BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID

K041616 · Orthos (Uk) Limited · MQV · Aug 25, 2004 · Orthopedic

Device Facts

• Record ID: K041616
• Device Name: BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID
• Applicant: Orthos (Uk) Limited
• Product Code: MQV · Orthopedic
• Decision Date: Aug 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ßGran Synthetic Osteoconductive Scaffold Bone Void Filler is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated for use in the treatment of surgically created osseous defects or osseous defects caused by traumatic injury to the bone. The scaffold should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. ßGran Scaffold is intended to be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) and may be combined with autogenous blood and/or bone marrow. Following implantation, the calcium phosphate matrix is resorbed and is replaced with bone during the healing process. BGran is intended for use by suitable trained surgical personnel only. BGran is not intended to and will not provide any mechanical stability. It should not therefore be used in osseous defects, which are intrinsic to the stability or integrity of the skeleton without concurrent treatment to directly address the mechanical stability.

Device Story

BGran is a porous, resorbable synthetic bone void filler; composed of highly pure β-tricalcium phosphate (β-TCP). Device acts as a 3D osteoconductive scaffold; mimics geometry of human cancellous bone; guides regenerating bone into defect. Input: granules packed into bony voids/gaps by trained surgical personnel; may be combined with autogenous blood or bone marrow. Principle of operation: material provides platform for cellular invasion and re-vascularization; resorbs over 3-12 months; replaced by host bone and connective tissue. Output: physical scaffold for bone regeneration. Used in clinical/surgical settings for orthopedic/trauma procedures. Benefits: provides osteoconductive matrix to support natural bone healing in non-load-bearing defects.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics, material composition (β-TCP), and performance comparisons to predicate devices. Bench testing confirms material purity per ASTM F 1088-87 (1992) e-1 and physical properties (porosity, pore size).

Technological Characteristics

Material: β-Tricalcium Phosphate (Ca3(PO4)2) per ASTM F 1088-87 (1992) e-1. Structure: Porous, interconnected scaffold; ~70% porosity; pore size 1µm–700µm. Form factor: Granules (three sieve sizes: 250–500µm, 1–2.8mm, 2–4mm). Energy source: None (passive). Sterilization: Gamma radiation. Non-load bearing.

Indications for Use

Indicated for use in individuals with surgically created osseous defects or osseous defects caused by traumatic injury to the bone. Intended for packing into bony voids or gaps of the skeletal system (extremities, spine, pelvis). Not for use in defects intrinsic to skeletal stability/integrity without concurrent fixation. Not for large defects that would fail to heal spontaneously.

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

• Vitoss™ Scaffold Synthetic Cancellous Bone Void Filler (K032409)
• CerasorbORTHO (K014156)

Submission Summary (Full Text)

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K041616

| AUG | 2 5 2004 |
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# 510(k) Summary ßGran synthetic osteoconductive scaffold

| Prepared & Submitted by: | Orthos (UK) Limited | | |
|--------------------------|-----------------------------------------------------------------------------------------------------|------------------------|---------------------------------------------------------|
| Contact Person: | Mr Alan Rorke | | |
| Address: | The Stables, Leigh Court,<br>Abbots Leigh<br>Bristol<br>North Somerset<br>BS8 3RA<br>United Kingdom | Tel:<br>Fax:<br>Email: | [phone]<br>[phone]<br>[e-mail] |

