Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a bone graft material and its physical properties and intended use. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.

Therapeutic

Yes
The device is described as a bone void filler that supports bone growth and remodels during the healing process, falling under the definition of a therapeutic device designed to treat a medical condition (bony defects).

Diagnostic

No
The device is a bone void filler intended for use in repairing bony defects, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a porous calcium phosphate resorbable material admixed with Type I bovine collagen, which is a physical material, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside the body.
Vitoss Scaffold Foam Function: Vitoss Scaffold Foam is a bone graft material intended to be implanted into the body to fill bony voids and support bone regeneration. It is a surgical implant used within the body.

The description clearly states its intended use is for filling bony voids and gaps in the skeletal system, and it is implanted during surgery. This is the opposite of how an IVD functions.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Vitoss Scaffold Foam Bone Graft Material 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 Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Scaffold Foam should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Vitoss Scaffold Foam Bone Graft Material is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

Product codes (comma separated list FDA assigned to the subject device)

MQV

Device Description

Vitoss Scaffold Foam is a porous calcium phosphate resorbable material admixed with Type I bovine collagen 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 both cylinder and strip forms. Vitoss Scaffold Foam may be mixed with autogenous blood or bone marrow.

Vitoss Scaffold Foam guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Vitoss Scaffold Foam is placed in direct contact with viable host bone, new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold.

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

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

Pre-clinical animal data demonstrate that Vitoss Scaffold Foam supports bone growth into a metaphyseal defect. These data show that Vitoss Scaffold Foam is resorbed concurrently with bone ingrowth and remodeling. These results, in conjunction with in-vitro data, demonstrate that Vitoss Scaffold Foam is as safe and as effective as the predicate devices, Vitoss Scaffold Synthetic Cancellous Bone Void Filler and Healos Bonc Graft Material.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

0

510(k) Summary Vitoss® Scaffold Foam Bone Graft Material

Submitted by	Address	Telephone	Contact Person
Orthovita, Inc.	45 Great Valley Parkway
Malvern, PA 19355	(610) 640-1775	Gina M. Nagvajara, Ph.D.
Director of Research and
Intellectual Property
	Subject Device		Predicate Devices
Trade Name	Vitoss® Scaffold Foam
Bone Graft Material		Vitoss® Scaffold Synthetic
Cancellous Bone Void Filler;
Healos® Bone Graft Material
Common Name	Bone Void Filler		Bone Void Filler
Classification Name	Filler, Calcium Sulfate
Preformed Pellets		Filler, Calcium Sulfate
Preformed Pellets

Device Description:

DEC 1 9 2003

Vitoss Scaffold Foam is a porous calcium phosphate resorbable material admixed with Type I bovine collagen 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 both cylinder and strip forms. Vitoss Scaffold Foam may be mixed with autogenous blood or bone marrow.

Vitoss Scaffold Foam guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Vitoss Scaffold Foam is placed in direct contact with viable host bone, new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold.

Intended Use:

Vitoss Scaffold Foam Bone Graft Material 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 Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Scaffold Foam should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Vitoss Scaffold Foam Bone Graft Material is intended to be used for filling bony voids or gaps of the skelctal system (i.e., the extremities, spine and pelvis). Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

1

Image /page/1/Picture/0 description: The image shows handwritten text that appears to be a combination of letters and numbers. The text includes 'FO32288' on the top line, followed by 'aofa' on the second line. The handwriting is somewhat stylized, with some characters slightly distorted or overlapping, giving it a unique and informal appearance.

510(k) Summary Vitoss Foam Orthovita, Inc.

Comparison to Predicate:

| | NEW DEVICE:
VITOSS SCAFFOLD
FOAM | PREDICATE:
VITOSS SCAFFOLD
SYNTHETIC | PREDICATE:
HEALOS BONE
GRAFT MATERIAL |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Intended Use | Bone Void Filler | Bone Void Filler | 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 | Vitoss Scaffold Foam's product label contains the same intended use,
contraindications, warnings, precautions, and adverse events as for the Vitoss
Scaffold Synthetic Cancellous Bone Void Filler with the addition of collagen
related contraindications and adverse events from the Healos Bone Graft
Material product label; wording is not identical but is substantially equivalent | | |
| Materials | | | |
| Chemical
Composition | Calcium salt with Type
I bovine collagen | Calcium salt | Calcium salt with Type I
bovine collagen |
| Mineral Phase(s) | $β$ -Tricalcium phosphate
$Ca_3(PO_4)_2$ | $β$ -Tricalcium phosphate
$Ca_3(PO_4)2$ | Hydroxyapatite
$Ca{10}(PO_4)_6(OH)_2$ |
| Design | | | |
| Physical
Structure | Trabecular structure
similar to cancellous
bone | Trabecular structure
similar to cancellous
bone | Three dimensional,
open-cell matrix |
| Pore Size (range) | 1-1000 μm | 1-1000 μm | 4-200 μm |
| Performance | | | |
| Osteoconductivity | Osteoconductive | Osteoconductive | Osteoconductive |
| 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
irradiation, single use
only | Sterilized by gamma
irradiation, single use
only | Sterilized by e-beam,
single use only |
| Biocompatibility | Established | Established | Established |
| Dosage Form(s) | Cylinders (Blocks),
Strips | Blocks, Morsels | Strips, Pads |

Non-clinical Performance Data:

Pre-clinical animal data demonstrate that Vitoss Scaffold Foam supports bone growth into a metaphyseal defect. These data show that Vitoss Scaffold Foam is resorbed concurrently with bone ingrowth and remodeling. These results, in conjunction with in-vitro data, demonstrate that Vitoss Scaffold Foam is as safe and as effective as the predicate devices, Vitoss Scaffold Synthetic Cancellous Bone Void Filler and Healos Bonc Graft Material.

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2003

Gina M. Nagvajara, Ph.D. Director of Research and Intellectual Property Orthovita, Inc. 45 Great Valley Parkway Malvern, Pennsylvania 19355

Re: K032288

K032206 Regulation Number: 21 CFR 888.3045 Regulation Name: Bone void filler Regulatory Class: II Product Code: MQV Dated: December 1, 2003 Received: December 2, 2003

Dear Dr. Nagvajara:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regary the Medical Device Amendments, or to commerce province to may 20, 1978, the excordance with the provisions of the Federal Food. Ding, devices that have tocer rechassined in avere approval of a premarket approval application (PMA). and Cosmette Act (11ct) market the device, subject to the general controls provisions of the Act. The 1 the may, therefore, thans of the Act include requirements for annual registration, listing of general controls provisions 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 If your device is enabilional controls. Existing major regulations affecting your device can may be sunyeet to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the councements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean I has be advised that I Dr o waters at your device complics with other requirements of the Act that 1177 hab intatutes and regulations administered by other Federal agencies. You must of any i-cutcal statutes and regaraments, including, but not limited to: registration and listing (21 Comply with an the Hot 3 requirements)); good manufacturing practice requirements as set Of It fart 6077, abounting (21 CFR Part 820); and if applicable, the electronic Routh m the quants (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

3

Page 2 - Mr. Lewis Ward

This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotter with and wyourse FDA finding of substantial equivalence of your device to a legally premance notification 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 in you attire 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 A. Millican

Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

INDICATIONS FOR USE

STATEMENT

510(k) Number (If Known): K032288

Device Name: Vitoss® Scaffold Foam Bone Graft Material

Indications For Use:

Vitoss Scaffold Foam Bone Graft Material 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 Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Scaffold Foam should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Vitoss Scaffold Foam Bone Graft Material is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

Prescription Use_ X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N Milker

Division of General, Restorative
and Neurological Devices

K032288