(266 days)
No
The device description focuses on the material composition and biological function of a bone void filler, with no mention of AI or ML technology.
Yes
The device is intended to fill bony voids or gaps and resorbs to be replaced by bone during the healing process, indicating a therapeutic function in aiding tissue regeneration.
No
This device is a bone void filler intended to fill bony voids or gaps; it is not used to diagnose a medical condition.
No
The device description clearly states it is a bone void filler composed of physical materials (demineralized bone matrix, hydrogel, bone chips) and includes an accessory kit with hydrating solution and a spatula. This is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes.
- Device Description and Intended Use: The description clearly states that this device is an implant intended to fill bony voids or gaps within the skeletal system. It is a physical material placed inside the body to aid in bone healing.
- Lack of Specimen Examination: The device does not involve the examination of any specimens (like blood, urine, tissue samples, etc.) outside of the body.
- Purpose: Its purpose is to provide structural support and promote bone regeneration in vivo, not to provide diagnostic information based on laboratory analysis of specimens.
Therefore, this device falls under the category of a surgical implant or bone graft substitute, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Moldable Bone Void Filler and Moldable Bone Void Filler + CCC is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Moldable Bone Void Filler and Moldable Bone Void Filler + CCC can be used with autogenous bone marrow. Moldable Bone Void Filler and Moldable Bone Void Filler + CCC resorbs and are replaced with bone during the healing process.
Moldable Bone Void Filler and Moldable Bone Void Filler + CCC are for single patient use only.
Product codes
MOV, MBP
Device Description
Moldable Bone Void Filler and Moldable Bone Void Filler + CCC are bone void fillers composed of processed demineralized bone matrix (DBM), a synthetic macromer hydrogel, and cortical cancellous bone chips (CCC) for Moldable Bone Void Filler + CCC only. Both are provided with an accessory kit containing pre-measured hydrating solution and a spatula to mix the components.
After the implant is hydrated, the resultant putty can then be handled and placed in the appropriate bone voids or gaps. Moldable Bone Void Filler and Moldable Bone Void Filler + CCC gradually resorb and are replaced with new bone during the healing process. At the 12 week timepoint, animal study data demonstrated new bone formation averages of 16.21% in the Optecure group, 13.8% in the Optecure + CCC group, 15.75% in the Exactech Optecure + CCC predicate group, and 12.08 % in the empty defect negative control group.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., extremities 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)
Non-Clinical Performance Data:
In accordance with the “Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device”, the following testing has been performed to support substantial equivalence and to demonstrate safety and effectiveness:
Chemical and physical properties
Biocompatibility
Sterility
Shelf Life
Animal Study
At the 12 week timepoint, animal study data demonstrated new bone formation averages of 16.21% in the Optecure group, 13.8% in the Optecure + CCC group, 15.75% in the Exactech Optecure + CCC predicate group, and 12.08 % in the empty defect negative control group.
Clinical Performance:
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Exactech Optecure and Optecure + CCC, K121989
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image shows the date February 21, 2025. The text is written in a clear, sans-serif font. The date is written out in full, with the month, day, and year clearly visible. The image is simple and straightforward, with the focus on the date itself.
Image /page/0/Picture/10 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
RTI Surgical, Inc. Ellen Rounds Sr. Regulatory Affairs Specialist 11621 Research Circle Alachua, Florida 32615
Re: K241555
Trade/Device Name: Moldable Bone Void Filler and Moldable Bone Void Filler + CCC Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV, MBP Dated: January 24, 2025 Received: January 24, 2025
Dear Ellen Rounds:
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.
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"
1
(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 OS 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 (QS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 MUR ->
Date: 2025.02.21 11:57:51 -05'00'
Jesse Muir, PhD 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
510(k) Number (if known) K241555
Device Name
Moldable Bone Void Filler and Moldable Bone Void Filler + CCC
Indications for Use (Describe)
Moldable Bone Void Filler and Moldable Bone Void Filler + CCC is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Moldable Bone Void Filler and Moldable Bone Void Filler + CCC can be used with autogenous bone marrow. Moldable Bone Void Filler and Moldable Bone Void Filler + CCC resorbs and are replaced with bone during the healing process.
Moldable Bone Void Filler and Moldable Bone Void Filler + CCC are for single patient use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/1 description: The image shows the logo for RTI Surgical. The logo consists of the letters "rti" in a blue rounded square, followed by the word "surgical" in gray. The letters "rti" are white, with a small green accent on the "i".
