(79 days)
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No
The device description focuses solely on the physical components and materials of a knee prosthesis, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
A therapeutic device is one that treats or prevents a disease or condition. This device is a prosthesis intended for resurfacing a knee joint, which would address conditions like osteoarthritis or injury, thereby having a therapeutic effect.
No.
The device description indicates that it is a prosthesis intended for resurfacing a knee joint, not for diagnosing a condition.
No
The device description clearly outlines physical components made of metallic and polyethylene materials, indicating it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for resurfacing of one side of the knee joint." This is a surgical procedure performed in vivo (within the living body) to replace damaged joint surfaces.
- Device Description: The device is a physical implantable prosthesis consisting of metallic and polyethylene components designed to be surgically implanted into the knee joint.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the living body) to provide information about a person's health. This device does not interact with biological specimens in this way.
The Natural-Knee II - Unicompartmental Knee Prosthesis is a surgical implant or prosthetic device, not an IVD.
N/A
Intended Use / Indications for Use
The Natural-Knee II - Unicompartmental Knee Prosthesis is intended for resurfacing of one side of the knee joint.
Product codes
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Device Description
The Natural-Knee II - Unicompartmental Knee Prosthesis is intended for resurfacing of one side of the knee joint. The system consists of metallic femoral and tibial components as well as a polyethylene tibial insert.
The femoral component is a symmetrically designed component, eliminating the need for left/right orientations. The femoral component is manufactured from cast cobalt chromium/molybdenum (CoCrMo) and features a central cruciate stem which aids in stabilization. A central posterior runner is incorporated into the inner surface to provide further rotational stability. Contact area is maximized by the "sweeping" condylar geometry. Both a nonporous and CSTi porous coated version are available. The femoral component is available in 7 sizes (1-7).
The tibial component is a symmetrically designed component, eliminating the need for left/right orientations. The tibial component is manufactured from wrought titanium alloy (Ti-6AI-4V). The baseplate features three pegs on the underside which aid in rotational stabilization. A screw hole has been placed in the center of the baseplate for optional screw fixation. The baseplate is designed with capture features which permit the UHMWPE tibial insert to be snapped into place. Both a nonporous and CSTi porous coated version are available. The baseplate is available in 6 sizes (1-6).
The tibial insert is a symmetrically designed component manufactured from Ultra-High Molecular Weight Polyethylene (ASTM F648). The insert articulating geometry is semiconstrained and is captured in the baseplate by the mating capture features. The insert is available in 3 thicknesses (9, 11, and 13 mm) and 3 sizes (1-2, 3-4, and 5-6).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Knee joint
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Contact area and constraint testing on the femoral and tibial components showed the Natural-Knee II Unicompartmental Knee Prosthesis to be comparable to other legally marketed devices.
Testing on the baseplate-insert locking mechanism indicated that the push-out strength was comparable to other legally marketed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
510(k) SUMMARY
December 14, 1995
MAR - 8 550
In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a 510(k) Summary for the Intermedics Orthopedics, Inc. Natural-Knee® II - Unicompartmental Knee System.
| Submitter: | Intermedics Orthopedics, Inc.
9900 Spectrum Drive
Austin, TX 78717
(512) 432-9687 |
|----------------------|------------------------------------------------------------------------------------------------|
| Contact Person: | Jacquelyn Hughes
Manager, Regulatory Affairs |
| Classification Name: | Knee joint femorotibial metal/polymer semi-constrained
cemented prothesis, 21 CFR 888.3530. |
| Common/Usual Name: | Unicondylar knee prosthesis, partially constrained |
| Trade/Proprietary: | Natural-Knee* II - Unicompartmental Knee Prosthesis |
Product Description/Substantial Equivalence:
The Natural-Knee II - Unicompartmental Knee Prosthesis is intended for resurfacing of one side of the knee joint. The system consists of metallic femoral and tibial components as well as a polyethylene tibial insert.
The femoral component is a symmetrically designed component, eliminating the need for left/right orientations. The femoral component is manufactured from cast cobalt chromium/molybdenum (CoCrMo) and features a central cruciate stem which aids in stabilization. A central posterior runner is incorporated into the inner surface to provide further rotational stability. Contact area is maximized by the "sweeping" condylar geometry. Both a nonporous and CSTi porous coated version are available. The femoral component is available in 7 sizes (1-7).
The tibial component is a symmetrically designed component, eliminating the need for left/right orientations. The tibial component is manufactured from wrought titanium alloy (Ti-6AI-4V). The baseplate features three pegs on the underside which aid in rotational stabilization. A screw hole has been placed in the center of the baseplate for optional screw fixation. The baseplate is designed with capture features which permit the UHMWPE tibial insert to be snapped into place. Both a nonporous and CSTi porous coated version are available. The baseplate is available in 6 sizes (1-6).
The tibial insert is a symmetrically designed component manufactured from Ultra-High Molecular Weight Polyethylene (ASTM F648). The insert articulating geometry is semiconstrained and is captured in the baseplate by the mating capture features. The insert is available in 3 thicknesses (9, 11, and 13 mm) and 3 sizes (1-2, 3-4, and 5-6).
1
Contact area and constraint testing on the femoral and tibial components showed the Natural-Knee II Unicompartmental Knee Prosthesis to be comparable to other legally marketed devices.
Testing on the baseplate-insert locking mechanism indicated that the push-out strength was comparable to other legally marketed devices.
The Natural-Knee II Unicompartmental Knee Prosthesis is also similar to the Howmedica PCA Unicompartmental Knee System, the DePuv Synatomic Unicondylar Knee, the Wright Medical Whiteside Ortholoc II Unicondylar Knee System, the Osteonics Omnifit SCR Knee System, the Zimmer Miller/Galante Unicompartmental Knee System, the Kirschner Performance Unicompartmental Knee, the Smith & Nephew Richards Genesis Unicompartmental Knee, and the Johnson & Johnson PFC Unicompartmental Knee System.