(69 days)
No
The device is a mechanical surgical instrument used to cut bone and there is no mention of AI/ML in the description or performance studies.
No
Explanation: The device is described as an accessory device intended to assist in the implantation of total knee systems by cutting bone, and mechanical testing was performed for intraoperative impact loads. It is a surgical tool, not a device directly treating or alleviating a disease or condition.
No
The device is described as an "accessory device" and its intended use is to "assist in the implantation of Smith & Nephew Total Knee Systems" and to "cut the bone to prepare the tibia to accept the tibial base implant." These functions are surgical and preparative, not diagnostic.
No
The device description and performance studies clearly indicate this is a physical, disposable surgical instrument used to cut bone, not a software application.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is an "accessory device" used to "assist in the implantation of Smith & Nephew Total Knee Systems." This is a surgical instrument used during a surgical procedure on a patient.
- Device Description: The description reinforces this by stating it's a "line addition to the Smith & Nephew Disposable Knee Instruments" and is intended to "cut the bone to prepare the tibia to accept the tibial base implant." This is a tool for bone preparation during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples, while this device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
Smith & Nephew Disposable Fin Punch is an accessory device and is 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.
Indications for Total Knee Replacement
-
- Rheumatoid arthritis.
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
-
- Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
- Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.
Product codes (comma separated list FDA assigned to the subject device)
JWH, MBH
Device Description
Per U.S. Food and Drug Administration (FDA) regulation, device-specific instruments are accessory devices and take on the classification of the device(s) with which they are used. Although these instruments are similar in design to 510k-exempt orthopaedic manual instruments classified under 21 CFR 888.4540, instruments which assist in the implantation of Class II Smith & Nephew Total Knee Systems and are classified as Class II devices are subject to pre-market notifications and regulations.
The Smith & Nephew Disposable Fin Punch is a line addition to the Smith & Nephew Disposable Knee Instruments that were cleared in K123159. The subject device is intended to cut the bone to prepare the tibia to accept the tibial base implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint / Tibia
Indicated Patient Age Range
older patients
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)
Mechanical testing has been conducted to address the intraoperative impact loads expected to be experienced by the fin punch. Additionally, biocompatibility testing for the black Polyetherimide (PEI) material was conducted per the recommendations of ISO 10993-1. A review of the results indicates that the Disposable Fin Punch is equivalent to existing, legally marketed predicate instrumentation with regards to mechanical performance and that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K093746, K951987, K032295, K041825, K121393
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol depicts a stylized human figure with three faces in profile, representing the department's focus on health and human well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2014
Smith & Nephew, Inc. Ms. Jenny Waldrip Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K141585
Trade/Device Name: Smith & Nephew Disposable Fin Punch Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBH Dated: July 1, 2014 Received: July 2, 2014
Dear Ms. Jenny Waldrip:
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
1
(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 (OS) 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 Industry and Consumer Education 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. 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 vours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Premarket Notification Indications for Use Statement
K141585 510(k) Number (if known):
Device Name: Disposable Fin Punch
Indications for Use:
Smith & Nephew Disposable Fin Punch is an accessory device and is 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.
Indications for Total Knee Replacement
-
- Rheumatoid arthritis.
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
- Failed osteotomies, unicompartmental replacement, or total knee replacement. က်
-
- Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
- Constrained knee systems are designed for use in patients in primary and revision surgery, 5. where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (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)
Page 1 of _ 1
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Image /page/3/Picture/0 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew". The words "We are" are in gray, while "smith&nephew" is in orange, matching the flower symbol.
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | August 5, 2014 |
| Contact Person and Address: | Jenny Waldrip
Regulatory Affairs Specialist
T 901.399.6022
F 901.721.2735 |
| Name of Device: | Smith & Nephew, Inc. Disposable Fin Punch |
| Common Name: | Orthopaedic Surgical Instrumentation |
| Device Classification Name and
Reference: | 21 CFR 888.3560 Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented
prosthesis
21 CFR 888.3565 Knee joint patellofemorotibial
metal/polymer porous-coated uncemented prosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | JWH, MBH |
Device Description
Per U.S. Food and Drug Administration (FDA) regulation, device-specific instruments are accessory devices and take on the classification of the device(s) with which they are used. Although these instruments are similar in design to 510|k}-exempt orthopaedic manual instruments classified under 21 CFR 888.4540, instruments which assist in the implantation of Class II Smith & Nephew Total Knee Systems and are classified as Class II devices are subject to pre-market notifications and regulations.
The Smith & Nephew Disposable Fin Punch is a line addition to the Smith & Nephew Disposable Knee Instruments that were cleared in K123159. The subject device is intended to cut the bone to prepare the tibia to accept the tibial base implant.
Intended Use
Smith & Nephew Disposable Fin Punch is an accessory device and is intended to be used to assist in the implantation of Smith & Nephew's Genesis II and Legion Knee Systems and their cleared Indications for Use as presented below. Table 5.1 includes the Smith & Nephew Total Knee Systems to be used in conjunction with the subject device.
| Description | 510(k) | Clearance Date |
|---|---|---|
| LEGION PRIMARY 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 |
Table 5.1 Smith & Nephew Inc. Compatible Total Knee Systems
4
Indications for Total Knee Replacement
-
- Rheumatoid arthritis.
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
- Failed osteotomies, unicompartmental replacement, or total knee replacement. 3.
-
- Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
- Constrained knee systems are designed for use in patients in primary and revision surgery. 5. where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.
Technological Characteristics
Mechanical testing has been conducted to address the intraoperative impact loads expected to be experienced by the fin punch. Additionally, biocompatibility testing for the black Polyetherimide (PEI) material was conducted per the recommendations of ISO 10993-1. A review of the results indicates that the Disposable Fin Punch is equivalent to existing, legally marketed predicate instrumentation with regards to mechanical performance and that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.
Substantial Equivalence Information
The subject devices are identical in function, intended use, and indications for use and very similar in overall design to the GENESIS II Non-Porous Fin-Stem Punch via premarket notification K121393. In addition, the material composition of the subject device is identical to the Disposable Ream-Through Trial cleared via premarket notification K123159. Refer to Exhibit 4 for Premarket Info for Predicate Devices.
| Manufacturer | Description | Submission
Number | Clearance Date |
|-----------------------|-----------------------------------------|----------------------|----------------|
| Smith and Nephew Inc. | GENESIS II Non-Porous Fin-Stem
Punch | K121393 | August 7, 2012 |
| Smith and Nephew Inc. | Disposable Ream-Through Trial | K123159 | May 3, 2013 |
| Table 5.2 Substantially Equivalent Predicates to the Disposable Fin Punch | |||||
|---|---|---|---|---|---|
Conclusion
As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the Smith and Nephew Disposable Fin Punch. Based on the similarities to the predicate devices and a review of the testing performed, the devices are substantially equivalent to above predicate Total Knee Instrumentation.