(224 days)
Not Found
Not Found
No
The summary describes a bone void filler material and its intended use, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
Genex® Putty is a bone void filler that resorbs and is replaced with bone during the healing process, indicating it is used for therapeutic tissue repair.
No
Explanation: The provided text describes Genex® Putty as a "bone void filler" which "resorbs and is replaced with bone during the healing process." Its intended use is to "fill defects," and it acts as a "calcium salt bone graft substitute." There is no mention of the device detecting, identifying, or monitoring any medical conditions or physiological processes, which are characteristics of a diagnostic device.
No
The device description clearly states that Genex® Putty is a "calcium salt bone graft substitute" and is provided as a physical material ("putty") for filling bone defects. This indicates it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Genex® Putty's Function: Genex® Putty is a bone void filler. It is a material implanted directly into the body to fill a physical defect in bone. It does not analyze or test specimens taken from the body.
- Intended Use: The intended use clearly states it's a "bone void filler intended to fill defects." This is a therapeutic or structural function, not a diagnostic one.
Therefore, based on the provided information, Genex® Putty is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Genex® Putty is a bone void filler intended to fill defects not intrinsic to the stability of the spine and pelvis.
Genex® Putty provides a bone void filler that resorbs and is replaced with bone during the healing process.
Product codes
MQV
Device Description
Genex® Putty is a calcium salt bone graft substitute and is provided sterile for single patient use. When Genex® Putty is placed in the defect; bone grows in apposition to the implant, filling the pores with new bone during the healing process.
Genex® Putty is completely resorbed and replaced with bone during the healing process.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Non Clinical Testing
Data supplied demonstrates that Genex® Putty is substantially equivalent to the predicate device and any differences do not raise any concerns regarding safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
KO73341
510(k) SUMMARY
JUL - 9 2008
Genex® Putty
Applicant
Biocomposites Ltd Keele Science Park Keele Staffordshire England ST5 SNL
Contact Person
Mr Simon Fitzer Tel: +44 (0) 1782 338580 +44 (0) 1782 338599 Fax Email: sf@biocomposites.com
Classification Name: Common/Usual Name: Trade/Proprietary Name Product Code
Filler, bone void, calcium compound Bone void filler Genex® Putty MQV
Device Description
Genex® Putty is a calcium salt bone graft substitute and is provided sterile for single patient use. When Genex® Putty is placed in the defect; bone grows in apposition to the implant, filling the pores with new bone during the healing process.
Genex® Putty is completely resorbed and replaced with bone during the healing process.
1
K073341 (pg. 1 of 2)
Intended Use / Indications
Genex® Putty is a bone void filler intended to fill defects not intrinsic to the stability of the spine and pelvis.
Genex® Putty provides a bone void filler that resorbs and is replaced with bone during the healing process.
Summary of Technology
Genex® Putty has the same technological characteristics as the predicate device and any differences do not raise any concerns regarding safety and effectiveness.
Genex® Putty provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
The indications, contraindications, risks and potential adverse events are the same as the identified predicate device and are thus substantially equivalent.
Non Clinical Testing
Data supplied demonstrates that Genex® Putty is substantially equivalent to the predicate device and any differences do not raise any concerns regarding safety and effectiveness.
Substantial Equivalence
Documentation provided demonstrates that the Genex® Putty is substantially equivalent to the legally marketed predicate device in basic features and intended uses. No new concerns have been identified regarding safety and effectiveness of the new device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, with three curved lines forming the body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biocomposites Ltd. % Mr. Simon Fitzer Keele Sciences Park Keele, Staffordshire United Kingdom ST5 5NL
JUL - 9 2008
Re: K073341
Trade/Device Name: Genex® Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone filler device Regulatory Class: Class II Product Code: MQV Dated: July 3, 2008 Received: July 7, 2008
Dear Mr. Fitzer:
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.
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 - Mr. Simon Fitzer
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) 276-0120. 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 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 M. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known):
Genex® Putty Device Name:
Indications For Use:
Genex® Putty is a bone void filler intended to fill defects not intrinsic to the stability of the spine and pelvis.
Genex® Putty provides a bone void filler that resorbs and is replaced with bone during the healing process.
OR
Prescription Use (Part 21 CFR 801 Subpart D)
Over
(Part
No Over-The-Counter use (Part 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)
Jarlare Buerno
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K67 334/