(74 days)
Not Found
No
The summary describes a bone void filler material and its composition, with no mention of AI or ML technology.
Yes
The device is described as a "Bone Void Filler" used to fill gaps or voids in osseous defects resulting from trauma or surgery, and it "resorbs during healing and is replaced by bone." This indicates a direct role in treating a medical condition and facilitating the healing process, aligning with the definition of a therapeutic device.
No.
The device is a bone void filler intended for treatment of osseous defects, not for diagnosing medical conditions.
No
The device description clearly states it is constructed of synthetic ß-tricalcium phosphate granules in a poloxamer based carrier, indicating it is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- TheriGraft™ Function: TheriGraft™ Bone Void Filler is a material implanted directly into the body to fill bone defects and promote bone healing. It does not analyze specimens taken from the body.
The provided information clearly describes a device used in vivo (within the living body) for a surgical procedure, not a device used in vitro (in a lab setting) for diagnostic testing.
N/A
Intended Use / Indications for Use
TheriGraft™ TCP Putty Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and is intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i.e. the extremities, spine and pelvis). TheriGraft™ putty creates a network within the defect site that resorbs during healing and is replaced by bone.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
The TheriGraft™ Bone Void Filler is constructed of synthetic ß-tricalcium phosphate granules (0.1 - 0.4 mm diameter) in a poloxamer based carrier.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
defects of the skeletal system (i.e., the extremities, spine and pelvis).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital or Health Care Practitioner’s surgical suite.
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)
Pre-clinical performance testing conducted on TheriGraft™ and Vitoss™ in a canine animal model according to indication yielded similar results based on tissue reation, bone ingrowth, residual material, and mechanical testing.
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.
Vitoss™ K994337
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.
0
THERICS, LLC. 115 CAMPUS DRIVE PRINCETON, NJ 08540 TELEPHONE: 609-514-7200 609-514-0255 FAX: E-MAIL: therics(@therics.com
JAN 3 ] 2006
THERICS HEFERENG SPREFIALISTS
510(k) SUMMARY
Therics' TheriGraft™ Bone Void Filler
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Submitter's Name:
Sunil Saini
609.514.7200 x7262 or 609.514.7200 (main) Telephone: Facsimile: 609.514.0255 Contact Person: Sunil Saini
Date Prepared: November 1, 2005
Name of Device and Name/Address of Sponsor
TRADE/PROPRIETARY NAME OF DEVICE:
TheriGraft™ TCP Putty Bone Void Filler
ADDRESS:
115 Campus Drive Princeton, New Jersey 08540
Common or Usual Name:
Bone Void Filler. Synthetic Bone Void Filler. Synthetic Cancellous Bone Void Filler. Bone Graft Substitute. Synthetic Bone Substitute. Synthetic Cancellous Bone Substitute.
Classification Name
Bone Void Filler
Predicate Device
Orthovita's Vitoss™
1
THERICS, L.L.C. 115 CAMPUS DRIVE PRINCETON, NJ 08540 TELEPHONE: 609-514-7200 FAX: FAX: --------------------------------------------------------------------------------------------------------------------------------------------------------------------609-514-0255 E-MAIL: therics@therics.com
Image /page/1/Figure/1 description: The image shows the logo for THERICS. The logo features a stylized letter "T" made of plus signs. Below the "T" is the word "THERICS" in a stylized font, and below that are the words "ENGINEERING SPECIALISTS" in a smaller font.
Intended Use / Indications for Use
TheriGraft™ TCP Putty Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and is intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i.e. the extremities, spine and pelvis). TheriGraft™ putty creates a network within the defect site that resorbs during healing and is replaced by bone.
Technological Characteristics and Substantial Equivalence
The TheriGraft™ Bone Void Filler is constructed of synthetic ß-tricalcium phosphate granules (0.1 - 0.4 mm diameter) in a poloxamer based carrier.
Pre-clinical performance testing conducted on TheriGraft™ and Vitoss™ in a canine animal model according to indication yielded similar results based on tissue reation, bone ingrowth, residual material, and mechanical testing. TheriGraft™ bone void filler has the same intended use and indications, the same or similar principles of overation and technological characteristics, and equivalent performance in an appropriate animal model. Therefore, TheriGraff™ Bone Void Filler is substantially equivalent to the predicate device (see Table 1).
