(56 days)
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No
The summary describes a bone void filler made of Beta-Tricalcium Phosphate with a modified shape and size. There is no mention of AI, ML, image processing, or any software-driven analysis or decision-making. The device is a passive material.
No.
The device is a bone void filler intended for use in the skeletal system. It is not designed to treat a specific disease or condition but rather to fill voids or gaps in bone. Therapeutic devices are typically defined as those that treat or cure a disease or condition.
No
The device, Cerasorb® M ORTHO, is a bone void filler intended for use in the skeletal system. Its function is to be gradually resorbed and replaced with bone, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly states it is a bone void filler made of Beta-Tricalcium Phosphate, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a bone void filler in the skeletal system. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The device is a synthetic, porous, resorbable, and osteoconductive material used to fill bone voids. This describes a medical device used for treatment and repair, not for testing biological samples to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.) or to provide information for diagnosis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Cerasorb® M ORTHO (polygonal broken morsels) is intended for use as a bone void filler in voids or gaps (resulting from surgery, trauma or degenerative processes) in the skeletal system (e.g. extremities, spine, pelvis) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the ß-TCP ceramic material is gradually resorbed and replaced with bone. The placement of Cerasorb® M ORTHO should not be in dry form, the material should be mixed with autologous blood.
Product codes
MQV
Device Description
The predicate device Cerasorb® ORTHO, a synthetic, porous, resorbable and osteoconductive bone void filler, was developed in granular form (spherical granules) of different diameter (500-1000um, 1000-2000um) to be filled in the bone void(s). The material consists of pure phase Beta-Tricalcium Phosphate of interconnecting porosity.
This submission is intended to address a modification in the shape of the bone void filler. The bone void filler is now additionally presented as polygonal shaped morsels of different sizes ranging from 50 8000m. The pure phase Beta-Tricalcium Phosphate material is of interconnecting microporosity and additionally contains defined interconnecting meso-, and macropores (50 - 500 um).
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
skeletal system (e.g. extremities, spine, pelvis)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
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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).
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
March 12, 2004
MAR 2 6 2004
Image /page/0/Picture/2 description: The image shows a handwritten text string "K040216" on the top line. Below the first line, there is another line of text that reads "9-1". The text appears to be written in black ink on a white background.
Image /page/0/Picture/3 description: The image shows the word "curasan" in a bold, sans-serif font. The letters are black and appear to be slightly curved along the bottom edge. The word is presented in a simple, straightforward manner, with no additional design elements or background distractions.
Special 510 (K) Summary: Line Extension to Cerasorb® ORTHO (granular form)
Submission Information:
| Name and Address
of the Sponsor: | curasan AG
Lindigstrasse 4
63801 Kleinostheim
Germany |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Stefan Meiners
Head of Regulatory Affairs and Quality Management
Tel.: ++49 - 6027 - 4686-94
Fax: ++49 - 6027 - 4686-33
E - Mail: stefan.meiners@curasan.de |
| Registered U. S. agent: | Dr. Eric Wiechert
109 Shore Drive
Garner, NC 27529
USA
Phone: 919 - 772-8518, fax: 919 - 772-1300
E - Mail: ewiecher@bellsouth.net |
Device Identification:
| Proprietary Name: | Cerasorb® M ORTHO |
|---|---|
| Common Name: | Bone Void Filler |
| Classification: | Class II |
Predicate Devices:
| | Cerasorb® ORTHO (granular form): Bone void filler consisting of pure phase
Beta-Tricalcium Phosphate. |
|----------------------------|--------------------------------------------------------------------------------------------------------------------|
| | Cerasorb® ORTHO (block forms): Bone void filler, block forms consisting of pure
phase Beta-Tricalcium Phosphate |
| Vitoss Scaffold Synthetic: | Bone void filler, granules, block forms and morsels
consisting of Beta-Tricalcium Phosphate |
1
Description of the Device Modification:
The device modification is a change in the shape resp. size of the bone void filler. The predicate device Cerasorb® ORTHO, a synthetic, porous, resorbable and osteoconductive bone void filler, was developed in granular form (spherical granules) of different diameter (500-1000um, 1000-2000um) to be filled in the bone void(s). The material consists of pure phase Beta-Tricalcium Phosphate of interconnecting porosity.
This submission is intended to address a modification in the shape of the bone void filler. The bone void filler is now additionally presented as polygonal shaped morsels of different sizes ranging from 50 8000m. The pure phase Beta-Tricalcium Phosphate material is of interconnecting microporosity and additionally contains defined interconnecting meso-, and macropores (50 - 500 um).
Intended Use:
Cerasorb® M ORTHO (morsels) is intended for use as a bone void filler in voids or gaps (resulting from surgery, trauma or degenerative processes) in the skeletal system (extremities, spine, pelvis) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the ß-TCP ceramic material is gradually resorbed and replaced with bone. The placement of Cerasorb® M ORTHO should not be in dry form, the material should be mixed with autologous blood.
Statement of technological comparison
All design modifications consist of pure phase Beta-Tricalcium Phosphate ceramic material according to ASTM F 1088-87, reapp. 1992. The material is of interconnecting porosity, osteoconductive and resorbable.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 6 2004
Curasan AG C/o Eric Wiechert, Ph.D., RAC President Applications Specialists International, Inc. 109 Shore Drive Garner. North Carolina 27529
Re: K040216
Trade/Device Name: Cerasorb® M ORTHO Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: II Product Code: MQV Dated: March 12, 2004 Received: March 18, 2004
Dear Dr. Wiechert:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Eric Wiechert, Ph.D., RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N Milkman
Celia M. Witten, PhD. MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K040216
Cerasorb® M ORTHO Device Name:
Indications for Use:
Cerasorb® M ORTHO (polygonal broken morsels) is intended for use as a bone void filler in voids or gaps (resulting from surgery, trauma or degenerative processes) in the skeletal system (e.g. extremities, spine, pelvis) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the ß-TCP ceramic material is gradually resorbed and replaced with bone. The placement of Cerasorb® M ORTHO should not be in dry form, the material should be mixed with autologous blood.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of 1
510(k) Number кон 0216