(454 days)
Not Found
No
The summary describes a mechanical implant (tibial insert) and its material properties and mechanical testing. There is no mention of software, algorithms, or any technology that would suggest AI/ML.
Yes
The device, a tibial insert for joint replacement, is used to treat conditions like arthritis and avascular necrosis, which are medical conditions causing disability. Its function is to restore joint configuration and kinematics, directly addressing and alleviating these health issues.
No
The device description clearly states it is a "Highly Cross-Linked Vitamin E UHMWPE (HXL VE) Tibial Inserts," which are components for joint replacement surgery. The "Intended Use" section describes conditions for which joint replacement is indicated, not for diagnosing those conditions. The performance studies listed are related to material characterization, mechanical properties, and biocompatibility of the implant, not diagnostic accuracy.
No
The device description clearly states it is a physical implant (tibial inserts made of UHMWPE) and details its manufacturing process and physical characteristics.
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 surgical implant for joint replacement to treat conditions affecting the knee joint. This is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body) on biological specimens.
- Device Description: The device is a physical implant (tibial insert) made of a specific material for use in knee replacement surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens like blood, urine, tissue, etc., or to provide information about a patient's health status through in vitro analysis.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
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;
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
The Highly Cross-Linked Vitamin E UHMWPE (HXL VE) Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) powder that is blended with pure liquid pharmaceutical grade alpha-tocopheral, compression molded and then highly cross-linked. The tibial inserts are available in 9 sizes (2- 12) and 5 thicknesses (9-19) and are provided in right and left orientations. The HXL VE Tibial Insert design is identical to the 3DKnee Tibial Insert cleared via K020114. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle. The baseplate attachment mechanism is the same as the previously cleared 3DKnee System inserts.
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)
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.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DJOsurgical
SEP 2 8 2010
Summary of Safety and Effectiveness
| Preparation Date: | September 22, 2010 |
|---|---|
| Applicant/Sponsor: | Encore Medical (d.b.a. DJO Surgical) |
| 9800 Metric Blvd | |
| Austin, TX 78758 | |
| Contact Person: | Elizabeth Pugh |
| Regulatory Affairs Specialist | |
| 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 | ||
|---|---|---|
| 3DKnee | K020114 | Encore Medical |
| E-Poly Tibial Bearings | K080528 | Biomet |
Device Description:
The Highly Cross-Linked Vitamin E UHMWPE (HXL VE) Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) powder that is blended with pure liquid pharmaceutical grade alpha-tocopheral, compression molded and then highly cross-linked. The tibial inserts are available in 9 sizes (2- 12) and 5 thicknesses (9-19) and are provided in right and left orientations. The HXL VE Tibial Insert design is identical to the 3DKnee Tibial Insert cleared via K020114. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle. The baseplate attachment mechanism is the same as the previously cleared 3DKnee System inserts.
| Compatible Systems | Clearance | Cemented/Cementless |
|---|---|---|
| 3DKnee System | K020114 | Cemented |
| 3DKnee Porous Coated Femoral | K032905 | Cementless |
| Component |
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;
1
K091956 *みよ
- post-traumatic loss of joint configuration, particularly when ● there is patellofemoral erosion, dysfunction or prior patellectomy;
- . moderate valgus, varus or flexion deformities;
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.
Summary of Technologies:
| Design Feature | Equivalent Device |
|---|---|
| Highly Cross-Linked Vitamin E | |
| Polyethylene Material | |
| UHMWPe (α-tocopherol) | E-Poly Tibial Bearings – Biomet |
| (K080528) | |
| Indications for Use | 3DKnee Tibial Insert – Encore |
| Medical (K020114) | |
| Design (size, thickness, configuration, | |
| dimensions) | 3DKnee Tibial Insert – Encore |
| Medical (K020114) |
Substantial Equivalence Table
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Encore Medical, L.P. % Mrs. Beth Pugh Regulatory Affairs Specialist 9800 Metric Boulevard Austin, Texas 78758
SEP 2 8 2010
Re: K091956
Trade/Device Name: Highly Cross-linked Vitamin E UHMWPE Tibial Inserts Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prothesis Regulatory Class: Class II Product Code: OIY, JWH, MBH Dated: July 29, 2010 Received: July 30, 2010
Dear Mrs. Pugh:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21
3
Page 2 - Mrs. Beth Pugh
CFR Part 807); laheling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SEP 2 8 2010
510(k) Number (if known): K091956
Device Name: Highly Cross-Linked Vitamin E UHMWPE Tibial Insert
Indications for Use:
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;
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.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C) '
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Omitir for mxm
Dission Sign-OH) Division of Surgical, Orthepedic, and Restorative Devices
510(k) Number K091956
Page 1 of 1