OSTEO 9MM IC TIBIAL NAIL

• K Number: K984353
• Device Name: OSTEO 9MM IC TIBIAL NAIL
• Manufacturer: OSTEONICS CORP.
• Date Cleared: 1998-12-16 ( 9 days)
• Product Code: HSB
• Regulation Number: 888.3020
• Type: Special
• Panel: Orthopedic
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Osteo 9mm IC Tibial Nail is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:

• Static and compression locking
• Transverse and short oblique fractures
• Pseudarthrosis
• Correction osteotomies

Device Description

The Osteo 9mm IC Tibial Nail is a cylindrical, cannulated stainless steel tube. Tibial Nails provide for the alignment and stabilization of long bone fractures while maintaining limb length and resisting rotation of the fracture segments. The Osteo 9mm IC Tibial Nail is implanted in association with proximal and distal locking screws with the aid of several associated Class I manual surgical instruments. The Tibial Nails are stainless steel tubes gun-drilled from a solid Stainless Steel bar. Three external longitudinal grooves are pressed into the tube and are intended to provide greater resistance to bending and increased torsional stability. The Osteo 9mm IC Tibial Nail is available in lengths from 240mm to 420mm in 15mm increments, and has a distal shaft diameter of 9mm. A compression screw and locking screw may be used with the Tibial Nail. An end cap is also available for use with the Tibial Nail. An end cap is used if a compression screw has not been used.

The following changes have been made to the modified Tibial Nail.

• The wall thickness of the Tibial Nail has been increased by 0.2mm, resulting in a reduction in the distal cannulation diameter from 6.4mm to 6.0mm. The 9mm outer diameter of the distal end of the nail remains the same.
• The length of the ø11mm proximal portion of the Tibial Nail was increased from 33mm to 60mm, and the proximal portion of the nail is tapered at a 2° angle from o1 1mm to 09mm.
• In order to reduce irritation of the patella tendon, the proximal anterior end of the modified Tibial Nail features a small 10° chamfer 5.7mm in length.

AI/ML Overview

The provided 510(k) K984353 is for a special premarket notification for a modified Osteo 9mm IC Tibial Nail and does not contain a clinical study with acceptance criteria and device performance as typically expected for software-as-a-medical-device (SaMD) or AI-based devices.

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device based on design and material modifications and mechanical testing, which is common for implantable orthopedic devices.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable to this type of submission.

Here's a breakdown of the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of acceptance criteria and device performance in the way one would for a diagnostic or AI device (e.g., sensitivity, specificity, AUC).

Instead, the "acceptance criteria" are implied by demonstrating that the modified device maintains its mechanical integrity and functionality despite changes, thus remaining substantially equivalent to the predicate device. The "performance" is implicitly demonstrated through the modifications described, which suggest improved characteristics while maintaining the core function.

• Acceptance Criteria (Implied):

  • Maintain overall mechanical integrity and strength for long bone fracture fixation.
  • Continue to provide for alignment and stabilization of long bone fractures.
  • Resist bending and provide increased torsional stability.
  • Be compatible with associated Class I manual surgical instruments.
  • Maintain the same indications for use as the predicate device.
  • Reduce irritation of the patella tendon (new improvement).
  • Wall thickness increase, cannulation diameter reduction, proximal length increase, and taper angle are within acceptable engineering parameters for the intended function.

• Reported Device Performance (Implicit through modifications):

  • Increased wall thickness (by 0.2mm): This generally implies greater strength and resistance to deformation.
  • Reduction in distal cannulation diameter (from 6.4mm to 6.0mm): A consequence of increased wall thickness, still allowing for guide wire usage.
  • Increased length of ø11mm proximal portion (from 33mm to 60mm) and 2° taper: These changes likely improve fit, stability, or surgical technique.
  • Small 10° chamfer (5.7mm in length) on proximal anterior end: Specifically designed to "reduce irritation of the patella tendon," indicating an improvement in patient comfort/safety.
  • The modifications are described to "provide greater resistance to bending and increased torsional stability" (though the pre-modification nail also claimed this, the increased wall thickness would support this for the modified nail).

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

• Not applicable for this type of submission. This submission relies on engineering design changes and mechanical performance evaluations, not clinical data from a "test set" in the context of diagnostic accuracy. The testing would involve physical samples of the device.
• Data Provenance: Not specified as it's a device modification, relying on in-house engineering and potentially biomechanical testing.

