(414 days)
Not Found
Not Found
No
The device description focuses on the material composition and physical properties of a bone void filler, with no mention of AI or ML technology.
Yes
The device is intended for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury. This indicates a therapeutic purpose of treating and healing bone defects.
No
This device is described as a bone void filler and is indicated for the treatment of osseous defects. It is a material implanted to aid in bone repair, not a tool used to diagnose a medical condition.
No
The device description clearly states it is a porous calcium phosphate bone void filler provided in block, cylinder, morsel, and ball form, indicating it is a physical implant, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that Synthacer® and Syntricer® are "bone void fillers" and "porous calcium phosphate bone void fillers" intended for "use as a bone void filler for voids or gaps in bone." They are implanted directly into the body to aid in bone repair.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's condition. Its function is purely therapeutic and structural.
Therefore, this device falls under the category of an implantable medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Synthacer® Calcium Salt Bone Void Filler is intended only for use as a bone void filler for voids or gaps in bone that are not intrinsic to the stability of the bony structure. Synthacer® is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury.
Syntricer® Calcium Salt Bone Void Filler is intended only for use as a bone void filler for voids or gaps in bone that are not intrinsic to the stability of the bony structure. Syntricer® is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury.
Product codes (comma separated list FDA assigned to the subject device)
MQU, MQV
Device Description
Synthacer® Calcium Salt Bone Void Filler is a porous calcium phosphate bone void filler for the repair of bony defects. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. Pore diameter averages 600um and the average porosity is 60 - 80%. The implant is provided sterile in block. cylinder, morsel and ball form. Synthacer® is composed of a calcium phosphate ceramic which is at least 95% pure hydroxyapatite Cas(PO4)3OH.
Synthacer® promotes three-dimensional regeneration of bone in the defect site into which it is implanted. When Synthacer® is placed in direct contact with viable host bone, new bone growth occurs in apposition to the calcium phosphate surfaces of the implant. As the Synthacer® is resorbed, bone grows into the space previously occupied by the scaffold the implant provides. Synthacer® is radiopaque.
Syntricer® Calcium Salt Bone Void Filler is intended only for use as a bone void filler for yoids or gaps in bone that are not intrinsic to the stability of the bony structure. Syntricer® is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury. Syntricer® should not be used to treat large defects that in the surgeon's opinion would not heal spontaneously. Pore diameter averages 600um and the average porosity is 60 -80%. Syntricer® is composed of a calcium phosphate ceramic which is at least 95% pure tricalcium phosphate Ca3(PO4)2. The implant is provided sterile in block, cylinder, morsel and ball form.
Syntricer® is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void, the Syntricer® will slowly resorb and be replaced with bone over time during the healing process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., the extremities, spine and 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)
Not Found
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.
Not Found
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.
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K04 1177 V3
JUN 2 3 2005
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Synthacer® and Syntricer® Calcium Salt Bone Void Filler(s)
In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
The safety and effectiveness of Synthacer® and Syntricer® is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices.
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
| MedArtis AG | Phone: | +49 89 642 30 89 |
|---|---|---|
| Medizinprodukte and Forschung | Facsimile: | +49 89 642 34 87 |
| Gabriel-Max-Str. 3 | Date Prepared: | June 20, 2005 |
| D-81545 Muenchen | ||
| Germany | ||
| Contact Person: | Phone: | +41 71 694 5585 |
| Facsimile: | +41 71 694 5589 | |
| Knut Hülse, Ph.D. | Email: | N/A |
Name of Device and Name/Address of Sponsor
-
- Synthacer® Calcium Salt Bone Void Filler
-
- Syntricer® Calcium Salt Bone Void Filler
MedArtis AG Medizinprodukte and Forschung Gabriel-Max-Str. 3 D-81545 Muenchen Germany
Classification Name
The submitted resorbable calcium salt bone void filler is a Class II product with the associated regulation and product code.
