(85 days)
Not Found
No
The device description explicitly states that the subject of the 510(k) is "manual instruments" used to assist in the implantation of knee systems. There is no mention of any software, algorithms, or AI/ML capabilities.
No
The device described is a set of manual instruments used to assist in the implantation of knee systems, rather than the therapeutic knee systems themselves.
No
The device is described as "manual instruments associated with the Smith & Nephew Unicompartmental and Bicompartmental Knee Systems." Its intended use is "to assist in the implantation of the Unicompartmental and Bicompartmental Knee Systems." This clearly indicates it is a surgical instrument for implantation, not for diagnosis.
No
The device description explicitly states that the subject of the 510(k) are "manual instruments" which are "accessory devices" used to assist in the implantation of knee systems. This indicates physical hardware, 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 intended use clearly describes the device as being used to restore compartments of the knee affected by various conditions like osteoarthritis, traumatic arthritis, avascular necrosis, etc. This is a surgical intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as "manual instruments associated with the Smith & Nephew Unicompartmental and Bicompartmental Knee Systems." These are tools used during surgery to assist in the implantation of knee implants.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is a set of surgical instruments used for knee replacement procedures.
N/A
Intended Use / Indications for Use
Smith and Nephew Unicondylar Knee Systems are indicated for restoring either compartment of a knee that has been affected by the following:
- Noninflammatory 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
Smith and Nephew Bicompartmental Knee Systems are intended to be used for those patients whereby conditions exist that cannot be solely addressed by a device that treats a single compartment (i.e. unicondylar or patellofemoral prosthesis) of the knee.
Indications include:
- Post-traumatic arthritis;
- Degenerative arthiritis; and
- Failed osteotomies, hemi-arthroplasties; and unicompartmental replacement
These indications will be used for Smith and Nephew Bicompartmental Knee Systems, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.
The Smith and Nephew Patello-Femoral Joint Knee Systems are indicated for replacement of the femoral side of the patello-femoral joint. They are intended to be used in patellofemoral arthoplasty in patients with:
- Degenerative arthritis in the distal femur and patella.
- A history of patellar dislocation or patellar fracture.
- Failed previous surgery (arthroplasty, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.
Product codes (comma separated list FDA assigned to the subject device)
HSX, KRR, NPJ
Device Description
Subject of this Traditional 510(k) Premarket Notification are manual instruments associated with the Smith & Nephew Unicompartmental and Bicompartmental Knee Systems. The subject devices are accessory devices and are intended to be used to assist in the implantation of the Unicompartmental and Bicompartmental Knee Systems designed and manufactured by Smith & Nephew. The Smith & Nephew Unicompartmental and Bicompartmental Knee System Instruments can be separated into instrument families which are categorized as follows: Trials, Cutting Instruments and Cutting Guides; Cutting Blocks, Alignment Instruments, Impactors and Handles; and Speed Pins and Adaptors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint, distal femur, patella
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): 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.
K073175, K030301, K061569, K051086, K912735, K102069, K061011, K061779
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.
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
§ 888.3520 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.
0
. ..
JAN - 5 2012
Summary of Safety and Effectiveness Unicompartmental and Bicompartmental Knee System Instruments Smith & Nephew, Inc.
Date of Summary: November 29, 2011
Contact Person and Address Gino J. Rouss, MS Group Manager, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 7135 Goodlett Farms Parkway Memphis, Tennessee 38016 T (901) 399-6707
Name of Device: Unicompartmental and Bicompartmental Knee System Instruments Common Name: Orthopaedic Surgical Instrumentation
Device Classification Name and Reference:
21 CFR 888.3520 - Knee joint femorotibial metal/polymer non-constrained cemented prosthesis
21 CFR 888.3560 - Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis
21 CFR 888.3540 - Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis Device Class: Class II
Panel Code: Orthopaedics/87
Predicate Devices:
Journey Unicondylar Femoral Implant (K073175)
Unicondylar Femoral Component (K030301)
Competitor Deuce (Journey) Femoral Component - Sizes 1-8, Oxinium and CoCr (K061569)
Competitor (Journey) PFJ Patello-Femoral Knee Implant (Oxinium) (K051086)
Genesis Unicompartmental Knee System (K912735)
Journey Unicondylar Tibial Baseplastes (K102069)
Competitor Unicondylar Knee Tibial Baseplate (K061011)
Competitor Unicondylar All-Poly Tibial Baseplate (K061779)
Device Description
Subject of this Traditional 510(k) Premarket Notification are manual instruments associated with the Smith & Nephew Unicompartmental and Bicompartmental Knee Systems. The subject devices are accessory devices and are intended to be used to assist in the implantation of the Unicompartmental and Bicompartmental Knee Systems designed and manufactured by Smith & Nephew. The Smith & Nephew Unicompartmental and Bicompartmental Knee System Instruments can be separated into instrument families which are categorized as follows: Trials, Cutting Instruments and Cutting Guides; Cutting Blocks, Alignment Instruments, Impactors and Handles; and Speed Pins and Adaptors.
