The intended use of the I.T.S. IM Nail Systems is to stablilize and fix long bone fractures to facilitate healing in an adult patient and is composed of the following categories:

The I.T.S. CFN - Cannulated Femur Nail System is indicated for use in long bone femur fracture fixation which include:

Open and closed femur shaft fractures; Intertrochanteric, supracondylar and ipsilateral fractures; High subtrochanteric fractures; Combined inter and subrochanteric fractures; Pertrochanteric fractures; Pseudoarthrosis and correction osteotomy; Non-union, malunion and delayed union fractures; Pathological fractures, impending pathologic fractures, and tumor resections and; Fractures proximal to a total knee arthroplasty; The system is not for spinal use.

The I.T.S. CTN - Cannulated Tibia Nail System is indicated for use in long bone tibia fracture fixation which include:

Proximal, metaphyseal, epiphyseal and distal shaft fractures; Segmental, simple, compound and comminuted fractures; Transverse, oblique and spiral fractures; Surgically created defects using osteotomies,such as for leg length discrepencies or deformity; Pathologic fractures; Pseudoarthrosis, non-union, mal-union and delayed union of the tibia; Fractures involving osteopenic and osteoporotic bone; Open fractures of the tibia and; Reconstruction of the tibia after tumor resection and/or bone loss.

The system is not for spinal use.

The I.T.S. CHN - Cannulated Humeral Nail System is indicated for use in long bone humerus fracture fixation which include:

Dislocated, unstable 2, 3 and 4 part fractures of the proximal humerus; Valgusimpacted 4 part fractures of the proximal humerus; Proximal humeral fractures with diaphyseal extension into the shaft; Pseudoarthrosis, non-unions, mal-unions and malalignments of the proximal humerus and; Pathological and impending pathological fractures.

The system is not for spinal use.

Device Description

The I.T.S. IM Nail Systems CFN-CTN-CHN consists of Predicate type intramedullary nail trauma implant components commonly found with large companies with orthopedic markets in the United States. These 'Intramedullary (IM) Nail trauma implant devices' consist of the following categories:

CFN - Cannulated Femur Nail System
CTN - Cannulated Tibia Nail System
CHN - Cannulated Humeral Nail System

A brief and concise description of each system is enclosed as follows:

CFN - Cannulated Femur Nail System: The I.T.S. CFN -Cannulated Femur Nail System is a curved/bowed Intramedullary(IM) Nail in a right and left configuration to fit the natural bow of the femur and is inserted proximally/antegrade over 3.5/3.0mm calibrated guide wires. The CFN - IM Nail is composed of various nail diameters in sizes of 9.0, 10.0, 11.0, 12.0 and 13.0mm and various lengths from 240mm to 480mm in 20mm increments. The CFN - IM Nail accepts a 6.5mm Cortical Screw in various lengths for cross-screw fixation in the larger diameter proximal region of the nail and a 4.7mm Triple-lead Cortical Screw in various lengths for crossscrew fixation in the distal portion of the nail. A dynamization slot is located in the distal portion of the nail and an End Cap (in +0, +5, +10, +15, +20, +25 & +30 lengths) is available for proximal closing of the nail. The nail proximal cross-screw insertion uses Insertion Guide instrumentation for location of the hole and screw insertion preparation throught the bone cortex and nail. The nail distal cross-screw insertion uses x-ray fluoroscopic imaging for nail distal hole/slot location.

All CFN - JM Nail, End Cap and Screw components are manufactured from Alloyed 6-4 Titanium material to ASTM F136 and are processed with an anodize DOTIZE surface treatment.

Associated instrumentation such as Insertion Guide accessories, guide pins, drill sleeves, drill guides, drills, screwdriver, depth gauge with removal instruments are available with the system. All CFN - IM Nails, End Caps and Screws are provided Non-Sterile.

