← Product Code [LYC](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC) · K023998 # THERIRIDGE BLOCK, BONE GRAFT SUBSTITUTE (K023998) _Therics, Inc. · LYC · Mar 26, 2003 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K023998 ## Device Facts - **Applicant:** Therics, Inc. - **Product Code:** [LYC](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC.md) - **Decision Date:** Mar 26, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3930 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Indications for Use TheriRidge™ Block Bone Graft Substitute is indicated and intended for the augmentation of deficient maxillary and mandibular alveolar ridges. ## Device Story TheriRidge™ Block is a synthetic bone graft substitute composed of hydroxylapatite (HA). Designed for dental/oral surgery, the device is implanted by a clinician to augment deficient maxillary and mandibular alveolar ridges. The block features specific porosity and geometric characteristics intended to encourage natural tissue in-growth. It serves as a scaffold for bone regeneration. The device is provided in three sizes (small, medium, large) to accommodate varying anatomical needs. Clinical benefit is derived from its ability to provide structural support and facilitate healing in the alveolar ridge, aiding in subsequent dental restoration or stabilization. It is a passive implantable material; it does not involve electronic processing, software, or active sensing. ## Clinical Evidence Pre-clinical performance testing was conducted in a canine animal model comparing TheriRidge™ to the predicate Pro Osteon® 200. The study evaluated handling characteristics, wound healing, implant stability, and the presence of healthy tissue in or adjacent to the devices. Results indicated similar performance between the subject and predicate devices. ## Technological Characteristics Material: Hydroxylapatite (HA) >95% crystallinity. Porosity: 43% (excluding channels). Median pore diameter: 12 microns. Bulk density: 1.7 g/cc. Compressive strength: 4.3 MPa. Form factor: Solid blocks in three sizes (small, medium, large). Principle: Passive scaffold for tissue in-growth. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Interpore's Pro Osteon® 200 ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Attachment – 6 MAR 2 6 2003 $$ \chi \otimes \chi \otimes \chi \otimes \chi $$ # 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. K023998 # 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. K023998 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 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K023998](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LYC/K023998) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com