BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM
Device Facts
| Record ID | K982139 |
|---|---|
| Device Name | BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM |
| Applicant | Bionx Implants, Inc. |
| Product Code | JEY · Dental |
| Decision Date | Sep 15, 1998 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.4760 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The BioSorbFX System is intended for use in trauma and reconstructive procedures in the midface and craniofacial skeleton. Specifically, the device is indicated for use in treating comminuted fractures of the naseothmoidal and infraorbital areas; comminuted fractures of the frontal sinus wall; trauma of the midface and craniofacial skeleton, and reconstructive procedures of the midface or craniofacial skeleton. The BioSorbFX System is used to stabilize bone during healing, in conjunction with appropriate postoperative immobilization. The BioSorbFX System includes an instrumentation set containing bone drills, bone taps, screwdrivers and plate benders. The BioSorbFX System is not intended for use in and is contraindicated for: 1) the mandible; 2) full load bearing procedures; 3) areas with active infection; or 4) patient conditions, including blood supply limitations, insufficient quantity or quality of bone, or latent infections.
Device Story
BioSorbFX System comprises bioabsorbable plates, meshes, and threaded screws for bone stabilization in midface/craniofacial trauma and reconstruction. Device inputs include surgical site preparation via drilling, tapping, and flushing; surgeon uses provided instrumentation (drills, taps, screwdrivers, plate benders) to secure plates to bone fragments. Principle of operation involves mechanical stabilization of bone during healing; device remains in situ while gradually degrading and absorbing into body, eliminating need for removal surgery. Used in clinical/surgical settings by surgeons. Output is stable bone fixation allowing biological healing. Benefits include avoidance of secondary removal surgery and biocompatible material integration.
Clinical Evidence
No clinical data. Substantial equivalence is based on technological characteristics, material biocompatibility, and intended use comparisons to legally marketed predicate devices.
Technological Characteristics
Plates, meshes, and screws composed of poly-L/D,L-lactide (P(L/DL)LA) copolymer (70% L-lactide, 30% D,L-lactide). Available in 1.5mm and 2.0mm fastener diameters. Includes instrumentation set (drills, taps, screwdrivers, benders). Sterile, gamma-radiation sterilized, single-use. Mechanical fixation principle.
Indications for Use
Indicated for trauma and reconstructive procedures of the midface and craniofacial skeleton, including comminuted fractures of the naseothmoidal, infraorbital, and frontal sinus wall areas. Contraindicated for mandible, full load-bearing procedures, active infection, or patients with compromised blood supply or insufficient bone quality/quantity.
Regulatory Classification
Identification
A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.
Predicate Devices
- Synthes, Inc. Resorbable Fixation System (K974554)
- Walter Lorenz Surgical, Inc. LactoSorb® Trauma Plating System (K974309, K971870, and K960988)
- Bionx BioSorb Endobrow Screw (K972919)
- Bionx Biodegradable Threaded Suture Anchor (K972783)
Submission Summary (Full Text)
{0}------------------------------------------------
K982139
SEP 1 5 1998
## 510(k) SUMMARY BIONX IMPLANTS, INC.'S BioSorbFX 1.5/2.0 Bioabsorbable Fixation System
# Submitter's Name, Address, Telephone Number, And Contact Person
Bionx Implants, Inc. 1777 Sentry Parkway West Gwynedd Hall Suite 400 Bluebell, PA 19422
David W. Anderson. Contact: President and CEO Phone: (215) 643-5000 Facsimile: (215) 653-0984
### Date Prepared
June 16, 1998
### Name of the Device
BioSorbFX 1.5/2.0 Bioabsorbable Fixation System
### Common or Usual Name
Bioabsorbable Craniofacial Bone Plates and Plate Fasteners
### Classification Name
Bone Plate (Product Code 76JEY)
#### Predicate Devices
- (1) Synthes, Inc. Resorbable Fixation System (K974554),
- Walter Lorenz Surgical, Inc. LactoSorb® Trauma (2) Plating System (K974309, K971870, and K960988),
- Bionx BioSorb Endobrow Screw (K972919), (3)
- Bionx Biodegradable Threaded Suture Anchor (K972783) (4)
{1}------------------------------------------------
## Intended Use
The BioSorbFX System is intended for use in trauma and reconstructive procedures in the midface and craniofacial skeleton. Specifically, the device is indicated for use in treating comminuted fractures of the naseothmoidal and infraorbital areas; comminuted fractures of the frontal sinus wall; trauma of the midface and craniofacial skeleton, and reconstructive procedures of the midface or craniofacial skeleton. The BioSorbFX System is used to stabilize bone during healing, in conjunction with appropriate postoperative immobilization. The BioSorbFX System includes an instrumentation set containing bone drills, bone taps, screwdrivers and plate benders.
The BioSorbFX System is not intended for use in and is contraindicated for: 1) the mandible; 2) full load bearing procedures; 3) areas with active infection; or 4) patient conditions, including blood supply limitations, insufficient quantity or quality of bone, or latent infections.
## Device Description and Principles of Operation
The BioSorbFX System contains various plates, meshes and screws that are made from poly-L/D,L-lactide ("P(L/DL)LA") copolymer, which consists of 70 molar percent poly-L lactide and 30 molar percent poly-D,L-lactide. Plates and meshes are provided as either straight-edged or scalloped edged of varying thickness, lengths, and shapes (e.g., rectangular, straight line, X-, L-, and C-shape). The plates are sized to be secured to the midface or craniofacial skeleton with a 1.5mm or 2.0mm bioabsorbable fastener (i.e., threaded screw). The BioSorbFX System is supplied pyrogen free and sterile following gamma radiation sterilization and is not intended to be resterilized by the user.
