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.

Device Description

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.

AI/ML Overview

Here's an analysis of the provided text regarding the BioSorbFX 1.5/2.0 Bioabsorbable Fixation System, focusing on acceptance criteria and study information.

Executive Summary:

The provided 510(k) summary for the BioSorbFX 1.5/2.0 Bioabsorbable Fixation System does not contain explicit acceptance criteria or a description of a clinical study that proves the device meets specific performance criteria. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. This means that the device is deemed safe and effective because it is similar in intended use, technological characteristics, and principles of operation to devices already legally marketed.

The key arguments for substantial equivalence are:

Identical material: The BioSorbFX System uses the same P(L/DL)LA copolymer as other FDA-cleared Bionx products (e.g., Biodegradable Threaded Suture Anchor, BioSorb Endobrow Screw) and the Synthes, Inc. Resorbable Fixation System.
Similar intended use and principles of operation: It’s intended for craniofacial trauma and reconstructive procedures, similar to the Synthes Resorbable Fixation System and the Walter Lorenz Surgical, Inc. LactoSorb® Trauma Plating System.
Similar technological characteristics: It offers a variety of plate sizes/shapes and fasteners (1.5mm and 2.0mm diameters) and customized instrumentation sets, mirroring the predicate devices.

Therefore, the answers to most of your specific questions related to acceptance criteria and a study design will be "Not Applicable" or "Not Provided" in this document, as the regulatory pathway chosen was substantial equivalence, not a direct demonstration through a new clinical trial with pre-defined acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated within this 510(k) summary. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than meeting novel performance acceptance criteria based on new clinical data.	The device meets the criteria for substantial equivalence to legally marketed predicate devices, implying comparable safety and effectiveness. Specifically: - Made of P(L/DL)LA copolymer (70% poly-L lactide, 30% poly-D,L-lactide). - Intended for trauma and reconstructive procedures in the midface and craniofacial skeleton. - Stabilizes bone during healing and gradually degrades/absorbs. - Operates similar to predicate devices by attaching plates with fasteners. - Materials are biocompatible and maintain sufficient physical integrity and mechanical holding properties within the bone for healing.
(Implied) Biocompatibility	P(L/DL)LA material is "biocompatible" and shown to maintain "sufficient physical integrity and mechanical holding properties."
(Implied) Mechanical strength/stability for healing period	"Maintain sufficient physical integrity and mechanical holding properties within the bone for a sufficient period of time during the biological healing process."
(Implied) Complete absorption	Device "gradually degrade and are completely absorbed by the body."

2. Sample size used for the test set and the data provenance

Not applicable. The 510(k) summary does not describe a new clinical "test set" or a new clinical study with human subjects for the BioSorbFX System. The evidence provided is primarily based on the material properties and comparison to predicate devices, which would have had their own studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No new clinical study or test set requiring expert ground truth establishment for this device is described in the provided document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No new clinical study or test set requiring an adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a bioabsorbable fixation system, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to its regulatory pathway based on this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable to a new study for this device. The "ground truth" for the substantial equivalence argument relies on the established safety and effectiveness of the predicate devices and the known properties of the P(L/DL)LA material, which would have been established through preclinical and clinical data for those antecedent products/materials (e.g., biocompatibility testing, mechanical testing, animal studies, and clinical outcomes for the predicate devices).

8. The sample size for the training set

Not applicable. No new "training set" for an algorithm is relevant to this device's submission.

9. How the ground truth for the training set was established

Not applicable. No new "training set" for an algorithm is relevant to this device's submission.

Summary

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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)

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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

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

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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.

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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

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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

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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:

(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

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
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.(b)
Classification. Class II.