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.

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.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define acceptance criteria in terms of specific numerical thresholds (e.g., "resorption rate must be X% by Y weeks"). Instead, the device is deemed acceptable through demonstrating substantial equivalence to predicate devices by meeting recognized standards and exhibiting similar performance for key characteristics.

Therefore, the table below reflects what appear to be the implicit acceptance criteria based on the comparisons made and the studies performed, and the reported performance.

Criteria/Characteristic (Implicit Acceptance Criteria)	BIOSORB® Reported Device Performance	Predicate (VITOSS® / PRO OSTEON®) Performance (for comparison)
Biocompatibility	Conforms to ASTM F 1088-87 (reapproved 1992). Established (by meeting standards and extensive testing, found to be non-toxic, non-allergenic, biocompatible, no inflammation, no adverse systemic effects).	VITOSS®: ASTM F1088-87; Biocompatibility established.
Osseous Rehabilitation (New Bone Formation)	New bone formation clearly evident by 4 weeks and a quasi-complete (>90%) rehabilitation observed by 10 weeks (rabbit model).	VITOSS®: New bone formation clearly evident by 6 weeks - complete by 12 weeks (canine model).
In vivo TCP Dissolution (Resorption)	35% at 6 months and 72% at 12 months in human (clinical trial data). Local mineralization process from dissolved calcium involved in bone healing (rabbit model).	VITOSS®: Significantly by 3 months in human (76% at 6 weeks, 86% at 12 weeks in canine).PRO OSTEON®: About 6 months in human; 20% at 6 weeks, 45% at 12 weeks in canine.
Clinical Safety and Effectiveness	Clinical and radiological data demonstrate biocompatibility, osseointegration, and resorption, and replacement with osseous tissues. Absence of inflammatory or septic response, stable osseous fusion (human clinical trial).	The predicate devices also have established clinical safety and effectiveness through their prior market clearance.
Compliance with Standards	Conforms to ASTM F-1088-87; ISO 10993 (long-term implantable, bone/tissue contact).	VITOSS®: ASTM F1088-87. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Physical Characteristics (Porosity, Pore size)	Porosity: 40-50% & 60-80%. Pore size: 250-400 µm. Trabecular structure similar to cancellous bone with interconnected porosity. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	VITOSS®: Porosity 88-92%, Pore size 1-1000 µm.PRO OSTEON®: Porosity 55%, Pore size 435 µm [280-779 µm].
Mechanical Strength	Does not impart mechanical strength to surgical site; rigid fixation techniques recommended.	(Not explicitly stated for predicates, but implied for bone void fillers not intended for load-bearing.)
Sterility	Sterilized by Gamma radiation; Single use only.	(Implied for similar implantable devices.)

2. Sample Sizes Used for the Test Set and Data Provenance

The document describes several studies:

Animal Studies:
- Osseous Rehabilitation: Rabbit condyles were used for histo-morphometric analyses. No specific number for "test set" sample size (i.e., number of rabbits or samples) is provided. This data is animal (rabbit) provenance.
- In Vivo TCP Dissolution: Rabbits were used to evaluate local calcium content around implants. No specific sample size is provided. This data is animal (rabbit) provenance.
Human Clinical Trial: A human clinical trial investigated safety, effectiveness, achievement of stable osseous fusion, absence of inflammatory/septic response, and resorption/replacement by osseous tissues. No specific sample size for the test set (number of patients) is provided. This data is human, prospective clinical trial data.
Retrospective Clinical Studies: Several published retrospective clinical studies support the use of BIOSORB beta-tricalcium phosphate ceramic. These include:
- "Use of β -tricalcium phosphate in foot and ankle surgery: a report of 20 cases" (reported as 20 cases).
- "Filling of bone defects with tricalcium phosphate beta in traumatology. In Ann Chir . 2000 Dec:125(10):972-81" (sample size not specified in this summary).
- "Beta-tricalcium phosphate ceramic as a bone substitute in orthopaedic surgery in Int . Orthop 2002;26(2):109-15" (sample size not specified in this summary).

