MODIFICATION TO: LONG LENGTH GAMMA NAIL by HOWMEDICA OSTEONICS CORP.

The intended use of the modified Long Length Gamma® Nail is identical to that of the predicate Long Length Gamma® Nail: the product is intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intracondylar notch. Fracture types include basilar neck, intertrochanteric, subtrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, mal-union, pathological fractures, and impending pathological fractures.

Device Description

This Special 510(k) submission is intended to address a design modification to the predicate Long Length Gamma® Nail. The existing Long Length Gamma® Nail is an intramedullary rod intended to be used in the fixation of femoral fractures' occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. The current design is cannulated, with a medial/lateral and anterior/posterior curve. The design modification involves changing the radius of curvature in the A-P plane. The modified device will allow the surgeon greater intraoperative flexibility in treating a variety of femoral fractures. The modified Long Length Gamma® Nails are substantially equivalent to the existing design of Long Length Gamma® Nail which was determined substantially equivalent via the 510(k) process. The materials used to manufacture the modified device are identical to those of the predicate. There is no change in intended use for the modified device when compared to the previously cleared product.

AI/ML Overview

The provided text describes a Special 510(k) submission for a design modification to the Long Length Gamma Nail. This submission primarily focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a performance study with acceptance criteria in the way a new, innovative device might.

Therefore, the requested information elements related to performance criteria, sample sizes, expert involvement, and ground truth are largely not applicable in this context. The document's purpose is to show that a modified device (with a changed radius of curvature) is as safe and effective as the original, cleared device.

Here's a breakdown of the applicable and non-applicable information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not Applicable (The submission asserts substantial equivalence based on material and intended use, not new performance metrics with specific acceptance criteria.)	The modified device maintains identical intended use and materials to the predicate, with a design change in the radius of curvature. This change is claimed to allow "greater intraoperative flexibility." The FDA's clearance (K012158) confirms substantial equivalence.

Explanation: The filing is a Special 510(k), which is used for modifications to a manufacturer's own legally marketed device. The primary "acceptance criteria" for this type of submission is demonstrating that the modification does not raise new questions of safety or effectiveness and that the modified device remains substantially equivalent to the predicate. This is typically done through engineering analysis, material comparison, and confirming no change in intended use, rather than extensive new clinical performance studies with specific statistical targets.

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

Not Applicable. This Special 510(k) does not describe a performance study with a "test set" in the sense of clinical data or human subjects to evaluate the device against specific performance criteria. The evaluation is based on design comparison and engineering principles. The data provenance would be internal design and engineering specifications.

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

Not Applicable. As no clinical "test set" or ground truth requiring expert consensus is described for this specific modification, this information is not relevant to this submission. The "ground truth" for the device's efficacy and safety relies on the predicate device's prior clearance and the engineering assessment of the modification.

4. Adjudication Method for the Test Set:

Not Applicable. No test set or expert adjudication is described in this Special 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No. This type of study is entirely irrelevant to a Special 510(k) for a mechanical device modification like an intramedullary nail. MRMC studies are typically used for medical imaging devices where human interpretation is a key component.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No. This concept is not applicable to a mechanical orthopedic implant. "Standalone performance" or "algorithm only" refers to AI or software-as-a-medical-device, which is not what the Long Length Gamma® Nail is.

7. The Type of Ground Truth Used:

Implicit Engineering and Clinical Equivalence. For this Special 510(k), the "ground truth" is that the modified device's design (specifically the changed radius of curvature) does not alter its fundamental mechanical properties, biological compatibility, or clinical performance in a way that would require new safety or efficacy data. This is established by comparing the modified design to the predicate device's known and accepted performance, supported by engineering analysis. The FDA's clearance serves as confirmation of this "ground truth."

8. The Sample Size for the Training Set:

Not Applicable. This device is a mechanical implant, not an AI or machine learning system that requires a "training set."

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

Not Applicable. As there is no training set, this question is not relevant.

Summary of the Special 510(k) for the Long Length Gamma® Nail Modification:

The provided document is a Special 510(k) submission for a design change to an existing intramedullary nail. The core of such a submission is to demonstrate that the modified device is substantially equivalent to the predicate device, meaning it is as safe and effective. This is achieved by showing:

Identical Intended Use: The modified device has the same indications for use as the predicate (fixation of femoral fractures from the base of the femoral neck to ~10 cm proximal to the intercondylar notch).
Identical Materials: The materials used are the same as the predicate.
Minor Design Change without Affecting Safety/Effectiveness: The change is specifically to the radius of curvature in the A-P plane, which is described as enhancing "intraoperative flexibility." The FDA's clearance (K012158) confirms that this modification does not raise new questions of safety or effectiveness and maintains substantial equivalence.

Therefore, the "proof" the device meets "acceptance criteria" here is the successful 510(k) clearance by the FDA, signifying that the modification does not compromise the device's established safety and effectiveness as determined by its predicate. There are no detailed performance studies presented in this document with specific statistical acceptance criteria because the nature of the submission is to demonstrate equivalence of a modified design.

Summary

{0}------------------------------------------------

Special 510(k) Summary of Safety and Effectiveness:

Device Modifications to the Long Length Gamma Nail

Submission Information

Name and Address of the Sponsorof the 510(k) Submission:	Howmedica Osteonics Corp59 Route 17Allendale, NJ 07401-1677
Contact Person:	Karen AriemmaRegulatory Affairs Specialist
Date of Summary Preparation:	July 10, 2001
Device Identification

Long Length Gamma® Nail Proprietary Name: Intramedullary Nail Common Name: Classification Name and Reference: Intramedullary Fixation Rod, 21 CFR §888.3020

1 Historically, Howmedica Osteonics has intended this product to be used in fracture management as a result of trauma, non-unions, mal-unions, pathological fractures, and impending pathological fractures.

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple and recognizable, representing the department's role in public health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 2001 AUG

Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

K012158 Re :

Long Length Gamma® Nails Trade/Device Name: 888.3020 Regulation Number: Requlatory Class: II Product Code: HSB Dated: July 10, 2001 Received: July 11, 2001

Dear Ms. Ariemma:

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 general The general controls controls provisions of the Act. 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 be basyood of bacting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਰ 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:

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

Page 2 - Ms. Ariemma

this response to your premarket notification submission does this response to your premained on the have under sections 531 not arrect any obligation for devices under the Electronic through 542 of the Act 101 xovisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as a This lecter will arrow your warket notification. The FDA described in your 510 (K) promazios of your device to a legally marketed predicate device results in a classification for your marketed predicate device robated in the market.

If you desire specific advice for your device on our labeling II you desire specific advice additionally 809.10 for in regulation (21 cm fare son and son and the Office of
vitro diagnostic devices), please contact the for guegti Compliance at (301) 594-4692. Additionally, for questions on Compliance at (301) 354 ining of your device, please contact the Dromocion and adversibling on July 2019 - Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be Information on your responsible of Small Manufacturers Assistance Obcalled from the Browbion (800) 638-2041 or (301) 443-6597 or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

втилелиноко

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

Enclosure

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

Page 1 of 1

510(k) Number (if known): K___________________________________________________________________________________________________________________________________________________

Device Name: Long Length Gamma® Nails

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X

(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Asmuklellertpmcuu

(Division Sign-Off) (Division of General, Restorative and Neurological Devices

510(k) Number K012158

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.