(87 days)
No
The summary describes a physical implant (femoral posterior spacer) used in knee surgery and makes no mention of software, algorithms, or any AI/ML related terms or concepts.
Yes
The device is described as a spacer intended to augment bone loss in the posterior condyle of the femur, indicating a direct role in patient treatment and therapy.
No
The device is a femoral posterior spacer, an implant designed to augment bone loss during knee arthroplasty. Its function is structural and reconstructive, not diagnostic.
No
The device description clearly indicates it is a physical implant (a spacer cemented to a femoral component) and not a software product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Duracon® Femoral Posterior Spacer is a physical implant designed to augment bone loss in the femur during knee surgery. It is a surgical device, not a device used to test biological samples.
- Intended Use: The intended use clearly states it's for use with a total knee system to address bone loss, which is a surgical procedure.
The information provided describes a surgical implant, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Duracon® Femoral Posterior Spacer is intended to be used with the femoral components of the Duracon® Total Knee System (reference premarket notifications K910235, K920034, K932070, and K954138) to augment bone loss in the area of the posterior condyle of the femur. Posterior bone loss that requires augmentation by spacers may be noted in primary or revision total knee arthroplasty cases.
Product codes
Not Found
Device Description
The Duracon® Femoral Posterior Spacer is cemented to the femoral component, and then the spacer-femoral component assembly is cemented into place.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior condyle of the femur
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)
K910235, K920034, K932070, K954138, K915512
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510 (k) Summary
NOV 1 4 1996
Duracon® Femoral Posterior Spacer Device:
The Duracon® Femoral Posterior Spacer is intended to be used with the femoral components of the Duracon® Total Knee System (reference premarket notifications K910235, K920034, K932070, and K954138) to augment bone loss in the area of the posterior condyle of the femur. Posterior bone loss that requires augmentation by spacers may be noted in primary or revision total knee arthroplasty cases.
The Duracon® Femoral Posterior Spacer is cemented to the femoral component, and then the spacer-femoral component assembly is cemented into place.
The Duracon® Femoral Posterior Spacer is substantially equivalent to several other legally marketed devices. Examples of these are listed below: Duracon® Total Knee System Distal Femoral Spacers 1. (K915512) - Howmedica Duracon® Total Knee System Distal-Posterior Femoral 2 . Spacers (K915512) - Howmedica Kinemax® Plus Superstabilizer Total Knee 3. System Femoral Posterior Spacers (K904208) - Howmedica Series 7000 Total Knee System Femoral Posterior 4 . Spacers - Osteonics Corporation 5 . Genesis Total Knee System Femoral Posterior Spacers - Smith & Nephew Richards Coordinate Total Knee System Femoral Posterior ୧ . Spacers - DePuy For information contact: Margaret F. Crowe Manager, Regulatory Affairs Howmedica Inc.
359 Veterans Boulevard Rutherford, NJ 07070 (201) 507-7431 (201) 507-6870 Fax: