NANOSS BONE VOID FILLER

K050025 · Angstrom Medica, Inc. · MQV · Feb 3, 2005 · Orthopedic

Device Facts

• Record ID: K050025
• Device Name: NANOSS BONE VOID FILLER
• Applicant: Angstrom Medica, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Feb 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

NanOss Bone Void Filler is intended only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., 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 void filler that resorbs and is replaced by the growth of new bone during the healing process.

Device Story

NanOss Bone Void Filler is a resorbable, osteoconductive bone graft substitute consisting of prefabricated, sintered hydroxyapatite cylindrical pellets. Used by surgeons in clinical settings to fill non-load-bearing osseous defects in the extremities, spine, and pelvis. The pellets are manually packed into the void; they act as a scaffold for new bone growth and are gradually resorbed by the body during the healing process. The device is radiopaque, allowing for visualization during and after the procedure. It provides a synthetic alternative to autograft or allograft for filling surgically created or trauma-induced bone gaps.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on chemical, physical, and functional comparison to legally marketed predicate devices.

Technological Characteristics

Osteoconductive, resorbable, sintered hydroxyapatite (calcium phosphate) cylindrical pellets. Nanocrystalline processing. Radiopaque. Trace elements comply with ASTM F1185. Presterilized for single use.

Indications for Use

Indicated for patients with non-load-bearing bony voids or gaps in the skeletal system, including extremities, spine, and pelvis, resulting from surgery or traumatic injury.

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

• Biomet Calcium Phosphate Granular Bone Void Filler (K011531)
• NovaBone Resorbable Bone Graft Substitute (K021336)
• Wright Medical Technology Osteoset Resorbable Mini Bead Kit (K010532)
• Orthovita Vitoss Scaffold (K994337)
• Interpore Pro Osteon 500R (K990131)

Submission Summary (Full Text)

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FEB - 3 7005

0 50025

510(k) Summary

Angstrom Medica NanOss™ Bone Void Filler

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# ADMINISTRATIVE INFORMATION

| Manufacturer Name: | Angstrom Medica, Inc.<br>150-A New Boston Street,<br>Woburn, MA 01801 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Paul J. Mraz, CEO<br>Telephone: [phone]<br>FAX: [phone] |
| Representative/Consultant: | Floyd G. Larson<br>PaxMed International<br>4329 Graydon Road<br>San Diego, CA 92130<br>Telephone: [phone]<br>FAX: [phone]<br>e-mail: [e-mail] |

#### DEVICE NAME

Classification Name: Trade/Proprietary Name: Common Name: Product Code:

Filler, calcium sulfate preformed pellets NanOss™ Bone Void Filler bone void filler MQV

#### DEVICE CLASSIFICATION

Calcium sulfate preformed pellets have been classified by FDA as Class II, Special Controls, in a Final Rule effective July 2, 2003 (68 FR 32635) (21 CFR 888.3045). Calcium phosphate devices have been cleared as substantially equivalent to calcium sulfate devices.

### CONFORMANCE WITH PERFORMANCE STANDARDS

No performance standards have been established under Section 514.

#### INTENDED USE

NanOss Bone Void Filler is intended only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., 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 void filler that resorbs and is replaced by the growth of new bone during the healing process.

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## DEVICE DESCRIPTION

NanOss Bone Void Filler is an osteoconductive, resorbable, calcium phosphate implant for use as a bone graft substitute or bone void filler. The device consists of prefabricated cylindrical calcium phosphate pellets. The device is radiopaque and is presterilized for single use. The nanocrystalline processing of the material results in sintered hydroxyapatite pellets that are translucent and uniform in density and strength.

## EQUIVALENCE TO MARKETED PRODUCT

NanOss Bone Void Filler is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices. The intended use, design and functional characteristics of NanOss Bone Void Filler and the predicate devices are substantially the same. These devices include Biomet Calcium Phosphate Granular Bone Void Filler (K011531); NovaBone Resorbable Bone Graft Substitute (K021336); Wright Medical Technology Osteoset Resorbable Mini Bead Kit (K010532); Orthovita Vitoss Scaffold (K994337) and Interpore Pro Osteon 500R (K990131). These devices all are intended to fill voids or gaps in osseous defects, are not intended to be load-bearing and consist of a variety of calcium compounds.

NanOss Bone Void Filler pellets are chemically similar to the calcium phosphate predicates, with the expected phase purity and calcium/phosphorus stoichiometry, and with trace element levels below the limit set by ASTM F1185. Density is essentially the theoretical density for ceramic hydroxyapatite and bulk density is in the expected range for small cylindrical pellets. Dissolution behavior is within the range of that of the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

FEB - 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Floyd G. Larson Angstrom Medica, Inc. C/o Paxmed International 4329 Graydon Road San Diego, California 92130

Re: K050025

Trade/Device Name: NanOss™Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: January 04, 2005 Received: January 07, 2005

Dear Mr. Larson:

We have reviewed your Section 510(k) premarket notification of intent to market the device w f nave a showe 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 for abo stated in the 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 r ou may, arons 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 or any I ederal battler and sequirements, 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.

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Page 2- Mr. Floyd G. Larson

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yours of substantial equivalence of your device to a legally prematics notification. The 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 If you desire specific at not any at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Misoranding by reference to presence to presessorsibilities under the Act from the Division of Small other general informational 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,

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):

Device Name: NanOss™ Bone Void Filler

Indications for Use:

NanOss Bone Void Filler is intended only for bony voids or gaps that are not intrinsic to the NahObs Done Vota Finer ire. The product is indicated to be gently packed into bony voids or buoney of the skeletal system (i.e., 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 void filler that resorbs and is replaced by the growth of new bone during the healing process.

Mark N. Millenn

Division Sign Division of General, Restorative, and Neurological Devices

510(k) Number K050025

Prescription Use __X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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