(39 days)
No
The summary describes a mechanical implant (tibial baseplate) and makes no mention of software, algorithms, image processing, AI, or ML.
Yes
The device is indicated for treating various knee conditions like degenerative joint disease, correcting functional deformity, and treating fractures, all of which aim to restore or improve physiological function.
No
The device is a knee implant (tibial baseplate components), indicated for surgical restoration of a knee affected by various conditions, and is not used for diagnosing medical conditions.
No
The device description clearly states it is a "tibial baseplate component," which is a physical implant used in knee surgery, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical implantation to restore a knee joint affected by various conditions. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a surgical implant (tibial baseplate components) made of specific materials and designed for implantation with bone cement.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
The Competitor Unicondylar All-Poly Tibial Baseplate Components 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
The all-poly baseplate components are single use only and are intended for implantation only with bone cement.
Product codes
HSX
Device Description
New unicondylar knee all-poly tibial baseplate components have been designed and developed by Smith & Nephew Orthopaedics. The overall material and design of the all-poly components are based upon the existing Genesis Unicompartmental tibial implants and the existing Mod II Knee System implants cleared under 510(k) Notifications K912735 and K760245, respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee
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)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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K061779 Page 1/1
510(K) Summary
AUG - 4 2006
Smith & Nephew Competitor Unicondylar All-Poly Tibial Baseplate Components
| SUBMITTER'S NAME: | Smith & Nephew, Inc., Orthopaedic Division |
|---|---|
| SUBMITTER'S ADDRESS: | 1450 East Brooks Road, Memphis, TN 38116 |
| SUBMITTER'S TELEPHONE NUMBER: | 901-399-6707 |
| CONTACT PERSON: | Gino J. Rouss |
| DATE SUMMARY PREPARED: | June 23, 2006 |
| TRADE OR PROPRIETARY DEVICE NAME: | Smith & Nephew Competitor Unicondylar All-Poly Tibial Baseplate |
| Components | |
| COMMON OR USUAL NAME: | Knee Prosthesis |
| CLASSIFICATION NAME: | Knee ioint femorotibial metal/polymer non-constrained cemented |
| prosthesis, 21 CFR 888.3520 | |
| DEVICE CLASS: | Class II |
| PANEL CODE: | HSX Orthopedics Panel/87 |
A. INTENDED USE:
The Competitor Unicondylar All-Poly Tibial Baseplate Components 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;
- 트 correction of functional deformity;
- 체 revision procedures where other treatments or devices have failed; and
- treatment of fractures that are unmanageable using other techniques 해
The all-poly baseplate components are single use only and are intended for implantation only with bone cement.
DEVICE DESCRIPTION: B.
New unicondylar knee all-poly tibial baseplate components have been designed and developed by Smith & Nephew Orthopaedics. The overall material and design of the all-poly components are based upon the existing Genesis Unicompartmental tibial implants and the existing Mod II Knee System implants cleared under 510(k) Notifications K912735 and K760245, respectively.
C. SUBSTANTIAL EQUIVALENCE INFORMATION:
The Smith & Nephew Competitor Unicondylar All-Poly Tibial Baseplate Components are similar to the following commercially available devices regarding design features, overall indications, and materials:
- Smith & Nephew Genesis Unicompartmental Knee System (K912735)
- · Howmedica Osteonics EIUS Unicompartmental Knee System (K033769)
- · Smith & Nephew Mod II Knee System (K760245)
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 4 2006
Mr. Gino J. Rouss Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116
Re: K061779
Trade/Device Name: Competitor Unicondylar All-Poly Tibial Baseplate Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Code: HSX Dated: June 23, 2006 Received: June 26, 2006
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 such 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
2
Page 2 – Mr. Gino J. Rouss
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 contact the Office of Compliance at (240) 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hiler Lunes us
Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): KO6 \779
Device Name: Competitor Unicondylar All-Polyethylene Tibial Baseplate Components
Indications for Use:
The Competitor Unicondylar All-Poly Tibial Baseplate Components 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
The all-poly baseplate components are for single use only and are intended for implantation only with bone cement.
Prescription Use × (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)
Haled Lener
(Division Sign-Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number K061179