(22 days)
Not Found
Not Found
No
The 510(k) summary describes a metallic internal fixation device for orthopedic repairs and makes no mention of AI, ML, image processing, or any related technologies.
Yes.
The device is indicated for general orthopedic repairs, including the fixation and reduction of bone fractures, which is a therapeutic purpose.
No
The device is described as a "Metallic Internal Fixation Device" indicated for general orthopedic repairs, specifically for fixing fractures and reinforcing bone. Its purpose is to treat or repair bone structures, not to diagnose medical conditions.
No
The device description explicitly states "Metallic Internal Fixation Device," indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body.
- Osse-Lign System Description: The description clearly states it is a "Metallic Internal Fixation Device" used for "general orthopedic repairs" and "supplementary fixation and reduction." This means it is a device implanted inside the body to stabilize bones.
The intended use and device description are consistent with a surgical implant, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Osse-Lign System is indicated for general orthopedic repairs. This includes such procedures as long bone fractures, bone grafting and reinforcement of bone. This system may also be used for supplementary fixation and reduction with approved bone plates, screws, pins, nails and bone grafting material.
Long Bone Fractures
- Femur fractures
- Tibia fractures
- Humerus fractures
Joint Fractures
- Ankle fractures
- Knee Fractures
- Hip Fractures
- Shoulder Fractures
- Elbow Fractures
Other bone fractures
- Olecranon
- Pelvis fractures
- Patella fractures
- Acetabular fractures
- Trocanteric reattachment
- Fixation of fractures in conjunction with I/M nailing and plating techniques
- Stabilization of cortical onlay strut graft
- Temporary reduction techniques for ORIF (Open Reduction Internal Fixation)
Product codes (comma separated list FDA assigned to the subject device)
JDQ
Device Description
Mctallic Internal Fixation Device
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bones, joints, olecranon, pelvis, patella, acetabulum.
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.
Not Found
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
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
0
510(K) SUMMARY
Subject 510(k) Number
040199
page 1 of 1
Sponsor
Osseus, IIC
3131 Princeton Pike Bldg 5, Suite 200 Lawrenceville, NJ 08648
Official Contact
Shawn T. Huxel, President/GM 3131 Princeton Pike Bldg 5, Suite 200 Lawrenceville, NJ 08648 Phone - (908) 997-0127 Fax - (908) 842-0347 Mobile - (908) 896-5893
Proprietary Name
Osse-Lign
Common Name
Mctallic Internal Fixation Device
Classification Name and Reference
888.3010 - Bone Fixation Cerclage
Regulatory Class Class II
Device Product Code
(Panel 87) JDQ
Date Prepared
27 January, 2004
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with outstretched wings, symbolizing protection and care. The eagle is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 2004
Mr. Shawn T. Huxel President/General Manager Osseus, LLC 3131 Princeton Pike Building 5, Suite 200 Lawrenceville, New Jersey 08648
Re: K040199
Trade/Device Name: 1.5 mm Osse-Lign Internal Fracture Fixation System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: II Product Code: JDQ Dated: January 27, 2004 Received: January 29, 2004
Dear Mr. Huxel:
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 enclosurc) 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, labcling, 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 docs 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.
2
Page 2 - Mr. Shawn T. Huxel
This letter will allow you to begin marketing your device as described in your Section 510(k) The retet notification. The FDA finding of substantial equivalence of your device to a legally prematicated predicated." - 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), plcase 11 you atent o epocesse an any of Compliance at (301) 594-4659. 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 other general micronal and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
L. Mark N. Millherson
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
3
Indications for Use Statement
510 (K) NUMBER IF KNOWN: KO401999
DEVICE NAME: 1.5 mm Osse-Lign Internal Fracture Fixation System
The Osse-Lign System is indicated for general orthopedic repairs. This includes such procedures as long bone fractures, bone grafting and reinforcement of bone. This system may also be used for supplementary fixation and reduction with approved bone plates, screws, pins, nails and bone grafting material.
Long Bone Fractures
- . Femur fractures
- Tibia fractures .
- l lumerus fractures l
Joint Fractures
- 트 Ankle fractures
- Knee Fractures 트
- Hip Fractures 비
- . Shoulder Fractures
- Elbow Fractures
Other bone fractures
- 발 Olecranon
- Pelvis fractures .
- Patella fractures ■
- . Acetabular fractures
- Trocanteric reattachment .
- Fixation of fractures in conjunction with I/M nailing and plating techniques
- Stabilization of cortical onlay strut graft
- Temporary reduction techniques for ORIF (Open Reduction Internal Fixation)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE, IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
or
Over-the-Counter Use __
(Optional Format 1-27-1996) of
(Optional Format 1-2,1996)
Division
Division of General, Restorative,
and Neurological Services
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