(252 days)
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No
The document describes modifications to existing hip replacement components and focuses on mechanical testing and material properties, with no mention of AI or ML.
Yes
The device is a component of a hip replacement system, indicated for conditions like osteoarthritis and rheumatoid arthritis, which are therapeutic medical conditions.
No
Explanation: The device is an Exactech Hip System component, such as acetabular liners and femoral heads, which are indicated for use in hip replacement procedures. These are orthopedic implants used for treatment, not for diagnosing a condition.
No
The device description clearly indicates the device is a physical implant (acetabular liners and femoral heads) and associated trials, not software. The performance studies involve physical testing of these components.
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 device used in vivo (within the body) for hip replacement surgery. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue.
- Device Description: The device is described as components of a hip replacement system (acetabular liners and femoral heads), which are implanted into the patient.
- Performance Studies: The performance studies involve mechanical testing (wear, lever-out, push-out, torque, fatigue, burst, pull-off, range of motion) of the physical components, not analysis of biological samples.
The device is a surgical implant, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
- Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
- Press-fit femoral stems and acetabular cups are intended for press-fit fixation.
- Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.
Product codes (comma separated list FDA assigned to the subject device)
LZO, JDI, LWJ, MEH, LPH
Device Description
The proposed Novation Crown Cup Acetabular Liners and associated Liner Trials are a modification to the Novation Crown Cup Acetabular Liners and associated Liner Trials cleared through premarket notification #K070479.
The proposed 12/14 Cobalt Chromium, Bioloxdelta and Biolox Option Femoral Heads and associated Head Trials are a modification to the 12/14 Cobalt Chromium, Bioloxdelta and Biolox Option Femoral Heads and associated Head Trials cleared through premarket notifications #K041906 and #K103012.
The predicate and proposed devices have the same intended use and basic fundamental scientific technology.
The modified devices share the following similarities with the predicate devices:
- Indications for use
- Design features
- Material
- Shelf life
- Packaging and sterilization materials and processes
This submission proposes the following design change:
- The proposed acetabular liners have a minimum polyethylene thickness of 4mm for compatibility with 32mm, 36mm and 40mm femoral heads.
- The proposed femoral heads have an outer diameter of 40mm.
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
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 following engineering analyses were conducted to demonstrate substantial equivalence of the proposed devices to the predicate devices:
- Wear testing per ASTM F1714 to determine that the proposed devices have equivalent or better wear results than the predicate devices.
- Lever-out testing per Tradonsky, et al. 1993, Axial push-out per ASTM F1820, Torque testing was conducted to determine that the proposed acetabular liner devices are substantially equivalent to the predicate devices.
- Impingement fatigue testing was conducted to determine that the proposed acetabular liner devices are substantially equivalent to the predicate devices.
- Engineering justification to support the applicability of the predicate device testing to the proposed devices:
- Burst Testing per ISO 7206-10
- Fatigue per ISO 7206-10
- Post Fatigue per ISO 7206-10
- Pull-Off per Ceramtec specifications, FDA Guidance and ASTM F2009
- Torque per Ceramtec specifications, FDA Guidance
- Range of Motion per ISO 21535
The results of engineering analyses demonstrate the proposed devices are substantially equivalent to the predicate 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.
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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§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
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Exactech® Femoral Heads and Novation® Crown Cup® Acetabular Liners Special 510(k) - 510(k) Summary of Safety and Effectiveness
Sponsor: Exactech. Inc. 2320 N.W. 66th Court Gainesville, FL 32653
Phone: (352) 377-1140 (352) 378-2617 Fax:
FDA Establishment Number 1038671
Contact: Nicole Kassner QA/RA Compliance, Project Manager
Date: January 11, 2013
Trade of Proprietary or Model Name(s):
Exactech® Novation® Crown Cup® GXL UHMWPE Liner Exactech 12/14 CoCr Femoral Head Exactech 12/14 Bioloxdelta® Femoral Head Exactech 12/14 Biolox Option Femoral Head Exactech Novation Crown Cup 40mm Liner Trials Exactech 12/14 40mm Head Trials
Common Name:
Total Hip Arthroplasty Prosthesis - Acetabular Liners and Femoral Heads
Classification Name:
Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented (CFR 888.3353, Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis, Class II, Product Code LZO)
Prosthesis, hip, semi-constrained, metal/polymer, cemented (CFR 888.3350. Hip joint metal/polymer semi-constrained cemented, Class II, Product Code JDI)
Prosthesis, hip, semi-constrained, metal/polymer, uncemented (CFR 888.3360, Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis, Class II, Product Code LWJ)
Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calciumphosphate (CFR 888.3353, Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis, Class II, Product Code MEH)
Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (CFR 888.3358, Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis, Class II, Product Code LPH)
JAN 1 6 2013
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Exactech® Femoral Heads and Novation® Crown Cup® Acetabular Liners Special 510(k) - 510(k) Summary of Safety and Effectiveness
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade of Proprietary Model Name | Manufacturer |
|---|---|---|
| K070479 | Exactech Novation® Crown Cup® Liners | Exactech, Inc. |
| K041906 | Exactech 12/14 CoCr Femoral Heads | Exactech, Inc. |
| K103012 | Exactech Bioloxdelta® and Biolox Option | |
| Femoral Heads and Adapters | Exactech, Inc. |
Indications for Use:
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia. revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
- Cemented femoral stems and cemented acetabular cups are intended for . cemented fixation only.
- Press-fit femoral stems and acetabular cups are intended for press-fit . fixation.
- . Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.
Device Description:
The proposed Novation Crown Cup Acetabular Liners and associated Liner Trials are a modification to the Novation Crown Cup Acetabular Liners and associated Liner Trials cleared through premarket notification #K070479.
The proposed 12/14 Cobalt Chromium, Bioloxdelta and Biolox Option Femoral Heads and associated Head Trials are a modification to the 12/14 Cobalt Chromium, Bioloxdelta and Biolox Option Femoral Heads and associated Head Trials cleared through premarket notifications #K041906 and #K103012.
The predicate and proposed devices have the same intended use and basic fundamental scientific technology.
The modified devices share the following similarities with the predicate devices:
- . Indications for use
- . Design features
- Material ●
- Shelf life
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