(206 days)
Not Found
No
The 510(k) summary describes disposable knee instruments, which are mechanical accessory devices, and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The devices are described as "accessory devices" and "intended to be used to assist in the implantation" of knee systems. They do not directly treat a condition but rather aid in a surgical procedure for implantation.
No
The device is described as an "accessory device" intended "to assist in the implantation" of knee systems, not for diagnosing medical conditions.
No
The device description explicitly states "Disposable Knee Instruments," which are physical tools used in surgery, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The text explicitly states the devices are "accessory devices and are intended to be used to assist in the implantation of Smith & Nephew, Inc. Genesis II and Legions total knee systems". This describes a surgical instrument used during a procedure, not a device used to test samples outside the body for diagnostic purposes.
- Device Description: The description reinforces the intended use as "accessory devices and are intended to be used to assist in the implantation".
- Lack of IVD characteristics: The text does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), providing diagnostic information, or being used in a laboratory setting.
Therefore, the Smith & Nephew Disposable Knee Instruments are surgical instruments, not IVDs.
N/A
Intended Use / Indications for Use
Smith & Nephew Disposable Knee Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Total Knee Systems including Legion and Genesis II Knee Systems and their cleared Indications for Use.
Smith & Nephew Disposable Knee Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew, Inc. Genesis II and Legions total knee systems and their cleared indications for use for Total Knee Replacement.
Product codes
JWH, MBH
Device Description
Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. Disposable Knee Instruments. The subject devices are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew, Inc. Genesis II and Legions total knee systems and their cleared indications for use for Total Knee Replacement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
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)
K093746, K951987, K032295, K041825, K121393
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Sto (K) Summary of Safety and Effectiveness Disposable Knee Instruments Smith & Nephew, Inc.
Contact Person and Address Martin Ostmann Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, TN 38116 Tel: (901) 399-1809 FAX: (901) 566-7080
Date of Summary: May 3, 2013
MAY 0 3 2013
Name of Device: Disposable Knee Instruments Common Name: Orthopaedic Surgical Instrumentation Device Classification Name and Reference:
| CFR Number | Description | Classification |
|---|---|---|
| 888.3560 | Knee joint patellofemorotibial polymer/metal/polymer | |
| semi-constrained cemented prosthesis | II | |
| 888.3565 | Knee joint patellofemorotibial metal/polymer porous- | |
| coated uncemented prosthesis | II |
Device Class: Class II
Panel Code: Orthopaedics/87 Product Code: JWH, MBH
Predicate Devices:
Smith & Nephew Inc. Compatible Knee Systems
| Description | 510(k) | Clearance Date |
|---|---|---|
| LEGION PRIMARY KNEE SYSTEM | K093746 | 4/14/10 |
| GENESIS II TOTAL KNEE SYSTEM | K951987 | 8/22/1995 |
| GENESIS II P/S HIGH FLEXION KNEE INSERT | K032295 | 8/21/03 |
| GENESIS II DEEP FLEXION C/R ARTICULAR INSERT | K041825 | 3/11/05 |
| TOTAL KNEE SYSTEM INSTRUMENTATION | K121393 | 8/7/12 |
1
Summary of Safety and Effectiveness Disposable Knee Instruments Smith & Nephew, Inc.
Device Description
Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. Disposable Knee Instruments. The subject devices are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew, Inc. Genesis II and Legions total knee systems and their cleared indications for use for Total Knee Replacement.
Intended Use / Indications for Use
Smith & Nephew Disposable Knee Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Total Knee Systems including Legion and Genesis II Knee Systems and their cleared Indications for Use.
Substantial Equivalence Information
The Disposable Knee Instruments are considered substantially equivalent to previously cleared device specific instruments in that both subject and predicate instruments:
- Have demonstrated biocompatibility through ISO 10993 testing or through use of previously cleared predicate raw materials;
- . Have similar or equivalent dimensions;
- Share identical surgical procedures;
- Utilize the same sterilization procedures; and ●
- Have similar nature of body contact .
The Smith and Nephew Disposable Knee Instruments are similar in design and function to the existing Smith and Nephew Total Knee Instrumentation cleared via K121393.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 3, 2013
Smith & Nephew, Incorporated % Mr. Martin Ostmann Regulatory Affairs Specialist 1450 Brooks Road Memphis. Tennessee 38116
Re: K123159
Trade/Device Name: Disposable Knee Instruments Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBH Dated: April 12, 2013 Received: April 15, 2013
Dear Mr. Ostmann:
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
3
Page 2 - Mr. Martin Ostmann
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
· Sincerely yours.
Erin Meith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K123159
Device Name: Disposable Knee Instruments Indications for Use:
Smith & Nephew Disposable Knee Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew, Inc. Genesis II and Legions total knee systems and their cleared indications for use for Total Knee Replacement.
| Prescription Use | X | AND/OR |
|---|---|---|
| (Part 21 CFR 801 Subpart D) |
Over-The-Counter Use (21 CFR 807 Subpart C)
ter Use
nart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of _ 1
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices