(30 days)
The Modular Rotating Hinge Knee is intended to be implanted with bone cement for the following conditions:
- There is destruction of the joint surfaces, with or without significant bone deformity.
- The cruciate and/or collateral ligaments do not stabilize the knee joint.
- The ligaments are inadequate and/or the musculature is weak.
- Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.
This Special 510(k) submission is a line extension intended to add offset adapters to the Howmedica Osteonics® Modular Rotating Hinge Knee.
This submission, K060360, describes a line extension for the Howmedica Osteonics® Modular Rotating Hinge Knee, introducing offset adapters. This is a Special 510(k) submission, meaning it relies on a comparison to substantially equivalent predicate devices. Due to the nature of a Special 510(k) for a line extension of an existing device, a full-scale clinical study with acceptance criteria and device performance as typically seen for novel devices is not provided. Instead, the submission focuses on demonstrating equivalent mechanical properties to the predicate devices.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Mechanical Properties comparable to predicate devices. | "An engineering analysis demonstrated comparable mechanical properties to the predicate components and substantial equivalence to these devices." (This is the primary performance claim for this Special 510(k), as it's a line extension for offset adapters.) |
| No alteration to the Intended Use of the predicate devices. | "The combination of the predicate systems as cleared in the Howmedica Osteonics® Modular Rotating Hinge Knee and Howmedica Total Stabilizer Knee Components 510(k) premarket notifications does not alter the intended use." and "The subject and predicate devices are single use, sterile knee replacement systems. The indications for use for the Howmedica Osteonics® Modular Rotating Hinge Knee with Offset Adapters are provided below." (The listed indications for use are identical to those of the predicate devices, implying no change to intended use or patient population). |
| Same design, materials, and operational principle as predicate devices. | "The subject Howmedica Osteonics® Modular Rotating Hinge Knee with Offset Adapters share the same design, intended use, performance, materials, and operational principle as that of the currently available Howmedica Osteonics® Modular Rotating Hinge Knee and Howmedica Total Stabilizer Knee Components." |
2. Sample Size Used for the Test Set and Data Provenance:
This document describes an engineering analysis, not a clinical study involving human subjects or a test set in the traditional sense for evaluating diagnostic or predictive performance. Therefore, there is no mention of a "test set" sample size or data provenance (country of origin, retrospective/prospective). The "test set" would implicitly refer to the physical components of the offset adapters undergoing mechanical testing. The specific number of components tested is not detailed in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not applicable. The "ground truth" for an engineering analysis focused on mechanical properties would be established through established scientific principles, standardized testing procedures, and validated measurement equipment, not through expert consensus in a clinical context.
4. Adjudication Method for the Test Set:
This information is not applicable, as it pertains to clinical studies involving human assessments or diagnostic outcomes.
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 is not applicable. The device is a mechanical knee implant, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a mechanical implant.
7. The Type of Ground Truth Used:
For the engineering analysis, the "ground truth" would be the physical and mechanical properties of the materials and component designs, measured and quantified according to industry standards for orthopedic implants. This would involve stress tests, fatigue tests, and other biomechanical evaluations to ensure the new offset adapters meet the same performance criteria as the existing predicate devices.
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 study. The development of the offset adapters would have involved engineering design, material selection, and manufacturing processes, but not a data-driven training set in the computational sense.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable. As explained above, there is no training set. The "ground truth" for the design and manufacturing of the device relies on established engineering principles, material science, and regulatory standards for medical device safety and efficacy.
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MAR 1 5 2006 Summary of Safety and Effectiveness Howmedica Osteonics® Modular Rotating Hinge Knee with Offset Adapters
| Proprietary Name: | Howmedica Osteonics® Modular RotatingHinge Knee with Offset Adapters | |
|---|---|---|
| Common Name: | Modular Rotating Hinge Knee | |
| Classification Name and Reference | Knee joint femorotibial metal/polymerconstrained cemented prosthesis, 21 CFR§888.3510 | |
| Device Product Code: | 87 KRO | |
| For Information contact: | Francisco Haro, Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5493Fax: (201) 831-6038 | |
| Date Summary Prepared: | February 9, 2006 |
Description:
This Special 510(k) submission is a line extension intended to add offset adapters to the Howmedica Osteonics® Modular Rotating Hinge Knee.
Intended Use:
The combination of the predicate systems as cleared in the Howmedica Osteonics® Modular Rotating Hinge Knee and Howmedica Total Stabilizer Knee Components 510(k) premarket notifications does not alter the intended use. The subject and predicate devices are single use, sterile knee replacement systems. The indications for use for the Howmedica Osteonics® Modular Rotating Hinge Knee with Offset Adapters are provided below.
Indications for Use:
The Modular Rotating Hinge Knee is intended to be implanted with bone cement for the following conditions:
- . There is destruction of the joint surfaces, with or without significant bone deformity.
- The cruciate and/or collateral ligaments do not stabilize the knee joint. .
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- The ligaments are inadequate and/or the musculature is weak. .
- Revision is required of a failed prosthesis where there has been gross instability, with . or without bone loss or inadequate soft tissue.
Substantial Equivalence:
The subject Howmedica Osteonics® Modular Rotating Hinge Knee with Offset Adapters share the same design, intended use, performance, materials, and operational principle as that of the currently available Howmedica Osteonics® Modular Rotating Hinge Knee and Howmedica Total Stabilizer Knee Components. An engineering analysis demonstrated comparable mechanical properties to the predicate components and substantial equivalence to these devices.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design of an eagle with three stripes representing its wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2006
Howmedica Osteonics Corp. C/o Mr. Francisco Haro Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K060360
. K000500
Trade/Device Name: Howmedica Osteonics Modular Rotating Hinge Knee with Offset Adapters Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: KRO Dated: February 9, 2006 Received: February 13, 2006
Dear Mr. Haro:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your because is receipe is substantially equivalent (for the indications referenced above and haves sure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreated to togens actment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food. Drug. de vices that have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelore, manner of the Act include requirements for annual registration, listing of general voltable proficturing 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 If your device is exassinou (sonal controls. Existing major regulations affecting your device can may oc subject to back additions, 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 r that FDA has made a determination that your device complies with other requirements of the Act that + Dr mas Intacted and regulations administered by other Federal agencies. You must or any I catal 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
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Page 2 - Mr. Francisco Haro
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. 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hubert Lemmens
/ Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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0360
510(k) Number (if known):
Device Name: Howmedica Osteonics® Modular Rotating Hinge Knee with Offset Adapters
Indications for Use:
The Modular Rotating Hinge Knee is intended to be implanted with bone cement for the following conditions:
- There is destruction of the joint surfaces, with or without significant bone . deformity.
- The cruciate and/or collateral ligaments do not stabilize the knee joint. .
- The ligaments are inadequate and/or the musculature is weak. .
- The ngailents are many a failed prosthesis where there has been gross instability, . with or without bone loss or inadequate soft tissue.
| 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)
Concurrence of CDR
Hulut
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number___ K060360 34
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.