Attachment - 6 Page 3 of 4
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THERICS, LLC. 115 CAMPUS DRIVE PRINCETON, NJ 08540 TELEPHONE: 609-514-7200 FAX: 609-514-0255 E-MAIL: therics@therics.com
Image /page/2/Picture/1 description: The image shows the logo for "THERICS". The logo consists of a stylized letter "T" made up of plus signs, with the word "THERICS" written in a blocky, sans-serif font below it. Underneath the company name are the words "TISSUE ENGINEERING SPECIALISTS" in a smaller, sans-serif font. The logo is simple and modern, with a focus on the company's name and area of expertise.
| Characteristics
or Attributes | TheriGraft™
(NEW) | Vitoss ™
K994337 | Comments |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Indications for Use | Indicated for use in filling
the gaps or voids of osseous
defects surgically created or
resulting from trauma.
TheriGraft™ may be used
with autogenous bone
marrow | Indicated for use in filling
the gaps or voids of osseous
defects surgically created or
resulting from trauma.
Vitoss may be used with
autogenous bone marrow | Same |
| Intended Use | Intended for treatment of
osseous defects not intrinsic
to the stability of the bone
structure. The product is
intended for use in defects of
the skeletal system (i.e., the
extremities, spine and
pelvis). | Intended for treatment of
osseous defects not intrinsic
to the stability of the bone
structure. The product is
intended for use in defects
of the skeletal system (i.e.,
the extremities, spine and
pelvis). | Same. |
| Labeling | See Indications for Use and
Intended Use. | See Indications for Use and
Intended Use. | SE. |
| Target Population | Patients with osseous defects
surgically created or
resulting from trauma. | Patients with osseous
defects surgically created or
resulting from trauma. | Same. |
| Design | Porous trabecular structures
similar to cancellous bone.
Approximately 0.1 – 0.4 mm
granules. | Porous trabecular structures
similar to cancellous bone.
1 – 4 mm granules. | Similar internal structures for
TheriGraft & Vitoss.
Granule dimensions are
different. |
| Materials | Calcium salt; β-tricalcium
phosphate mineral phase in
poloxamer carrier. | Calcium salt; β-tricalcium
phosphate mineral phase. | Same. |
| Performance | Pre-clinical study to
demonstrate performance
characteristics. | Pre-clinical study to
demonstrate performance
characteristics. | SE. |
| Sterility | Gamma irradiation. | Gamma irradiation. | Same. |
| Biocompatibility | Product tested according to
ISO 10993, Biological
Evaluation of Medical
Devices. | Unknown. | Same. |
| Chemical Safety | Product tested according to
ISO 10993, Biological
Evaluation of Medical
Devices. | Unknown. | Same. |
| Anatomical Sites | Osseous defects not intrinsic
to the stability of the bone
structure. | Osseous defects not intrinsic
to the stability of the bone
structure. | Same. |
| Where Used:
Hospital, home,
ambulance, etc. | Hospital or Health Care
Practitioner’s surgical suite. | Hospital or Health Care
Practitioner’s surgical suite. | Same. |
| Design Control | Design Controls:
Verification & Validation | Unknown. | SE. |
Table 1: TheriGraft™ & Vitoss™ SE and Comparison Chart
3
Image /page/3/Picture/0 description: The image shows a logo for a company called "THERICS'." The logo features a stylized letter "T" formed by a series of plus signs. Below the company name, there is some text that is difficult to read due to the image quality, but it appears to say "TISSUE ENGINEERING SPECIALISTS."
CONFIDENTIAL
Attachment - 12
Indications for Use Form
510(k) Number (if known): Not assigned at this time
Device Name:
TheriGraft™ TCP Putty Bone Void Filler
Indications for Use:
TheriGraft™ Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and is intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i.e., the extremities, spine and pelvis). TheriGrafTM parts create a network within the defect site that resorbs during healing and is replaced by bone
(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 C.F.R. 801.109)
OR
Over-The-Counter Use_ ________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
4
Image /page/4/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. 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.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 1 2006
Sunil Saini, Ph.D. Director, Biomaterials THERICS, LLC. 115 Campus Drive Princeton, New Jersey 08540
Re: K053228
Trade/Device Name: TheriGraft™ TCP Putty 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: November 16, 2005 Received: November 21, 2005
Dear Dr. Saini:
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 sct 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.
5
Page 2 -- Sunil Saini, Ph.D.
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 (240) 276-0120 . 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/industry/support/index.html.
Sincerely yours,
sincerely yours,
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): Ko5 3228
Device Name:_Therigraft™ TCP Putty Bone Void Filler
Indications For Use:
TheriGraft™ Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and is intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i.e. the extremities, spine and pelvis). TheriGraft™ putty creates a network within the defect site that resorbs during healing and is replaced by bone.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (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)
Signature
KOS3228
Page 1 of 1