(166 days)
Not Found
No
The summary describes a resorbable bone graft substitute and does not mention any AI or ML components or functionalities.
Yes.
The device is a resorbable bone graft substitute used to fill bony voids or gaps and promotes bone formation during the healing process, which is a therapeutic function.
No
The device is a resorbable bone graft substitute, indicated for filling bony voids or gaps. It is used in the treatment and healing process of bone, not for diagnosis.
No
The device description clearly states it is a "porous implant" and "supplied sterile in various shapes and sizes," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that PRO OSTEON® 500R is a "Resorbable Bone Graft Substitute" and an "osteoconductive porous implant." Its intended use is to be "gently packed into bony voids or gaps of the skeletal system." This involves direct implantation into the body to aid in bone healing.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens outside of the body.
Therefore, PRO OSTEON® 500R is a medical device intended for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
PRO OSTEON® 500R Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. PRO OSTEON® 500R is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PRO OSTEON® 500R can be combined with autogenous bone marrow aspirate, autogenous blood, and/or sterile fluids (saline or Ringer's solution). The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
Pro Osteon® 500R Resorbable Bone Graft Substitute is an osteoconductive porous implant similar in structure to human cancellous bone. It is supplied sterile in various shapes and sizes.
When Pro Osteon® 500R is placed in direct contact with viable bone, the reticulated spaces in the implant are infiltrated with tissue. Bone formation occurs in apposition to the Pro Osteon® 500R surface and within the interstices of the implant skeleton. As the implant resorbs, bone and soft tissue grow into the space previously occupied by the implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., the 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)
Non-Clinical Testing: Non-clinical laboratory testing was previously performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
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.
K990131/K980817, K032286, K051695, K040047, K043005/K051774
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.
0
510(k) Summary
APR 1 8 2007
| Preparation Date: | March 16, 2006 |
|---|---|
| Applicant/Sponsor: | Biomet Osteobiologics also known as EBI, L.P. |
| 100 Interpace Parkway | |
| Parsippany, NJ 07054 | |
| Establishment Registration Number: 1450662 | |
| Contact Person: | Debra Bing |
| Director of Regulatory Affairs | |
| Proprietary Name: | Pro Osteon® 500R |
| Common Name: | Bone Graft Substitute |
Classification Name: Filler, Bone Void, Calcium Compound (888.3045)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
- Pro Osteon® 500R K990131/K980817 (Interpore Cross International) .
- Calcigen™ PSI K032286 (Biomet Orthopedics) .
- Marrow Plus (M+™) K051695 (Berkeley Advanced Biomaterials, Inc.) .
- . PolyGraff™/TruBlock™ BGS - K040047 (OsteoBiologics, Inc.)
- . MBCP™ - K043005/K051774 (Biomatlante)
Device Description: Pro Osteon® 500R Resorbable Bone Graft Substitute is an osteoconductive porous implant similar in structure to human cancellous bone. It is supplied sterile in various shapes and sizes.
When Pro Osteon® 500R is placed in direct contact with viable bone, the reticulated spaces in the implant are infiltrated with tissue. Bone formation occurs in apposition to the Pro Osteon® 500R surface and within the interstices of the implant skeleton. As the implant resorbs, bone and soft tissue grow into the space previously occupied by the implant.
Indications for Use: PRO OSTEON® 500R Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. PRO OSTEON® 500R is indicated to be gently packed into bony volds or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PRO OSTEON® 500R can be combined with autogenous bone marrow aspirate, autogenous blood, and/or sterile fluids (saline or Ringer's solution). The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Summary of Technologies: The technological characteristics (materials, design sizes, and indications) are similar to or identical to that of the predicate devices.
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510(k) Summary Pro Osteon® 500R- Expanded Indications Biomet Osteobiologics Page 2 of 2
Non-Clinical Testing: Non-clinical laboratory testing was previously performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc. except for:
M+™ is a trademark of Berkeley Advanced Biomaterials, Inc. (Berkeley, CA) PolyGraft™ (TruBlock™ BGS are trademarks of OsteoBiologics, Inc. (San Antonio, TX) MBCP™ is a trademark of Biomatiante (France)
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol resembling a person with outstretched arms, with three curved lines representing the body and arms. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the border.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet % Ms. Debra Bing Director, Regulatory Affairs 100 Interspace Parkway Parsippany, New Jersey 07054
APR 1 8 2007
Re: K063346
Trade/Device Name: Pro Osteon® 500R Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Bone Void Filler, Calcium Compound Regulatory Class: II Product Code: MQV Dated: April 3, 2007 Received: April 4, 2007
Dear Mrs. Bing:
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 - Ms. Debra Bing
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
sincerely, yours,
Qarbaye BuelnD
Mark N. Melkerson Director Division of General, Restorative Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):_
Device Name: PRO OSTEON® 500R
Indications For Use:
PRO OSTEON® 500R Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. PRO OSTEON® 500R is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PRO OSTEON® 500R can be combined with autogenous bone marrow aspirate, autogenous blood, and/or sterile fluids (saline or Ringer's solution). The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (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)
Barbara Anichumb
Division of Gener and Neurological Devices
510(k) Number K063346
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