THERIRIDGE BLOCK, BONE GRAFT SUBSTITUTE

K023998 · Therics, Inc. · LYC · Mar 26, 2003 · Dental

Device Facts

• Record ID: K023998
• Device Name: THERIRIDGE BLOCK, BONE GRAFT SUBSTITUTE
• Applicant: Therics, Inc.
• Product Code: LYC · Dental
• Decision Date: Mar 26, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Indications for Use

Indicated for the augmentation of deficient maxillary and mandibular alveolar ridges in patients requiring bone graft substitutes.

Regulatory Classification

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)

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Attachment – 6

MAR 2 6 2003

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# 510(k) Summary

Attachment-06-510kSummaryRevised20030318

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THERICS. INC 5 CAMPUS DR ETON, NJ (

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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: [phone] 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

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THERICS. INC. 115 CAMPUS DRIVE PRINCETON, NJ 08540 TELEPHONE: [phone] E-MAIL: [e-mail]

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### 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.

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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.

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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 [phone]. 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 [phone] or [phone] 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

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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