(79 days)
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No
The description focuses on the mechanical function and intended use of a physical implant component (a bolt/lug) for knee revision surgery. There is no mention of software, algorithms, data analysis, or any terms related to AI/ML.
Yes
The device is intended for cemented use to treat conditions such as noninflammatory degenerative joint disease, inflammatory joint disease, correctable deformity, and failed previous surgery, indicating a therapeutic purpose.
No
The device is a component of a knee arthroplasty system intended for treatment and revision surgeries, not for diagnosing conditions.
No
The device description clearly states it is a physical component ("a bolt") made of material that screws into another physical component. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (femoral spacer lugs) used in knee replacement surgery. Its purpose is to provide stability and hold other components in place within the knee joint.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical within the body.
Therefore, based on the provided information, the Natural-Knee II Revision Femoral Spacer Lugs are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Natural-Knee II Revision Femoral Spacer Lugs are intended for cemented use with the previously cleared Natural-Knee II Revision Femoral Component and associated components (e.g., tibial, patellar, etc.) in the treatment of:
- Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular 1. necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- Correctable valgus-varus deformity and moderate flexion contracture. 2.
- Those patients with failed previous surgery where pain, deformity or dysfunction persists. 3.
- Revision of previously failed knee arthroplasty. 4.
Product codes
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Device Description
The Natural-Knee II Revision Femoral Spacer Lug is in effect a bolt. The threaded portion of the lug screws into blind holes on the inner box of the Natural-Knee II Revision Femoral Component. A large hexagonal head allows the lug to be tightened into place. When used with a femoral spacer, the lug holds the spacer component firmly in place. When used without the spacer, the lug provides medial-lateral stability similar to that of conventionally cast or machined pegs usually found on the inner box of most femoral components.
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
Analysis of the lug shear strength indicated that the component should survive physiologic loading.
Key Metrics
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Predicate Device(s)
Smith & Nephew Richards Genesis and Tricon-M FlexLok Pegs, Smith & Nephew Richards Genesis Modular Femoral Lugs, Howmedica Duracon Modular Femoral Pegs
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
K970498
510(k) SUMMARY
APR 30 1997
January 22, 1997
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 Sulzer Orthopedics Inc. Natural-Knee® II Revision Femoral Spacer Lugs.
| Submitter: | Sulzer 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: | Femoral Spacer Lugs |
| Trade/Proprietary: | Natural-Knee® II Revision Femoral Spacer Lugs |
Product Description/Substantial Equivalence:
The Natural-Knee II Revision Femoral Spacer Lug is in effect a bolt. The threaded portion of the lug screws into blind holes on the inner box of the Natural-Knee II Revision Femoral Component. A large hexagonal head allows the lug to be tightened into place. When used with a femoral spacer, the lug holds the spacer component firmly in place. When used without the spacer, the lug provides medial-lateral stability similar to that of conventionally cast or machined pegs usually found on the inner box of most femoral components.
Analysis of the lug shear strength indicated that the component should survive physiologic loading.
The Natural-Knee II Revision Femoral Spacer Lugs are similar to the Smith & Nephew Richards Genesis and Tricon-M FlexLok Pegs, the Smith & Nephew Richards Genesis Modular Femoral Lugs, and the Howmedica Duracon Modular Femoral Pegs.
The Natural-Knee II Revision Femoral Spacer Lugs are intended for cemented use with the previously cleared Natural-Knee II Revision Femoral Component and associated components (e.g., tibial, patellar, etc.) in the treatment of:
- Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular 1. necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- Correctable valgus-varus deformity and moderate flexion contracture. 2.
- Those patients with failed previous surgery where pain, deformity or dysfunction persists. 3.
- Revision of previously failed knee arthroplasty. 4.