CTN - Cannulated Tibia Nail System: The I.T.S. CTN -Cannulated Tibia Nail System is a universal straight Intramedullary(IM) Naïl with a 50 proximal and distal bend configuration to fit the anatomy of the tibia and is inserted proximally/antegrade over 3.5/3.0mm calibrated guide wires. The CTN - IM Nail is composed of various nail diameters in sizes of 9.0, 10.0. 11.0. and 12.0mm and various lengths from 240mm to 420mm in 1 5mm increments. The CTN - IM Nail accepts only the 4.7mm Triple-lead Cortical Screw in various lengths for cross-screw fixation in both the proximal/distal portion of the nail. A dynamization slot is located in the proximal portion of the nail and an End Cap (in +0, +5, +10, +15, +20, +25, +30 lengths) is available for proximal closing of the nail. The nail proximal cross-screw insertion uses Insertion Guide instrumentation for location of the hole/slot and screw insertion preparation throught the bone cortex and nail. The nail distal cross-screw insertion uses x-ray fluoroscopic imaging for nail distal hole location.

All CTN - IM Nail, End Cap and Screw components are manufactured from Alloved 6-4 Titanium material to ASTM F136 and are processed with an anodize DOTIZE surface treatment.

Associated instrumentation such as Insertion Guide accessories, guide pins, drill sleeves, drill guides, drills, screwdriver, depth gauge and removal instruments are available with the system. All CTN - IM Nails, End Caps and Screws are provided Non-Sterile.

CHN - Cannulated Humeral Nail System: The I.T.S. CHN -Cannulated Humeral Nail System is a right and left Intramedullary (IM) straight Nail with a 4 proximal bend configuration to fit the anatomy of the humerus and is inserted proximally over 2.0/2.5mm calibrated guide wires. The CHN - IM Nail is composed of various nail diameters in sizes of 7.0. 8.0. and 9.0mm and various lengths from 140mm to 320mm in 10 and 20mm increments. The CHN - IM Nail accepts only a 3.5mm Double-lead Cortical Screw in various lengths for cross-screw fixation in both the proximal/distal portion of the nail. An End Cap (in +0, +5, +10, +15, +20, +25 & +30 lengths) is available for proximal closing of the nail. The nail proximal cross-screw insertion uses Insertion Guide instrumentation for location of the hole and screw insertion preparation throught the bone cortex and nail. The nail distal cross-screw insertion uses x-ray fluoroscopic imaging for nail distal hole location.

All CHN - IM Nail, End Cap and Screw components are manufactured from Alloyed 6-4 Titanium material to ASTM F136 and are processed with an anodize DOTIZE surface treatment.

Associated instrumentation such as Insertion Guide accessories, guide pin, drill sleeves, drill guides, drills, screwdriver, depth gauge and removal instruments are available with the system. All CHN -IM Nails, End Caps and Screws are provided Non-Sterile.

AI/ML Overview

The provided text is a 510(k) summary for the I.T.S. IM Nail Systems CFN-CTN-CHN, which describes various intramedullary nails for stabilizing and fixing long bone fractures. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study to prove acceptance criteria based on device performance metrics like sensitivity, specificity, or accuracy.

Therefore, the following information cannot be fully extracted as it is not contained within the provided 510(k) summary:

A table of acceptance criteria and the reported device performance: This document does not establish specific performance acceptance criteria or report a study comparing the device's performance against such criteria.
Sample size used for the test set and the data provenance: No test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described for a test set.
Adjudication method for the test set: No adjudication method is described.
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: No MRMC study is mentioned, nor is AI involved in this device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This pertains to algorithm performance and is not relevant to a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no ground truth is established for a performance study.
The sample size for the training set: Not applicable as this is not an AI/algorithm-based device and does not involve training sets.
How the ground truth for the training set was established: Not applicable.

The 510(k) summary explicitly states the method used for demonstrating the device meets acceptance criteria:

Equivalence and Study that Proves the Device Meets Acceptance Criteria:

The acceptance criterion for this device is "Substantial Equivalence" to legally marketed predicate devices. The study that proves the device meets this acceptance criterion is a comparison of technological characteristics to predicate devices.

