(90 days)
Not Found
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of bioresorbable plates and screws for trauma and reconstructive procedures. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The LactoSorb® Trauma Plating System is used for trauma and reconstructive procedures of the midface or craniofacial skeleton, including fixation of bones, which indicates it is used for treating or alleviating a disease or injury.
No
Explanation: The LactoSorb® Trauma Plating System is described as a system for fixation in midface or craniofacial procedures, indicating it is a therapeutic device used for treatment, not for diagnosis.
No
The device description explicitly states that the device is comprised of bioresorbable plates, mesh, and screws, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The LactoSorb® Trauma Plating System is a surgical implant used for fixing fractures and performing reconstructive procedures on the midface and craniofacial skeleton. It is a physical device implanted in vivo (within the body).
- Lack of Specimen Analysis: The description and intended use do not mention any analysis of biological specimens.
Therefore, the LactoSorb® Trauma Plating System falls under the category of a surgical implant or device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The LactoSorb® Trauma Plating System is indicated for use in the following midface or craniofacial procedures.
- A. General Indication: trauma procedures of the midface or craniofacial skeleton
Specific Indications:
-
- comminuted fractures of the naso-ethmoidal infraorbital areas
- comminuted fractures of the frontal sinus wall 2.
-
- pediatric midface or craniofacial trauma
- LeFort (I,II,III) fractures 4.
- orbital floor fractures 5.
- fractures of the maxilla, zygoma, zygomatic arch, orbital rim, 6. nasal, ethmoid, and lacrimal bones
- trauma of the craniofacial skeleton including: frontal, parietal, 7. temporal, sphenoid, and occipital bones
- General Indication: reconstructive procedures of the midface or B. craniofacial skeleton
Specific Indications:
- l. Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.)
- LeFort (I,II,III) osteotomies
-
- tumor reconstruction in midface or craniofacial procedures
- bone graft procedures in the midface or craniofacial skeleton 4.
- pediatric reconstructive procedures 5.
- reconstructive procedures of the craniofacial skeleton including: 6. frontal, parietal, temporal, sphenoid, and occipital bones
-
- craniotomy flap fixation
This system is not designed for use in the mandible and/or full load bearing procedures.
Product codes
HRS, HWC
Device Description
The LactoSorb® plates/mesh/screws are made of bioresorbable and biocompatible polymer that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic (PLA/PGA) acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body. The safety of PLA/PGA material has been well documented since the early 1970's when the FDA first approved the use of resorbable PLA/PGA sutures. The exact same LactoSorb® material has been implanted in humans for over 10 years in the Poly Surgiclip@ device manufactured by United States Surgical Corporation. The LactoSorb® material has been found to be biocompatible in both soft and hard bone tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
midface or craniofacial skeleton
Indicated Patient Age Range
pediatric, infant
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
The effectiveness of this resorbable system was determined by mechanical testing and an FDA approved clinical study. The LactoSorb® system was found to provide adequate fixation in the craniomaxillofacial region with no device related complications reported. This system is as effective as similar metal micro fixation systems on the market. The devices completely resorbs by 12 months IN VIVO eliminating the need for long-term removal.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
2002
K971870
Summary of Safety and Effectiveness
AUG 1 9 1997
The LactoSorb® Trauma Plating System is indicated for use in the following midface or craniofacial procedures.
- A. General Indication: trauma procedures of the midface or craniofacial skeleton
Specific Indications:
-
- comminuted fractures of the naso-ethmoidal infraorbital areas
- comminuted fractures of the frontal sinus wall 2.
-
- pediatric midface or craniofacial trauma
- LeFort (I,II,III) fractures 4.
- orbital floor fractures 5.
- fractures of the maxilla, zygoma, zygomatic arch, orbital rim, 6. nasal, ethmoid, and lacrimal bones
- trauma of the craniofacial skeleton including: frontal, parietal, 7. temporal, sphenoid, and occipital bones
- General Indication: reconstructive procedures of the midface or B. craniofacial skeleton
Specific Indications:
- l. Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.)
- LeFort (I,II,III) osteotomies ં 2.
- 3. tumor reconstruction in midface or craniofacial procedures
- bone graft procedures in the midface or craniofacial skeleton 4.
- pediatric reconstructive procedures 5.
- reconstructive procedures of the craniofacial skeleton including: 6. frontal, parietal, temporal, sphenoid, and occipital bones
-
- craniotomy flap fixation
This system is not designed for use in the mandible and/or full load bearing procedures.
The LactoSorb® plates/mesh/screws are made of bioresorbable and biocompatible polymer that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic (PLA/PGA) acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body. The safety of PLA/PGA material has been well documented since the early 1970's when the FDA first approved the use of
1
:
resorbable PLA/PGA sutures. The exact same LactoSorb® material has been implanted in humans for over 10 years in the Poly Surgiclip@ device manufactured by United States Surgical Corporation. The LactoSorb® material has been found to be biocompatible in both soft and hard bone tissue.
The effectiveness of this resorbable system was determined by mechanical testing and an FDA approved clinical study. The LactoSorb® system was found to provide adequate fixation in the craniomaxillofacial region with no device related complications reported. This system is as effective as similar metal micro fixation systems on the market. The devices completely resorbs by 12 months IN VIVO eliminating the need for long-term removal.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 9 1997
Ms. Mary L. Verstynen Clinical Research Manager Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana
Re : K971870 LactoSorb® Trauma Plating System Trade Name: Regulatory Class: II Product Codes: HRS and HWC May 20, 1997 Dated: May 21, 1997 Received:
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 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 general controls provisions The general controls provisions of the Act 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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. Please note: concerning your device in the Federal Reqister. 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 requlations.
Image /page/2/Picture/9 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
3
Page 2 - Ms. Mary L. Verstynen
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other qeneral 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/dsmamain.html".
Sincerely yours,
ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K1170
Page of
510(k) Number (if known):
Device Name: LactoSorb Trauma Plating System
Indications For Use:
- A. General Indication: trauma procedures-of-the midface or craniofacial skeleton
- Specific Indications:
-
- Comminuted fractures of the naso-ethmoidal infraorbital areas
-
- Comminuted fractures of the frontal sinus wall
-
- Pediatric midface or craniofacial trauma
-
- Lefort (I,II,III) fractures
-
- Orbital floor fractures
-
- Fractures of the maxilla, Zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones
-
- Trauma of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones
- B. General Indication: reconstructive procedures of the midface or craniofacial skeleton
Specific Indications:
-
- Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma etc.)
-
- Lefort (I,II,III) osteotomies
- Tumor reconstruction in midface or craniofacial procedures 3 .
-
- Bone graft procedures in the midface or craniofacial skeleton
-
- Pediatric reconstructive procedures
-
- Reconstructive procedures of the craniofacial skeleton including:
-
frontal, parietal, temporal, sphenoid, and occipital bones
Craniotomy flap fixation
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Acoils
(Division Sian-Off
Prescription use
X
(Per 21 CFR 801.109)
ીના
Over-The-Counter Use
(Optional Format 1-2-96)
00013