(64 days)
Not Found
Not Found
No
The document describes a bone void filler made of β-Tricalcium Phosphate and does not mention any AI or ML components or functionalities.
Yes
The device is a bone void filler used in the treatment of bony defects created surgically or through traumatic injury, which directly addresses a medical condition or injury.
No
The provided text describes Synthes chronOS™ as a resorbable bone void filler used to treat bony defects. Its function is to be placed into voids to facilitate bone growth and healing, not to identify or analyze a medical condition.
No
The device description clearly states that Synthes chronOS™ is a physical bone void filler made from β-Tricalcium Phosphate (TCP) and is provided in various physical forms (granules, blocks, wedges, cylinders). It is a physical implantable material, not software.
Based on the provided information, Synthes chronOS™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that Synthes chronOS™ is a bone void filler used to treat bony defects within the body (in vivo). It is placed into bony voids or gaps of the skeletal system to aid in the healing process.
- Device Description: The description details a porous, resorbable material made from β-Tricalcium Phosphate (TCP) that is implanted into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens from the human body (like blood, urine, tissue) outside the body (in vitro) to provide information for diagnosis, monitoring, or screening. Synthes chronOS™ does not perform any such analysis of bodily specimens.
Therefore, Synthes chronOS™ is a medical device intended for surgical implantation, not an IVD.
N/A
Intended Use / Indications for Use
Synthes chronOS™ is indicated for use in bony 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.
Synthes chronOS™ is intended to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine, and pelvis) and may be combined with autogenous blood and/or bone marrow. Following placement into the bony void, chronOS™ resorbs and is replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV, FMF
Device Description
Synthes chronOS™ is a porous, osteoconductive, resorbable bone void filler made from β-Tricalcium Phosphate (TCP). Synthes chronOS™ is resorbed and replaced by new bone during the healing process. The pore structure of chronOS™ provides a matrix for the ingrowth of bone. chronOS™ is provided sterile in a double sterile pack. It is available in various forms including granules, blocks, wedges and cylinders.
Synthes chronOS™ may be packaged with a perfusion syringe that is used to mix the bone void filler with the patient's blood components and/or bone marrow.
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
Prescription Use (Per 21 CFR 801 Subpart D)
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.
Synthes chronOS™, Orthovita, Inc. Vitoss® Scaffold Synthetic Cancellous Bone Void Filler and Imbibe II Syringe
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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Image /page/0/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 registered trademark symbol is located to the right of the word.
JAN - 7 2005
3.0 510(k) Summary
| Sponsor: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes (USA) chronOS™ |
| Classification: | Class II, 21 CFR §888.3045
Filler, Calcium Sulfate Performed Pellets |
| | Class II, 21 CFR §880.5860
Piston Syringe |
| Predicate Device: | Synthes chronOS™
Orthovita, Inc. Vitoss® Scaffold Synthetic Cancellous Bone Void
Filler and Imbibe II Syringe |
| Device Description: | Synthes chronOS™ is a porous, osteoconductive, resorbable bone
void filler made from β-Tricalcium Phosphate (TCP). Synthes
chronOS™ is resorbed and replaced by new bone during the
healing process. The pore structure of chronOS™ provides a matrix
for the ingrowth of bone. chronOS™ is provided sterile in a double
sterile pack. It is available in various forms including granules,
blocks, wedges and cylinders. |
| | Synthes chronOS™ may be packaged with a perfusion syringe that
is used to mix the bone void filler with the patient's blood
components and/or bone marrow. |
| Intended Use: | Synthes chronOS™ is indicated for use in bony 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. |
| | Synthes chronOS™ is intended to be gently packed or placed into
bony voids or gaps of the skeletal system (i.e. the extremities,
spine, and pelvis) and may be combined with autogenous blood
and/or bone marrow. Following placement into the bony void,
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. |
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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 stylized image inside. To the right of the word is a small, circled "R", indicating a registered trademark. A thin line runs horizontally beneath the word.
*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 F, under which a device can be marketed without pre-market approval or reclassification;. A determination of substantial equivalency under this notification is 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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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 7 2005
Ms. Kathy Anderson Regulatory Manager Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K043045
Trade/Device Name: Synthes (USA) Chronos with Perfusion Syringe Regulation Number: 21 CFR 888.3045, 21 CFR 880.5860 Regulation Name: Resorbable calcium salt bone void filler, Piston Syringe Regulatory Class: II Product Code: MQV, FMF Dated: January 3, 2005 Received: January 4, 2005
Dear Ms. Anderson:
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 - Mr. Kathy Anderson
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,
Willy Otto
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
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Image /page/4/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. There is a horizontal line below the word "SYNTHES".
Indications for Use
510(k) Number (if known):
Device Name:
Synthes (USA) chronOSTM
Indications:
Synthes chronOS™ is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. Synthes chronOS™ is indicated for use in the treatment of bony defects created surgically or through traumatic injury.
Synthes chronOS™ is intended to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine, and pelvis) and may be combined with autogenous blood and/or bone marrow. Following placement into the bony void, 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)
Division Sign-Off
Division of General, Restorative, and Neurological Devices
510(k) Number K043045
0004