(90 days)
No
The document describes traditional surgical instruments for knee replacement and does not mention any AI or ML capabilities.
No.
The device described consists of instruments and accessory devices used to assist in the implantation of total knee systems, not the total knee systems themselves. Therefore, these instruments are not directly involved in treating or mitigating a disease or condition but rather facilitate a surgical procedure.
No
The device is described as "accessory devices" used to "assist in the implantation" of knee systems, not to diagnose a condition.
No
The device description explicitly states that the subject devices are "instruments" and lists various categories of physical instruments (Trials, Cutting Instruments, Cutting Guides, etc.). There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices are "accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Total Knee Systems". This describes surgical instruments used during a procedure, not devices used to test samples outside the body to diagnose or monitor a condition.
- Device Description: The device description lists categories of instruments like "Trials, Cutting Instruments and Cutting Guides; Cutting Blocks, Alignment and Sizing Instruments, Impactors and Handles, Clamps, Extraction, Torque, Instrument Guides, and Covers and Protectors". These are all tools used in orthopedic surgery.
- 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, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
- Use in a laboratory setting
The device is clearly intended for use in a surgical setting to facilitate the implantation of knee replacement components.
N/A
Intended Use / Indications for Use
Smith & Nephew Total Knee Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Total Knee Systems and their cleared Indications for Use.
Indications for Cruciate Retaining Cemented Knee Replacement
-
- Rheumatoid arthritis.
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 2.
-
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
Cruciate Retaining Cemented Knee components are indicated for use with cement and are single use devices.
Indications for Cruciate Retaining Cementless Knee Replacement
- Rheumatoid arthritis.
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
- Failed osteotomies, unicompartmental replacement, or total knee replacement. 3.
Cruciate Retaining Cementless Knee components are indicated for use without cement and are single use devices.
Indications for Posterior Stabilized Cemented Knee Replacement
-
- Rheumatoid arthritis.
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
- Failed osteotomies, unicompartmental replacement, or total knee replacement. 3.
-
- Primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
Posterior Stabilized Cemented Knee components are indicated for use with cement and are single use devices.
Indications for Posterior Stabilized Cementless Knee Replacement
-
- Rheumatoid arthritis.
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
-
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
-
- Primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
Posterior Stabilized Cementless Knee components are indicated for use without cement and afe single use devices.
Indications for Constrained Total Knees
- Rheumatoid arthritis. 1.
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 2.
- Failed osteotomies, unicompartmental replacement, or total knee replacement. 3.
- Constrained knee systems are designed for use in patients in primary and revision surgery, 4. where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent.
Constrained Total Knee components are indicated for use with cement and are single use devices.
Indications for Hinged Total Knees
-
- Rheumatoid arthritis.
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
- Failed osteotomies, unicompartmental replacement, or total knee replacement. 3.
- Posterior stabilized knee systems are designed for use in patients in primary and revision বা surgery where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
- Hinge knee systems are designed for use in patients in primary and revision surgery, where 5. 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.
Hinged Total Knee components are indicated for use with cement and are single use devices.
Product codes
MBH, JWH, HRY, HSX, KRO, KRQ, KRR, NPJ
Device Description
Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. Total Knee System Instruments. The subject devices are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Total Knee Systems and their cleared Indications for Use. Smith & Nephew Total Knee System Instruments can be organized into instrument families which are categorized as follows: Trials, Cutting Instruments and Cutting Guides; Cutting Blocks, Alignment and Sizing Instruments, Impactors and Handles, Clamps, Extraction, Torque, Instrument Guides, and Covers and Protectors.
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): 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.
K951987, K953274, K954909, K032683, K041825, K042515, K051229, K101499, K962557, K032295, K946236, K030623, K030612, K100897, K073325, K091543, K962137, K043440, K060742, K071071, K072531, K963255, K041106, K081111
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
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
0
Summary of Safety and Effectiveness Total Knee System Instruments Smith & Nephew, Inc.
K12/393
Date of Summary: May 8, 2011
AUG 7 2012
Contact Person and Address Gino Rouss, MS Group Manager, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 7135 Goodlett Farms Parkway Memphis, Tennessee 38016 Tel: (901) 399-6707 FAX: (901) 566-7080
Name of Device: Total Knee System Instruments Common Name: Orthopaedic Surgical Instrumentation Device Classification Name and Reference:
| CFR Number | Description | Classification |
|---|---|---|
| 888.3510 | Knee joint femorotibial metal/polymer constrained cemented prosthesis | II |
| 888.3520 | Knee joint femorotibial metal/polymer non-constrained cemented prosthesis | II |
| 888.3530 | Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis | II |
| 888.3540 | Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis | II |
| 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
1
Summary of Safety and Effectiveness Total Knee System Instruments Smith & Nephew, Inc.
