(203 days)
Not Found
No
The summary describes a resorbable bone void filler made of tricalcium phosphate and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a resorbable calcium salt bone void filler that helps fill bony voids and promotes bone healing, indicating a therapeutic purpose.
No
The device description indicates that BF+ (Ph) is a "resorbable calcium salt bone void filler" and a "bone graft substitute" used to fill bony voids. Its function is to be replaced by bone during healing, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly states it is a physical bone void filler made of tricalcium phosphate, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "resorbable calcium salt bone void filler intended to fill bony voids or gaps of the skeletal system". This describes a device used in vivo (within the body) for a structural purpose.
- Device Description: The description details the material (tricalcium phosphate) and forms (cube, granule, stick, block) of the bone void filler, further confirming its use as an implantable or surgically placed material.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The information provided describes a medical device used for surgical implantation and bone regeneration, not an in vitro diagnostic test.
N/A
Intended Use / 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, 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.
Product codes
MQV
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e. the extremities, posterolateral spine and pelvis)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
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.(b)
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.
0
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: (512) 344-3333 (512) 344-3350 Fax:
2. Contact Person
James Burrows Director of Clinical Marketing LDR Spine USA 4030 West Braker Lane, Suite 360 Austin, TX 78759
Phone: (512) 344-3307 Fax: (512) 344-3350 Email: jamesburrows@ldrspine.com
3. Date 510(k) Summary Prepared: November 15, 2006
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- 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.
1
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).
2
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.
3
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 (800) 638-2041 or (240) 276-3150 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
4
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