(130 days)
Not Found
No
The summary describes a bone void filler made of collagen and ceramic, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is indicated as a bone void filler and extender for bony voids or gaps, which are therapeutic interventions. Its function is to facilitate bone healing by being replaced with bone during the healing process, demonstrating a direct therapeutic effect on the body.
No
The device is described as a bone void filler and bone graft extender for the skeletal system, which functions to support bone growth and regeneration rather than to diagnose medical conditions.
No
The device description clearly states it is a physical product made of collagen and ceramic, intended to be mixed and used as a bone void filler. It is a physical implant, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that MASTERGRAFT® Putty and Matrix are bone void fillers and bone graft extenders. They are implanted directly into bony voids or gaps in the skeletal system. This is an in vivo application (within the living body), not an in vitro application (outside the living body).
The device is a medical device used for surgical procedures, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
MASTERGRAFT® Putty combined with either autogenous bone marrow, and/or sterile water, and/or autograft is indicated as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. MASTERGRAFT® Putty can be used with autograft as a bone graft extender. MASTERGRAFT® Matrix is to be combined with autogenous bone marrow and is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Both devices are to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, pelvis, ileum, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Both devices resorb and is replaced with bone during the healing process.
Product codes
MQV
Device Description
MASTERGRAFT® Putty is made of medical grade combination of purified Type 1 bovine collagen and hydroxyapatite and ß-tricalcium phosphate ceramic. The ceramic portion of MASTERGRAFT® Putty is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. When mixed with either autogenous bone marrow, and/or sterile water, and/or autograft the product forms into a putty, which is moldable. The product is supplied sterile for single patient use. MASTERGRAFT® Putty is an osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The product is biocompatible.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (e.g., the posterolateral spine, pelvis, ileum, and/or extremities)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K051386, K051774, K020986, K012506, K032288, K043308, K012751
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
Medtronic Sofamor Danek MASTERGRAFT® Putty 510(K) Summary June 2007
I. Company: Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, TN 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738
Christine Scifert Contact: Director, Regulatory Affairs
- II. Proposed Proprietary Trade Name: MASTERGRAFT® Putty Classification Name: Bone Void Filler MQV Product Code: 888.3045 Regulation No .:
III. Product Description/Purpose of Application
MASTERGRAFT® Putty is made of medical grade combination of purified Type 1 bovine collagen and hydroxyapatite and ß-tricalcium phosphate ceramic. The ceramic portion of MASTERGRAFT® Putty is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. When mixed with either autogenous bone marrow, and/or sterile water, and/or autograft the product forms into a putty, which is moldable. The product is supplied sterile for single patient use. MASTERGRAFT® Putty is an osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The product is biocompatible.
The purpose of this 510(k) application is to expand the indication for the MASTERGRAFT® Putty device so that it may be used with autograft as a bone graft extender.
IV. Indications
MASTERGRAFT® Putty combined with either autogenous bone marrow, and/or sterile water, and/or autograft is indicated as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. MASTERGRAFT® Putty can be used with autograft as a bone graft extender. MASTERGRAFT® Matrix is to be combined with autogenous bone marrow and is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.
NOV 0 9 2007
1
Both devices are to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, pelvis, ileum, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Both devices resorb and is replaced with bone during the healing process.
V. Substantial Equivalence
Documentation was provided which demonstrated MASTERGRAFT®Putty to be substantially equivalent to the previously cleared MASTERGRAFT® Putty (K051386), MBCP™ (K051774), MASTERGRAFT® Matrix Resorbable Ceramic (K020986 and K012506), and to Orthovita's Vitoss Scaffold Foam Flow Bone Graft Material (K032288) and DePuy's HEALOS® Bone Graft Material (K043308 and K012751).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract eagle design, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The eagle is stylized and composed of thick, curved lines, giving it a modern and symbolic appearance. The text is in uppercase and evenly spaced to follow the circular shape of the seal.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 9 2007
Medtronic Sofamor Danek % Ms. Michelle Obenauer Regulatory Affairs Supervisor 1800 Pyramid Place Memphis, Tennessee 31832
K071813 Re:
Trade/Device Name: MASTERGRAFT® Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: Class II Product Code: MQV Dated: October 4, 2007 Received: October 9, 2007
Dear Ms. Obenauer:
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 for ass stated in the 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
3
Page 2 – Ms. Michelle Obenauer
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkers Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Ko71813 510(k) Number (if known):
MASTERGRAFT® Putty Device Name: --
Indications for Use:
MASTERGRAFT® Putty combined with either autogenous bone marrow, and/or sterile water, and/or autograft is indicated as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. MASTERGRAFT® Putty can be used with autograft as a bone graft extender. MASTERGRAFT® Matrix is to be combined with autogenous bone marrow and is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Both devices are to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, pelvis, ileum, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Both devices resorb and is replaced with bone during the healing process.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K071813