(212 days)
Not Found
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, data processing, or any terms related to AI/ML.
Yes
The device is a bone graft substitute indicated for bony voids or gaps, assisting in the healing process by being replaced with bone. This makes it a device intended for therapeutic purposes.
No
Explanation: The device, Pro Osteon 200R, is a bone graft substitute used to fill bony voids or gaps. Its function is to provide a scaffold for bone healing, not to diagnose a condition.
No
The device description clearly describes a physical implant made of calcium carbonate and calcium phosphate, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Pro Osteon 200R is a bone graft substitute used to fill bony voids or gaps in the skeletal system. This is a therapeutic and structural function within the body.
- Device Description: The description details a porous calcium carbonate implant that is surgically placed into the body to promote bone growth and eventually resorb. This is an implantable medical device.
- Lack of Diagnostic Function: There is no mention of this device being used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition, monitor a disease, or screen for health issues. This is the core function of an IVD.
IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. Pro Osteon 200R is used in vivo (within the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
Pro Osteon® 200R 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 200R 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 (comma separated list FDA assigned to the subject device)
MQV
Device Description
Pro Osteon 200R Resorbable Bone Graft Substitute is an osteoconductive porous calcium carbonate implant similar in structure to human cancellous bone. It is supplied sterile in various shapes and sizes.
Pro Osteon 200R Resorbable Bone Graft Substitute has a trabecular structure with multidirectional interconnected porosity with an approximate pore diameter of 190 - 230 microns. The product consists of an underlying calcium carbonate matrix covered by a very thin outer layer of calcium phosphate, approximately 2 to 10 microns in thickness. The calcium phosphate is located on the outer surface of the porosity throughout the entire structure of the implant. Once implanted, the calcium phosphate outer layer will slowly resorb, delaying exposure of the underlying and faster resorbing calcium carbonate.
When Pro Osteon 200R 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 calcium phosphate 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 calcium carbonate.
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
Surgeons familiar with bone grafting and rigid fixation techniques.
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)
Results of nonclinical testing, including bench testing and animal studies, support substantial equivalence of Pro Osteon 200R Resorbable Bone Graft Substitute to the predicate device, Pro Osteon 500R Resorbable Bone Graft Substitute.
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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SEP 1 5 2000
510(k) SUMMARY
SUBMITTED BY
Prosie Rey-Fessler Director, Regulatory Affairs & Quality Assurance Interpore Cross International 181 Technology Drive Irvine, California 92618 (949) 453-3200
February 14, 1999 Date Submitted:
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
| Classification Name: | Bone Void Filler |
|---|---|
| Common/Usual Name: | Bone Void Filler or Bone Graft Substitute |
| Product Classification: | Unclassified |
| Proprietary Name: | Pro Osteon® 200R Resorbable Bone Graft Substitute |
PREDICATE DEVICE
Interpore Cross International's Pro Osteon 500R Resorbable Bone Graft Substitute [reference 510(k) K980817]
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
DEVICE DESCRIPTION AND MATERIALS OF CONSTRUCTION
Pro Osteon 200R Resorbable Bone Graft Substitute is an osteoconductive porous calcium carbonate implant similar in structure to human cancellous bone. It is supplied sterile in various shapes and sizes.
Pro Osteon 200R Resorbable Bone Graft Substitute has a trabecular structure with multidirectional interconnected porosity with an approximate pore diameter of 190 - 230 microns. The product consists of an underlying calcium carbonate matrix covered by a very thin outer layer of calcium phosphate, approximately 2 to 10 microns in thickness. The calcium phosphate is located on the outer surface of the porosity throughout the entire structure of the implant. Once implanted, the calcium phosphate outer layer will slowly resorb, delaying exposure of the underlying and faster
1
resorbing calcium carbonate.
When Pro Osteon 200R 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 calcium phosphate 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 calcium carbonate.
INDICATIONS FOR USE
Pro Osteon 200R 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 200R 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.
PRECAUTIONS AND CONTRAINDICATIONS. WARNINGS, COMPLICATIONS
Contraindications 1.
Pro Osteon 200R 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.
Warnings and Precautions 2.
Pro Osteon 200R 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 200R Resorbable Bone Graft Substitute is intended for use by surgeons familiar with bone grafting and rigid fixation techniques. Complete postoperative wound closure is essential.
Pro Osteon 200R is radiopaque until resorbed. Radiopacity may mask underlying pathological conditions. Radiopacity may also make it difficult to radiographically assess the ingrowth of new bone.
2
3. Complications
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.
COMPARISON TO THE PREDICATE DEVICE
The Pro Osteon 200R Resorbable Bone Graft Substitute product design, materials of construction or chemical composition, and function as a bone void filler or bone graft substitute are substantially equivalent to the predicate device. Pro Osteon 500R Resorbable Bone Graft Substitute.
TESTING SUMMARY
Results of nonclinical testing, including bench testing and animal studies, support substantial equivalence of Pro Osteon 200R Resorbable Bone Graft Substitute to the predicate device, Pro Osteon 500R Resorbable Bone Graft Substitute.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 image of three human profiles facing right, with flowing lines representing hair or clothing.
SEP 1 5 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Prosie Rey-Fessler Director, Quality Assurance and Regulatory Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618
Re: K000515
Trade Name: ProOsteon 200R Regulatory Class: Unclassified Product Code: MQV Dated: June 16, 2000 Received: June 19, 2000
Dear Ms. Rey-Fessler:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have hove have determined the device is substantially equivalent (for the indications for use ato ve and in the enclosure) to legally marketed predicate devices marketed in interstate commerce stated in the energials, to regary and date of the Medical Device Amendments, or to devices that prior to frab, 20, 1976, and in the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control Costions of the Act. The general control provisions of the Act include requirements for annual provisions of the Fred - 12.0 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 ( Fecting 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 requirements, 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 mopely with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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.
This letter will allow you to begin 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.
4
Page 2 - Ms. Prosie Rey-Fessler
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you deally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for questions on the promotion and advertising of your device, (2017 59 1 100 m = 100 m = 100 m = 100 m = 100 m = 100 m = 10 m = 10 m = 10 m = 10 m = 10 m = 10 = 10 = 1 entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mountation on your responsible (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Dume R. lochner
Image /page/4/Picture/4 description: The image shows a handwritten signature or symbol on the left, followed by the letters "C" and "D" on the right. The signature appears to be a stylized combination of curves and lines. The letters "C" and "D" are in a simple, sans-serif font and are vertically aligned.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K000515
510(k) Number (if known):
Pro Osteon® 200R Resorbable Bone Graft Substitute Device Name:
Indications for Use:
Pro Osteon® 200R 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 200R 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Durne
(Division Sign-Off) Division of Gener Restorative Devices 510(k) Number_K000515
Prescription Use $\underline{\text{V}}$
(PER 21 CFR 801.109)
OR
Over-The-Counter Use
Optional Format 1-2-96)