(118 days)
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No
The device description focuses on mechanical and thermal principles for cement removal, with no mention of AI or ML technologies.
No
The device is used for the removal of a cement plug during revision hip arthroplasty, which is a procedural tool rather than a device intended to treat or cure a disease or condition for therapeutic benefit.
No
The device is described as a system for removing cement plugs during revision hip arthroplasty, and its function involves heating and removing material, not diagnosing a condition.
No
The device description clearly outlines multiple hardware components including a handpiece, tip, slide hammer, and battery charger.
Based on the provided information, the Stryker Cement Removal System (CRS) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves tests performed on blood, urine, tissue, etc., outside of the body.
- CRS Function: The Stryker CRS is a surgical tool used within the human body during revision hip arthroplasty. Its purpose is to physically remove a cement plug from the femoral canal. It does not analyze or test any biological specimens to provide diagnostic information.
The description clearly outlines a mechanical and thermal process for removing a foreign material (cement) from a patient's bone, which falls under the category of a surgical instrument or device, not an IVD.
N/A
Intended Use / Indications for Use
The Stryker Cement Removal System (CRS) is indicated for use in revision hip arthroplasty to remove the old PMMA distal cement plug from the area between the distal tip of the primary implant and proximal to any bony restriction within the femoral canal. The use of the CRS is contraindicated for removal of cement distal to any bony restriction within the medullary canal and removal of the cement mantle proximal to the distal tip of the primary implant. Additionally, the CRS is contraindicated for patients with unrestored fractures and severe osteoporosis.
Product codes
LZV
Device Description
The Stryker CRS consists of a rechargeable handpiece, a disposable, stainless steel tip, a reusable slide hammer, and a battery charger. The CRS is powered by nickel-cadnium batteries located within the handpiece housing. When activated, the handpiece provides power to an attached tip, allowing the tip to generate heat. The heated tip softens the cement plug, allowing the user to insert it into the cement plug. Once inserted, the tip is irrigated with irrigant allowing the cement to quickly resolidfy around the tip. The tip is then connected to a slide hammer which allows the tip and attached cement to be removed through impact loading.
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
femoral canal
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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.4580 Sonic surgical instrument and accessories/attachments.
(a)
Identification. A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.
0
Stryker®
NSTRUMENIS
alamazoo. MI 49 (616) 323-7700 (800) 253-32 : 0
196 11 01
JU 15 pos
Device Name:
| Classification Name: | Cement Removal/Extraction System
87LZV, Class II |
|----------------------|-------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Cement Removal System |
| Proprietary Name: | Stryker Cement Removal System |
| Device Sponsor: | Stryker Corporation
Instruments Division
4100 E. Milham
Kalamazoo, MI 49001
Registration No: 1811755 |
Regulatory Class:
Class II
Summary of Safety and Effectiveness:
The Stryker Cement Removal System (CRS) is indicated for use in revision hip arthroplasty to remove the old PMMA distal cement plug from the area between the distal tip of the primary implant and proximal to any bony restriction within the femoral canal. The use of the CRS is contraindicated for removal of cement distal to any bony restriction within the medullary canal and removal of the cement mantle proximal to the distal tip of the primary implant. Additionally, the CRS is contraindicated for patients with unrestored fractures and severe osteoporosis.
The Stryker CRS consists of a rechargeable handpiece, a disposable, stainless steel tip, a reusable slide hammer, and a battery charger. The CRS is powered by nickel-cadnium batteries located within the handpiece housing. When activated, the handpiece provides power to an attached tip, allowing the tip to generate heat. The heated tip softens the cement plug, allowing the user to insert it into the cement plug. Once inserted, the tip is irrigated with irrigant allowing the cement to quickly resolidfy
1
around the tip. The tip is then connected to a slide hammer which allows the tip and attached cement to be removed through impact loading.
The design and labeling of the Stryker CRS addresses the risks associated with thermal injury to surrounding tissue, toxicity of fumes, and breakage of tip and fracture of bone during removal process. Additionally, data collected at the University of Michigan and Michigan State University demonstrated that the CRS does not raise any new safety issues when compared to other heat generating cement removal systems and it does not produce a greater amount of fumes than what is created when hand mixing bone cement. The CRS device is contraindicated for use in patients with unrestored fractures, severe osteoporosis, and a cement plug distal to a restriction within the medullary canal.
The Stryker CRS is equivalent to existing marketed products by companies such as Biomet, Inc. Intended use, method of extraction, and safety risks are all substantially equivalent.
The Stryker CRS does not raise any new safety and efficacy concerns when compared to similar legally marketed devices. Therefore, the Stryker CRS is substantially equivalent to these existing devices.
Tommy Edwards
Tammy Lounds Supervisor, Regulatory Affairs Stryker Instruments