| MedArtis Product | Product Name | Regulation | Code |
|---|---|---|---|
| Synthacer® Calcium Salt Bone Void Filler | Synthacer® | 888.3045 | MQU |
| Syntricer® Calcium Salt Bone Void Filler | Syntricer® | 888.3045 | MQU |
Predicate Devices
| Trade Name | |
|---|---|
| Pore-Si Bone Graft | |
| Substitute/Apapore Bone Graft | |
| Substitute: Apatech LTD | Vitoss™ Scaffold Synthetic |
| Cancellous Bone Void Filler: | |
| Orthovita | |
| Common Name | |
| Bone Void Filler | Bone Void Filler |
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Device Description
Synthacer® Calcium Salt Bone Void Filler is a porous calcium phosphate bone void filler for the repair of bony defects. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. Pore diameter averages 600um and the average porosity is 60 - 80%. The implant is provided sterile in block. cylinder, morsel and ball form. Synthacer® is composed of a calcium phosphate ceramic which is at least 95% pure hydroxyapatite Cas(PO4)3OH.
Synthacer® promotes three-dimensional regeneration of bone in the defect site into which it is implanted. When Synthacer® is placed in direct contact with viable host bone, new bone growth occurs in apposition to the calcium phosphate surfaces of the implant. As the Synthacer® is resorbed, bone grows into the space previously occupied by the scaffold the implant provides. Synthacer® is radiopaque.
Syntricer® Calcium Salt Bone Void Filler is intended only for use as a bone void filler for yoids or gaps in bone that are not intrinsic to the stability of the bony structure. Syntricer® is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury. Syntricer® should not be used to treat large defects that in the surgeon's opinion would not heal spontaneously. Pore diameter averages 600um and the average porosity is 60 -80%. Syntricer® is composed of a calcium phosphate ceramic which is at least 95% pure tricalcium phosphate Ca3(PO4)2. The implant is provided sterile in block, cylinder, morsel and ball form.
Syntricer® is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void, the Syntricer® will slowly resorb and be replaced with bone over time during the healing process.
Intended Use
Synthacer® Calcium Salt Bone Void Filler is intended only for use as a bone void filler for voids or gaps in bone that are not intrinsic to the stability of the bony structure. Synthacer® is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury.
Syntricer® Calcium Salt Bone Void Filler is intended only for use as a bone void filler for voids or gaps in bone that are not intrinsic to the stability of the bony structure. Syntricer® is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury.
Technological Characteristics and Substantial Equivalence
From a clinical perspective and comparing design specifications, Synthacer® Calcium Salt Bone Void Filler and Syntricer® Calcium Salt Bone Void Filler and the predicate devices are substantially equivalent and have the same intended use. Based on the technological characteristics and overall performance of the device, medArtis AG believes that no significant differences exist between Synthacer® Calcium Salt Bone Void Filler and Syntricer® Calcium Salt Bone Void Filler and the predicate devices.
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MedArtis AG believes the minor differences of the medArtis AG calcium salt bone void filler(s) and its predicate devices should not raise any concerns regarding the overall safety or effectiveness.
- This information was prepared for the sole purpose of compliance with the Safe Advisory: Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular pattern.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2005
Knut Hülse, Ph.D. Regulatory Affairs MedArtis AG Gabriel-Max-Strasse 3 D-81545 München, Germany
Re: K041177
Trade Name: Synthacer® Calcium Salt Bone Void Filler and Syntricer® Calcium Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: June 1, 2005 Received: June 3, 2005
Dear Dr. Hülse:
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.
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Page 2 – Knut Hülse, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and wy a the FDA finding of substantial equivalence of your device to a legally premated 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 if you atence specific arrangliance at (240) 276-0120. Also, please note the regulation entitled, eonidor the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/industry/support/index.html.
Sincerely yours,
Muriam C. Provost
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K041177
Synthacer® Calcium Salt Bone Void Filler & Syntricer® Device Name: Calcium Bone Void Filler
Indications for Use:
Synthacer® Calcium Salt Bone Void Filler is intended only for use as a bone void filler for voids or gaps in bone that are not intrinsic to the stability is all a really area miller volus of gape in bone ted for use in the treatment of surgically created strature. Oynthator osseous defects created from traumatic injury.
Syntricer® Calcium Salt Bone Void Filler is intended only for use as a bone void Synthcer - Oalchum Oult Bone that are not intrinsic to the stability of the bony miler for volus of gaps in the treatment of surgically created Structure. Oynthour its easy defects created from traumatic injury.
Prescription Use: X (21 CFR 801 Subpart D) AND/OR
Over-The-Counter (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
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