(50 days)
Total joint replacement is indicated for patients suffering from disability due to:
- degenerative, post-traumatic or rheumatoid arthritis; .
- avascular necrosis of the femoral condyle; .
- post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, . dysfunction or prior patellectomy;
- . moderate valgus, varus or flexion deformities;
- Treatment of fractures that are unmanageable using other techniques .
This device may also be indicated in the salvage of previously failed surgical attempts. This device is intended to be used with the 3DKnee System for cemented or uncemented applications.
Subject of this Traditional 510(k) Premarket Notification is a request for labeling claims for the DJO Surgical 3DKnee HXL VE Tibial Insert. The in vitro wear claim will be made for the use of the 3DKnee femoral component coupled with a 3DKnee HXL VE Insert. It is important to note that there are no new total knee components being introduced as a result of this Traditional 510(k) premarket notification.
Acceptance Criteria and Study for DJO Surgical HXL VE Tibial Insert
This document analyzes the acceptance criteria and supporting studies for the DJO Surgical Highly Cross-Linked Vitamin E UHMWPE (HXL VE) Tibial Insert, based on the provided K103223 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The device demonstrates substantial equivalence to predicate devices based on five key claims. The acceptance criteria and reported performance for each claim are detailed below. It's important to note that the acceptance criteria are generally implied as either not showing significant degradation (for properties like oxidation resistance, mechanical strength after aging) or demonstrating performance at least equivalent to, or superior to, control/predicate materials.
| Claim | Acceptance Criteria (Implied) | Reported Device Performance (HXL VE) |
|---|---|---|
| Claim 1: No measurable oxidation during accelerated aging. | Oxidation index |
§ 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.