| Trade Name | βGran™ synthetic<br>osteoconductive scaffold | Vitoss™ Scaffold Synthetic<br>Cancellous Bone Void Filler | CerasorbORTHO |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Registration No: | | K032409 | K014156 |
| Common Name | Resorbable Synthetic Bone Void Filler/Bone Graft Substitute | | |
| Classification Name | Resorbable Calcium Salt Bone Void Filler Device | | |
| | | | |
| Trade Name | BGran™ synthetic<br>osteoconductive scaffold | Vitoss™ Scaffold Synthetic<br>Cancellous Bone Void Filler | CerasorbORTHO |
| 510(k) Registration No: | | K032409 | K014156 |
| Intended Use | The devices intended use is<br>the same as for the<br>Predicate devices. i.e. the<br>treatment of osseous<br>defects, which are not<br>intrinsic to the stability or<br>integrity of the skeleton.<br>For complete details please<br>refer to the Intend Use<br>Statement | As a bone void filler for<br>voids or gaps that are not<br>intrinsic to the stability of<br>bone structures. It is<br>indicated for use in the<br>treatment of surgically<br>created osseous defects or<br>osseous defects cause by<br>traumatic injury to the bone. | As a bone void filler for<br>voids or gaps that are not<br>intrinsic to the stability of<br>bone structures. It is<br>indicated for filling of bone<br>defects, caused by surgery,<br>trauma or degenerative<br>process. |
| Target Population | Individuals with bony defects<br>resulting from surgery or<br>trauma | Individuals with bony defects<br>resulting from surgery or<br>trauma | Patients with bone voids or<br>gaps, caused by surgery,<br>trauma or degeneration |
| Anatomical Locations | Bony voids or gaps of the<br>skeletal system, i.e., the<br>extremities, spine and pelvis | Bony voids or gaps of the<br>skeletal system, i.e., the<br>extremities, spine and pelvis | skeletal system,<br>(extremities, spine, pelvis) |
| Labeling | Labeling contains same<br>intended use,<br>contraindications and<br>adverse events as predicate<br>devices | Labeling contains same<br>intended use,<br>contraindications and<br>adverse events as ßGran<br>synthetic osteoconductive<br>scaffold | Labeling contains same<br>intended use,<br>contraindications and<br>adverse events as ßGran<br>synthetic osteoconductive<br>scaffold |
| Materials | ß-Tricalcium Phosphate<br>Ca3(PO4)2 satisfies ASTM F<br>1088 | ß-Tricalcium Phosphate<br>Ca3(PO4)2 satisfies ASTM F<br>1088 | ß-Tricalcium Phosphate<br>Ca3(PO4)2 |
| Design | | | |
| Physical Structure | Interconnective porosity | Trabecular structure similar<br>to cancellous bone | Interconnective porosity |
| Porosity | Approximately 70% | Approximately 90% | Approximately 60% to 70% |
| Pore Size (range) | <1µm - 700µm | 1-1000µm | Micropores >0 <80µm |
| Performance | | | |
| Osteoconductivity | Osteoconductive | Osteoconductive | Osteoconductive |
| Resorption | Complete resorption<br>demonstrated as occurring<br>between 3 and 12 months. | Demonstrated as 76%<br>resorbed at six weeks and<br>80% at twelve weeks | Resorption reported to<br>occur between 3 and 24<br>months. |
| Mechanical Strength | Does not impart mechanical<br>strength to surgical site | Does not impart mechanical<br>strength to surgical site | Granules have no weight<br>bearing capacity. Execution<br>of osteosynthetic measures<br>eventually necessary |
| Sterility | Sterilized by gamma<br>radiation, single use only | Sterilized by gamma<br>radiation, single use only | Sterilized by gamma<br>radiation, single use only |
| Biocompatibility | Established | Established | Established |
| Presentation | Granules in 3 sieve sizes.<br>250 – 500μm<br>1 – 2.8 mm<br>2 – 4 mm | Morsels 1-4mm and<br>Cylinders 9 x 23mm | Granules, and Blocks<br>Granule sizes:<br>500 - 1000μm<br>1000 - 2000μm |

## Description of the device:

BGran is a porous, resorbable osteoconductive scaffold constructed of highly pure ß tri-calcium phosphate for use in the repair of bony defects. The material is designed and manufactured to achieve the specification set out in the standard ASTM F 1088-87 (1992) e-1.

The interconnected pores provide a three-dimensional scaffold that mimics the geometry of human cancellous bone matrix. The three-dimensional platform provided by BGran's osteoconductive scaffold guides the regenerating bone throughout the defect into which it has been implanted. Pore diameters ranging from 1 pm to 700 m support re-vascularisation and cellular invasion throughout the matrix

Studies have shown that when ß tri-calcium phosphate is implanted in direct contact with host bone, which has a viable blood supply, that it responds physiologically. Throughout the healing process the matrix resorbs and is replaced by bone and connective tissue. Complete resobption takes between 3 to 12 months

BGran is supplied as granules, available in three sieve sizes, sterile for single patient use

### Intended Use of the Device:

BGran is intended for use by suitable trained surgical personnel only.

ßGran synthetic osteoconductive scaffold is only intended to be used as a bone void filler for use in the treatment of osseous defects, which can occur as a result of trauma, or in defects created surgically.

BGran is not intended too and will not provide any mechanical stability. It should not therefore be used in osseous defects, which are intrinsic to the stability or integrity of the skeleton without

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concurrent treatment to directly address the mechanical stability.

ßGran granules should be gently packed into the bony voids or defects of the skeletal system (i.e., long bones, extremities, spine and pelvis, mandible or maxilla). The granules may be combined with autogenous blood and/or bone marrow. The granules should not be crushed. Following implantation the calcium phosphate matrix will be resorbed and replaced with bone during the healing process.

# Comparison to Predicate:

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

Public Health Service

AUG 2 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Alan Rorke Managing Director Orthos (UK) Limited The Stables, Leigh Court, Abbots Leigh Bristol North Somerset United Kingdom BS8 3RA

Re: K041616

Trade Name: BGran™ Synthetic Osteoconductive Scaffold Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: II Product Code: MQV Dated: June 15, 2004 Received: June 15, 2004

Dear Mr. Rorke

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. Alan Rorke

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 [phone]. 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/dsma/dsmamain.html

Sincerely yours,

L. Mark A Wilkerson

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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510(k) Number (if known): Device Name: BGran Synthetic Osteoconductive Scaffold

Indications for Use:

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X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Mulkeren

**510(k) Number** K041616