OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE

K043420 · Regeneration Technologies, Inc. · MQV · Feb 10, 2005 · Orthopedic

Device Facts

• Record ID: K043420
• Device Name: OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE
• Applicant: Regeneration Technologies, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Feb 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

REGENAFIL® Allograft Paste; REGENAFIL® RT Allograft Paste; OPTEFIL™ Allograft Paste, Syringe; OPTEFIL™ RT Allograft Paste, Syringe; OSTEOFIL® DBM Paste; OSTEOFIL® RT DBM Paste; and RTI Allograft Paste are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone graft substitute that remodels into the recipient's skeletal system.

Device Story

Bone graft substitute paste composed of demineralized bone matrix (DBM) and gelatin carrier; functions as scaffold for osteoconduction; provides osteoinductive properties. Intended for surgical placement into non-structural bony voids or gaps in extremities, spine, or pelvis. Remodels into recipient's skeletal system over time. Used by surgeons in clinical settings to fill osseous defects resulting from surgery or trauma.

Clinical Evidence

No human clinical data provided. Evidence based on non-clinical animal model studies evaluating healing radiographically, histologically, and mechanically. DBM and finished product screened for osteoinductivity via rat assay.

Technological Characteristics

Composition: Allograft demineralized bone matrix (DBM) in a gelatin carrier. Function: Osteoconductive scaffold and osteoinductive agent. Form factor: Paste (some provided in syringes). Sterilization: Not specified.

Indications for Use

Indicated for patients with bony voids or gaps in the skeletal system (extremities, spine, pelvis) not intrinsic to bony stability. Defects may be surgically created or result from traumatic injury. Contraindications not specified.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Pro Osteon™ Implant 500R Resorbable Bone Graft Substitute

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Regeneration Technologies, Inc. The word "Regeneration" is in large, bold, black letters. Below it, in smaller letters, is the phrase "TECHNOLOGIES, INC."

11621 Research Circle Post Office Box 2650 Alachua. FL 32616-2650 USA

Tel [phone] Toll Free 877 343.6832 Fax [phone] www.rtix.com

## 510(K) Summary

February 2, 2005 Date:

Submitted by: Carrie Hartill Regeneration Technologies, Inc. 11621 Research Circle P.O. Box 2650 Alachua, FL 32616-2650 386-418-8888 Telephone: [phone] Facsimile:

Proprietary Name: REGENAFIL® Allograft Paste REGENAFIL® RT Allograft Paste OPTEFILTM Allograft Paste, Syringe OPTEFIL™ RT Allograft Paste, Syringe OSTEOFIL® DBM Paste OSTEOFIL® RT DBM Paste RTI Allograft Paste

Common Name: Bone Void Filler, Bone Graft Substitute

Classification Name: Filler, Calcium Sulfate Preformed Pellets (per 21CFR section 888.3045)

Predicate Devices:

The current devices have the same indications as and are substantially equivalent to the Pro Osteon™ Implant 500R Resorbable Bone Graft Substitute.

Description:

These devices are bone paste products made by combining gelatin and demineralized bone matrix.

Indications for Use:

REGENAFIL® Allograft Paste; REGENAFIL® RT Allograft Paste; OPTEFIL™ Allograft Paste, Syringe; OPTEFIL™ RT Allograft Paste, Syringe; OSTEOFIL® DBM Paste; OSTEOFIL® RT DBM Paste; and RTI Allograft Paste are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are

K Ö43420

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indicated to be placed into bony voids or gaps of the skeletal system (e.g., the extremittes, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone graft substitute that remodels into the recipient's skeletal system.

## Summary of Technological Characteristics:

These devices are composed of allograft demineralized bone in a gelatin carrier matrix. These devices have been screened for osteoinductivity in an in vivo assay and also provide a scaffold for osteoconduction. The processed coral in the Pro Osteon® Implant 500R Resorbable Bone Graft Substitute provides a scaffold for osteoconduction.

Non-Clinical Performance Data Supporting Substantial Equivalence Determination: Results from studies in animal models indicate that these products can be used as a bone graft substitute with equivalent or better healing results when compared to the predicate device. Healing was evaluated radiographically, histologically, and mechanically.

¹ DBM and finished product were screened for osteoinductivity in a rat assay. Findings from an animal model are not necessarily predictive of human clinical results.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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FEB 1 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Regeneration Technologies, Inc C/o Ms. Carrie Hartill 11621 Research Circle P.O. Box 2650 Alachua, Florida 32616-2650

Re: K043420

Ro43420
Trade Name: REGENAFIL® Allograft Paste, REGENAFIL® RT Allograft Paste, OPTEFILTM Allograft Paste, Syringe, OPTEFIL™ RT Allograft Paste, OP TEFIL™ Anografi Paste, Syrings, OF FEFIL® - TEFFE - Tell Frances
Syringe, OSTEOFIL® DBM Paste, OSTEOFIL® RT DBM Paste and RTI Allograft Paste Regulation Number: 21 CFR 888.3045 Regulation Name: Reabsorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: December 9, 2004 Received: December 13, 2004

Dear Ms. Hartill:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becareer and the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreatives to the enactment date of the Medical Device Amendments, or to conninered phor to May 20, 1978, the ecordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic rear (110.) that the device, subject to the general controls provisions of the Act. The I ou may, merelore, mannet 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 your device is etablifical controls. Existing major regulations affecting your device it may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA oun of the firther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be deviloed that I 19 mination that your device complies with other requirements of the Act that I DI has intass and regulations administered by other Federal agencies. You must or any I catal statutes and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quand provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Carrie Hartill

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse organ finding of substantial equivalence of your device to a legally premarce issues 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 11 you desire specific at [phone]. Also, please note the regulation entitled, Connect the Office of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general michinal and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Sincerely yours,

Mark A. Millam

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

Enclosure

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## Indications for Use

510(k) Number (if known): K043420

Device Name:

REGENAFIL® Allograft Paste REGENAFIL® RT Allograft Paste OPTEFIL™ Allograft Paste, Syringe OPTEFILTM RT Allograft Paste, Syringe OSTEOFIL® DBM Paste OSTEOFIL® RT DBM Paste RTI Allograft Paste

Indications for Use:

These products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone graft substitute that remodels into the recipient's skeletal system.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

*Minh M*

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

K043420

510(k) Number