(89 days)
Vitoss™ Scaffold Synthetic
Not Found
No
The summary describes a porous resorbable bone void filler made of Beta-Tricalciumphosphate. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The device functions as a passive scaffold for bone regeneration.
Yes
The device is intended for use as a bone void filler to repair bone defects caused by surgery, trauma, or degenerative processes, which is a therapeutic purpose.
No
Cerasorb ORTHO is a bone void filler intended for the repair of bone defects. It is a therapeutic device, not a diagnostic one, as it does not diagnose or detect a medical condition.
No
The device description clearly states it is a porous resorbable bone void filler made of Beta-Tricalciumphosphate in granular form, which is a physical material, not software.
Based on the provided information, Cerasorb ORTHO is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes.
- Cerasorb ORTHO's Intended Use: The intended use of Cerasorb ORTHO is as a bone void filler to be implanted directly into the skeletal system to aid in bone regeneration. It is a therapeutic device, not a diagnostic one.
- Device Description: The description focuses on the material composition and its function within the body (resorption and bone regeneration). There is no mention of analyzing specimens or providing diagnostic information.
Therefore, Cerasorb ORTHO falls under the category of an implantable medical device used for surgical repair and regeneration, not an IVD.
N/A
Intended Use / Indications for Use
Cerasorb ORTHO in granular form is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structures. It is indicated for filling of bone defects, caused by surgery, trauma or degenerative process. Cerasorb ORTHO granules are intended to be gently packed into the bony voids or gaps of the skeletal system. The material should not be packed in dry form, it should be mixed with autologous blood (blood from the void or venous blood). The implanted material must be in direct contact with the bleeding vital bone.
Cerasorb ORTHO granules have no weight-bearing capacity. Therefore, osteosynthetic measures may be required.
Following placement in the bony voids or gaps, the Beta-Tricalciumphosphate granules are gradually resorbed and replaced with new bone.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
Cerasorb ORTHO is a porous resorbable bone void filler for the repair of bony defects. Chemically the material consists of pure phase Beta-Tricalciumphosphate, as described in the ASTM F 1088 - 87 (reapproved 1992). It is an osteoconductive implant with interconnected porosity. The implant is provided sterile in granular form, granular sizes being 500 - 1000um or 1000 - 2000 um.
When Cerasorb ORTHO is placed in the defect site with direct contact with the viable host bone, it guides the three-dimensional regeneration of bone. As the Cerasorb ORTHO granules resorbs, newly formed bone grows into the space previously occupied by the granular Beta-Tricalciumphosphate material. Cerasorb ORTHO was shown to have 90% or greater resorption in animal studies and was also shown to resorb well clinically.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (extremities, spine, pelvis)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
Cerasorb ORTHO was shown to have 90% or greater resorption in animal studies and was also shown to resorb well clinically.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Vitoss™ Scaffold Synthetic
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.
Not Found
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).
Not Found
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
0
MAR 1 8 2002
Image /page/0/Picture/1 description: The image shows the word "curasan" in a bold, sans-serif font. Above the word, there is a handwritten code "KO14156" and "10F3". The word "curasan" is the main focus of the image, and the handwritten codes appear to be annotations or identifiers.
510 (K) Summary Cerasorb ORTHO Synthetic Bone Void Filler
Submitted by
Lindigstrasse 4, D - 63801 Kleinostheim, Germany curasan AG Contact person: Dr. Rolf Kaufmann, Head of Regulatory Affairs Tel.: ++49 -- 6027 -- 468653 Fax: ++49 - 6027 -- 468633 E - mail zul-3@curasan.de
CommERCIALIZATION GROUP, LLC KENNETH WEST Registered U. S. agent ECHNOLOGY SOPHIA DRIVE SAN' HILL, NC 27514 USA 116 4PEL 1.6748
Prepared:
Curasan Ab
| Subject Device | Predicate Device | |
|---|---|---|
| Trade name | Cerasorb ORTHO | Vitoss™ Scaffold Synthetic |
| Common Name | Bone void filler | Bone void filler |
| Classification Name | Filler, β-Tricalciumphosphate | |
| Preformed granules | Filler, β-Tricalciumphosphate | |
| Preformed granules |
1
Comparison To Predicate Tabulated Form
:
. . . . .
:
·
.
:
K014156
2 OF 3
: :
:
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
:
ු ක්රමුණු ප්රධාන කොට පැහැ
| Cerasorb ORTHO | Vitoss™ Scaffold | |
|---|---|---|
| Indication / intended use | Bone void filler, synthetic | Bone void filler, synthetic |
| Patient population | Patients with bone voids or | |
| gaps, caused by surgery, | ||
| trauma or degeneration | Patients with bone voids or | |
| gaps, caused by surgery or | ||
| trauma | ||
| Anatomical location | skeletal system (extremities, | |
| spine, pelvis) | skeletal system (extremities, | |
| spine, pelvis) | ||
| Labeling | Same intended use, | |
| contraindications, warnings, | ||
| precautions and adverse | ||
| events as predicate | see enclosure | |
| Chemical composition of the | ||
| material | β-Tricalciumphosphate, | |
| Ca3(PO4)2 | β-Tricalciumphosphate, | |
| Ca3(PO4)2 | ||
| Structure of the material | Interconnective porosity | Trabecular structure similar |
| to cancellous bone | ||
| Porosity of the material | Micropores >0 |