(78 days)
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No
The document describes a traditional hip implant system and does not mention any AI or ML components or functionalities.
Yes
The device is a total hip arthroplasty system, meaning it is surgically implanted to replace a damaged hip joint. Its intended use is to reduce or relieve pain, improve hip function, and treat various painful and degenerative joint conditions, which are clear therapeutic goals.
No
The device is an implantable hip system intended for total hip arthroplasty to treat various degenerative joint diseases and fractures. Its description and indicated uses focus on treatment and correction, rather than diagnosing conditions.
No
The device description explicitly states it is manufactured from titanium alloy and has a titanium plasma spray coating, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for total hip arthroplasty, which is a procedure performed in vivo (within the body) to replace a damaged hip joint. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as a hip stem manufactured from titanium alloy with a plasma spray coating. This is a physical implant, not a reagent, instrument, or system used to analyze biological samples.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, providing diagnostic information, or any of the typical components or functions of an IVD.
This device is a surgical implant, specifically a hip prosthesis.
N/A
Intended Use / Indications for Use
The PERFECTA® Plasma Spray Hip System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
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- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
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- inflammatory degenerative joint disease such as rheumatoid arthritis;
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- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and, 4)
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- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Product codes
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Device Description
The PERFECTA® Plasma Spray Hip System is manufactured from titanium alloy (ASTM F-136) with a titanium plasma spray coating. The stem is available in standard and reduced flare configurations, collared and collarless. The stem is designed to be press-fit or can be used with bone cement.
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
hip
Indicated Patient Age Range
skeletally mature patients
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)
Submitted abrasion testing demonstrates that the plasma spray porous coating is comparable to sintered bead coating.
Submitted validated finite element analysis indicates that the fatigue strength of the worst case subject device, the PERFECTA® 12mm reduced flare, collarless hip stem, is comparable to the fatigue strength of the predicate PERFECTA® 12mm calcar revision hip stem.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
PERFECTA® Plasma Spray Hip System and PERFECTA® Revision Hip System manufactured by Wright Medical Technology, Inc.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 an acetabular resurfacing 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.
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Image /page/0/Picture/0 description: The image shows a stylized letter W. The W is formed by three triangles that are connected at their vertices. The triangles are black, and the background is white. The overall design is simple and modern.
8 1997
Contact Person: Date:
Cristie Manuel October 21, 1996
510(k) Summary
| Trade/Proprietary Name: | PERFECTA® Plasma Spray Hip System |
|---|---|
| Common Name: | Plasma Spray Coated Femoral Hip Stem |
| Classification: | Class II |
| Predicate Devices: | PERFECTA® Plasma Spray Hip System and PERFECTA® |
| Revision Hip System manufactured by Wright Medical | |
| Technology, Inc. |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Description/Intended Use
The PERFECTA® Plasma Spray Hip System is manufactured from titanium alloy (ASTM F-136) with a titanium plasma spray coating. The stem is available in standard and reduced flare configurations, collared and collarless. The stem is designed to be press-fit or can be used with bone cement.
The PERFECTA® Plasma Spray Hip System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
-
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
-
- inflammatory degenerative joint disease such as rheumatoid arthritis;
-
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and, 4)
- ર) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Testing
Submitted abrasion testing demonstrates that the plasma spray porous coating is comparable to sintered bead coating.
Submitted validated finite element analysis indicates that the fatigue strength of the worst case subject device, the PERFECTA® 12mm reduced flare, collarless hip stem, is comparable to the fatigue strength of the predicate PERFECTA® 12mm calcar revision hip stem.