(50 days)
Not Found
No
The summary focuses on material properties, mechanical testing, and wear claims for a tibial insert, with no mention of AI or ML.
Yes.
The device is a total joint replacement for treating various knee conditions, which is inherently a therapeutic purpose.
No.
The device is a total joint replacement (tibial insert) used for treating conditions like arthritis and fractures, not for diagnosing them. The provided text discusses its indications for use as a treatment, its physical characteristics, and performance studies related to its material and wear, all of which confirm its function as a therapeutic device.
No
The device description clearly states it is a "Tibial Insert," which is a physical component of a knee replacement system. The performance studies focus on mechanical and material properties, wear testing, and biocompatibility, all related to a physical implant. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for total joint replacement to treat various conditions affecting the knee joint. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is a tibial insert, a component of a total knee replacement system. This is a physical implant.
- No mention of in vitro testing for diagnostic purposes: The document describes non-clinical testing related to the mechanical properties, wear, and biocompatibility of the implant. It does not mention any testing performed on biological samples (like blood, urine, or tissue) to diagnose a disease or condition.
- No mention of analyzing biological samples: The device itself is not designed to analyze biological samples.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OIY, JWH, MBH
Device Description
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.
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)
Non-Clinical Testing:
The following non-clinical laboratory testing was performed to determine substantial equivalence: mechanical material characterization (Tensile, Small Punch, Izod Impact, and crack propagation), physical and chemical characterization ( Oxidation Index, Compressive Modulus, Poisson's Ratio, Surface Roughness, Density, Onset Melting Temperature, Peak Melting Temperature, Delta H, Degree of Crystallinity, Crosslink Density, Swell Ratio, Molecular Weight, Polydispersity Index, Lamallae Thickness, Free Radical Concentration, Vitamin E Concentration, Vitamin E Consolidation, Vitamin E Elution/Extraction, Trans-vinylene Index), tibial insert peel-out strength, wear testing, and biocompatibility. All testing has demonstrated the device is substantially equivalent to the predicate devices.
Clinical Testing:
None provided as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Oxidation indices were 0.0440.02, 0.04±0.00, and 0.03±0.02 respectively.
Impact resistance for CM before and after accelerated aging was 93.5±7.2 KJ/m² and 25.1±7.0 KJ/m² respectively.
Impact resistance for HXL VEK before and after accelerated aging was 96.2±12.3 KJ/m2 and 102.3±13.3 KJ/m2 respectively.
Average yield strength for CM, HXL, and HXL VEK material was 24.98±0.76 MPa, and 25.09±0.72 MPa, and 25.09±0.72 MPa respectively.
Average resistance load to posterior peel-out for CM and HXL VEK were 169.67±18.18 lbs and 182.43±2.23 bs respectively.
Average yield strength for HXL VEK before and after accelerated aging was 26.76+0.96 MPa and 25.09+0.72 MPa respectively.
Average ultimate load for HXL VEK before and after accelerated aging was 80.80±4.56 N and 81.31±4.22 N respectively.
Average impact resistance for HXL VEK before and after accelerated aging was 96.2±12.3 KJ/m² and 102.3±13.3 KJ/m² respectively.
Average wear rate for the DCM and HXL VEK tibial inserts were 4.4±3.0 mg/million cycles and 1.9±1.9 mg/million cycles respectively. This was significant (p
§ 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
K103223
p 1/5
Summary of Safety and Effectiveness
| Preparation Date: | December 17, 2010 | DEC 21 2010 |
|---|---|---|
| Applicant/Sponsor: | Encore Medical (d.b.a. DJO Surgical) | |
| 9800 Metric Blvd | ||
| Austin, TX 78758 | ||
| Contact Person: | William Garzon | |
| Regulatory Affairs Technician | ||
| Device Name: | Highly Cross-Linked Vitamin E UHMWPE Tibial Insert | |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi- | |
| constrained cemented prosthesis (888.3560), OIY, JWH, MBH |
Legally Marketed Devices to Which Substantial Equivalence is Claimed:
Encore Medical L.P. - Highly Cross-Linked Vitamin E UHMWPE Tibial Insert, K091956
Device Description:
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.
Indications for Use:
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.
Intended Use:
DJO Surgical knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the indications for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
1
K103223
p2/5
. .
Comparable Features to Predicate Device(s):
- . similar product claims
- have the same indicated use, .
- incorporate the same design, .
- . incorporate the same materials.
- . have the same shelf life, and
- . packaged and sterilized using the same materials and processes
Claims:
The following is a summary of the claims submitted for clearance:
Claim 1:
DJO Surgical HXL VEK showed no measurable oxidation during accelerated age testing per ASTM-2003
FTIR analysis was performed on samples of HXL VEK tibial inserts at three different time points: non- aged, two weeks aged, and four weeks aged. Accelerated aging was performed per ASTM F2003 (oxygen environment at 5 atmospheres at 70℃ for 14 and 28 days). The oxidation index was calculated using the method described in ASTM F2102. All three time points showed no detectable oxidation indices