The Fixion Interlocking Proximal Femoral Nailing System ("Fixion PF") is intended for use in fixation of fractures in the femur. It is indicated for use in fractures in the femur shaft and proximal fractures and combinations of these fractures. Proximal femoral fractures include stable and unstable pertrochanteric and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures. Shaft fractures include those that are 5cm below the surgical neck to 5cm proximal to the distal end of the medullar canal.

The Fixion PF is also indicated for use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures, and revision procedures.

Device Description

The Fixion Interlocking Proximal Femoral Nailing System is a single use system that consists of the following components:

The Nail implant is an expandable non-slotted stainless steel cylindrical tube, with a cap protected, female threaded proximal end with holes for Femoral Neck Peg and Hip Pin, to fix fractures in the proximal femur.
The Inflation device is a single-use manual plastic pump that is filled with sterile inflation liquid an used to inflate the nail implant and Femoral Neck Peg.

Once the nail and the Femoral Neck Peg and hip pin are positioned within the medullary canal and femur neck, rotation of the "pump" handle allows for screw and nail diameter increase to their intended diameter under X-ray and controlled pressure.

AI/ML Overview

The provided text describes the "Fixion Interlocking Proximal Femoral Nailing System" (Fixion PF), a medical device designed for fracture fixation in the femur. The submission is a 510(k) summary, aiming to demonstrate substantial equivalence to existing predicate devices.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study Details
Material Compliance	Device manufactured from 316L Stainless Steel meets requirements of ASTM F138.	Device is made from 316L Stainless Steel.	Not explicitly stated if a specific test was performed, but compliance with ASTM F138 is claimed.
Mechanical Performance (4-point bending)	Testing performed according to ASTM F1264.	Device found to meet specifications.	Bench tests were performed. Specific performance values (e.g., bending strength, stiffness) are not provided.
Mechanical Performance (Hip Peg)	Testing performed according to ASTM F384-99.	Device found to meet specifications.	Bench tests were performed. Specific performance values are not provided.
Intended Use Equivalence	Fixation of fractures in the femur.	Substantially equivalent to predicate devices (Fixion™ Interlocking Nail and Synthes Proximal Femoral Nail).	Evaluated based on intended use and indications being the same.
Design/Material Equivalence	Made of 316L Stainless Steel, cannulated design. Circular cross-section with reinforcement bars. Fixation achieved by inflation.	Identical to cleared Fixion Interlocking nail components, specifically 316L Stainless Steel and cannulated/circular design.	Comparison to predicate devices.
Inflation Mechanism Equivalence	Inflation with sterile saline, a non-compressible biocompatible fluid.	Identical to the cleared Fixion Interlocking nail. No new safety and efficacy issues raised.	Comparison to predicate device.
Fixation Equivalence with Peg/Pin	Addition of Femoral Neck Peg and Hip Pin provides equivalent fixation to the end of the nail.	Substantially equivalent to that of the Synthes Proximal Femoral Nail.	Bench tests implicitly support this equivalence regarding performance.

2. Sample Size Used for the Test Set and Data Provenance

The document primarily describes bench testing for mechanical properties.
Sample Size for Test Set: Not specified in the provided text for any of the mechanical tests (ASTM F138, F1264, F384-99). The number of test articles used for these bench tests is not mentioned.
Data Provenance: The studies were bench tests conducted by the manufacturer (Disc-O-Tech Medical Technologies Ltd.). There is no mention of human subject data, countries of origin, or whether studies were retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

For the mechanical bench tests, the "ground truth" is defined by the standards themselves (ASTM F138, F1264, F384-99). These standards define the test methods and performance considerations.
There's no indication of external "experts" being involved in establishing the ground truth for these physical tests beyond the expertise inherent in conducting tests according to established ASTM standards. This is not a clinical study where expert review of patient data would be required.

4. Adjudication Method for the Test Set

Not applicable. This is a submission for a physical medical device, not a diagnostic algorithm requiring human adjudication of results. Bench tests follow defined protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an orthopedic implant, not an AI-assisted diagnostic tool.

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

Not applicable. This device is an orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used

For mechanical performance: The ground truth is established by ASTM (American Society for Testing and Materials) standards for material properties and mechanical performance of intramedullary fixation devices (ASTM F138, F1264, F384-99).
For substantial equivalence in intended use and design: The ground truth is established by comparison to legally marketed predicate devices based on their cleared indications for use, materials, and design principles.

8. The Sample Size for the Training Set

Not applicable. This is a physical device submission demonstrating substantial equivalence through bench testing, not a machine learning model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device submission.

Summary

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K010988

JUN 1 9 2001 510(K) Summary

Disc-O-Tech Medical Technologies Ltd. Fixion Interlocking Proximal Femoral Nailing System

Company Name

Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot St., Herzelia Israel, 46728

Submitter's Name and Contact Person

Jonathan S. Kahan, Esq. 555 Thirteenth Street, NW Washington, DC 20004 Tel: 202-637-5794 Fax: 202-637-5910

Date Prepared

March, 2001

Trade/Proprietary Name

Fixion The Interlocking Proximal Femoral Nailing System

Classification Name

Intramedullary Fixation Rod 21 C.F.R. § 888.3020 Class II

Predicate Devices

1. Fixion Interlocking Nailing System (K002783) by Disc-O-Tech.
1. Proximal Femoral Nail (K970097) by Synthes.

Performance Standards

The following standards were used:

1. The Interlocking Nail is manufactured from 316L Stainless Steel, which meets the requirements of ASTM F138 - Standard Specification for Stainless steel Bar and Wire for Surgical Implants.
1. The 4 point bending mechanical testing was performed according to ASTM F1264 - Standard for Mechanical Performance Considerations for Intramedullary Fixation Devices.
1. The Hip Peg testing was performed according to ASTM F384-99 Standard Specification for Metallic Angled Orthopedic Fracture Fixation Devices.