1
Summary of Safety and Effectiveness Unicompartmental and Bicompartmental Knee System Instruments Smith & Nephew, Inc.
Indications for Use
Unicompartmental Knee Systems
Smith and Nephew Unicondylar Knee Systems are indicated for restoring either compartment of a knee that has been affected by the following:
- 트 Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- . Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and 트
- Treatment of fractures that are unmanageable using other techniques
Bicompartmental Knee Systems
Smith and Nephew Bicompartmental Knee Systems are intended to be used for those patients whereby conditions exist that cannot be solely addressed by a device that treats a single compartment (i.e. unicondylar or patellofemoral prosthesis) of the knee.
Indications include:
- 트 Post-traumatic arthritis;
- Degenerative arthiritis; and
- Failed osteotomies, hemi-arthroplasties; and unicompartmental replacement ■
These indications will be used for Smith and Nephew Bicompartmental Knee Systems, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.
Patello-Femoral Joint Knee Systems
The Smith and Nephew Patello-Femoral Joint Knee Systems are indicated for replacement of the femoral side of the patello-femoral joint. They are intended to be used in patellofemoral arthoplasty in patients with:
- 트 Degenerative arthritis in the distal femur and patella.
- 트 A history of patellar dislocation or patellar fracture.
- Failed previous surgery (arthroplasty, tibial tubercle elevation, lateral release) where pain, ■ deformity or dysfunction persists.
2
Substantial Equivalence Information
The device specific instruments associated with the implant devices with which they are used are considered substantially equivalent to previously cleared device specific instruments in that both subject and predicate instruments:
- Share the same raw materials; .
- . Are manufactured though the same processes;
- . Utilize the same sterilization procedures; and
- . Have similar nature of body contact
The Smith and Nephew Unicompartmental and Bicompartmental Knee System Instruments are similar in design and function to competing unicompartmental and bicompartmental surgical instrumentation currently on the market.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN - 5 2012
Smith and Nephew, Inc. % Gino J. Rouss, MS 1450 Brooks Road Memphis. Tennessee 38116
Re: K113038
Trade/Device Name: Unicompartmental and Bicompartmental Knee System Instruments Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSX, KRR, NPJ Dated: October 10, 2011 Received: October 12, 2011
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
4
Page 2 - Gino J. Rouss, MS
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.
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erine Keith
Mark N. Melkerson
Mark N. Melke Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K113038
Device Name: Smith and Nephew, Inc. Unicondylar Knee Systems
Indications for Use:
Smith and Nephew Unicondylar Knee Systems are indicated for restoring either compartment of a knee that has been affected by the following:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or 1. 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 4.
Prescription Use x (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)
er Use
(part C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Kestolative Devices
Page 1 of _ গি
510(k) Number K113038
6
Indications for Use
510(k) Number (if known): K113038
Device Name: Smith and Nephew, Inc. Bicompartmental Knee Systems
Indications for Use:
Smith and Nephew Bicompartmental Knee Systems are intended to be used for those patients whereby conditions exist that cannot be solely addressed by a device that freats a single compartment (i.e. unicondylar or patellofemoral prosthesis) of the knee.
Indications include:
- 이 Post-traumatic arthritis;
- Degenerative arthiritis; and 이
- Failed osteotomies, hemiarthroplasties; and unicompartmental replacement ■
These indications will be used for Smith and Nephew Bicompartmental Knee Systems, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use
-- .-
(21 CFR 807 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
ـ -- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
BBRich fr
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page Lof 3
-- .--.
510(k) Number K 113038
7
Indications for Use
510(k) Number (if known): K113038
Device Name: Smith and Nephew, Inc. Patellofemoral Joint Knee Systems
Indications for Use:
The Smith and Nephew Patello-Femoral Joint Knee Systems are indicated for replacement of the femoral side of the patello-femoral joint. They are intended to be used in patellofemoral arthoplasty in patients with:
- Degenerative arthritis in the distal femur and patella. 1.
- A history of patellar dislocation or patellar fracture. 2.
- Failed previous surgery (arthroplasty, tibial tubercle elevation, lateral release) where pain, 3. deformity or dysfunction persists.
AND/OR Over-The-Counter Use Prescription Use X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
.. . .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
BBP for
Page of 3
(Division Sign-Oft) Division of Surgical, Jrthopedic, and Restorative Devices
510(k) Number K113038