(47 days)
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This document does not contain any Reference Devices with K/DEN numbers.
No
The device description and intended use focus solely on the material properties and biological function of a bone graft substitute. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for use in treating bony voids or gaps by providing a bone graft substitute that is replaced with bone during healing, directly addressing a medical condition.
No
The device is a resorbable bone graft substitute, indicated for filling bony voids or gaps. It is an implant that facilitates bone healing and replacement, not a tool for diagnosis.
No
The device description clearly describes a physical implant made of calcium carbonate and calcium phosphate, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Pro Osteon 500R Function: Pro Osteon 500R is a bone graft substitute that is implanted directly into the body to fill bony voids or gaps. It is a physical implant that interacts with the body's healing process.
- Lack of In Vitro Testing: The description focuses on the material composition, structure, and how it functions within the body during the healing process. There is no mention of it being used to test samples outside the body.
Therefore, Pro Osteon 500R falls under the category of an implantable medical device, not an In Vitro Diagnostic.
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. The product provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
Product codes
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.
Pro Osteon® 500R has a trabecular structure that resembles the multidirectional interconnected porosity of cancellous bone. It has a median pore diameter of 435 microns. The implant is trabecular calcium carbonate covered by a very thin outer layer of calcium phosphate representing approximately 13% of the total implant structure. The calcium phosphate is located on the outer surface of the porosity throughout the entire structure of the implant. It is approximately 2 to 10 microns in thickness and overlays the calcium carbonate substructure. Once implanted, the calcium phosphate outer layer will slowly resorb, delaying exposure of the underlying and faster resorbing calcium carbonate, Calcium carbonate resorption will normally occur within six months or less.
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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
skeletal system (i.e., the extremities, spine and pelvis)
Indicated Patient Age Range
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Intended User / Care Setting
surgeons familiar with bone grafting and rigid fixation techniques.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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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.
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510(k) SUMMARY
SUBMITTED BY
K 990/31
Lynn Rodarti Manager, Regulatory Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618
(949) 453-3200
January 13, 1999
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
Classification Name: Filler, Bone Void, Non-Osteoinductive Common/Usual Name: Bone Graft Substitute, Bone Void Filler Product Classification: Unclassified Proprietary Name: Pro Osteon® 500R Resorbable Bone Graft Substitute
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. The product provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
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.
Pro Osteon® 500R has a trabecular structure that resembles the multidirectional interconnected porosity of cancellous bone. It has a median pore diameter of 435 microns. The implant is trabecular calcium carbonate covered by a very thin outer layer of calcium phosphate representing approximately 13% of the total implant structure. The calcium phosphate is located on the outer surface of the porosity throughout the entire structure of the implant. It is approximately 2 to 10 microns in thickness and overlays the calcium carbonate substructure. Once implanted, the calcium phosphate outer layer will slowly
1
resorb, delaying exposure of the underlying and faster resorbing calcium carbonate, Calcium carbonate resorption will normally occur within six months or less.
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.
CONTRAINDICATIONS, WARNINGS, PRECAUTIONS AND COMPLICATIONS
1. Contraindications
Pro Osteon® 500R is contraindicated for fractures of the growth plate; for segmental defects; for indications which may be subjected to excessive impact or stresses; when there is significant vascular impairment proximal to the graft site; when there are metabolic or systemic disorders that affect bone or wound healing: when stabilization of the fracture is not possible; in cases where intraoperative soft tissue coverage is not planned or possible, and in infected sites.
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- Warning and Precautions
Pro Osteon® 500R does not possess sufficient mechanical strength to support reduction of a defect site prior to soft and hard tissue ingrowth. Rigid fixation techniques are recommended as needed to assure rigid stabilization of the defect in all planes. Pro Osteon® 500R Resorbable Bone Graft Substitute is intended for use by surgeons familiar with bone grafting and rigid fixation techniques. Complete postoperative wound closure is essential.
- Warning and Precautions
Pro Osteon® 500R is radiopaque until resorbed. Radiopacity may mask underlying pathological conditions. Radiopacity may also make it difficult to radiographically assess the ingrowth of new bone.
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- Potential complications using this device are the same as those encountered in autogenous bone grafting procedures and include the following: superficial wound infection, deep wound infection, deep wound infection with osteomyelitis, nonunion, wound dehiscence, delayed union, malunion, loss of reduction, refracture, cyst recurrence, hematoma, and cellulitis.
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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 image of an eagle or bird in flight, composed of three curved lines. The bird is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged in a circular fashion around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 2 1999
Ms. Lynn M. Rodarti Manager, Regulatory Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618-2402
Re: K990131 Pro Osteon® 500R Resorbable Bone Graft Substitute Regulatory Class: Unclassified Product Code: MQV Dated: January 13, 1999 January 14, 1999 Received:
Dear Ms. Rodarti:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Lynn M. Rodarti
This letter will allow you to beqin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
Pro Osteon® Bone Graft Substitute Device Name:
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 extremeities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Acostafo
(Division Division of General Rest 510(k) Numbe
Prescription Use (PER 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)