(27 days)
Not Found
No
The device description and intended use clearly define it as a physical bone graft substitute material, with no mention of software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is intended for use as a bone void filler to treat surgically created osseous defects or defects from traumatic injury to the bone, which aligns with the definition of a therapeutic device.
No
The device is a bone graft substitute intended to fill bone voids and promote bone healing; it does not diagnose medical conditions.
No
The device description clearly indicates that the device is a physical bone graft substitute intended for implantation, not a software product.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "bone void filler" for surgical and traumatic bone defects. It is implanted directly into the body to facilitate bone healing.
- Device Description: The description reinforces its function as a "bone void filler" that resorbs and is replaced by bone.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such use or interaction with bodily specimens for diagnostic purposes.
- Anatomical Site: The device is used within the skeletal system, which is an in vivo application.
- Intended User/Care Setting: The intended users are surgeons in an orthopaedic surgical setting, consistent with an implanted device.
Therefore, the Vitoss® Bone Graft Substitutes described are medical devices intended for surgical implantation, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip
These implants are intended for use as bone void fillers for voids or gaps that are not intrinsic to the stability of the bony structure.
They are indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.
The implants are intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and posterolateral spine) and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Vitoss® Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack Vitoss® Bioactive Foam Bone Graft Substitute 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® Bioactive Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss® Bioactive Foam Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and spine, which includes posterolateral fusion procedures) and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips, Vitoss® Foam Bone Graft Substitute. Vitoss® Bone Graft Substitute Filled Canister These implants are intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure.
These implants are indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. These implants should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
These implants are intended to be used for filling 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 scaffold resorbs and is replaced with bone during the healing process.
The Vitoss® Foam family of products may be mixed with saline in addition to autogenous blood or bone marrow.
The Vitoss® Filled Canister is intended for use as a piston syringe system for the aspiration of autogenous blood and/or bone marrow. This canister provides the surgeon with a convenient way to mix autogenous blood with Vitos® and deliver the material to the orthopaedic surgical site.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
Vitoss® Bone Graft Substitutes are intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure in the skeletal system. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., the extremities, pelvis and posterolateral spine)
skeletal system (i.e., the extremities, pelvis, and spine, which includes posterolateral fusion procedures)
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)
The device materials have been analyzed in accordance with ASTM F2503 to confirm they meet the definition of MR Safe.
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.
Vitoss BiModal Bone Graft Substitute Foam Strip (K153608), Vitoss BA Bimodal Bioactive Bone Graft Substitute (K103173), FM-02 Bone Graft Substitute (K102545), Vitoss Bioactive Foam Bone Graft Substitute Pack, Vitoss Bioactive Foam Bone Graft Substitute, Vitoss Foam Bone Graft Substitute, Vitoss Bone Graft Substitute Filled Canister, Vitoss Bone Graft Substitute (K083033)
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
§ 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.
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August 29, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Stryker Spine Fiorella Lopardo Staff Regulatory Specialist 2 Pearl Court Allendale, New Jersey 07401
Re: K242280
Trade/Device Name: Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip Vitoss® BiModal Bioactive Bone Graft Substitute Vitoss BBTrauma® Bioactive Bone Graft Substitute Vitoss® BA2X Bioactive Bone Graft Substitute Vitoss® Bioactive Bone Graft Substitute Pack Vitoss® Bioactive Bone Graft Substitute Vitoss® Foam Bone Graft Substitute Vitoss® Bone Graft Substitute Filled Canister Vitoss® Bone Graft Substitute Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips
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, 2024 Received: August 2, 2024
Dear Fiorella Lopardo:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
1
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely, JESSE MUIR - Digitally signed by JESSE
MUIR - MUIR - MUIR -S Date: 2024.08.29 15:27:32 S -04'00' Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip;
Vitoss® BiModal Bioactive Bone Graft Substitute ;
Vitoss BBTrauma® Bioactive Bone Graft Substitute ;
Vitoss® BA2X Bioactive Bone Graft Substitute ;
Vitoss® Bioactive Bone Graft Substitute Pack;
Vitoss® Bioactive Bone Graft Substitute;
Vitoss® Foam Bone Graft Substitute :
Vitoss® Bone Graft Substitute Filled Canister :
Vitoss® Bone Graft Substitute;
Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips
Indications for Use (Describe)
Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip
These implants are intended for use as bone void fillers for voids or gaps that are not intrinsic to the stability of the bony structure.
They are indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.
The implants are intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and posterolateral spine) and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Vitoss® Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack Vitoss® Bioactive Foam Bone Graft Substitute 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® Bioactive Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss® Bioactive Foam Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and spine, which includes posterolateral fusion procedures) and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.
Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips, Vitoss® Foam Bone Graft Substitute. Vitoss® Bone Graft Substitute Filled Canister These implants are intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure.
These implants are indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. These implants should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
4
These implants are intended to be used for filling 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 scaffold resorbs and is replaced with bone during the healing process.
The Vitoss® Foam family of products may be mixed with saline in addition to autogenous blood or bone marrow.
