K Number

Device Name

VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER

Manufacturer

ORTHOVITA, INC.

Date Cleared

2003-08-29

(25 days)

Product Code

MQV

Regulation Number

888.3045

Intended Use

Vitoss Scaffold Synthetic Cancellous 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. Vitoss Scaffold is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Scaffold should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. Vitoss 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 placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

Device Description

Vitoss Scaffold is a porous calcium phosphate resorbable bone void filler for the repair of bony defects. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. Pore diameters in the scaffold range from 1 um to 1000 um (1 mm). The implant is provided sterile in block and morsel forms. Vitoss Scaffold guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Vitoss Scaffold is placed in direct contact with viable host bone, new bone grows in apposition to the calcium phosphate surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold. Results from animal studies demonstrate that eighty percent of Vitoss Scaffold is resorbed within twelve weeks.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K022629, K013072

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a passive, resorbable bone void filler material and does not mention any computational or analytical functions, let alone AI/ML.

Therapeutic

Yes
The device is described as a bone void filler intended for use in the treatment of surgically created or traumatically induced osseous defects, facilitating bone regeneration and healing. This direct impact on the body's structure and function to treat a condition meets the definition of a therapeutic device.

Diagnostic

This device is a bone void filler intended for treatment of osseous defects, not for diagnosis.

SaMD (Software as a Medical Device)

The device description clearly states that Vitoss Scaffold is a "porous calcium phosphate resorbable bone void filler" and an "implant," indicating it is a physical material intended for implantation, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This includes tests performed on blood, urine, tissue, etc., outside of the body.
Vitoss Scaffold Function: Vitoss Scaffold is a bone void filler that is implanted directly into the body to aid in bone regeneration. It is a surgical implant, not a device used to test samples outside the body.

The description clearly states its intended use is to be "packed into bony voids or gaps of the skeletal system" and that it "resorbs and is replaced with bone during the healing process." This is a therapeutic function performed within the body, not a diagnostic test performed on a sample.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Vitoss 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 placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

Product codes

MQV

Device Description

Vitoss Scaffold guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Vitoss Scaffold is placed in direct contact with viable host bone, new bone grows in apposition to the calcium phosphate surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold. Results from animal studies demonstrate that eighty percent of Vitoss Scaffold is resorbed within twelve weeks.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis)

Indicated Patient Age Range

Individuals with bony defects resulting from surgery or trauma

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K022629, K013072

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

K032409

510(k) Summary Vitoss® Scaffold Synthetic Cancellous Bone Void Filler

Submitted by	Address	Telephone	Contact Person
Orthovita, Inc.	45 Great Valley Parkway
Malvern, PA 19355	(610) 640-1775	Andreina Ide, Sr. Director,
Regulatory Affairs
		Subject Device	Predicate Devices
Trade Name	Vitoss® Scaffold Synthetic
Cancellous Bone Void Filler		WMT-TCP K022629 chronOS K013072
Common Name	Resorbable Synthetic Bone Void Filler/Bone Graft Substitute
Classification Name	Resorbable Calcium Salt Bone Void Filler Device

Device Description:

Intended Use:

Vitoss 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 placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

	Vitoss Scaffold	WMT-TCP	ChronOS
Intended Use	Resorbable Synthetic Bone Void Filler	Resorbable Synthetic Bone Void Filler	Resorbable Synthetic Bone Void Filler
Target Population	Individuals with bony defects resulting from surgery or trauma	Individuals with bony defects resulting from surgery or trauma	Individuals with bony defects resulting from surgery or trauma
Anatomical Locations	Bony voids or gaps of the skeletal system, i.e., the extremities, spine and pelvis	Bony voids or gaps of the skeletal system, i.e., the extremities, spine and pelvis	Bony voids or gaps of the skeletal system, i.e., the extremities, spine and pelvis
Labeling	Labeling contains same intended use as predicate devices	Labeling contains same intended use as Vitoss Scaffold	Labeling contains same intended use as Vitoss Scaffold
Materials	β-Tricalcium Phosphate $Ca_3(PO_4)_2$ satisfies ASTM F 1088	Tricalcium Phosphate – satisfies ASTM F 1088	β-Tricalcium Phosphate $Ca_3(PO_4)_2$ satisfies ASTM F 1088
Design
• Physical Structure	Trabecular structure similar to cancellous bone	Trabecular structure similar to cancellous bone	Uniform, three-dimensional pore structure
• Porosity	Approximately 90%	Reported as “highly porous”	Approximately 60% to 70%
• Pore Size (range)	1-1000μm		100-500μm
Performance
• Osteoconductivity	Osteoconductive	Osteoconductive	Osteoconductive
• Resorption	Demonstrated as 80% resorbed at twelve weeks	Reported as “resorbable”	Resorption reported to occur between 6 and 12 months.
• Mechanical Strength	Does not impart mechanical strength to surgical site	Does not impart mechanical strength to surgical site	Does not impart mechanical strength to surgical site
Sterility	Sterilized by gamma radiation, single use only	Sterilized by gamma radiation, single use only	Sterilized by gamma radiation, single use only
Biocompatibility	Established	Established	Established
Dosage Form(s)	Morsels and Blocks	Granules and Blocks	Granules, Cylinders and Blocks

Comparison to Predicate:

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping heads suggesting a sense of community and support. The figure is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 9 2003

Ms. Andreina Ide Sr. Director, Regulatory Affairs Orthovita, Inc. 45 Great Valley Parkway Malvern, PA 19355

Re: K032409

Trade Name: Vitoss Scaffold Synthetic Cancellous Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: August 1, 2003 Received: August 4, 2003

Dear Ms. Ide:

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

Page 2 - Ms. Andreina Ide

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 yours,

Mark N. Milken

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

INDICATIONS FOR USE STATEMENT

510(k) Number: K032409

Device Name: Vitoss® Scaffold Synthetic Cancellous Bone Void Filler

Indications For Use:

(Per 21 CFR 801.109)

PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED

for
Concurrence of CDRH Office of Device Evaluation (ODE)
(
On Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K032409
Prescription Use OR Over-The-Counter Use