BIOSORB RESORBABLE VOID FILLER

K021963 · Sciences ET Bio Materiaux (Sbm) · MQV · Jan 28, 2003 · Orthopedic

Device Facts

• Record ID: K021963
• Device Name: BIOSORB RESORBABLE VOID FILLER
• Applicant: Sciences ET Bio Materiaux (Sbm)
• Product Code: MQV · Orthopedic
• Decision Date: Jan 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BIOSORB® 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. BIOSORB® Resorbable Void Filler does not possess sufficient mechanical strength to support reduction of a defect prior to soft and hard tissue ingrowth. Rigid fixation techniques are recommended as needed to assure rigid stabilization of the defect in all plans.

Device Story

BIOSORB is an osseo-conductive, macroporous, synthetic beta-tricalcium phosphate (βTCP) implant used as a bone void filler. It is provided in various shapes (granules, cylinders, blocks, cubes) to fill bony defects. The device features a multidirectional interconnected porosity structure mimicking human cancellous bone. It is implanted by surgeons in clinical settings to fill gaps caused by trauma or surgery. The device is not load-bearing and requires rigid fixation. Over time, the implant resorbs and is progressively replaced by host bone and soft tissue. It serves as a scaffold for bone ingrowth and a local source of calcium for mineralization during the healing process.

Clinical Evidence

Evidence includes bench testing (ASTM F1088-87), biocompatibility testing (ISO 10993: cytotoxicity, sensitization, genotoxicity, systemic toxicity, irritation, pyrogenicity), and animal studies (rabbit condyle model showing >90% osseous rehabilitation by 10 weeks). Clinical evidence includes a human trial demonstrating stable osseous fusion, absence of inflammatory/septic response, and resorption/replacement by bone. Supporting literature includes three retrospective clinical studies on βTCP ceramic in orthopedic and trauma surgery.

Technological Characteristics

Material: Synthetic beta-tricalcium phosphate (βTCP) conforming to ASTM F1088-87. Structure: Macroporous, multidirectional interconnected porosity (250-400 μm pore size, 40-80% porosity). Form factor: Granules, cylinders, blocks, cubes. Energy source: None (passive implant). Sterilization: Gamma radiation. Single-use.

Indications for Use

Indicated for patients requiring bone void filling in the skeletal system (extremities, spine, pelvis) due to trauma or surgery. Not for use in defects requiring structural stability; rigid fixation recommended.

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 (K994337)
• PRO OSTEON 500R Resorbable Bone void filler (K98017)

Submission Summary (Full Text)

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| BIOSORB Resorbable Void Filler | SBM (France) |
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| 510(k) Premarket Notification K021963 | Confidential |

K021963

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

JAN 2 8 2003

# 1. GENERAL INFORMATION

| Trade Name | BIOSORB® Resorbable Void Filler |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Resorbable Calcium Salt Bone Void Filler |
| Classification Name | Resorbable Calcium Salt Bone Void Filler |
| Class | Unclassified |
| Product Code | MQV |
| CFR section | 888.3045 |
| Device panel | Orthopedic |
| Special controls | As per 21 CFR 888.3045, the following special controls were established for Resorbable Calcium Salt Bone Void Filler: Draft Guidance for Resorbable Calcium Salt Bone Void Filler. FDA Guidance "Use of international standards Organization's ISO 10993 Biological evaluation of medical devices part I: Evaluation and testing" FDA Guidance "510(k) Sterility review Guidance – revision of 2/12/90 (K90-1)" |
| Performance Standard | ASTM F-1088-87 (reapproved 1992) "Standard specification for beta tricalcium phosphate for surgical implantation". |
| Submitter's name and address | Sciences et Bio Matériaux<br>ZI du Monge<br>F 65100 LOURDES - FRANCE |
| Contact | Denis CLEMENT, General Manager<br>Phone : [phone]<br>Fax : [phone]<br>e-mail : [e-mail] |

October 20, 2002 Summary preparation date:

