(49 days)
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.
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.
This document describes a 510(k) premarket notification for the "Synthes (USA) chronOSTM" device. This is a regulatory submission for a medical device to demonstrate that it is substantially equivalent to a legally marketed predicate device. This type of submission generally does not include detailed studies on device performance against specific acceptance criteria in the way a PMA (Premarket Approval) submission would.
Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone studies, and ground truth establishment for a medical device algorithm or AI system is not applicable to this document.
This document focuses on:
- Device Description: Synthes chronOS is a porous, osteoconductive, resorbable bone void filler made from β-Tricalcium Phosphate (TCP), with specific pore diameters.
- Intended Use: Repair or filling of craniofacial defects and craniotomy cuts (surface area no larger than 25 cm²), and restoration/augmentation of bony contours of the craniofacial skeleton.
- Substantial Equivalence: The primary "proof" in a 510(k) is demonstrating substantial equivalence to a predicate device, not necessarily meeting a new set of performance acceptance criteria through a clinical study. The predicate devices mentioned are Norian Cranial Repair System (CRS) Bone Cement and Etex α-BSM™ Bone Substitute Material for Cranioplasty.
In summary, this document does not contain the kind of performance study data you would find for an AI/algorithm-based device to establish its acceptance criteria and prove it meets them. The "study" here is the regulatory comparison to a predicate device to establish substantial equivalence.
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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 RoadPaoli, PA 19301(610) 647-9700 |
|---|---|
| Device Name: | Synthes (USA) chronOST™ |
| Classification: | Class II, 21 CFR §882.5300Methylmethacrylate for Cranioplasty |
| Class II, 21 CFR §880.5600Piston Syringe | |
| Predicate Device: | Norian Cranial Repair System (CRS) Bone CementEtex α-BSM™ Bone Substitute Material for Cranioplasty |
| Device Description: | Synthes chronOS is a porous, osteoconductive, resorbable bonevoid filler made from β-Tricalcium Phosphate (TCP). chronOSfeatures a uniform three dimensional pore structure. Porediameters within the material range from 100 to 500 μm. chronOSis provided sterile in granules and preformed shapes (e.g. blocks,cylinders, wedges). |
| chronOS may be packaged with a perfusion syringe that is used tomix the bone void filler with the patient's blood components. | |
| Intended Use: | Synthes chronOS is intended for the repair or filling of craniofacialdefects and craniotomy cuts with a surface area no larger than 25cm². It is also indicated for the restoration or augmentation of bonycontours of the craniofacial skeleton, including the fronto-orbital,malar and mental areas. |
| Synthes chronOS is intended to be gently packed or placed into thesite. chronOS resorbs and is replaced with bone during the healingprocess. | |
| SubstantialEquivalence: | Documentation is provided which demonstrates that SyntheschronOS is substantially equivalent* to other legally marketedSynthes devices. |
| *The term "substantial equivalence" as used in the 510(k)notification is limited to the definition of substantial equivalencefound in the Food, Drug and Cosmetic Act, as amended and asapplied under 21 CRF 807, Subpart E, under which a device can bemarketed without pre-market approval or reclassification. Adetermination of substantial equivalency under this notification is |
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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.
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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
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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
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Indications for Use
510(k) Number (if known):
| Device Name: | Synthes (USA) chronOSTM |
|---|---|
| Indications: | Synthes chronOS is intended for the repair or filling ofcraniofacial defects and craniotomy cuts with a surface area nolarger than 25 $cm^2$ . It is also indicated for the restoration oraugmentation 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 intothe site. chronOS resorbs and is replaced with bone during thehealing 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
§ 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).