The document states:

"The I.T.S. IM Nail Systems CFN-CTN-CHN are Substantially Equivalent(SE) to the various predicate IM Nail, End Cap and Screw Systems as listed." (Page 3)
"No nonclinical testing was used in the determination of substantial equivalence." (Page 3)
"The I.T.S. IM Nail Systems CEN-CTN-CHN are Similar in Material, Geometry Design/Markings, and Indications to predicate system(s) currently sold in the U.S. market." (Page 3)

This means the "study" for this 510(k) submission was a documentary comparison, not a clinical trial or performance study typical for AI/software devices. The device meets "acceptance criteria" by demonstrating that its materials, design, and intended uses are sufficiently similar to devices already approved by the FDA, thereby inferring the same safety and effectiveness.

Key information explicitly found in the document related to acceptance criteria and the "study":

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Demonstration for Substantial Equivalence)	Device "Performance" (Comparison to Predicate Devices)
Similar in Material	Manufactured from Alloyed 6-4 Titanium material to ASTM F136; anodize DOTIZE surface treatment (same as predicates, implied)
Similar in Geometry Design/Markings	Design features (cannulated, curved/straight, specific diameters/lengths, screw types, dynamization slot, end caps) are comparable to predicate devices.
Similar in Indications for Use	Indications for use for femur, tibia, and humerus fracture fixation are comparable to predicate devices.
No nonclinical testing required	Stated explicitly: "No nonclinical testing was used in the determination of substantial equivalence."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. No test set was used for a performance study. The evaluation was based on a comparison of device specifications and indications for use against predicate devices.

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

Not applicable. No ground truth was established by experts for a test set. The review was primarily regulatory, comparing the new device's characteristics to existing predicate devices.

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

Not applicable. No test set requiring adjudication was used.

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:

No MRMC study was done. This device is a physical intramedullary nail system and does not involve AI or human readers for diagnostic interpretation.

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

Not applicable. This device is a physical intramedullary nail system and does not involve algorithms.

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

Not applicable. For a substantial equivalence claim for a physical device like an intramedullary nail, the "ground truth" implicitly refers to the established safety and effectiveness of the predicate devices based on their prior approval and post-market experience.

8. The sample size for the training set:

Not applicable. This is not an AI/algorithm-based device.

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

Not applicable. This is not an AI/algorithm-based device.

Summary

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K132945 (1/4)

I.T.S. GmbH - 510(k) Summary -

510(k) Summary of Safety and Effectiveness

MAR 0 7 2014

SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary

NAME OF FIRM:	I.T.S. GmbHAutal 28Lassnitzhöehe A-8301AUSTRIAwww.its-implant.com
510(k) FIRM CONTACT:	Al LippincottEngineering Consulting Services, Inc.3150 E. 200th St.Prior Lake, MN 55372Tel. No. 952-492-5858e-mail: allippincott@msn.com
DATE:	August 31, 2013
TRADE NAME:	I.T.S. IM Nail Systems CFN-CTN-CHN
COMMON NAME:	Femoral, Tibial and Humeral - Intramedullary Nail
CLASSIFICATION:	Rod, Fixation, Intramedullary and Accessories;Screw, Fixation, Bone;Nail, Fixation, Bone;Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentIntramedullary fixation rod (See 21 CFR, Sec. 888.3020).Smooth or threaded metallic bone fixation fastener (See 21CFR, Sec.888.3040).Single/multiple component metallic bone fixation applieances andaccessories (See 21 CRF, Sec. 888.3030).
DEVICE PRODUCT CODE:	HSB
SUBSEQUENT PRODUCT CODE:	HWC, JDS, KTT
SUBSTANTIALLYEQUIVALENT DEVICES	Synthes - Proximal Femoral (PFN) & Cannulated Femoral Nail (CFN)Systems (K970097, K954856)Zimmer - Sirus IM Femur Nail System (K093270)Stryker - T2 RECON Nail System (K032898, K051624, K102992)Biomet - Femoral Locking Nail System (K072161)Synthes - Ti Cannulated Tibial Nail (CTN) System (K962047)Zimmer - Sirus IM Tibia Nail System (K093270, K082770)Stryker - T2 Tibial Nailing System (K021027,K011622,K003018)Biomet - Tibial Locking Nail System (K063570)I.T.S. - CONNEXX Locking Tibia Nail (K080706)

I.T.S. IM Nail Systems CFN-CTN-CTN-CHN Page 1 of 4 Section XII .

