(164 days)
Not Found
No
The 510(k) summary describes a ceramic bone graft substitute and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a bone filler and for bone reconstruction, which directly treats a medical condition (loss of bone substance) to restore normal function.
No
The device is described as a "resorbable, biphasic ceramic implant" used as a "bone filler and for bone reconstruction," which are therapeutic rather than diagnostic functions.
No
The device description clearly states that Cross.Bone is a resorbable, biphasic ceramic implant in the form of granules, which 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 clearly describes the device as a bone filler and for bone reconstruction in surgical procedures. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description confirms it's a ceramic implant used as a bone filler.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is implanted into the body for structural support and bone regeneration.
N/A
Intended Use / Indications for Use
Cross.Bone Blocks - CROSS.BONE BLOCK is recommended for bone reconstructive surgery or as a bone filler following loss of uninfected bone substance of artificial or degenerative origin, suitably reduced, fixed and stabilized where necessary.
— Filling losses of bone material resulting from a fracture.
— Filling losses of bone material after the resection of benign tumors or cysts
Cross.Bone Bottles - CROSS.BONE BOTTLE is recommended for bone reconstructive surgery or as a bone filler following loss of uninfected bone substance of artificial or degenerative origin, suitably reduced, fixed and stabilized where necessary.
-
Filling losses of bone material resulting from a fracture.
-
Filling losses of bone material after the resection of benign tumors or cysts.
Cross.Bone Syringe - CROSS.BONE SYRINGE is recommended for bone reconstructive surgery or as a bone filler following loss of uninfected bone substance of artificial or degenerative origin, suitably reduced, fixed and stabilized where necessary.
- Bone filler following a fracture,
- Bone filler following resection of benign tumors or cysts,
When the cavity to be filled is large, it is recommended to cover it with a resorbable membrane.
Cross.Bone Wedge - CROSS.BONE WEDGE is recommended for tibial osteotomy with internal fixation, and necessarily in combination with an osteosynthesis procedure (metallic plates and screws).
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
Cross.Bone is a resorbable, biphasic ceramic implant composed of 60% hydroxyapatite and 40% ß-tricalcium phosphate in the form of granules. It is used as a bone filler and for bone reconstruction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
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 of Safety and Effectiveness Cross.Bone
DEC 1 7 2007
Submitted By:
TriMed, Inc. 25864 Tournament Road, Ste. A Valencia, CA 91355 (800)633-7221
Registration #:
Prepared By/Contact Person:
Proprietary Name:
Classification:
Summary Preparation Date:
2031009
Kelli Anderson Phone: (661)312-7150 Fax: (661)254-8485
Cross.Bone
Class II: filler, bone void, calcium compound MQV - Section 888.3045
October 26, 2007
I. Indications for Use:
Cross.Bone Blocks - CROSS.BONE BLOCK is recommended for bone reconstructive surgery or as a bone filler following loss of uninfected bone substance of artificial or degenerative origin, suitably reduced, fixed and stabilized where necessary.
— Filling losses of bone material resulting from a fracture.
— Filling losses of bone material after the resection of benign tumors or cysts
Cross.Bone Bottles - CROSS.BONE BOTTLE is recommended for bone reconstructive surgery or as a bone filler following loss of uninfected bone substance of artificial or degenerative origin, suitably reduced, fixed and stabilized where necessary.
- Filling losses of bone material resulting from a fracture.
– Filling losses of bone material after the resection of benign tumors or cysts.
Cross.Bone Syringe - CROSS.BONE SYRINGE is recommended for bone reconstructive surgery or as a bone filler following loss of uninfected bone substance of artificial or degenerative origin, suitably reduced, fixed and stabilized where necessary.
- Bone filler following a fracture,
- Bone filler following resection of benign tumors or cysts,
1
When the cavity to be filled is large, it is recommended to cover it with a resorbable membrane.
Cross.Bone Wedge - CROSS.BONE WEDGE is recommended for tibial osteotomy with internal fixation, and necessarily in combination with an osteosynthesis procedure (metallic plates and screws).
II. Device Description:
Cross.Bone is a resorbable, biphasic ceramic implant composed of 60% hydroxyapatite and 40% ß-tricalcium phosphate in the form of granules. It is used as a bone filler and for bone reconstruction.
III. Substantial Equivalence:
K032268 - BIOMATLANTE, MBCP (Blocks) K051774 - BIOMATLANTE, MBCP (Granules) K060061 - Stryker Corp., Stryker Injectable Cement
Kelli Anderson Regulatory Affairs Specialist
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Trimed, Inc % Ms. Kelli Anderson Regulatory Affairs Specialist 25864 Tournament Rd, Suite A Valencia CA 91355
Re: K071876
Trade/Device Name: Cross.Bone Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: December 1, 2007 Received: December 3, 2007
Dear Ms. Anderson:
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.
DEC 1 7 2007
3
Page 2 - Ms. Kelli Anderson
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 the reporting 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 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,
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): _ Unknown
Device Name: Cross.Bone
Indications For Use:
Cross.Bone Blocks - CROSS.BONE BLOCK is recommended for bone reconstructive surgery or as a bone filler following loss of uninfected bone substance of artificial or degenerative origin, suitably reduced, fixed and stabilized where necessary.
-
Filling losses of bone material resulting from a fracture.
-
Filling losses of bone material after the resection of benign tumors or cysts
Cross.Bone Bottles - CROSS.BONE BOTTLE is recommended for bone reconstructive surgery or as a bone filler following loss of uninfected bone substance of artificial or degenerative origin, suitably reduced, fixed and stabilized where necessary.
-
Filling losses of bone material resulting from a fracture.
-
Filling losses of bone material after the resection of benign tumors or cysts.
Cross.Bone Syringe - CROSS.BONE SYRINGE is recommended for bone reconstructive surgery or as a bone filler following loss of uninfected bone substance of artificial or degenerative origin, suitably reduced, fixed and stabilized where necessary.
-
Bone filler following a fracture,
-
Bone filler following resection of benign tumors or cysts,
When the cavity to be filled is large, it is recommended to cover it with a resorbable membrane.
Cross.Bone Wedge - CROSS.BONE WEDGE is recommended for tibial osteotomy with internal fixation, and necessarily in combination with an osteosynthesis procedure (metallic plates and screws).
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Barbare Briese
eral. Restorative, and Neurological Devices
Page 1 of
5 Number K0718282