(325 days)
K01-4289, K03-3815
Not Found
No
The summary describes a bone void filler material and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
ORTHOSS® Resorbable Bone Void Filler is indicated for bony voids or gaps of the skeletal system, which addresses a medical condition or ailment, defining it as a therapeutic device.
No
Explanation: The device is a resorbable bone void filler, used to fill bony voids or gaps. It is a material implanted in the body for structural support and is not used to diagnose a medical condition.
No
The device description clearly states that ORTHOSS® is a "natural non-antigenic, porous bone mineral," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a "Resorbable Bone Void Filler" for filling bony voids or gaps in the skeletal system. This is a therapeutic or structural use, not a diagnostic one.
- Device Description: The description details the material and structure of the bone mineral, which is consistent with a medical device used for implantation or filling, not for analyzing samples from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's condition.
- Anatomical Site: The device is used directly on the skeletal system, which is a therapeutic application.
- Predicate Devices: The predicate devices listed (ORTHOSS® and BIO-OSS®) are also bone graft substitutes, which are not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
ORTHOSS® Resorbable Bone Void Filler is indicated for bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). ORTHOSS® is indicated only for use in bone voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
ORTHOSS® Resorbable Bone Void Filler is intended to be used in the spine only for posterolateral fusion.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
ORTHOSS® is a natural non-antigenic, porous bone mineral. It is produced by removal of all organic components from bovine bone. Due to its natural structure, it is physically and chemically comparable to the mineralized matrix of human bone.
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)
Not Found
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.
ORTHOSS® (K01-4289), BIO-OSS® (K03-3815)
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
1090-101
510(k) Summary
ORTHOSS®
1. SPONSOR
JAN - 8 2010
Ed. Geistlich Soehne Ag für Chemische Industrie Geistlich Pharma Ag Bahnhofstrasse 40 CH-6110 Wolhusen SWITZERLAND
Contact Person: Peter S. Reichertz, (202) 772-5333 Date Prepared: January 8, 2010
2. DEVICE NAME
| Proprietary Name | ORTHOSS® Resorbable Bone Void Filler |
|---|---|
| Common/Usual Name: | Resorbable Bone Void Filler |
| Classification Name: | Resorbable calcium salt bone void filler (MQV) |
| 21 CFR § 888.3045 |
3. PREDICATE DEVICES
ORTHOSS® (K01-4289) BIO-OSS® (K03-3815)
4. INTENDED USE
ORTHOSS® Resorbable Bone Void Filler is indicated for bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). ORTHOSS® is indicated only for use in bone voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
ORTHOSS® Resorbable Bone Void Filler is intended to be used in the spine only in posterolateral fusion.
న్. DEVICE DESCRIPTION
ORTHOSS® is a natural non-antigenic, porous bone mineral. It is produced by removal of all organic components from bovine bone. Due to its natural structure, it is physically and chemically comparable to the mineralized matrix of human bone.
1
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
ORTHOSS® is similar to the previously cleared ORTHOSS® product sourced from U.S. bone. The only change is the source of the bovine bone used to make the product from the U.S. sourced bovine bone, to Australia sourced bovine bone. Australia has been found to have a level I geographical BSE – Risk by the European Union, which means it is highly unlikely that there is the presence of one or more cattle clinically or preclinically infected with the BSE agent in Australia. Australia is also not on the U.S. Department of Agriculture's list of countries where BSE is known to exist. See 9 C.F.R. § 94.18. Therefore, the use of Australia source bone will not negatively impact the safety of the product.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, on the right side. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Ed. Geistlich Soehne Ag für Chemische Industrie % Sheppard Mullin Richter & Hampton LLP Mr. Peter S. Reichertz JAN - 8 2010 1300 I Street, N.W., 11th Floor, East Washington, District of Columbia 20005
Re: K090401
Trade/Device Name: ORTHOSS® Resorbable Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: December 24, 2009 Received: December 30, 2009
Dear Mr. Reichertz:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Peter S. Reichertz
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Barbara Ruehrup
for
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K090401
ORTHOSS® Resorbable Bone Void Filler. Device Name:
- Indications for Use: ORTHOSS® Resorbable Bone Void Filler is indicated for bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). ORTHOSS® is indicated only for use in bone voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
ORTHOSS® Resorbable Bone Void Filler is intended to be used in the spine only for posterolateral fusion.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-the-Counter Use (21 CFR 801 Subpart C)
FOR M.MELKERSON
(Division Sign-Off)
Division of Surgical, Ofthopedic, and Restorative Devices
OR
510(k) Number K090401