(439 days)
Pro Osteon 500R Resorbable Bone Void Filler, Vitoss Scaffold Synthetic Bone Void filler
Not Found
No
The summary describes a passive, resorbable bone void filler material and does not mention any computational or analytical functions, let alone AI/ML.
Yes
The device is described as a "bone void filler" used in the "treatment of bony defects" and assists in the "healing process" by being replaced with bone, which aligns with the definition of a therapeutic device designed to treat a condition or disease.
No
The device is described as a bone void filler used for treatment, not for diagnosing conditions.
No
The device description clearly states that Synthes chronOS is a physical, porous material made from β-Tricalcium Phosphate (TCP) and is provided in granules and preformed shapes. It is a bone void filler, not a software application.
Based on the provided information, the Synthes chronOS device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Synthes chronOS Function: Synthes chronOS is a bone void filler. Its purpose is to be implanted into the body to fill gaps in bone and promote bone healing. It is a medical device used in vivo (within the living body), not in vitro (in a test tube or laboratory setting).
- Intended Use: The intended use clearly states it's for use as a bone void filler in bony defects. This is a surgical application, not a diagnostic test.
- Device Description: The description details its composition and form as a porous material for implantation.
Therefore, Synthes chronOS falls under the category of an implantable medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Synthes chronOS is intended for use as a bone void filler in voids or gaps that are not intrinsic to the stability of the bony structure. chronOS is indicated for use in the treatment of bony defects created surgically or through traumatic injury.
chronOS is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine, and pelvis). Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
Product codes
MQV, 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
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)
Pro Osteon 500R Resorbable Bone Void Filler, Vitoss Scaffold Synthetic Bone Void filler
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Confidential
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K013072
NOV 2 6 2002
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510(k) Summary
| SPONSOR: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700
Contact: Thomas M. Maguire |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | chronOS |
| CLASSIFICATION: | chronOS: Unclassified. Product Code is MQV.
Perfusion Syringe: Piston Syringe; Product Code is FMF. |
| PREDICATE DEVICE: | Pro Osteon 500R Resorbable Bone Void Filler
Vitoss Scaffold Synthetic Bone Void filler |
| 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 use as a bone void filler in voids or gaps
that are not intrinsic to the stability of the bony structure. chronOS is
indicated for use in the treatment of bony defects created surgically or
through traumatic injury. chronOS is indicated to be gently packed or placed into bony voids or gaps
of the skeletal system (i.e. the extremities, spine, and pelvis). Following
placement in the bony void or gap, the calcium phosphate scaffold resorbs
and is replaced with bone during the healing process. |
| MATERIAL: | β-Tricalcium Phosphate [Ca3(PO4)2] |
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DEPARTMENT OF HEALTH S
Image /page/1/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and appears to be part of a document or sign. The text is slightly faded, suggesting it may be from an older document or a low-resolution image.
9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas M. Maguire Regulatory Compliance Manager Synthes (USA) 1690 Russell Road Post Office Box 1766 Paoli, PA 19301
Re: K013072
Synthes chronOS Tricalcium Phosphate and Synthes Perfusion Syringe Regulatory Class: unclassified Product code: MQV Dated: August 29, 2002 Received: August 30, 2002
Dear Mr. Maguire:
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 Acts requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice
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Page 2 – Mr. Thomas M. Maguire
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. 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) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrl/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
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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| 2.0 | Indications for Use Statement |
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| ------------ | -------------------------------------- |
510(k) Number (if known):
Device Name: and the contract of the contract and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comme
Indications/Contraindications:
Synthes ChronOS is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. ChronOS is indicated for use in the treatment of bony defects created surgically or through traumatic injury.
ChronOS Tricalcium Phosphate is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine, and pelvis). Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Division Sign Off)
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sorative and Neurological ive
510/
K01307
Synthes (USA) Svstem Name 510(k) - ChronOS Confidential