Data Provenance:

Animal studies: Rabbit models.
Human Clinical Trial: Human, prospective.
Retrospective Clinical Studies: Human, retrospective (France for the 2000 and 2002 publications, if the "Ann Chir" and "Int Orthop" are French journals, or broader European/international for "Int Orthop").

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish ground truth for the test sets.

For the animal histo-morphometric analyses, it would imply qualified veterinary pathologists or histologists.
For the human clinical trial and retrospective studies, the ground truth (clinical outcomes, radiological findings) would be established by the treating physicians and radiologists involved in those studies. Their specific qualifications are not detailed in this 510(k) summary but would be part of the full study protocols.

4. Adjudication Method

The document does not specify any adjudication methods (e.g., 2+1, 3+1) for establishing ground truth in any of the described studies. The results from the clinical trial and published studies would likely rely on standard medical practice by the treating clinicians/radiologists.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor any effect size of human readers improving with AI vs. without AI assistance, is included. This device is a bone void filler, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study is mentioned, as this is a physical medical device (bone void filler), not an algorithm or software.

7. Type of Ground Truth Used

Animal Studies:
- Osseous Rehabilitation: Histological and morphometric analysis of tissue samples from rabbit condyles, directly observing new bone formation and integration. This is a form of direct biological/pathological ground truth.
- In Vivo TCP Dissolution: Measurement of local calcium content in rabbit models, indicating biological activity and resorption. This is a biochemical/physiological ground truth.
Human Clinical Trial: Clinical and radiological data, which includes patient outcomes, imaging findings (X-rays, etc.), and clinical assessment of inflammation, infection, fusion, and resorption. This combines clinical and imaging ground truth.
Retrospective Clinical Studies: Patient case reports, clinical observations, and radiological follow-ups as documented in the published literature. This is clinical/imaging ground truth from real-world applications.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable as this is a physical medical device, not a machine learning model. The studies described are for validation and establishing substantial equivalence.

9. How Ground Truth for the Training Set Was Established

As there is no training set for a machine learning model, this point is not applicable.

Summary

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BIOSORB Resorbable Void Filler	SBM (France)
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 MatériauxZI du MongeF 65100 LOURDES - FRANCE
Contact	Denis CLEMENT, General ManagerPhone : 33 5 62 42 21 01Fax : 33 5 62 42 21 00e-mail : denis.clement.sr@wanadoo.fr

October 20, 2002 Summary preparation date:

2. PREDICATE DEVICES

Trade Name	VITOSS scaffold synthetic cancellous bone voidfiller® K 994337PRO OSTEON 500R Resorbable Bone void fillerK98017
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.

4. INTENDED USE

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 ChildrenBIOSORB Resorbable Void Filler	SBM (France)
510(k) Premarket Notification K021963	Confidential- 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 CalciumPhosphate Ca3(PO4)2	Beta Tri CalciumPhosphate Ca3(PO4)2	Calcium CarbonateCalcium 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 Filler510(k) Premarket Notification K021963	SBM (France)Confidential
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Criteria	BIOSORB®	VITOSS®	PRO OSTEON® 500
	40-50%& 60-80%	88-92 %	55%
Pore size	250-400 μm	1-1000 μm	435 μm[280-779 μm]
Mechanicalstrength	Does not impart mechanical strength to surgical site
Resorption
	35% at 6 months and72% at 12 months inhuman	Significantly by 3months in human(76% at 6 weeks,86% at 12 weeks inCanine)	About 6 months inhuman20% at 6 weeks, 45%at 12 weeks inCanine)
Osseous
Rehabilitation	New bone formationclearly evident by 4weeks and quasicomplete (>90%) by10 weeks (Rabbit)	New bone formationclearly evident by 6weeks - complete by12 weeks (Canine)
Presentation	Various shapes - Various sizes
Sterility	Sterilized by Gamma radiationSingle 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 (301) 594-4659. 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 (301) 443-6597 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 Filler510(k) Premarket Notification K021963	SBM (France)Confidential
-------------------------------------------------------------------------	------------------------------

510(k) Number: K021963

Device Name : BIOSORB® RESORBABLE BONE VOID FILLER

Indications for Use:

(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

Regulation Number and Section

§ 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.