# 2. PREDICATE DEVICES

| Trade Name | VITOSS scaffold synthetic cancellous bone void<br>filler® K 994337<br>PRO OSTEON 500R Resorbable Bone void filler<br>K98017 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Common Name | Resorbable Calcium Salt Bone Void Filler |
| Classification Name | Resorbable Calcium Salt Bone Void Filler |
| Class | unclassified |
| Product Code | MQV |
| CFR section | 888.3045 |
| Device panel | Orthopedic |

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| BIOSORB Resorbable Void Filler | SBM (France) |
| 510(k) Premarket Notification K021963 | Confidential |

# 3. DEVICE DESCRIPTION

BIOSORB® is an osseo-conductive macroporous implant made of synthetic beta tri Calcium Phosphate (ßTCP) indicated for Bone Void Filling.

BIOSORB® implants are available in various shapes and sizes in order to fill various bone defect. Shapes are basic such as granules, cylinders, blocks and cubes.

BIOSORB® presents a multidirectional interconnected porosity structure, similar to that of the human cancellous bone. BIOSORB® implant slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues. The progressive resorption of BIOSORB® resorbable void filler is intended to prevent premature resorption.

# 4. INTENDED USE

BIOSORB® 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.

BIOSORB® Resorbable Void Filler does not possess sufficient mechanical strength to support reduction of a defect prior to soft and hard tissue ingrowth. Rigid fixation techniques are recommended as needed to assure rigid stabilization of the defect in all plans.

# 5. SAFETY AND EFFECTIVENESS TESTING SUMMARY

# 5.1 Biocompatibility

BIOSORB® conforms to the recognized consensus standard specification, ASTM F 1088-87 (reapproved 1992) for surgically implantable beta tricalcium phosphate. FDA has recognized the use of this consensus standard as verification of material characteristics and biocompatibility for surgical application (Recognition List Number 001, effective date: 19 feb 1998).

Moreover, the biocompatibility of ßTCP implants is well documented. As a biomaterial ß TCP has consistently proven to be non toxic, non allergenic, biocompatible and elicits no inflammation. No adverse svstem effects have been reported.

A wide variety of tests was performed on вюѕояв ®

According to ISO 10993 « Biologic evaluation of medical devices » and to the type of medical device (long-term implantable medical device. bone/tissue contact) the following biologic effects have been investigated: Cytotoxicity, Sensitization, Genotoxicity and mutagenicity, Systemic toxicity, Irritation (intradermic injection), Systemic tolerance, Pyrogenicity Testing performed on BIOSORB ® shows an excellent biocompatibility with no significant adverse observations of any kind.

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| And Concession Compress of Children Comments of Children Comments of Children Comments of Children<br>BIOSORB Resorbable Void Filler | SBM (France) |
|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| 510(k) Premarket Notification K021963 | Confidential<br>- Real Property of Children Comments of Children Comments of Children Comments of Children |

### 5.2. Osseous rehabilitation

Histo-morphometric analyses were performed to estimate the percentage of osseous rehabilitation and the ingrowth depth within the pores of BIOSORB cvlinders implanted in rabbit condyles up to four months. New bone formation is clearly evident by 4 weeks and a quasi complete (>90%) rehabilitation was observed by 10 weeks.

#### 5.3. In vivo TCP dissolution

The evolution of the local calcium content around irradiated beta tricalcium phosphate ceramic implants has been evaluated in vivo (rabbit). Results indicate that part of the calcium dissolved from the implant is involved in a local mineralization process. The calcium of resorbable TCP implants represents a store which is probably involved in both local mineralization process during bone healing and circulating calcium pool, like physiological bone mineral.

### 5.4 Clinical data

A human clinical trial has been performed to investigate the safety and effectiveness of BIOSORB® bone void filler and more especially the achievement of a stable osseous fusion in consolidation of bone defects. the absence of inflammatory or septic response and the resorption of the BIOSORB implant and its replacement by osseous tissues.

Clinical and radiological data demonstrate the biocompatibility, the osseo integration and the resorption of BIOSORB ® bone void filler.

