BF+ (PH)

K061462 · Ldr Spine USA · MQV · Dec 15, 2006 · Orthopedic

Device Facts

• Record ID: K061462
• Device Name: BF+ (PH)
• Applicant: Ldr Spine USA
• Product Code: MQV · Orthopedic
• Decision Date: Dec 15, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BF+ (Ph) resorbable void filler is a resorbable calcium salt bone void filler intended to fill bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine and pelvis), caused by trauma or surgery, that are not intrinsic to the stability of the bony structure. BF+ (Ph) is a bone graft substitute that resorbs and is replaced with bone during the healing process.

Device Story

BF+ (Ph) is a synthetic bone graft substitute composed of 100% tricalcium phosphate. Available in cube, granule, stick, and block forms; features multidirectional interconnected porosity mimicking human cancellous bone. Intended for surgical use to fill non-structural bony voids or gaps in the extremities, spine, and pelvis. Device resorbs over 6-12 months, facilitating replacement with natural bone during the healing process. No mechanical testing performed due to material and process identity with predicate device.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on identical material composition and manufacturing processes to the predicate device.

Technological Characteristics

Material: 100% tricalcium phosphate [Ca3(PO4)2]. Forms: cubes, granules, sticks, blocks. Porosity: multidirectional interconnected structure. Density: 1.228-1.842 g/cm³ (cubes/granules); 1.535-1.842 g/cm³ (sticks/blocks).

Indications for Use

Indicated for filling bony voids or gaps of the skeletal system (extremities, spine, pelvis) caused by trauma or surgery, not intrinsic to bony structure stability.

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

• BIOSORB® Resorbable Bone Void Filler (K021963)

Submission Summary (Full Text)

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K06/462

Image /page/0/Picture/1 description: The image shows the logo for LDR Spine. The letters "LDR" are stacked on top of the word "spine." The font is bold and sans-serif. The logo is black and white.

A Passion for Innovation

# 510(k) Summary

DEC 1 6 2006

# BF+® (Ph) Bone Void Filler

# 1. Owner's Name & Address

LDR Spine USA 4030 West Braker Lane, Suite 360 Austin, TX 78759

Phone: [phone] [phone] Fax:

### 2. Contact Person

James Burrows Director of Clinical Marketing LDR Spine USA 4030 West Braker Lane, Suite 360 Austin, TX 78759

Phone: [phone] Fax: [phone] Email: [e-mail]

# 3. Date 510(k) Summary Prepared: November 15, 2006

- 4. BF+® (Ph) Trade Name: Common Name: Bone Void Filler MQV: Filler, Bone Void, Calcium Compound - Class II Classification: per 21 CFR 888.3045
# Legally Marketed Equivalent Predicate Devices: 5.

> K021963 - Sciences et Bio Materiaux (SBM) France BIOSORB® Resorbable Bone Void Filler

# 6. Device Description

The BF+ (Ph) system is manufactured using 100% tricalcium phosphate [Ca3(PO4)2]. BF+ (Ph) is a bone graft substitute that resorbs within 6-12 months and is replaced with bone during the healing process.

The identical (3 tricalcium phosphate (TCP) proposed for use has been used in other legally marked devices within the same classification for the same intended use.

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The cube, granule, stick, and block forms are intended to allow for a full range of surgeon preference, and provide a multidirectional interconnected porosity structure similar to that of human cancellous bone. Density for cubes and granules range from 1.228 to 1.842 g/cm³, and from 1.535 to 1.842 g/cm³ for sticks and blocks.

### 7. Intended Use of the Device

BF+ (Ph) resorbable void filler is a resorbable calcium salt bone void filler intended to fill bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine and pelvis), caused by trauma or surgery, that are not intrinsic to the stability of the bony structure. BF+ (Ph) is a bone graft substitute that resorbs and is replaced with bone during the healing process.

### 8. Non-Clinical Performance Data

Mechanical testing of the LDR Spine USA BF+® (Ph) device was not performed, as the materials, processes and supplier are identical to that of the predicate BIOSORB® Resorbable Bone Void Filler manufactured by SBM France (Premarket Notification K021963).

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol resembling an eagle or bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

LDR Spine USA % Mr. James Burrows Director of Clinical Marketing 4030 West Braker Lane Austin, Texas 78759

Re: K061462

Trade/Device Name: BF+® (PH) Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Filler, Bone Void, Calcium Compound Regulatory Class: Class II Product Code: MQV Dated: November 15, 2006 Received: November 17, 2006

DEC 1 5 2006

Dear Mr. Burrows:

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 applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Mr. James Burrows

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), please contact the Office of Compliance at 240-276-0120. 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/industry/support/index.html.

Sincerely yours.

Aenbeue Pruchud

Mark N. Melkerson Division 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:

BF+® (Ph) Bone Void Filler Device Name(s):

Indications for Use:

BF+ (Ph) resorbable void filler is a resorbable calcium salt bone void filler intended to fill bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis), caused by trauma or surgery, that are not intrinsic to the stability of the bony structure.

Prescription Use __ X

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional format 1-2-96)

Barbara Burchms

(Division Caroli) Division of General. Restorative, and Neardingican De 10:3

**510(k) Number** K061462