(223 days)
Zimmer Cement Restrictor #4043-20, Howmedica Charnley Cement Restrictor, Motech Titanium Surgical Mesh
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No
The summary describes a physical surgical mesh device made of porous metal, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a surgical mesh intended for restriction of effusion of bone cement, allograft bone, and/or autograft bone into the pelvis. Its purpose is mechanical restriction, not direct treatment or prevention of a disease or condition for the patient.
No
The device description and intended use indicate it is an implantable surgical mesh designed to restrict cement/bone effusion, not to diagnose a condition or disease. It is a therapy/treatment device.
No
The device description clearly states it is a surgical mesh fabricated from porous metal, indicating it is a physical hardware device, not software.
Based on the provided information, the Hedrocel® Acetabular Restrictor is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for restricting the effusion of bone cement, allograft, and autograft into the pelvis during acetabular procedures. This is a surgical intervention performed in vivo (within the body).
- Device Description: The description details a surgical mesh made of porous metal, designed to be implanted. This is a medical device used in vivo.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. The Hedrocel® Acetabular Restrictor is a surgical implant used during a procedure.
N/A
Intended Use / Indications for Use
The Hedrocel® Acetabular Restrictor is a device intended for restriction of effusion of bone cement, allograft bone, and/or autograft bone into the pelvis if defects in the acetabulum are encountered.
Product codes
Not Found
Device Description
The Hedrocel® Acetabular Restrictor is manufactured as a surgical mesh fabricated from Hedrocel® porous metal. The tantalum lattice mesh device is available in three (3) sizes. The Hedrocel® material is a tantalum deposited upon vitreous carbon construct which possesses dodecahedron shaped, fully interconnecting pores resulting in a relatively high bulk volume porosity, approximately 80%. Cement restrictors are classified as Surgical Meshes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
pelvis, acetabulum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Zimmer Cement Restrictor #4043-20, Howmedica Charnley Cement Restrictor, Motech Titanium Surgical Mesh
Reference Device(s)
Not Found
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.
0
510(k) Deficiency Letter Dated September 6, 1996
Implex Corp. 510(k) Number K962468
FEB - 3 1997
510(k) SUMMARY - HEDROCEL® ACETABULAR RESTRICTOR
| Submitter Name: | Implex Corp. |
|---|---|
| Submitter Address: | 80 Commerce Drive |
| Allendale, New Jersey 07401-1600 | |
| Contact Person: | Robert Cohen, Vice President, Product Development |
| Phone Number: | (201) 818-1800 |
| Fax Number: | (201) 818-0567 |
| Date Prepared: | November 21, 1996 |
| Device Trade Name: | Hedrocel® Acetabular Restrictor |
| Device Common Name: | Prosthesis, Hip, Cement Restrictor |
| Classification Name: | Surgical Mesh (per CFR § 878.3300) |
| Predicate Devices: | Zimmer Cement Restrictor #4043-20 |
| Howmedica Charnley Cement Restrictor | |
| Motech Titanium Surgical Mesh | |
| Device Description: | The Hedrocel® Acetabular Restrictor is manufactured as a |
| surgical mesh fabricated from Hedrocel® porous metal. The | |
| tantalum lattice mesh device is available in three (3) sizes. | |
| The Hedrocel® material is a tantalum deposited upon | |
| vitreous carbon construct which possesses dodecahedron | |
| shaped, fully interconnecting pores resulting in a relatively | |
| high bulk volume porosity, approximately 80%. Cement | |
| restrictors are classified as Surgical Meshes. | |
| Intended Use: | The Hedrocel® Acetabular Restrictor is a device intended for |
| restriction of effusion of bone cement, allograft bone, and/or | |
| autograft bone into the pelvis if defects in the acetabulum are | |
| encountered. | |
| Device Technological | |
| Characteristics and | |
| Comparison to | |
| Predicate Devices: | The design features of the Hedrocel® Acetabular Restrictor |
| are identical to the predicate devices. For example, these | |
| devices all use an open lattice design and are fabricated from | |
| metallic alloys. The specific alloys utilized varies among the | |
| devices. The Hedrocel® Acetabular Restrictor is | |
| manufactured using a process in which tantalum is deposited | |
| onto a reticulated vitreous carbon (RVC) skeleton. | |
| Conclusion: | The Hedrocel® Acetabular Restrictor is substantially |
| equivalent to predicate devices in terms of intended use, | |
| safety, and effectiveness. |