Several retrospective clinical studies have been published, supporting the use of BIOSORB beta-tricalcium phosphate ceramic (45% porosity -- 250-400 um pore-size).

- . Use of ß -tricalcium phosphate in foot and ankle surgery: a report of 20 cases in Foot and Ankle Surgery- Volume 7 (4)- 217 - December 2001.
- Filling of bone defects with tricalcium phosphate beta in traumatology. In Ann Chir . 2000 Dec:125(10):972-81
- Beta-tricalcium phosphate ceramic as a bone substitute in orthopaedic surgery in Int . Orthop 2002;26(2):109-15

| Criteria | BIOSORB® | VITOSS® | PRO OSTEON® 500 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|----------------------------------------|
| Indication | Synthetic bone void filler | | |
| Intended use | To fill bony void or gaps of the skeletal system (i.e. the extremities, spine and pelvis) resulting from surgery or trauma that are not intrinsic to the stability of the bony structure. | | |
| Labeling | Same intended use, contra-indications, warnings, precautions and adverse invents as predicate | | |
| Chemical | Calcium salt | | |
| Mineral phase | Beta Tri Calcium<br>Phosphate Ca3(PO4)2 | Beta Tri Calcium<br>Phosphate Ca3(PO4)2 | Calcium Carbonate<br>Calcium Phosphate |
| Performance Std. | ASTM F1088-87 | ASTM F1088-87 | |
| Biocompatibility | Established | | |
| Physical structure | Trabecular structure similar to cancellous bone | | |
| Porosity | Interconnected porosity | | |

# 6. SUBSTANTIAL EQUIVALENCE

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| BIOSORB Resorbable Void Filler<br>510(k) Premarket Notification K021963 | SBM (France)<br>Confidential |
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| Criteria | BIOSORB® | VITOSS® | PRO OSTEON® 500 |
|------------------------|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| | 40-50%<br>& 60-80% | 88-92 % | 55% |
| Pore size | 250-400 μm | 1-1000 μm | 435 μm<br>[280-779 μm] |
| Mechanical<br>strength | Does not impart mechanical strength to surgical site | | |
| Resorption | | | |
| | 35% at 6 months and<br>72% at 12 months in<br>human | Significantly by 3<br>months in human<br>(76% at 6 weeks,<br>86% at 12 weeks in<br>Canine) | About 6 months in<br>human<br>20% at 6 weeks, 45%<br>at 12 weeks in<br>Canine) |
| Osseous | | | |
| Rehabilitation | New bone formation<br>clearly evident by 4<br>weeks and quasi<br>complete (>90%) by<br>10 weeks (Rabbit) | New bone formation<br>clearly evident by 6<br>weeks - complete by<br>12 weeks (Canine) | |
| Presentation | Various shapes - Various sizes | | |
| Sterility | Sterilized by Gamma radiation<br>Single use only | | |

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Image /page/4/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 image of a human figure with three heads, representing health, services, and people. The figure is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Denis Clement General Manager Sciences et Bio Matériaux (SBM) Z.I. du Monge 65100 Lordes France

JAN 28 2003

Re: K021963

Tade Name: BIOSORB® Resorbable Bone Void Filler Regulatory Class: Unclassified Product Code: MQV Dated: October 28, 2002 Received: October 30, 2002

Dear Mr. Clement:

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. Denis Clement

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 vours.

Mark A. Milleson

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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| BIOSORB Resorbable Void Filler<br>510(k) Premarket Notification K021963 | SBM (France)<br>Confidential |
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#### 510(k) Number: K021963

#### Device Name : BIOSORB® RESORBABLE BONE VOID FILLER

#### Indications for Use:

BIOSORB® 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.

BIOSORB® Resorbable Void Filler does not possess sufficient mechanical strength to support reduction of a defect prior to soft and hard tissue ingrowth. Rigid fixation techniques are recommended as needed to assure stabilization of the defect in all plans.

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

h Mark N. Milken

ral. Restorative

510(k) Number.

Prescription Use (PER 21 CFR 801.109) or

Over-the-Counter Use

(optional Format 1-2-96)

000002