(85 days)
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No
The summary describes a mechanical hip implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is used for rehabilitating hips damaged due to various conditions, indicating a therapeutic purpose.
No
Explanation: The device described is a Revision Hip System, which is a surgical implant used to replace or rehabilitate damaged hips. Its intended use is therapeutic (treatment), not diagnostic (identifying a condition).
No
The device description clearly states "The Revision Hip System stems are single use devices" and refers to "components," indicating a physical implant, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing damaged hip joints. This is a therapeutic device, not a diagnostic one.
- Device Description: The description confirms it's a hip system component for surgical fixation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are used to diagnose diseases or conditions, monitor treatments, or screen for health issues by examining samples in vitro (outside the body).
This device is a medical device, specifically a surgical implant.
N/A
Intended Use / Indications for Use
The Revision Hip System stems are single use devices. The components are indicated for cemented and uncemented use for individuals undergoing primary and revision surgery where other treatments or devices have failed for rehabilitating hips damaged as a result of trauma, or noninflammatory degenerative joint disease (NID) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Indications also include inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection of the hip; and correction of deformity.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Revision Hip System stems are single use devices. The components of the Revision Hip System have the same function as other hip systems designed for cemented and cementless fixation.
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
hips, proximal femur
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)
The engineering analyses of these devices was acceptable and the components of the Revision Hip System should perform as well as other hip systems.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
0
NOV 27 1996
K96 3486
Summary of Safety and Effectiveness
Smith & Nephew Orthopaedics
Revision Hip System -
The Revision Hip System stems are single use devices. The components are indicated for cemented and uncemented use for individuals undergoing primary and revision surgery where other treatments or devices have failed for rehabilitating hips damaged as a result of trauma, or noninflammatory degenerative joint disease (NID) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Indications also include inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection of the hip; and correction of deformity.
The components of the Revision Hip System have the same function as other hip systems designed for cemented and cementless fixation.
The engineering analyses of these devices was acceptable and the components of the Revision Hip System should perform as well as other hip systems.