The BioSorbFX System is used in standard surgical procedures for reconstructive surgery or in the treatment of fractures of the midface and craniofacial skeletons. In conjunction with adequate surgical technique, the appropriate sized bioabsorbable craniofacial plates are used to stabilize bone fragments by attachment of the plate to the bones with plate fasteners (i.e., threaded screws). The BioSorbFX fasteners are inserted through the predrilled, counter sunk plate holes following drilling, pre-tapping, and flushing of the corresponding holes in the midface or craniofacial skeleton using standard surgical technique. The BioSorbFX fastener holds the BioSorbFX plate securely in place to allow for biological healing of the midface or craniofacial skeleton fracture or reconstruction. The plate remains securely fastened to the midface or craniofacial skeleton throughout the healing period, after which the plate and fasteners gradually degrade and are completely absorbed by the body. Thus, there is no need to surgically remove the devices.
## Technological Characteristics and Substantial Equivalence
The BioSorbFX Bioabsorbable Fixation System ("BioSorbFX System") contains various plates and threaded fasteners made of a biodegradable poly-L/D,Llactide ("P(L/DL)LA") copolymer, which consists of 70 molar percent poly-L lactide and 30
{2}------------------------------------------------
molar percent poly-D,L-lactide. The P(L/DL)LA material used in the BioSorbFX System is the same material used in other bioabsorbable devices previously cleared for implant use including the Bionx Implant Inc.'s Biodegradable Threaded Suture Anchor (K972783) and BioSorb Endobrow Screw (K972919), and Synthes, Inc. Resorbable Fixation System (K974555).
The BioSorbFX System has the same intended use and principles of operation and very similar technological characteristics as the bone plates and fasteners used in the previously cleared Synthes, Inc. Resorbable Fixation System (K974555) and the Walter Lorenz Surgical, Inc. LactoSorb® Trauma Plating System (K974309, K971870, and 960988). Like these predicate devices, the BioSorbFX System is intended for craniofacial trauma and reconstructive surgical procedures in the midface and craniofacial skeleton. All three fixation systems offer a variety of plate sizes and shapes and plate fasteners in both a 1.5 mm and 2.0 mm diameter size. Both the BioSorbFX System and the LactoSorb Trauma Plating System provide the user with customized instrumentation sets for use with their products. Additonally, the instrumentation set of the BioSorbFX System is similar to the instrumentation set included with Bionx's BioSorb Endobrow Screw (K972919).
The BioSorbFX System, the Synthes, Inc. Resorbable Fixation System and the LactoSorb Trauma Plating System are made of bioabsorbable materials. The BioSorbFX System and the Synthes, Inc. Resorbable Fixation System are made of the same biodegradable poly-L/D,L-lactide ("P(L/DL)LA") copolymer, while the LactoSorb is made of a reabsorbable copolymer consisting of a synthetic polyester derived from lactic and glycolic acids ("PLA/PGA"). All of these materials are biocompatible and have been shown to maintain sufficient physical integrity and mechanical holding properties within the bone for a sufficient period of time during the biological healing process. Unlike nonbioabsorbable fixation devices, the BioSorbFX System and the predicate devices do not require a second operation to remove the devices after the site has healed.
### Summary Basis for the Finding of Substantial Equivalence
Like the previously cleared Synthes Resorbable Fixation System, and the Lorenz LactoSorb® Trauma Plating System, the BioSorbFX system has the same intended use and principles of operation and very similar technological characteristics. Furthermore, the BioSorbFX System is made of the identical biodegradable P(L/DL)LA material used in other Bionx products, including the Bionx Endobrow Screw and the Biodegradable Threaded Suture Anchor, and to the Synthes Fixation System, all of which have previously been cleared by the FDA for implant use. Any minor product design differences, such as differences in configurations, between the BioSorbFX System and the predicate devices do not raise any new issues of safety or effectiveness.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other. The faces are abstract and appear to be made of curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 5 1998
Bionx Implants, Incorporated C/O Mr. Jonathan S. Kahan Partner Hogan & Hartson L.L.P. Columbia Square 555 Thirteenth Street, N.W. Washington, DC 20004-1109
Re : K982139 BioSorbFX 1.5/2 0 Bioabsorbable Fixation Trade Name: System Requlatory Class: II Product Code: JEY Dated: June 17, 1998 Received: June 17, 1998
Dear Mr. Kahan:
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, qood manufacturing practice, labeling, and prohibitions aqainst 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 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 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
{4}------------------------------------------------
Page 2 - Mr. Kahan
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 beqin 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) 594-4692. 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" (21CFR 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/dsmamain.html".
Sincerely yours,
Patricia Cucente/flor
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Page 1 of 1
### INDICATIONS FOR USE
510(K) Number (if known): and the state of the state of the state of the states of the states of
Device Name:
BioSorbFX 1.5/2.0 Bioabsorbable Fixation System
Indications for Use:
The BioSorbFX System is intended for use in trauma and reconstructive procedures in the midface and craniofacial skeleton. Specifically, the device is indicated for use in treating comminuted fractures of the naseothmoidal and infraorbital areas; comminuted fractures of the frontal sinus wall; trauma of the midface and craniofacial skeleton, and reconstructive procedures of the midface or craniofacial skeleton. The BioSorbFX System is used to stabilize bone during healing in conjunction with appropriate postoperative immobilization. The BioSorbFX System includes an instrumentation set containing bone taps, screwdrivers and plate benders.
The BioSorbFX System is not intended for use in: 1) the mandible; 2) full load bearing procedures; 3) areas with active infection; or 4) patient conditions, including blood supply limitations, insufficient quantity or quality of bone, or latent infections.
### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rower
(Division Sign-off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_K9 Sol) 39
Prescription Use (Per 21 CFR 801.109)
\\\DC - 63547/13 - 0668113.01
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