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

• Not applicable. "Ground truth" in this context would refer to the physical and mechanical properties of the device, established through engineering specifications and testing. It doesn't involve clinical expert consensus on an interpretation.

4. Adjudication Method for the Test Set:

• Not applicable. No adjudication process as it's not a diagnostic study.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• No. This is not a diagnostic device or an AI-assisted interpretation tool. It's an orthopedic implant.

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

• No. This is a physical orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used:

• Engineering specifications and biomechanical testing (implied). The "ground truth" for this device's performance relies on its physical and mechanical properties as designed and confirmed through standard engineering tests, ensuring it meets the requirements for load-bearing and fracture fixation.

8. The Sample Size for the Training Set:

• Not applicable. No "training set" in the context of an algorithm. Design iterations and materials research would be more analogous to "training," but not in the AI sense.

9. How the Ground Truth for the Training Set was Established:

• Not applicable. See point 8.

Summary

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K984353

SPECIAL 510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS Osteo 9mm IC Tibial Nail

Submission Information

Name and Address of the Sponsor of the 510(k) Submission:

Contact Person:

Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677 201-825-4900

Kate Sutton Regulatory Affairs Specialist

Date Summary Prepared:

Device Identification

Proprietary Name:

Common Name:

Classification Name and Reference:

December 1, 1998

Osteo 9mm IC Tibial Nail

Intramedullary Nail, Tibial Nail

Intramedullary Fixation Rod 21 CFR §888.3020

Predicate Device Identification

The design and function of the Osteo 9mm IC Tibial Nail is substantially equivalent to that of the predicate Osteo 9mm IC Tibial Nail. The subject and predicate systems offer tibial nails in varying lengths, and utilize compression screws, a locking screw, and an end cap.

Device Description

The Osteo 9mm IC Tibial Nail is a cylindrical, cannulated stainless steel tube. Tibial Nails provide for the alignment and stabilization of long bone fractures while maintaining limb length and resisting rotation of the fracture segments. The Osteo 9mm IC Tibial Nail is implanted in association with proximal and distal locking screws with the aid of several associated Class I manual surgical instruments. The Tibial Nails are stainless steel tubes gun-drilled from a solid Stainless Steel bar. Three external longitudinal grooves are pressed into the tube and are intended to provide greater resistance to bending and increased torsional stability. The Osteo 9mm IC Tibial Nail is available in lengths from 240mm to 420mm in 15mm increments, and has a distal shaft diameter of 9mm. A compression screw and locking screw may be used with the Tibial Nail. An end cap is also available for use with the Tibial Nail. An end cap is used if a compression screw has not been used.

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The following changes have been made to the modified Tibial Nail.

• The wall thickness of the Tibial Nail has been increased by 0.2mm, resulting in a reduction 1) in the distal cannulation diameter from 6.4mm to 6.0mm. The 9mm outer diameter of the distal end of the nail remains the same.
• The length of the ø11mm proximal portion of the Tibial Nail was increased from 33mm to 2) 60mm, and the proximal portion of the nail is tapered at a 2° angle from o1 1mm to 09mm.
• 3. In order to reduce irritation of the patella tendon, the proximal anterior end of the modified Tibial Nail features a small 10° chamfer 5.7mm in length.

Intended Use

The Osteo 9mm IC Tibial Nail is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:

• 0 Static and compression locking

• Transverse and short oblique fractures

• Pseudarthrosis
• Correction osteotomies থা

Statement of Technological Comparison

The subject modified Osteo 9mm IC Tibial Nail components are substantially equivalent in design and intended use to the predicate unmodified Osteo 9mm IC Tibial Nail components.

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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle.

DEC I 6 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kate Sutton Regulatory Affairs Specialist Osteonics Corporation 59 Route 17 07401-1677 Allendale, New Jersey

Re: K984353 Osteo 9mm IC Tibial Nail Trade Name: Regulatory Class: II Product Code: HSB December 1, 1998 Dated: December 7, 1998 Received:

Dear Ms. Sutton:

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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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.

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Page 2 - Ms. Kate Sutton

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Colin M. Whitton, Ph.D.

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

Enclosure

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510(k) Number (if known): K984353

Device Name: Osteo 9mm IC Tibial Nail

Indications For Use:

The indications for the use of the Osteo 9mm IC Tibial Nail remain unchanged and are as follows:

• . Static and compression locking
• Transverse and short oblique fractures .
• Pseudarthrosis
• Correction osteotomies ●

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

Concurrence of CDRH, Office of Device Evaluation

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
K984353

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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.