(49 days)
Not Found
Not Found
No
The device description focuses on the material properties and physical form of a bone void filler, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a bone void filler intended for the repair and filling of craniofacial defects and does not directly treat or cure a disease or condition in a therapeutic sense.
No
The device is described as a bone void filler intended for the repair, filling, restoration, and augmentation of bony defects and contours, which are therapeutic actions, not diagnostic ones.
No
The device description clearly states that Synthes chronOS is a physical material (porous, osteoconductive, resorbable bone void filler made from β-Tricalcium Phosphate) provided in granules and preformed shapes. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a bone void filler for repairing and augmenting craniofacial defects. This is a surgical implant used directly in the body.
- Device Description: The description details the material (β-Tricalcium Phosphate), form (granules, shapes), and how it's used (packed or placed into the site). This is consistent with a medical device for surgical implantation.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The provided information does not mention any such use or interaction with bodily specimens for diagnostic purposes.
Therefore, Synthes chronOS is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Synthes chronOS is intended for the repair or filling of craniofacial defects and craniotomy cuts with a surface area no larger than 25 cm². It is also indicated for the restoration or augmentation of bony contours of the craniofacial skeleton, including the fronto-orbital, malar and mental areas.
Synthes chronOS is intended to be gently packed or placed into the site. chronOS resorbs and is replaced with bone during the healing process.
Product codes
GXP, FMF
Device Description
Synthes chronOS is a porous, osteoconductive, resorbable bone void filler made from β-Tricalcium Phosphate (TCP). chronOS features a uniform three dimensional pore structure. Pore diameters within the material range from 100 to 500 μm. chronOS is provided sterile in granules and preformed shapes (e.g. blocks, cylinders, wedges).
chronOS may be packaged with a perfusion syringe that is used to mix the bone void filler with the patient's blood components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial defects and craniotomy cuts; craniofacial skeleton, including the fronto-orbital, malar and mental areas
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)
Norian Cranial Repair System (CRS) Bone Cement, Etex α-BSM™ Bone Substitute Material for Cranioplasty
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5300 Methyl methacrylate for cranioplasty.
(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a handwritten alphanumeric string. The string is "K041350". The characters are written in a simple, slightly irregular style, typical of handwriting.
Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized representation of a human figure inside of a circle. There is a registered trademark symbol to the right of the word "SYNTHES".
JUL - 8 2004
3.0 510(k) Summary
| Sponsor: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes (USA) chronOST™ |
| Classification: | Class II, 21 CFR §882.5300
Methylmethacrylate for Cranioplasty |
| | Class II, 21 CFR §880.5600
Piston Syringe |
| Predicate Device: | Norian Cranial Repair System (CRS) Bone Cement
Etex α-BSM™ Bone Substitute Material for Cranioplasty |
| Device Description: | Synthes chronOS is a porous, osteoconductive, resorbable bone
void filler made from β-Tricalcium Phosphate (TCP). chronOS
features a uniform three dimensional pore structure. Pore
diameters within the material range from 100 to 500 μm. chronOS
is provided sterile in granules and preformed shapes (e.g. blocks,
cylinders, wedges). |
| | chronOS may be packaged with a perfusion syringe that is used to
mix the bone void filler with the patient's blood components. |
| Intended Use: | Synthes chronOS is intended for the repair or filling of craniofacial
defects and craniotomy cuts with a surface area no larger than 25
cm². It is also indicated for the restoration or augmentation of bony
contours of the craniofacial skeleton, including the fronto-orbital,
malar and mental areas. |
| | Synthes chronOS is intended to be gently packed or placed into the
site. chronOS resorbs and is replaced with bone during the healing
process. |
| Substantial
Equivalence: | Documentation is provided which demonstrates that Synthes
chronOS is substantially equivalent* to other legally marketed
Synthes devices. |
| | *The term "substantial equivalence" as used in the 510(k)
notification is limited to the definition of substantial equivalence
found in the Food, Drug and Cosmetic Act, as amended and as
applied under 21 CRF 807, Subpart E, under which a device can be
marketed without pre-market approval or reclassification. A
determination of substantial equivalency under this notification is |
1
Image /page/1/Picture/0 description: The image shows the word "SYNTHES" in bold black letters. To the left of the word is a circular logo with a design inside. A horizontal line is underneath the word "SYNTHES" and the logo. The "R" in a circle is to the right of the word "SYNTHES".
not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 8 2004
Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes(USA). 1690 Russell Road Paoli, PA 19301
K041350 Re:
Synthes chronOS™ and Perfusion Syringe Regulation Number: 21 CFR 882.5300, 880.5860 Regulation Name: Methy Methacrylate for Cranioplasty and Piston Syringe Regulatory Class: Class II Product Code: GXP, FMF Dated: May 19, 2004 Received: May 20, 2004
Dear Ms. Musgnung:
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 Eederal 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
3
Page 2 - Ms. Sheri L. Musgnung
applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I ins icter will anow you to obgan finding of substantial equivalence of your device to a premits notification. - The PDF 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), If you desire specific at not to: Joinsee 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 may obtain 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,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized design. A horizontal line runs beneath the word, and a registered trademark symbol appears to the upper right of the word.
Indications for Use
510(k) Number (if known):
| Device Name: | Synthes (USA) chronOSTM |
|---|---|
| Indications: | Synthes chronOS is intended for the repair or filling of |
| craniofacial defects and craniotomy cuts with a surface area no | |
| larger than 25 $cm^2$ . It is also indicated for the restoration or | |
| augmentation of bony contours of the craniofacial skeleton, | |
| including the fronto-orbital, malar and mental areas. | |
| Synthes chronOS is intended to be gently packed or placed into | |
| the site. chronOS resorbs and is replaced with bone during the | |
| healing process. |
Prescription Use
(Per 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)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K041350