Intended Use

The Fixion Interlocking Proximal Femoral Nailing System ("Fixion PF") is intended for use in fixation of fractures in the femur. It is indicated for use in fractures in the femur

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shaft and proximal fractures and combinations of these fractures. Proximal femoral fractures include stable and unstable pertrochanteric and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures. Shaft fractures include those that are 5cm below the surgical neck to 5cm proximal to the distal end of the medullar canal.

The Fixion PF is also indicated for use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures, and revision procedures.

System Description

The Fixion Interlocking Proximal Femoral Nailing System is a single use system that consists of the following components:

The Nail implant is an expandable non-slotted stainless steel cylindrical tube, with a cap protected, female threaded proximal end with holes for Femoral Neck Peg and Hip Pin, to fix fractures in the proximal femur.
The Inflation device is a single-use manual plastic pump that is filled with sterile inflation liquid an used to inflate the nail implant and Femoral Neck Peg.

Substantial Equivalence

The Fixion Interlocking Proximal Femoral Nailing System Nail has substantially equivalent intended use and indications as the Fixion™ Interlocking Nail and the Synthes Proximal Femoral Nail, i.e., fixation of fractures of the femur.

The performance characteristics of the Fixion Proximl Femoral Nail have been tested and found to meet the specifications through a series of bench tests.

The Fixion Interlocking Proximal Femoral Nail, like the Fixion TM Interlocking Nail, is made of 316L Stainless Steel and has cannulated design. The cross section of the Fixion Interlocking Proximal Femoral and the Fixion Interlocking nails is circular with reinforcement bars.

Fixation of the Fixion Interlocking Proximal Femoral and Interlocking nails is achieved by inflation and results in the attachment of the 4 reinforcement bars to the medullary canal wall. The addition of Femoral Neck Peg and Hip Pin provides equivalent fixation to the end of the nail, in a manner that is substantially equivalent to that of the Synthes Proximal Femoral Nail. The inflation of the Fixion Interlocking Proximal Femoral nail with saline, which is a non-compressible biocompatible fluid, is identical to the cleared Fixion Interlocking nail and does not raise any new safety and efficacy issues.

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Premarket Notification Truthful and Accurate Statement* (As required by 21 CFR 807.87(j))

I certify that, in my capacity as the General Manager of Disc-O-Tech Medical Technologies, Ltd., I believe to the best of my knowledge, that all data and information submitted in the premarket notification for the Fixion Interlocking Nailing System are truthful and accurate and that no material fact has been omitted.

Art. K

Signature

Elad Magal - General Manager Typed Name and Title

Disc-O-Tech Medical Technologies, Ltd. Company

03 / 28 / 01
Date

Premarket Notification 510(k) Number

* Must be signed by a responsible person of the firm required to submit the premarket notification (e.g., not a consultant for the 510(k) submitter)

Page 31 of 39

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three curved lines that suggest a head, body, and legs. The figure is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

# JUN 1 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Disc-O-Tech Medical Technologies, LTD. c/o Mr. Johnathan S. Kahan, Esq. 555 Thirteenth Street, NW Washington, DC 20004

Re: [K010988](https://510k.innolitics.com/search/K010988)

Trade Name: Fixion Interlocking Proximal Femoral Nailing System Regulation Number: 888.3020 Regulatory Class: II Product Codes: HSB Dated: March 28, 2001 Received: April 2, 2001

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 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 control provisions of the Act. The general control 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.

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.

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# Page 2 - Mr. Johnathan S. Kahan, Esq.

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,

Psmt dweelllwa kon

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indication for Use

510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________

Fixion Interlocking Proximal Femoral Nailing System Device Name:

Indication for Use:

The Fixion Interlocking Proximal Femoral Nailing System ("Fixion PF") is intended for use in fixation of fractures in the femur. The Fixion PF is indicated for use in fractures in the femur shaft, proximal femoral fractures, and combinations of these fractures. Proximal femoral fractures include stable and unstable pertrochanteric, intertrochanteric and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures. The long Fixion PF may also be used in mid shaft fractures, 5cm below the surgical neck to 5cm proximal to the distal end of the medullar canal.

The Fixion PF is also indicated for use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures, revision procedures.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(per 21 CFR 801.109) | X                                                                                          |
|------------------------------------------|--------------------------------------------------------------------------------------------|
| OR Counter Use                           |                                                                                            |
|                                          | <div style="text-decoration: overline;">Dsmita elllrus An chu</div><br>(Division Sign-Off) |
| Page 32 of 39                            | Division of General, Restorative<br>and Neurological Devices                               |
|                                          | 510(k) Number [K010988](https://510k.innolitics.com/search/K010988)                                                                      |

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.