(210 days)
Not Found
No
The document describes a bone graft substitute material and associated instruments. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The focus is on the material properties and surgical procedure.
Yes.
The device is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps, which classifies it as a therapeutic device aimed at treating or alleviating a condition.
No
The device, PRO-DENSE®, is described as a bone graft substitute used to fill bone voids and facilitate bone healing. Its function is therapeutic/restorative, not to diagnose a condition.
No
The device description clearly states it is a bone graft substitute supplied as a powder and liquid, mixed into a paste, and delivered with instruments. This indicates a physical material and associated hardware, not software.
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 PRO-DENSE® is a bone graft substitute to be injected or packed into bone voids/gaps within the skeletal system. This is a therapeutic and structural application within the body.
- Device Description: The description details the composition of the material (calcium sulfate - calcium phosphate composite) and how it functions as a bone void filler that resorbs and is replaced by bone. This is a material implanted into the body.
- Lack of Diagnostic Function: There is no mention of this device being used to diagnose a condition, analyze a sample from the body (like blood, urine, or tissue), or provide information about a patient's health status based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. PRO-DENSE® does not fit this description.
N/A
Intended Use / Indications for Use
PRO-DENSE® resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and turnors (in adults and pediatric patients ≥ 6 years old), surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
The PRO-DENSE® paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K. Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.
PRO-DENSE® is provided sterile for single use only.
For the PRO-DENSE® Core Decompression Procedure Kit:
The PRO-DENSE® Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process. The bone void filler included in the PRO-DENSE® Core Decompression Procedure Kit is not intended to be used as a load-bearing device.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
PRODENSE® is indicated as a bone graft substitute to be injected and/or digitally packed into open bone voids/gaps that are not intrinsic to the structural stability of the skeletal system and cure in-situ. It is supplied in separate powder and liquid vials along with the instruments for mixing it into a paste and delivering it to the defect site. The triphasic resorption of PRODENSE® results in a scaffold that is osteoconductive allowing tissue infiltration and must eventually be degraded through osteoclastic action as bone remodels within the scaffold. The clinical use of calcium sulfate, calcium phosphate, and composites thereof as a bone void filler has been well established through many peer reviewed publications.
PRO-DENSE® is a calcium sulfate - calcium phosphate composite bone graft substitute consisting of a powder component and an aqueous mixing solution. When the two components are mixed according to directions, an injectable paste forms and subsequently hardens via hydration reactions. The benefits of this composite include:
- Calcium Sulfate .
- Primary osteoconductive filler
- . Resorbs first primarily through simple dissolution to allow early vascular infiltration
- . Excellent clinical history
- Calcium Phosphate ●
- Osteoclastic resorption I
- Secondary porous scaffold that is resorbed after primary filler
- . TCP granules are resorbed in the third and final phase
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremities and pelvis
Indicated Patient Age Range
adults and pediatric patients ≥ 6 years old
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)
Design control testing was conducted in accordance with the FDA special control guidance for resorbable calcium salt bone void filler devices. The results of this analysis determined that set-time was the only significantly altered characteristic of the PRODENSE® modification relative to the original product and a risk analysis indicated all risks associated with the PRODENSE® product line remain adequately mitigated.
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.
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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K132656
510(K) SUMMARY
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92(c), this information serves as a Summary of Safety and Effectiveness for the use of the PRODENSE® Bone Graft Substitute.
| 1. Submitted By: | Wright Medical Technology, Inc.
5677 Airline Road
Arlington, TN 38002 |
|------------------------------------|-------------------------------------------------------------------------------------------------------|
| Date: | August 23, 2013 |
| Contact Person: | Leslie Fitch, PhD
Regulatory Affairs Specialist II
Phone: (901) 867-4120
Fax: (901) 867-4190 |
| 2. Proprietary Name: | PRO-DENSE® Bone Graft Substitute |
| Common Name: | Bone Void Filler |
| Classification Name and Reference: | 21 CFR 888.3045 - Class II |
| Device Product Code, Device Panel: | MQV: Orthopedic |
| 3. Predicate Devices: | K113871 – PRODENSE® Bone Graft Substitute
K072597 – PRODENSE® Core Decompression
Procedure Kit |
Device Description 4.
