(28 days)
The Genesis Unicondylar UHMWPe Articular Inserts are indicated for restoring either compartment of a knee that has been affected by the following:
- Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and
- Treatment of fractures that are unmanageable using other techniques.
The implants are single use only and are designed to be used in combination with Genesis Unicondylar baseplates that are intended for implantation with bone cement.
New unicondylar UHMWPe articular inserts have been designed and developed by Smith & Neohew Orthopaedics. The subject devices were designed to be used with existing Genesis Unicondylar baseplates (K912735) and are intended to replace either the medial or lateral tibial compartment of the knee. The overall design of the articular inserts is based on the existing Genesis Unicondylar inserts cleared via 510(k) Premarket Notification K912735.
This 510(k) summary (K100197) describes the Smith & Nephew Genesis Unicondylar UHMWPe Articular Inserts. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study with acceptance criteria and device performance metrics in the typical sense of a diagnostic or AI device.
Therefore, the requested information elements related to a study proving acceptance criteria (like sample size, ground truth, experts, MRMC studies, standalone performance, training set details) are not applicable and cannot be extracted from this document because such a study is not part of this type of submission for this device.
The document states: "The overall design of the articular inserts is based on the existing Genesis Unicondylar inserts cleared via 510(k) Premarket Notification K912735." and "The Smith & Nephew Genesis Unicondylar UHMWPe Articular Inserts are similar to the following commercially available devices regarding design features, overall indications, and materials: Smith & Nephew Genesis Unicompartmental Articular Knee Inserts (K912735) and Smith & Nephew Journey Unicondylar Articular Knee Inserts (K061011)."
This indicates that the device's acceptance is based on its substantial equivalence to predicate devices already on the market, meaning it has similar technological characteristics and is intended for the same use as legally marketed devices without raising new questions of safety and effectiveness.
Therefore, here is an attempt to address the request based on the provided document and the nature of a 510(k) submission for a physical medical device like this:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from Substantial Equivalence and Device Type) | Reported Device Performance / Justification |
|---|---|---|
| Material Composition | UHMWPe (Ultra-High Molecular Weight Polyethylene) | The device uses UHMWPe, consistent with predicate devices and established orthopedic material standards. |
| Design Features | Overall design based on existing Genesis Unicondylar inserts; compatibility with existing Genesis Unicondylar baseplates. | The device's overall design is based on the cleared K912735 inserts and is designed for compatibility with existing Genesis Unicondylar baseplates (K912735). |
| Indications for Use | Same indications as predicate devices (non-inflammatory degenerative joint disease, functional deformity correction, revision procedures, unmanageable fractures). | The stated indications for use are consistent with those of the predicate devices. |
| Biocompatibility | Materials are biocompatible (inherent to UHMWPe and similar to predicate). | Assumed to be met through material selection (UHMWPe) and substantial equivalence to predicate devices using similar materials. |
| Mechanical Performance | Mechanical properties suitable for knee prosthesis (e.g., wear resistance, strength) and comparable to predicate devices. | Not explicitly detailed in this summary, but typically proven through bench testing to standards and comparison to predicate devices as part of the substantial equivalence determination. The 510(k) process accepts that if a device is "similar" in design and material to a predicate, and the predicate has demonstrated safe and effective mechanical performance, then the new device has "met" this criterion by analogy. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document describes a 510(k) submission for a physical orthopedic implant based on substantial equivalence, not a clinical study or a study involving a "test set" as understood for diagnostic or AI devices. The "data" provenance would relate to the design documents, material specifications, and regulatory history of the predicate devices.
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)
- Not applicable. "Ground truth" for a physical implant like this is established through engineering design, material science, and the regulatory history of similar devices. It does not involve expert consensus on interpreting data from a "test set" in the context of an AI or diagnostic study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication process of this nature is described or relevant for this type of 510(k) submission.
