ORTHOSS RESORBABLE BONE VOID FILLER

K014289 · Geistlich-Pharma · LYC · Mar 28, 2002 · Dental

Device Facts

• Record ID: K014289
• Device Name: ORTHOSS RESORBABLE BONE VOID FILLER
• Applicant: Geistlich-Pharma
• Product Code: LYC · Dental
• Decision Date: Mar 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ORTHOSS is indicated for bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). ORTHOSS is indicated only for use in bone voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Device Story

ORTHOSS is a resorbable bone void filler used to fill osseous defects in the extremities, spine, and pelvis. It is intended for non-load-bearing applications where the defect is not intrinsic to skeletal stability. The device is applied by a surgeon during orthopedic or trauma procedures to fill surgically created or injury-related bone voids. It acts as a scaffold to support bone healing. The device is provided for prescription use only.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Resorbable bone void filler material. No specific material composition, dimensions, or software characteristics provided in the document.

Indications for Use

Indicated for patients with bony voids or gaps in the skeletal system (extremities, spine, pelvis) resulting from surgical procedures or traumatic injury. Contraindicated for use in defects intrinsic to the stability of the bony structure.

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.

Submission Summary (Full Text)

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

d and Drug Administrati Corporate Boulevard ockville MD 20850

# MAR 2 8 2002

Mr. Peter S. Reichertz Counsel for Geistlich Pharma Ag Arent Fox Kintner Plotkin & Kahn, PLLC 1050 Connecticut Avenue, NM Washington, DC 20036-5339

Re: K014289

ORTHOSS™ Resorbable Bone Void Filler Regulatory Class: unclassified Product Code: MQV and LYC Dated: December 27, 2001 Received: December 28, 2001

Dear Mr. Reichertz:

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 set forth in the quality systems (QS) regulation (21 CFR Part 820); and if

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### Page 2 - Mr. Peter S. Reichertz

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 your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Sincerely yours,

ko Mark N Millikens

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices

Enclosure

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510(k) Number (if know

ORTHOSS Resorbable Bone Void Filler Device Name:

### Indications For Use:

ORTHOSS is indicated for bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). ORTHOSS is indicated only for use in bone voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X | OR | Over-The-Counter Use |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----|----------------------|
| (Per 21 CFR 801.109) | | | |
| | <div> Mark N Milburn <br/> (Division Sign-Off) <br/> Division of General, Restorative <br/> and Neurological Devices </div> | | (Optional Format) |
| | 510(k) Number | | 02/13 '96 11:07 |
| | K014289 | | |

(Optional Format 1-2-96)