Predicate Devices:
Smith & Nephew Inc. Cemented Total Knee Systems
| Description | 510(k) | Clearance Date |
|---|---|---|
| GENESIS II TOTAL KNEE SYSTEM | K951987 | 8/22/1995 |
| GENESIS POROUS TIBIAL TRAYS & REVISION | ||
| KNEE SYSTEM | K953274 | 2/5/1996 |
| PROFIX POSTERIOR STABILIZED KNEE SYSTEM | K954909 | 1/31/1996 |
| GENESIS II POROUS PLUS HA KNEE SYSTEM | K032683 | 10/15/2003 |
| GENESIS II DEEP FLEXION CRUCIATE RETAINING | ||
| ARTICULAR INSERT | K041825 | 3/11/2005 |
| HIGH PERFORMANCE KNEE | K042515 | 3/14/2005 |
| PROFIX FLEX CRUCIATE RETAINING ARTICULAR | ||
| INSERT | K051229 | 7/20/2005 |
| JOURNEY CR KNEE SYSTEM | K101499 | 8/26/2010 |
| GENESIS II ZIRCONIUM FEMORAL | ||
| COMPONENT/PROFIX ZIRCONIUM FEMORAL | ||
| COMPONENT | K962557 | 12/5/1996 |
| GENESIS II POSTERIOR STABILIZED HIGH FLEXION | ||
| INSERT | K032295 | 8/21/2003 |
| PROFIX CONFORMING PLUS TIBIAL INSERT | K946236 | 7/6/1995 |
Smith & Nephew Inc. Cementless Total Knee Systems
| Description | 510(k) | Clearance Date |
|---|---|---|
| GENESIS II POROUS PLUS HA KNEE SYSTEM | K032683 | 10/15/2003 |
| PROFIX TOTAL KNEE SYSTEM | K030623 | 5/22/2003 |
| GENESIS II TOTAL KNEE SYSTEM | K030612 | 5/27/2003 |
| LEGION POROUS + HA TIBIAL BASEPLATES | K100897 | 5/13/2010 |
| LEGION POROUS PRIMARY | K073325 | 12/20/2007 |
| LEGION POROUS PLUS HA PRIMARY FEMORAL | ||
| COMPONENTS | K091543 | 12/21/2009 |
| PROFIX FLEX CRUCIATE RETAINING ARTICULAR | ||
| INSERT | K051229 | 7/20/2005 |
| GENESIS II POSTERIOR STABILIZED HIGH FLEXION | ||
| INSERT | K032295 | 8/21/2003 |
| GENESIS II DEEP FLEXION CRUCIATE RETAINING | ||
| ARTICULAR INSERT | K041825 | 3/11/2005 |
2
Summary of Safety and Effectiveness Total Knee System Instruments Smith & Nephew, Inc.
Smith & Nephew Inc. Constrained Total Knee Systems
| Description | 510(k) | Clearance Date |
|---|---|---|
| GENESIS II CONSTRAINED KNEE SYSTEM | K962137 | 8/2/1996 |
| REVISION KNEE SYSTEM | K043440 | 2/18/2005 |
| LEGION COBALT CHROME REVISION KNEE | ||
| SYSTEM | K060742 | 5/3/2006 |
| CROSSLINKED POLYETHYLENE ARTICULAR | ||
| INSERTS | K071071 | 9/19/2007 |
| LEGION STEM WITH HOLES | K072531 | 12/6/2007 |
| PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS | ||
| TIBIAL INSERT, PROFIX P/S TIBIAL INSERT | K963255 | 1/2/1997 |
| REVISION KNEE SYSTEM | K041106 | 7/1/2004 |
Smith & Nephew Inc. Hinged Total Knee System
| Description | 510(k) | Clearance Date |
|---|---|---|
| LEGION HINGE KNEE SYSTEM | K081111 | 7/23/2008 |
Device Description
Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. Total Knee System Instruments. The subject devices are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Total Knee Systems and their cleared Indications for Use. Smith & Nephew Total Knee System Instruments can be organized into instrument families which are categorized as follows: Trials, Cutting Instruments and Cutting Guides; Cutting Blocks, Alignment and Sizing Instruments, Impactors and Handles, Clamps, Extraction, Torque, Instrument Guides, and Covers and Protectors.
Intended Use / Indications for Use
Smith & Nephew Total Knee Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Total Knee Systems and their cleared Indications for Use.
Indications for Cruciate Retaining Cemented Knee Replacement
-
- Rheumatoid arthritis.
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 2.
-
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
Cruciate Retaining Cemented Knee components are indicated for use with cement and are single use devices.
3
Indications for Cruciate Retaining Cementless Knee Replacement
- Rheumatoid arthritis. ﺎ ﻳﺘﻢ ﺍﻟﻤﺴﺘﻘﺒﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
- Failed osteotomies, unicompartmental replacement, or total knee replacement. 3.
Cruciate Retaining Cementless Knee components are indicated for use without cement and are single use devices.
Indications for Posterior Stabilized Cemented Knee Replacement
-
- Rheumatoid arthritis.