The Vitoss® Filled Canister is intended for use as a piston syringe system for the aspiration of autogenous blood and/or bone marrow. This canister provides the surgeon with a convenient way to mix autogenous blood with Vitos® and deliver the material to the orthopaedic surgical site.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) Summary | ||
|---|---|---|
| Submitter: | Stryker Spine | |
| 2 Pearl Court | ||
| Allendale, NJ 07401 | ||
| Contact Person : | Name: Fiorella Lopardo | |
| Phone: 954-871-5460 | ||
| Email: fiorella.lopardo@stryker.com | ||
| Secondary Contact: | ||
| Name: Shraddha Moore | ||
| Phone: 201-831-5804 | ||
| Email: shraddha.more@stryker.com | ||
| Date Prepared: | August 29, 2024 | |
| Trade Names: | 1. Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip |
- Vitoss® BiModal Bioactive Bone Graft Substitute
- Vitoss BBTrauma® Bioactive Bone Graft Substitute
- Vitoss® BA2X Bioactive Bone Graft Substitute
- Vitoss® Bioactive Bone Graft Substitute Pack
- Vitoss® Bioactive Bone Graft Substitute
- Vitoss® Foam Bone Graft Substitute
- Vitoss® Bone Graft Substitute Filled Canister
- Vitoss® Bone Graft Substitute
- Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips | |
| Common Name: | Resorbable Calcium Salt Bone Void Filler Device | |
| Proposed Class: | Class II | |
| Classification Name: | Filler, Bone Void, Calcium Compound (21 CFR 888.3045) | |
| Product Code: | MQV | |
| Predicate Devices: | Primary Predicate: Vitoss BiModal Bone Graft Substitute Foam Strip
(K153608)
Additional Predicates:
Vitoss BA Bimodal Bioactive Bone Graft Substitute (K103173)
FM-02 Bone Graft Substitute (K102545)
Vitoss Bioactive Foam Bone Graft Substitute Pack, Vitoss Bioactive Foam
Bone Graft Substitute, Vitoss Foam Bone Graft Substitute, Vitoss Bone Graft
Substitute Filled Canister, Vitoss Bone Graft Substitute (K083033) | |
| 510(k) Summary | | |
| Device Description: | Vitoss® Bone Graft Substitutes are intended for use as a bone void filler for
voids or gaps that are not intrinsic to the stability of the bony structure in the
skeletal system. Following placement in the bony void or gap, the scaffold
resorbs and is replaced with bone during the healing process. | |
| Indications for Use: | Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss BBTrauma®
Bioactive Bone Graft Substitute, Vitoss® BiModal Bioactive Bone Graft
Substitute, Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip
These implants are intended for use as bone void fillers for voids or gaps that
are not intrinsic to the stability of the bony structure.
They are indicated for use in the treatment of surgically created osseous
defects or osseous defects created from traumatic injury to the bone.
The implants are intended to be used for filling bony voids or gaps of the
skeletal system (i.e., the extremities, pelvis and posterolateral spine) and may
be combined with saline, autogenous blood, and/or bone marrow. Following
placement in the bony void or gap, the scaffold resorbs and is replaced with
bone during the healing process. | |
| | Vitoss® Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft
Substitute Pack
Vitoss® Bioactive Foam Bone Graft Substitute 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® Bioactive Foam is indicated for use in the treatment of
surgically created osseous defects or osseous defects created from traumatic
injury to the bone. Vitoss® Bioactive Foam Bone Graft Substitute is intended to
be used for filling bony voids or gaps of the skeletal system (i.e., the extremities,
pelvis, and spine, which includes posterolateral fusion procedures) and may be
combined with saline, autogenous blood, and/or bone marrow. Following
placement in the bony void or gap, the scaffold resorbs and is replaced with
bone during the healing process. | |
| | Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic
Cancellous Chips, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft
Substitute Filled Canister
These implants are intended for use as a bone void filler for voids or gaps that
are not intrinsic to the stability of the bony structure.
These implants are indicated for use in the treatment of surgically created
osseous defects or osseous defects created from traumatic injury to the bone.
These implants should not be used to treat large defects that in the surgeon's
opinion would fail to heal spontaneously.
These implants are intended to be used for filling 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. | |
| | 510(k) Summary | |
| | void or gap, the scaffold resorbs and is replaced with bone during the healing
process.
The Vitoss® Foam family of products may be mixed with saline in addition to
autogenous blood or bone marrow.
The Vitoss® Filled Canister is intended for use as a piston syringe system for
the aspiration of autogenous blood and/or bone marrow. This canister
provides the surgeon with a convenient way to mix autogenous blood with | |
| Summary of the
Technological
Characteristics | Vitoss® and deliver the material to the orthopaedic surgical site.
The subject devices have similar technological characteristics as their
predicate devices. Changes implemented since the last clearance of the
subject devices were assessed and detailed in this submission. Minor
differences in technological characteristics of the subject devices do not
impact safety and efficacy of the devices. Therefore, the fundamental scientific
technology of the subject devices is the same as previously cleared devices. | |
| Summary of the
Performance Data | The device materials have been analyzed in accordance with ASTM F2503
to confirm they meet the definition of MR Safe. | |
| Conclusion | The subject devices have the same intended use with minor differences in the
indications for use and technological characteristics as the predicate devices.
Per the assessments detailed in this submission, the minor differences in
indications for use and technological characteristics of the subject devices and
updates to the labeling do not impact safety and efficacy of the devices.
Therefore, the subject devices are substantially equivalent to their predicate
devices. | |
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