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I.T.S. GmbH - 510(k) Summary -

I.T.S. - Distal Humeral 3.5mm Cortical Scew (K080184) Synthes - MultiLoc Humeral Nailing System (K120807) Smith & Nephew - TriGen Straight Humeral Nail (K032722) Stryker - T2 Proximal Humeral Nailing System (K042396) Acumed - Polarus Humeral Rod (K920666, K951673, K951740)

DEVICE DESCRIPTION:

1. CFN - Cannulated Femur Nail System

2. CTN - Cannulated Tibia Nail System

3. CHN - Cannulated Humeral Nail System

A brief and concise description of each system is enclosed as follows:

CFN - Cannulated Femur Nail System: The I.T.S. CFN -Cannulated Femur Nail System is a curved/bowed Intramedullary(IM) Nail in a right and left configuration to fit the natural bow of the femur and is inserted proximally/antegrade over 3.5/3.0mm calibrated guide wires. The CFN - IM Nail is composed of various nail diameters in sizes of 9.0, 10.0, 11.0, 12.0 and 13.0mm and various lengths from 240mm to 480mm in 20mm increments. The CFN - IM Nail accepts a 6.5mm Cortical Screw in various lengths for cross-screw fixation in the larger diameter proximal region of the nail and a 4.7mm Triple-lead Cortical Screw in various lengths for crossscrew fixation in the distal portion of the nail. A dynamization slot is located in the distal portion of the nail and an End Cap (in +0, +5, +10, +15, +20, +25 & +30 lengths) is available for proximal closing of the nail. The nail proximal cross-screw insertion uses Insertion Guide instrumentation for location of the hole and screw insertion preparation throught the bone cortex and nail. The nail distal cross-screw insertion uses x-ray fluoroscopic imaging for nail distal hole/slot location.

All CFN - JM Nail, End Cap and Screw components are manufactured from Alloyed 6-4 Titanium material to ASTM F136 and are processed with an anodize DOTIZE surface treatment.

I.T.S. IM Nail Systems CFN-CTN-CHN

{2}------------------------------------------------

I.T.S. GmbH - 510(k) Summary -DEVICE DESCRIPTION CONTINUED:

CTN - Cannulated Tibia Nail System: The I.T.S. CTN -Cannulated Tibia Nail System is a universal straight Intramedullary(IM) Naïl with a 50 proximal and distal bend configuration to fit the anatomy of the tibia and is inserted proximally/antegrade over 3.5/3.0mm calibrated guide wires. The CTN - IM Nail is composed of various nail diameters in sizes of 9.0, 10.0. 11.0. and 12.0mm and various lengths from 240mm to 420mm in 1 5mm increments. The CTN - IM Nail accepts only the 4.7mm Triple-lead Cortical Screw in various lengths for cross-screw fixation in both the proximal/distal portion of the nail. A dynamization slot is located in the proximal portion of the nail and an End Cap (in +0, +5, +10, +15, +20, +25, +30 lengths) is available for proximal closing of the nail. The nail proximal cross-screw insertion uses Insertion Guide instrumentation for location of the hole/slot and screw insertion preparation throught the bone cortex and nail. The nail distal cross-screw insertion uses x-ray fluoroscopic imaging for nail distal hole location.

All CTN - IM Nail, End Cap and Screw components are manufactured from Alloved 6-4 Titanium material to ASTM F136 and are processed with an anodize DOTIZE surface treatment.

CHN - Cannulated Humeral Nail System: The I.T.S. CHN -Cannulated Humeral Nail System is a right and left Intramedullary (IM) straight Nail with a 4 proximal bend configuration to fit the anatomy of the humerus and is inserted proximally over 2.0/2.5mm calibrated guide wires. The CHN - IM Nail is composed of various nail diameters in sizes of 7.0. 8.0. and 9.0mm and various lengths from 140mm to 320mm in 10 and 20mm increments. The CHN - IM Nail accepts only a 3.5mm Double-lead Cortical Screw in various lengths for cross-screw fixation in both the proximal/distal portion of the nail. An End Cap (in +0, +5, +10, +15, +20, +25 & +30 lengths) is available for proximal closing of the nail. The nail proximal cross-screw insertion uses Insertion Guide instrumentation for location of the hole and screw insertion preparation throught the bone cortex and nail. The nail distal cross-screw insertion uses x-ray fluoroscopic imaging for nail distal hole location.

