(144 days)
Not Found
No
The device description and intended use focus on the material composition and physical properties of a bone graft extender/filler, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is intended to extend bone grafts and fill bone voids, gradually resorbing and being replaced with new bone during the healing process, which clearly indicates a therapeutic function for skeletal repair.
No
The device is described as a bone graft extender and bone void filler, intended to fill bony voids or gaps and be replaced by new bone during healing. It does not diagnose conditions.
No
The device description clearly states that Optecure and Optecure + CCC are provided as a kit with physical components including polymer powder, demineralized bone matrix, corticocancellous bone chips, mixing solution, and tools. This indicates a physical medical device, not a software-only one.
No, 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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that Optecure and Optecure + CCC are intended for use within the body as bone graft extenders and bone void fillers. They are surgically implanted to aid in bone healing.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient. The device is a material placed directly into the body.
Therefore, based on the provided information, this device falls under the category of a surgical implant or bone graft material, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Optecure and Optecure +CCC are intended for use in combination with autogenous bone as a bone graft extender (extremities, spine and pelvis) and as bone void fillers (extremities and pelvis) for bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. Optecure and Optecure + CCC can be used with autogenous bone marrow. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Optecure and Optecure +CCC may be used with rigid fixation systems.
Product codes
MQV, MBP
Device Description
Optecure and Optecure + CCC are aseptically processed, single use, ready-to-mix devices intended for use as bone graft extenders (extremities, spine and pelvis) and as bone void fillers (extremities and pelvis) for bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Optecure products are provided in the form of a kit with pre-measured polymer powder, demineralized bone matrix (DBM), corticocancellous bone chips (CCC), pre-measured mixing solution and all the tools necessary to mix the components. After the powder is hydrated, the resultant putty can then be handled and placed in the appropriate bone voids or gaps.
Optecure products gradually resorb and are replaced with new bone during the healing process.
The purpose of this 510(k) submission is to expand the current Indications for Use so that Optecure and Optecure + CCC may be used in combination with autogenous bone marrow as a bone graft extender.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Optecure and Optecure + CCC formulations underwent several preclinical testing including, but not limited to, testing on the handling properties, osteoinductive potential, and bone healing effectiveness of the formulations in both tibial defect and spinal fusion animal models. The results of these studies are substantially equivalent to those of the predicate devices identified in this 510(k) Summary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K050806, K061668, K110003, K113167, K053218, K063676, K080399, K103784, K103795
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
K121989
Exactech® Optecure® and Optecure® + CCC Traditional 510(k)
510(k) Summary
| Company: | Exactech®, Inc
2320 NW 66th Court
Gainesville, FL 32653 | | | NOV 2 7 2012 |
|-----------------------|-------------------------------------------------------------------------|--|--|--------------|
| | Tel: 352-377-1140
Fax: 352-378-2617
E-mail: gina.cassidy@exac.com | | | |
| Date of Submission: | September 25, 2012 | | | |
| Contact Person: | Gina Cassidy
Director, Regulatory Affairs | | | |
| Proprietary Name: | Exactech® Optecure® and Optecure® + CCC | | | |
| Common Name: | Bone Void Filler | | | |
| Classification Name: | 21CFR §888.3045 Resorbable calcium salt bone | | | |
| Regulatory Class: | II | | | |
| Product Code: | MQV, MBP | | | |
| Classification Panel: | Orthopedic | | | |
Legally Marketed Devices for Substantial Equivalence Comparison:
| Produc Code | Manufacturer | 510(k) Number | Product |
|---|---|---|---|
| MQV, MBP | Exactech Inc. | K050806 | Optecure |
| MQV, MBP | Exactech, Inc. | K061668 | Optecure+CCC |
| MQV, MBP | Musculoskeletal | ||
| Transplant | |||
| Founation | K110003 | ||
| K113167 | MTF New Bone Void | ||
| Filler | |||
| MQV, MBP | Musculoskeletal | ||
| Transplant | |||
| Founation | K053218 | ||
| K063676 | |||
| K080399 | |||
| K103784 | |||
| K103795 | DBX Demineralized | ||
| Bone Matrix Putty |
1
く
Exactech® Optecure® and Optecure® + CCC Traditional 510(k)
Device Description/Purpose of Premarket Notification
Optecure and Optecure + CCC are aseptically processed, single use, ready-to-mix devices intended for use as bone graft extenders (extremities, spine and pelvis) and as bone void fillers (extremities and pelvis) for bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Optecure products are provided in the form of a kit with pre-measured polymer powder, demineralized bone matrix (DBM), corticocancellous bone chips (CCC), pre-measured mixing solution and all the tools necessary to mix the components. After the powder is hydrated, the resultant putty can then be handled and placed in the appropriate bone voids or gaps.
Optecure products gradually resorb and are replaced with new bone during the healing process.
The purpose of this 510(k) submission is to expand the current Indications for Use so that Optecure and Optecure + CCC may be used in combination with autogenous bone marrow as a bone graft extender.
Indications for Use
Optecure and Optecure +CCC are intended for use in combination with autogenous bone as a bone graft extender (extremities, spine and pelvis) and as bone void fillers (extremities and pelvis) for bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. Optecure and Optecure + CCC can be used with autogenous bone marrow. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Optecure and Optecure +CCC may be used with rigid fixation systems.
Osteoinductive Potential
Samples from each lot of donor demineralized bone matrix (DBM) are formulated with the carrier and tested for osteoinductivity in an in vivo athymic mouse assay.
Osteoinduction assay results using the athymic mouse assay should not be interpreted to predict clinical performance in human subjects.
Preclinical testing
Optecure and Optecure + CCC formulations underwent several preclinical testing including, but not limited to, testing on the handling properties, osteoinductive potential, and bone healing effectiveness of the formulations in both tibial defect and spinal fusion animal models. The results of these studies are substantially equivalent to those of the predicate devices identified in this 510(k) Summary.
2
Exactech® Optecure® and Optecure® + CCC Traditional 510(k)
Substantial Equivalence Conclusion
Optecure® and Optecure® + CCC are substantially equivalent to the legally marketed predicate devices identified above in that they share either same or similar intended use, design, material composition and functions.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 27, 2012
Exactech. Incorporated Ms. Gina Cassidy Director, Regulatory Affairs 2320 Northwest 66th Court Gainesville, Florida 32653
. Re: K121989
Trade/Device Name: Exactech® Optecure® and Optecure® + CCC Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, MBP Dated: September 25, 2012 Received: September 26, 2012
Dear Ms. Cassidy:
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. 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.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 - Ms. Gina Cassidy
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Ronald P. Jean
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Exactech® Optecure® and Optecure® + CCC Traditional 510(k)
Indications for Use Statement
510(k) Number:
121189
Device Name: Exactech® Optecure® and Optecure® + CCC
INDICATIONS FOR USE:
Optecure and Optecure +CCC are intended for use in combination with autogenous bone as a bone graft extender (extremities, spine and pelvis) and as bone void fillers (extremities and pelvis) for bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. Optecure and Optecure + CCC can be used with autogenous bone marrow. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Optecure and Optecure +CCC may be used with rigid fixation systems.
and/or
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number
(Division Sign-Off)
Division of Orthopedic Devices