PRODENSE® is indicated as a bone graft substitute to be injected and/or digitally packed into open bone voids/gaps that are not intrinsic to the structural stability of the skeletal system and cure in-situ. It is supplied in separate powder and liquid vials along with the instruments for mixing it into a paste and delivering it to the defect site. The triphasic resorption of PRODENSE® results in a scaffold that is osteoconductive allowing tissue infiltration and must eventually be degraded through osteoclastic action as bone remodels within the scaffold. The clinical use of calcium sulfate, calcium phosphate, and composites thereof as a bone void filler has been well established through many peer reviewed publications.
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5. Materials
PRO-DENSE® is a calcium sulfate - calcium phosphate composite bone graft substitute consisting of a powder component and an aqueous mixing solution. When the two components are mixed according to directions, an injectable paste forms and subsequently hardens via hydration reactions. The benefits of this composite include:
- Calcium Sulfate .
- Primary osteoconductive filler 트
- . Resorbs first primarily through simple dissolution to allow early vascular infiltration
- . Excellent clinical history
- Calcium Phosphate ●
- Osteoclastic resorption I
- 로 Secondary porous scaffold that is resorbed after primary filler
- . TCP granules are resorbed in the third and final phase
6. Intended Use
PRO-DENSE® resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients > 6 years old), surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
The PRO-DENSE® paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K. Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.
PRO-DENSE® is provided sterile for single use only.
PRODENSE® Core Decompression Procedure Kit
The PRO-DENSE® Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process. The bone void filler included in the PRO-DENSE® Core Decompression Procedure Kit is not intended to be used as a load-bearing device.
7. Technological Characteristics Comparison
The components of PRODENSE® were slightly adjusted to decrease its set-time. The characteristics of this PRODENSE® modification were analyzed according to design control testing and found to be equivalent to the original product. The indications for use of the subject device were not changed as a result of the modification and the fundamental scientific technology of the device, including the bone void filler's mechanism of action, remain identical to the original product.
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Substantial Equivalence - Non-Clinical Evidence 8.
Design control testing was conducted in accordance with the FDA special control guidance for resorbable calcium salt bone void filler devices. The results of this analysis determined that set-time was the only significantly altered characteristic of the PRODENSE® modification relative to the original product and a risk analysis indicated all risks associated with the PRODENSE® product line remain adequately mitigated.
9. Substantial Equivalence - Clinical Evidence
N/A
10. Substantial Equivalence - Conclusions
The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate systems.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an abstract caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring. MD 20993-0002
March 24, 2014
Wright Medical Technology, Incorporated Leslie Fitch, Ph.D. Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002
Re: K132656
Trade/Device Name: PRO-DENSE® Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: February 7, 2014 Received: February 20, 2014
Dear Dr. Fitch:
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 or any I vith 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
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Page 2 - Leslie Fitch. Ph.D.
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/Safetv/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K132656 - Page 1 of 1
INDICATIONS FOR USE STATEMENT
510(k) Number: K132656
PRO-DENSE® Bone Graft Substitute Device Name:
Indications For Use:
PRO-DENSE® resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and turnors (in adults and pediatric patients ≥ 6 years old), surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
The PRO-DENSE® paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K. Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.
PRO-DENSE® is provided sterile for single use only.
For the PRO-DENSE® Core Decompression Procedure Kit:
The PRO-DENSE® Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process. The bone void filler included in the PRO-DENSE® Core Decompression Procedure Kit is not intended to be used as a load-bearing device.
Prescription Use (Per21 CFR 801.109) OR
Over-The Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Laurence D. Coyne -S
(Division Sign-OM) Division of Orthopedic Devices 510(k) Number: K132656