(176 days)
Not Found
Not Found
No
The device description focuses on the material composition and biomechanical properties of the screws, with no mention of AI or ML technology.
No
The device is described as fixation for mandibular osteotomy procedures and is composed of bioresorbable polymers. Its purpose is to provide stability, not to treat, cure, mitigate, or prevent disease.
No
The device is described as screws for fixation in mandibular osteotomy procedures, indicating a surgical or therapeutic intended use rather than a diagnostic one.
No
The device description explicitly states the device is composed of bioresorbable and biocompatible polymers, which are physical materials, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the screws are for "fixation in mandibular osteotomy procedures." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details the material composition and how the screws function in vivo (within the living body) by degrading and resorbing.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. This device is implanted inside the body for structural support.
N/A
Intended Use / Indications for Use
The 2.5 mm LactoSorb® Screws are indicated for use as fixation in mandibular osteotomy procedures, including but not limited to:
- sagittal split osteotomy
- vertical ramus osteotomy
- inferior border osteotomy
- subapical osteotomy
- genioplasty
Product codes
JEY, DZL
Device Description
The 2.5 mm LactoSorb® Screws are composed of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/pclyglycolic acid copolymer degrades and resorb IN vIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body. In animal studies LactoSorb® has been found to be biocompatible in both soft tissue and bone tissue. Lact:oSorb® devices have been marketed for over two years for use in trauma and reconstructive procedures in the craniomaxillofacial skeleton and have been found to be both safe and effective.
The efficacy of the 2.5 mm LactoSorb® Screws have been demonstrated by biomechanical testing and clinical use. The screws maintain their strength for at least 6-8 weeks and completely resorb in approximately one year.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular
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)
The efficacy of the 2.5 mm LactoSorb® Screws have been demonstrated by biomechanical testing and clinical use. The screws maintain their strength for at least 6-8 weeks and completely resorb in approximately one year.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.
0
3 1998 NOV
510 (k) Summary of Safety and Effectiveness
Biomet, Inc. Submitter: P.(). Box 587 Ai::port Industrial Park Warsaw, IN 46581-0587
Contact Person: Mary L. Verstynen
Product Code: JEY
2.5 mm LactoSorb® Screws Device Name:
The 2.5 mm LactoSorb® Screws are indicated for use as fixation in mandibular osteotomy procedures, including but not limited to:
::
:
ﺮ ﺍﻟ
- sagittal split osteotomy 1.
-
- vertical ramus osteotomy
- inferior border osteotomy 3 .
- subapical osteotomy বাংলাদেশে
- genioplasty 5.
The 2.5 mm LactoSorb® Screws are composed of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/pclyglycolic acid copolymer degrades and resorbs IN vIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body. In animal studies LactoSorb® has been found to be biocompatible in both soft tissue and bone tissue. Lact:oSorb® devices have been marketed for over two years for use in trauma and reconstructive procedures in the craniomaxillofacial skeleton and have been found to be both safe and effective.
The efficacy of the 2.5 mm LactoSorb® Screws have been demonstrated by biomechanical testing and clinical use. The screws maintain their strength for at least 6-8 weeks and completely resorb in approximately one year.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human figures. The figures are connected and appear to be moving forward.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 1998
Ms. Mary L. vertstynen Biomet, Incorporated Airport Industrial Park Warsaw, Indiana 46581-0587
Re: K981666 Trade Name: 2.5 mm LactoSorb® Screws Requlatory Class: II Product Code: DZL Dated: August 5, 1998 Received: August 6, 1998
Dear Ms. Verstynen:
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 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). You may, therefore, market the device, subject to the qeneral 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, 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 comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
Page 2 - Ms. Verstynen
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (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/dsma/dsmamajn.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
રું .
3
of
510 (k) NUMBER (IF KNOWN) : __________________________________________________________________________________________________________________________________________________
2.5mm LactoSorb Screw__ DEVICE NAME:
INDICATIONS FOR USE:
The 2.5mm IactoSorb Screws are indicated for use as fixation
The 2.5mm Iactores are associence, including but not limited The 2.5mm Iacto5orb Screws are Indicated 10. about 10.000
in mandibular osteotomy procedures, including but not limited to:
-
- sagittal split osteotomy
-
- vert:cal ramus osteotomy
-
- infecior border osteotomy
-
- subapical osteotomy
-
- genioplasty
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescript:.on Use
(Per 21 CFR 801.109)
. ...
Over-The-Counter-Use
(Optional Format 1-2-96)
ﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. K981666
00003