(113 days)
Not Found
Not Found
No
The summary describes a bone graft substitute material and its physical properties, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is a bone graft substitute intended for the augmentation of deficient alveolar ridges, which is a therapeutic intervention to treat a medical condition.
No
Explanation: The TheriRidge™ Block Bone Graft Substitute is described as a material for augmenting deficient bone ridges, not for diagnosing conditions. It is a therapeutic device.
No
The device description clearly states it is a physical block made of hydroxylapatite material, indicating 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 is for the "augmentation of deficient maxillary and mandibular alveolar ridges." This describes a surgical procedure to repair or rebuild bone structure within the body.
- Device Description: The device is a "Block Bone Graft Substitute" made of hydroxylapatite material. This is a material designed to be implanted into the body to promote bone growth.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The description of the TheriRidge™ Block does not involve any testing of samples or analysis of biological markers.
Therefore, the TheriRidge™ Block Bone Graft Substitute is a surgical implant or medical device used for bone grafting, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
TheriRidge™ Block Bone Graft Substitute is indicated and intended for the augmentation of deficient maxillary and mandibular alveolar ridges.
Product codes (comma separated list FDA assigned to the subject device)
LYC
Device Description
The TheriRidge™ Block device consists of hydroxylapatite material, the primary mineral content of human bone, with porosity and geometric features that encourage tissue in-growth. The device will be available in three (3) basic sizes: small (approximately 10.4 mm x 5.6 x 5.0), medium (approximately 10.4 mm x 10.0 x 5.0), and large (approximately 20.0 mm x 10.0 x 5.0).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and mandibular alveolar ridges
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)
Pre-clinical performance testing conducted on TheriRidge™ and Pro Osteon® 200 in a canine animal model according to indication vielded similar results based on handling characteristics, wound healing, implant stability, and the presence of healthy tissue in or adjacent to the devices.
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.
Interpore's Pro Osteon® 200
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
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Attachment – 6
MAR 2 6 2003
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510(k) Summary
Attachment-06-510kSummaryRevised20030318
1
THERICS. INC 5 CAMPUS DR ETON, NJ (
Image /page/1/Picture/1 description: The image shows the word "THERICS" in a stylized font. To the left of the word is a pattern of black circles arranged in a grid-like formation. The circles appear to fade from dark to light as they move from left to right. The word "THERICS" is in all capital letters and has a textured appearance.
510(k) SUMMARY
Therics' TheriRidge™ Block
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Submitter's Name:
Umberto V. Parrotta
Telephone: 609.514.7237 or 609.514.7200 (main) Facsimile: 609.514.7219 Contact Person: Umberto V. Parrotta
Date Prepared: December 2, 2002
Name of Device and Name/Address of Sponsor
TRADE/PROPRIETARY NAME OF DEVICE: TheriRidge™ Block, Bone Graft Substitute
ADDRESS:
115 Campus Drive Princeton, New Jersey 08540
Common or Usual Name:
Bone Graft Substitute Hydroxylapatite (HA) Blocks Hydroxyapatite (HA) Blocks Synthetic Bone Substitute
Classification Name
Bone Augmentation Materials
Predicate Devices
Interpore's Pro Osteon® 200
Attachment - 6 Attachment-06-510kSummaryRevised20030318
2
THERICS. INC. 115 CAMPUS DRIVE PRINCETON, NJ 08540 TELEPHONE: 609-514-7200 609-514-7219 E-MAIL: therics@therics.com
Image /page/2/Picture/1 description: The image shows the word "THERICS" in a stylized font. To the left of the word is a grid of black circles that fade from dark to light. The word "THERICS" is in a sans-serif font with a textured fill. The overall image has a clean and professional look.
Intended Use / Indications for Use
TheriRidge™ Block Bone Graft Substitute is indicated and intended for the augmentation of deficient maxillary and mandibular alveolar ridges.
Technological Characteristics and Substantial Equivalence
The TheriRidge™ Block device consists of hydroxylapatite material, the primary mineral content of human bone, with porosity and geometric features that encourage tissue in-growth. The device will be available in three (3) basic sizes: small (approximately 10.4 mm x 5.6 x 5.0), medium (approximately 10.4 mm x 10.0 x 5.0), and large (approximately 20.0 mm x 10.0 x 5.0).
A summary of the physical and chemical characteristics of both TheriRidge™ Block and Pro Osteon® 200 is below in Table 1.
| Characteristics | TheriRidge™ | ProOsteon 200™ |
|---|---|---|
| Median Pore Diameter | 12 microns | 80 microns |
| Bulk Density | 1.7 g/cc | 1.3 g/cc |
| True/Skeletal Density | 3.0 g/cc | 3.0 g/cc |
| Porosity | 43 % * | 57 % |
| Crystallinity | > 95% HA | > 90% HA |
| Compressive Strength | 4.3 MPa (3 to 6 MPa) | 5.8 MPa (4 to 10 MPa) |
Tahle 1
- Excluding channels
Pre-clinical performance testing conducted on TheriRidge™ and Pro Osteon® 200 in a canine animal model according to indication vielded similar results based on handling characteristics, wound healing, implant stability, and the presence of healthy tissue in or adjacent to the devices.
The TheriRidge™ implants have the same intended use and indications, the same or similar principals of operation and technological characteristics, and equivalent performance in an appropriate animal model. Theric's Theric's TheriRidge™ Block is substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three stripes representing the feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 6 2003
Mr. Umberto V. Parrotta, Jr. Director of QA & RA Therics, Incorporated 115 Campus Drive Princeton, New Jersey 08540
Re: K023998
Trade/Device Name: TheriRidge™ Block, Bone Graft Substitute Regulatory Class: Unclassified Product Code: LYC Dated: February 24, 2003 Received: February 25, 2003
Dear Mr. Parrotta:
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.
4
Page 2 -- Mr. Parrotta
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.
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 vour 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) 594-4613. 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,
Susan Juniper
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows a logo with a pattern of black circles on the left and the word "THERICS" on the right. The circles are arranged in a grid-like pattern, with the density of the circles decreasing from left to right. The word "THERICS" is written in a bold, sans-serif font, with each letter outlined in black. The overall design of the logo is modern and minimalist.
CONFIDENTIAL
Attachment - 12
Indications for Use Form
510(k) Number: K023998.
Device Name:
TheriRidge™ Block, Bone Graft Substitute
Indications for Use:
TheriRidge™ Block Bone Graft Substitute is indicated and intended for the augmentation of deficient maxillary and mandibular alveolar ridges.
(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
Kein Muluy for MSR
(Optional Format 1-2-96)
inn Sian Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K023998
File: Attachment-12-IndicationsForUseStatementRevised20030318