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
- Failed osteotomies, unicompartmental replacement, or total knee replacement. 3.
-
- Primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
Posterior Stabilized Cemented Knee components are indicated for use with cement and are single use devices.
Indications for Posterior Stabilized Cementless Knee Replacement
-
- Rheumatoid arthritis.
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
-
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
-
- Primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
Posterior Stabilized Cementless Knee components are indicated for use without cement and afe single use devices.
Indications for Constrained Total Knees
- Rheumatoid arthritis. 1.
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 2.
- Failed osteotomies, unicompartmental replacement, or total knee replacement. 3.
- Constrained knee systems are designed for use in patients in primary and revision surgery, 4. where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent.
Constrained Total Knee components are indicated for use with cement and are single use devices.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew, Inc. % Mr. Gino Rouss Group Manager, Regulatory Affairs 1450 E Brooks Road Memphis, Tennessee 38116
Re: K121393
Trade/Device Name: Smith & Nephew Inc. Total Knee System Instrumentation Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH, HRY, HSX, KRO, KRQ, KRR, NPJ Dated: May 8, 2012 Received: May 9, 2012
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.
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
7 2012 AUG
5
Page 2 - Mr. Gino Rouss
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,
Mark A. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known):
Device Name: Smith & Nephew Inc. Hinged Total Knee Systems
Indications for Use:
Smith & Nephew Hinge Total Knee Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Hinge Total Knee Systems and their cleared' Indications for Use.
Indications for Hinged Total Knees
-
- Rheumatoid arthritis.
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
- Failed osteotomies, unicompartmental replacement, or total knee replacement. 3.
- Posterior stabilized knee systems are designed for use in patients in primary and revision বা surgery where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
- Hinge knee systems are designed for use in patients in primary and revision surgery, where 5. 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.
Hinged Total Knee components are indicated for use with cement and are single use devices.
Over-The-Counter Use x AND/OR Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Andut
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121393
Page of
7
510(k) Number (if known):
Device Name: Smith & Nephew Inc. Constrained Total Knee Systems
Indications for Use:
inditorient to revew Constrained Total Knee Instruments are accessory devices and are intended to Smith & Rophen and and of Smith & Nephew Constrained Total Knee Systems and their cleared Indications for Use.
Indications for Constrained Total Knees
- Rheumatoid arthritis. 1.
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 2.
- Failed osteotomies, unicompartmental replacement, or total knee replacement. 3.
- r uned restored thee systems are designed for use in patients in primary and revision surgery, 4. where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent.
Constrained Total Knee components are indicated for use with cement and are single use devices.
| 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 IF NEÉDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Page_ ੀ
8
510(k) Number (if known):
Device Name: Smith & Nephew Inc. Posterior Stabilized Cementless Knee Systems
Indications for Use:
Smith & Nephew Posterior Stabilized Cementless Knee Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Posterior Stabilized Cementless Knee Systems and their cleared Indications for Use.
Indications for Posterior Stabilized Cementless Knee Replacement
-
- Rheumatoid arthritis.
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 2.
-
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
-
- Primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
Posterior Stabilized Cementless Knee components are indicated for use without cement and are single use devices.
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)
Aisul
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121393
Page _________________________________________________________________________________________________________________________________________________________________________ of
9
510(k) Number (if known):
Device Name: Smith & Nephew Inc. Posterior Stabilized Cemented Knee Systems
Indications for Use:
Smith & Nephew Posterior Stabilized Cemented Knee Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Posterior Stabilized Cemented Knee Systems and their cleared Indications for Use.
Indications for Posterior Stabilized Cemented Knee Replacement
- Rheumatoid arthritis. 1.
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 2.
-
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
-
- Primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intáct.
Posterior Stabilized Cemented Knee components are indicated for use with cement and are single use devices.
AND/OR
Prescription Use x (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)
As
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121393
Page of
10
510(k) Number (if known):
Device Name: Smith & Nephew Inc. Cruciate Retaining Cementless Knee Systems
Indications for Use:
Smith & Nephew Cruciate Retaining Cementless Knee Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Cruciate Retaining Cementless Knee Systems and their cleared Indications for Use.
Indications for Cruciate Retaining Cementless Knee Replacement
-
- Rheumatoid arthritis.
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 2.
-
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
AND/OR
Cruciate Retaining Cementless Knee components are indicated for use without cement and are single use devices.
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121393
Page of
11
510(k) Number (if known):
Device Name: Smith & Nephew Inc. Cruciate Retaining Cemented Knee Systems
Indications for Use:
Smith & Nephew Cruciate Retaining Cemented Knee Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Cruciate Retaining Cemented Knee Systems and their cleared Indications for Use.
Indications for Cruciate Retaining Cemented Knee Replacement
-
- Rheumatoid arthritis.
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
-
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
Cruciate Retaining Cemented Knee components are indicated for use with cement and are single use devices.
| 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121393
Page