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
- Not applicable. This is an orthopedic implant, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related effectiveness assessment was performed or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. There is no algorithm or software component described in this 510(k) submission for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Inferred: The "ground truth" for demonstrating the safety and effectiveness of this device is primarily based on the established safety and effectiveness of the predicate devices (K912735 and K061011) through previous regulatory clearances, and adherence to relevant material standards (for UHMWPe) and design principles for knee prostheses. This involves engineering data, material specifications, and historical clinical performance of similar devices, rather than a "ground truth" derived from patient-specific data in a clinical trial for a new diagnostic.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that utilizes training sets.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set is described or utilized for this medical device.
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Kl:00197
510(K) Summary
Smith & Nephew Genesis Unicondylar UHMWPe Articular Inserts
| SUBMITTER'S NAME: | Smith & Nephew, Inc., Orthopaedic Division |
|---|---|
| SUBMITTER'S ADDRESS: | 1450 East Brooks Road, Memphis, TN 38116 |
| SUBMITTER'S TELEPHONE NUMBER: | 901-399-6707 FEB 1 9 2010 |
| CONTACT PERSON: | Gino J. Rouss |
| DATE SUMMARY PREPARED: | January 20, 2010 |
| TRADE OR PROPRIETARY DEVICE NAME: | Smith & Nephew Genesis Unicondylar UHMWPe Articular Inserts |
| COMMON OR USUAL NAME: | Knee Prosthesis |
| CLASSIFICATION NAME: | Knee joint femorotibial metal/polymer non-constrained cementedprosthesis, 21 CFR 888.3520 |
| DEVICE CLASS: | Class II |
| PANEL CODE: | HSX Orthopedics Panel/87 |
A. Intended Use
The Genesis Unicondylar UHMWPe Articular Inserts are indicated for restoring either compartment of a knee that has been affected by the following:
- l Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis:
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and
- Treatment of fractures that are unmanageable using other techniques. 포
The implants are single use only and are designed to be used in combination with existing Genesis Unicondylar baseplates that are intended for implantation with bone cement.
B. Device Description
New unicondylar UHMWPe articular inserts have been designed and developed by Smith & Neohew Orthopaedics. The subject devices were designed to be used with existing Genesis Unicondylar baseplates (K912735) and are intended to replace either the medial or lateral tibial compartment of the knee. The overall design of the articular inserts is based on the existing Genesis Unicondylar inserts cleared via 510(k) Premarket Notification K912735. *
C. Substantial Equivalence
The Smith & Nephew Genesis Unicondylar UHMWPe Articular Inserts are similar to the following commercially available devices regarding design features, overall indications, and materials:
- · Smith & Nephew Genesis Unicompartmental Articular Knee Inserts (K912735)
- · Smith & Nephew Journey Unicondylar Articular Knee Inserts (K061011)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Smith & Nephew, Inc. % Mr. Gino J. Rouss, MS Manager, Regulatory Affairs 1450 East Brooks Road
Memphis, Tennessee 38116
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
FEB 1 9 2010
Re: K100197
Trade Name: Smith & Nephew Genesis Unicondylar UHMWPe Articular Inserts Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented
prosthesis
Regulatory Class: II Product Code: HSX Dated: January 20, 2010 Received: January 22, 2010
Dear Mr. Rouss:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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Page 2 - Dr. Kelly J. Baker
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.
Barbara Buehm
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Smith & Nephew Genesis Unicondylar UHMWPe Articular Inserts
INDICATIONS FOR USE:
The Genesis Unicondylar UHMWPe Articular Inserts are indicated for restoring either compartment of a knee that has been affected by the following:
- Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and 전
- 미 Treatment of fractures that are unmanageable using other techniques.
The implants are single use only and are designed to be used in combination with Genesis Unicondylar baseplates that are intended for implantation with bone cement.
| Prescription Use | X | AND/OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Omitti for mxn
vision of Surgical, Ohhopedic, and Restorative Devices
Page 1 of 1
510(k) Number K100197
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.