510(k) Summary
| Date Prepared: | 02/20/2025 |
|---|---|
| Submitter: | RTI Surgical, Inc. |
| 11621 Research Circle | |
| Alachua, FL 32615 USA | |
| Contact Information: | Ellen Rounds |
| Sr. Regulatory Affairs Specialist | |
| Email: erounds@rtix.com | |
| Name of Device: | Moldable Bone Void Filler and Moldable Bone Void Filler + CCC |
| Common Name: | Optecure and Optecure + CCC |
| Classification Name: | Resorbable calcium salt bone void filler device |
| Filler, Bone Void, Calcium Compound | |
| Regulation Number: | 21 CFR 888.3045 |
| Regulatory Class: | Class II |
| Product Code: | MQV, MBP |
| Panel: | Orthopedic |
| Legally Marketed Predicate Device(s): | Exactech Optecure and Optecure + CCC, K121989 |
| Device Description: | Moldable Bone Void Filler and Moldable Bone Void Filler + CCC are |
| bone void fillers composed of processed demineralized bone matrix | |
| (DBM), a synthetic macromer hydrogel, and cortical cancellous bone | |
| chips (CCC) for Moldable Bone Void Filler + CCC only. Both are | |
| provided with an accessory kit containing pre-measured hydrating | |
| solution and a spatula to mix the components. |
After the implant is hydrated, the resultant putty can then be handled
and placed in the appropriate bone voids or gaps. Moldable Bone Void
Filler and Moldable Bone Void Filler + CCC gradually resorb and are
replaced with new bone during the healing process. At the 12 week
timepoint, animal study data demonstrated new bone formation
averages of 16.21% in the Optecure group, 13.8% in the Optecure +
CCC group, 15.75% in the Exactech Optecure + CCC predicate group,
and 12.08 % in the empty defect negative control group. |
| Indications for Use: | Moldable Bone Void Filler and Moldable Bone Void Filler + CCC is
an implant intended to fill bony voids or gaps of the skeletal system
(i.e., extremities and pelvis). These osseous defects are surgically
created or the result of traumatic injury to the bone and are not intrinsic
to the stability of the bony structure. Moldable Bone Void Filler and
Moldable Bone Void Filler + CCC can be used with autogenous bone
marrow. Moldable Bone Void Filler and Moldable Bone Void Filler +
CCC resorbs and are replaced with bone during the healing process.
Moldable Bone Void Filler and Moldable Bone Void Filler + CCC are
for single patient use only |
| Substantial
Equivalence
Comparison: | The subject device are demonstrated to be substantially equivalent to
the predicate device cited above with respect to indications for use,
materials, biocompatibility, storage, and performance. |
| Non-Clinical
Performance Data: | In accordance with the “Guidance for Industry and FDA Staff - Class
II Special Controls Guidance Document: Resorbable Calcium Salt
Bone Void Filler Device”, the following testing has been performed to
support substantial equivalence and to demonstrate safety and
effectiveness Chemical and physical properties Biocompatibility Sterility Shelf Life Animal Study |
| | At the 12 week timepoint, animal study data demonstrated new bone
formation averages of 16.21% in the Optecure group, 13.8% in the
Optecure + CCC group, 15.75% in the Exactech Optecure + CCC
predicate group, and 12.08 % in the empty defect negative control
group. |
| Clinical Performance: | There was no clinical testing required to support the medical device as
the indications for use is equivalent to the predicate device. The non-
clinical testing detailed in this submission supports the substantial
equivalence of the device. |
| Substantial
Equivalence: | The determination of a device are substantially equivalent to a
predicate device when the device has the same intended use and the
same technological characteristics as the predicate devices.
Additionally, if the device has the same intended use but different
technological characteristics and can be demonstrated that the new
device does not raise any safety and effectiveness concerns as
compared to the predicate device. |
| | In the provided 510(k) submission the difference between the predicate
device and Moldable Bone Void Filler and Moldable Bone Void Filler
- CCC do not raise safety and/or effectiveness concerns. Therefore,
Moldable Bone Void Filler and Moldable Bone Void Filler + CCC is
determined to be substantially equivalent to the predicate device. |
| Conclusion: | The submitted 510(k) demonstrates Moldable Bone Void Filler and
Moldable Bone Void Filler + CCC are substantially equivalent to the
predicate device. |
5
Image /page/5/Picture/1 description: The image shows the logo for RTI Surgical. The logo consists of the letters "rti" in a blue rounded square, followed by the word "surgical" in gray. The "i" in "rti" has a small green leaf on top.