrates that the modified Rejuvenate Modular Hip System (line extension for combined head/neck length options) is substantially equivalent to a previously cleared predicate device, the Stryker Modular Hip (K07182).
The key "proof" provided in the document for meeting this acceptance criterion is the direct statement:
- "With the addition of this line extension The Rejuvenate Modular Hip System is substantially equivalent to the Stryker Modular Hip cleared under K07182 in regards to intended use, design, materials, and operational principles as a hip prosthesis."
This statement, along with the detailed technical information (which is not fully provided in this excerpt but would be part of the complete 510(k) submission), forms the basis for the FDA's decision. The FDA's issuance of the 510(k) clearance letter on June 3, 2008, confirms that the Agency found the device to be substantially equivalent. This means the FDA agreed that the modifications (line extension for head/neck length options) did not introduce new safety or effectiveness concerns compared to the predicate device.
The study is essentially a technical assessment and comparison rather than a clinical trial or performance study against quantitative metrics like those used for AI/diagnostic devices.
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K08/044
Summary of Safety and Effectiveness Rejuvenate Modular Hip System Line Extension
| Proprietary Name: | Rejuvenate Modular Hip System Line Extension | JUN - 3 2008 |
|---|---|---|
| Common Name: | Rejuvenate Modular Stem | |
| Classification Name and Reference: | Hip prosthesis | |
| Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis, 21 CFR §888.3353 | ||
| Hip joint metal/polymer/metal semi-constrained porous coateduncemented prosthesis, 21 CFR §888.3358 | ||
| Hip joint metal/polymer semi-constrained cemented prosthesis 21CFR §888.3350 | ||
| Hip joint femoral (hemi-hip) metal/polymer cemented or uncementedprosthesis. 21 CFR §888.3390 | ||
| Hip joint metal/polymer constrained cemented or uncementedprosthesis. 21 CFR §888.3310 | ||
| Hip joint femoral (hemi-hip) metallic cemented or uncementedprosthesis. 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, porousuncemented | ||
| 87 JDI - prosthesis, hip, semi-constrained, metal/polymer, cemented | ||
| 87 KWY - prosthesis, hip, hemi-, femoral, metal/polymer, cementedor 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:
Denise Daugert, Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-5413 Fax: (201) 831-6038
Date Prepared:
April 11, 2008
Description:
This Special 510(k) submission is a line extension to address modifications to the Stryker Modular Hip System. This line extension extends the combined head/neck length options.
Intended Use
The Stryker 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 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; 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 ર) 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 K07182 in regards to intended use, design, materials, and operational principles as a hip prosthesis.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Howmedica Osteonics Corp. % Ms. Denise Daugert Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
JUN - 3 2008
K081044 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 prosthesis. Regulatory Class: Class II Product Code: MEH, LZO, LPH, JDI, KWY, KWZ, KWL, LWJ Dated: May 13, 2008 Received: May 14, 2008
Dear Ms. Daugert:
Re:
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 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 cquivalence 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 N. Mullison
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): 《ΟΥΊΟΥΎ
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; 1)
- 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 5) involvement that are unmanageable using other techniques.
This hip is intended for cementless use only.
| Prescription Use(Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use(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)
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Nilke Oden for nxn
(D: size, bss
Division of General, Restorative, and Neurological Devices
510(k) Number_
§ 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.