LogoFDA 510(k) Search
K Number
K992355
Device Name
LACTOSORB TRAUMA PLATING SYSTEM
Manufacturer
BIOMET, INC.
Date Cleared
1999-12-20

(159 days)

Product Code
HRSHWC
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A. General Indication: trauma procedures of the midface or craniofacial skeleton Specific Indications: 1. Comminuted fractures of the naso-ethmoidal infraorbital areas 2. Comminuted fractures of the frontal sinus wall 3. Pediatric midface or craniofacial trauma 4. LeFort (I,II,III) fractures 5. Orbital floor fractures 6. Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones 7. 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: 1. Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.) 2. LeFort (I,II,III) osteotomies 3. Tumor reconstruction in midface or craniofacial procedures 4. Bone graft procedures in the midface or craniofacial skeleton 5. Pediatric reconstructive procedures 6. Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones 7. Craniotomy flap fixation
Device Description
The devices are made of LactoSorb®, which is comprised of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. The LactoSorb® resorbable copolymer is synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs In Vivo by hydrolysis into lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found to be biocompatible in animal and clinical studies in both soft tissue and bone tissue. Additional designs have been added to the system which pose no new risks regarding safety and effectiveness.
More Information

Not Found

Not Found

No
The summary describes a bioresorbable implant system and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.

Yes
The device is used for trauma and reconstructive procedures of the midface or craniofacial skeleton, which indicates a therapeutic purpose.

No
The document describes a device used for surgical procedures (trauma and reconstructive procedures of the midface or craniofacial skeleton) by providing materials for fixation (plates, screws, etc.). It does not mention any function related to diagnosing diseases or conditions.

No

The device description explicitly states the devices are made of LactoSorb®, a bioresorbable and biocompatible polymer, indicating it is a physical implantable device, not software only.

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: The description clearly states the device is made of bioresorbable polymers intended for surgical implantation to treat fractures and perform reconstructive procedures of the midface and craniofacial skeleton.
  • Intended Use: The intended use is for surgical procedures to fix fractures and reconstruct bones, not to analyze biological samples.

The device is a surgical implant, not a diagnostic tool that analyzes samples outside the body.

N/A

Intended Use / Indications for Use

The LactoSorb® Trauma Plating System is intended for use in the following indications.

  • A. General Indication: trauma procedures of the midface or craniofacial skeleton Specific Indications:
      1. Comminuted fractures of the naso-ethmoidal infraorbital areas
      1. Comminuted fractures of the frontal sinus wall
      1. Pediatric midface or craniofacial trauma
      1. LeFort (I,II,III) fractures
      1. Orbital floor fractures
      1. Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones
      1. 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:
      1. Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.)
      1. LeFort (I,II,III) osteotomies
      1. Tumor reconstruction in midface or craniofacial procedures
      1. Bone graft procedures in the midface or craniofacial skeleton
      1. Pediatric reconstructive procedures
    • Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, 6. temporal, sphenoid, and occipital bones
      1. Craniotomy flap fixation

Product codes

HRS, HWC

Device Description

The devices are made of LactoSorb®, which is comprised of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. The LactoSorb® resorbable copolymer is synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs In Vivo by hydrolysis into lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found to be biocompatible in animal and clinical studies in both soft tissue and bone tissue. Additional designs have been added to the system which pose no new risks regarding safety and effectiveness.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

midface or craniofacial skeleton, naso-ethmoidal infraorbital areas, frontal sinus wall, maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, lacrimal bones, frontal, parietal, temporal, sphenoid, and occipital bones

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 (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

§ 888.3030 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

DEC 20 1999

510 (k) Summary of Safety and Effectiveness

Submitter: Biomet Inc. Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0587

Contact Person: Tracy Bickel

Product Code: HRS, HWC

Device Name: LactoSorb® Trauma Plating System

The LactoSorb® Trauma Plating System is intended for use in the following indications.

  • A. General Indication: trauma procedures of the midface or craniofacial skeleton Specific Indications:
      1. Comminuted fractures of the naso-ethmoidal infraorbital areas
      1. Comminuted fractures of the frontal sinus wall
      1. Pediatric midface or craniofacial trauma
      1. LeFort (I,II,III) fractures
      1. Orbital floor fractures
      1. Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones
      1. 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:
      1. Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.)
      1. LeFort (I,II,III) osteotomies
      1. Tumor reconstruction in midface or craniofacial procedures
      1. Bone graft procedures in the midface or craniofacial skeleton
      1. Pediatric reconstructive procedures
    • Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, 6. temporal, sphenoid, and occipital bones
      1. Craniotomy flap fixation

The devices are made of LactoSorb®, which is comprised of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. The LactoSorb® resorbable copolymer is synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs In Vivo by hydrolysis into lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found to be biocompatible in animal and clinical studies in both soft tissue and bone tissue. Additional designs have been added to the system which pose no new risks regarding safety and effectiveness.

000000

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Public Health Service

DEC 20 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tracy J. Bickel Regulatory Specialist Biomet Incorporated Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581-0587

K992355 Re:

LactoSorb Trauma Plating System Regulatory Class: II Product Code: HRS, HWC Dated: December 2, 1999 Received: December 6, 1999

Dear Ms. Bickel:

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 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: 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 regulations.

2

Page 2 – Ms. Tracy J. Bickel

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) 594-4659. 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 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Neil R.P. Ogden

James E. Dillaro Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

3

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:
      1. Comminuted fractures of the naso-ethmoidal infraorbital areas
      1. Comminuted fractures of the frontal sinus wall
      1. Pediatric midface or craniofacial trauma
      1. LeFort (I,II,III) fractures
      1. Orbital floor fractures
      1. Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones
      1. 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:
      1. Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.)
      1. LeFort (I,II,III) osteotomies
      1. Tumor reconstruction in midface or craniofacial procedures
      1. Bone graft procedures in the midface or craniofacial skeleton
      1. Pediatric reconstructive procedures
      1. Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones
      1. Craniotomy flap fixation

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)DRO for
Division of General Restorative Devices
510(k) NumberK992355
Prescription Use (Per 21 CFR 801.109)X
-----------------------------------------------------

OR
Over-The-Counter Use (Optional Format 1-2-96)