All CHN - IM Nail, End Cap and Screw components are manufactured from Alloyed 6-4 Titanium material to ASTM F136 and are processed with an anodize DOTIZE surface treatment.

{3}------------------------------------------------

I.T.S. GmbH - 510(k) Summary -

INTENDED USE:

The intended use of the I.T.S. IM Nail Systems CFN-CTN-CHN is to stablilize and fix long bone fractures to facilitate healing in an adult patient and is composed of the following categories:

The I.T.S. CFN - Cannulated Femur Nail System is indicated for use in long bone femur fracture fixation which include:

Open and closed femur shaft fractures; Intertrochanteric, supracondylar and ipsilateral fractures; High subtrochanteric fractures; Combined inter and subrochanteric fractures; Pertrochanteric fractures; Pseudoarthrosis and correction osteotomy; Non-union, mal-union and delayed union fractures; Pathological fractures, impending pathologic fractures, and tumor resections and; Fractures proximal to a total knee arthroplasty; The system is not for spinal use.

The I.T.S. CTN - Cannulated Tibia Nail System is indicated for use in long bone tibia fracture fixation which include:

The system is not for spinal use.

The I.T.S. CHN - Cannulated Humeral Nail System is indicated for use in long bone humerus fracture fixation which include: Dislocated, unstable 2, 3 and 4 part fractures of the proximal humerus; Valgus-impacted 4 part fractures of the proximal humerus; Proximal hiumeral fractures with diaphyseal extension into the shaft; Pseudoarthrosis, non-unions, mal-unions and malalignments of the proximal humerus and; Pathological and impending pathological fractures.

The system is not for spinal use.

EQUIVALENCE:

The I.T.S. IM Nail Systems CFN-CTN-CHN are Substantially Equivalent(SE) to the various predicate IM Nail, End Cap and Screw Systems as listed. No nonclinical testing was used in the determination of substantial equivalence.

SUMMARY OF TECH-NOLOGICAL CHAR-ACTERISTICS

The I.T.S. IM Nail Systems CEN-CTN-CHN are Similar in Material, Geometry Design/Markings, and Indications to predicate system(s) currently sold in the U.S. market.

SUMMARY OF SAFETY AND EFFECTIVENESS:

The I.T.S. IM Nail Systems CFN-CTN-CHN are shown to be safe and effective for use in long bone fracture stablization and fixation in the femur, tibia and humerus.

I.T.S. IM Nail Systems CFN-CTN-CHN

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 7, 2014

I.T.S. GmbH % Mr. Al Lippincott U.S Agent and Official Correspondent for I.T.S. GmbH Engineering Consulting Services, Inc. 3150 E. 200th Street Prior Lake, Minnesota 55372

Re: K132945

Trade/Device Name: I.T.S. IM Nail Systems CFN-CTN-CHN Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Codes: HSB, HWC, JDS, KTT Dated: December 16, 2013 Received: December 20, 2013

Dear Mr. Lippincott:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{5}------------------------------------------------

Page 2 - Mr. Al Lippincott

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Vincent JFDAvlin -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

· Enclosure

{6}------------------------------------------------

INDICATIONS FOR USE

510(k) NUMBER: ﺷﻘﻪ

DEVICE NAME: I.T.S. IM Nail Systems CFN-CTN-CHN

The intended use of the I.T.S. IM Nail Systems is to stablilize and fix long bone fractures to facilitate healing in an adult patient and is composed of the following categories:

The I.T.S. CFN - Cannulated Femur Nail System is indicated for use in long bone femur fracture fixation which include:

The I.T.S. CTN - Cannulated Tibia Nail System is indicated for use in long bone tibia fracture fixation which include:

The system is not for spinal use.

The I.T.S. CHN - Cannulated Humeral Nail System is indicated for use in long bone humerus fracture fixation which include:

The system is not for spinal use.

Prescription Use

Over-The-Counter-Use - -

(Per 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L. Hanley, Ph.D.

1 | Page

Division of Orthopedic Devices

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.