(33 days)
No
The document describes a physical implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an implant for joint replacement intended to address degenerative arthritis, patellar dislocation, or patellar fracture, and failed previous surgeries, which are conditions that cause pain, deformity, or dysfunction. Its purpose is to restore function and alleviate symptoms, qualifying it as a therapeutic device.
No
Explanation: The device is an implantable prosthetic component for joint replacement, not a tool used to identify or diagnose a condition. Its purpose is to treat an existing condition by replacing a part of the body.
No
The device description clearly states it is a physical implantable component made from Oxinium, intended for surgical replacement of a joint. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an implant for replacing a joint in the human body (patello-femoral joint). This is a surgical implant, not a device used to test samples taken from the body (like blood, urine, or tissue) to diagnose a condition.
- Device Description: The description details a physical implant made of Oxinium, designed to be surgically placed in the femur. This aligns with a medical device for treatment, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
IVD devices are used outside the body to examine specimens obtained from the body to provide information for diagnosis, monitoring, or screening. This device is implanted within the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
The Smith & Nephew Patello-Femoral Implant is indicated for replacement of the femoral side of the patello-femoral joint. It is intended to be used in patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patients with a history of patellar dislocation or patellar fracture, and patients with failed previous surgery (arthroplasty, tibial tubercle elevation, and lateral release) where pain, deformity or dysfunction persists. The components are for single use only and are intended for implantation with bone cement.
Product codes
KRR
Device Description
The Smith & Nephew Patello-Femoral Components are intended to replace the patellofemoral articulating surface of the femur. The components will be manufactured from Oxinium and will be initially manufactured in sizes x-small, medium, and large. Each size will be provided in both left and right configurations. The trochlear groove geometry is the same geometry as found with the Smith & Nephew Genesis II Total Knee Femoral Component subject of K951987.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral side of the patello-femoral joint, patellofemoral arthroplasty, distal femur, patellar
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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace part of a knee joint in the treatment of primary patellofemoral arthritis or chondromalacia. 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 a component made of alloys, such as cobalt-chromium-molybdenum or austenitic steel, for resurfacing the intercondylar groove (femoral sulcus) on the anterior aspect of the distal femur, and a patellar component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those devices intended for use with bone cement (§ 888.3027). The patellar component is designed to be implanted only with its femoral component.(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” and
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,”
(vii) ISO 7207-2:1998 “Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 2: Articulating Surfaces Made of Metal, Ceramic and Plastic Materials,” and
(viii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants,” and
(viii) F 1672-95 “Specification for Resurfacing Patellar Prosthesis.”
0
K051086 (pg 1 of 1)
MAY 3 1 2005 510(K) Summary SMITH & NEPHEW PATELLO-FEMORAL KNEE IMPLANT
SUBMITTER'S NAME: SUBMITTER'S ADDRESS: SUBMITTER'S TELEPHONE NUMBER: CONTACT PERSON: DATE SUMMARY PREPARED: TRADE OR PROPRIETARY DEVICE NAME: COMMON OR USUAL NAME: CLASSIFICATION NAME:
DEVICE CLASS: PANEL CODE:
Smith & Nephew, Inc., Orthopaedic Division 1450 Brooks Road, Memphis, TN 38116 901-399-6707 Gino J. Rouss April 26, 2005 Smith & Nephew Patello-Femoral Implant Patello-Femoral Replacement Knee joint patellofemoral polymer/metal semiconstrained cemented prosthesis Class II Orthopedics/87 KRR
DEVICE INFORMATION:
A. INTENDED USE:
The Smith & Nephew Patello-Femoral Implant is indicated for replacement of the femoral side of the patello-femoral joint. It is intended to be used in patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patients with a history of patellar dislocation or patellar fracture, and patients with failed previous surgery (arthroplasty, tibial tubercle elevation, and lateral release) where pain, deformity or dysfunction persists. The components are for single use only and are intended for implantation with bone cement.
These indications are the same as found with the Howmedica Osteonics Avon" Patello-Femoral Joint Prosthesis cleared via K010100 and K041160.
B. DEVICE DESCRIPTION:
The Smith & Nephew Patello-Femoral Components are intended to replace the patellofemoral articulating surface of the femur. The components will be manufactured from Oxinium and will be initially manufactured in sizes x-small, medium, and large. Each size will be provided in both left and right configurations. The trochlear groove geometry is the same geometry as found with the Smith & Nephew Genesis II Total Knee Femoral Component subject of K951987.
SUBSTANTIAL EQUIVALENCE INFORMATION: C.
The Smith & Nephew Patello-Femoral Components are similar to the following commercially available devices regarding design features, overall indications, and materials:
- · Smith & Nephew (formerly Richards Medical) Patella Type 1 (preamendment)
- · Howmedica Osteonics Corporation Avon" Patello-Femoral Joint Prosthesis (K010100 and K041160)
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized representation of three human figures, depicted as abstract shapes with flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 1 2005
Mr. Gino J. Rouss, M.S. Regulatory Affairs Specialist Smith & Nephew Incorporated Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116
Re: -K051086
Trade/Device Name: Smith & Nephew Patello-Femoral Knee Implant Regulation Number: 21 CFR 888.3540 Regulation Name: Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis Regulatory Class: II Product Code: KRR Dated: April 26, 2005 Received: April 28, 2005
Dear Mr. Rouss:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the enclosale) (c region) the enactment date of the Medical Device Amendments, or to connineres prior to May 20, 1978, in encordance with the provisions of the Federal Food, Drug, devices that have been rochise in assessoval of a premarket approval application (PMA). and Costinette Ace (110.) market the device, subject to the general controls provisions of the Act. The r ou may, dicrerore, maines of the Act include requirements for annual registration, listing of general one of the resuring 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 If your device is clubsition (600 as controls. Existing major regulations affecting your device can may be subject to subject to submitted in the 21, Parts 800 to 898. In addition, FDA may be found in the Overnments concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oe advised that I Dri 3 issuance or our device complies with other requirements of the Act that I DA has made a decerminations administered by other Federal agencies. You must or any it cacal statutes and regaraneers, including, but not limited to: registration and listing (21 Comply with an the Act 3 requirements, moreans, and manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Gino J. Rouss, M.S.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and wyou to obgen inding of substantial equivalence of your device to a legally premaince notification - nesults in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acrice for your 2009 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Provost, Ph.D.
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K051086 Indications for Use
510(k) Number (if known):
Device Name: Smith & Nephew Patello-Femoral Knee Implant
Indications for Use:
The Smith & Nephew Patello-Femoral Implant is indicated for replacement of the femoral side of the Shillin & Nephen Patello remoral to be used in patellofemoral arthroplasty 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 3. pain, deformity or dysfunction persists.
The Smith & Nephew Patello-Femoral Implants are for single use only and are intended for implantation with bone cement.
| 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)
Hypt Church
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Division of General, Restorative, and Neurological Devices
510(k) Number Kos1086