SLIM GLIDING NAIL SYSTEM by PLUS ORTHOPEDICS

pertrochanteric femoral fractures
subtrochanteric femoral fractures and
lateral femoral neck fractures.
Internal fixation with the SLIM Gliding Nail System is indicated in all combination injuries involving the lateral femoral neck or trochanter region and femoral shaft fractures. Thanks to its biomechanical characteristics, the SLIM Gliding Nail System is also suitable for medial femoral neck fractures with retention of the head and simple femoral shaft fractures down to the distal metaphysis. Gliding nail fixation can also be used to secure pathological fractures or to provide weight-bearing stability after varus and valgus revision osteotomies of the proximal femur.

Device Description

We added the following smaller nails to our predicate device (FRIEDL Gliding Nail System, K974409):

132071 Slim Gliding Nail, 125°, 220 mm, 17 mm / 11 mm Ø
132072 Slim Gliding Nail, 135°, 220 mm, 17 mm / 11 mm Ø
132073 Slim Gliding Nail, 125°, 180 mm, 17 mm / 11 mm Ø,

These 3 nails are narrower than the conventional nails, which 19 mm diameter proximally and 12 mm distally.

132140 Femoral Neck Blade, 75 mm length

In addition, this 75 mm long femoral neck blade has been added to the existing range from 80 mm to 125 mm.

AI/ML Overview

This document describes a Special 510(k) Device Modification for the SLIM Gliding Nail System. The modification involves the addition of smaller nails and a shorter femoral neck blade to the existing system. The primary study described is a biomechanical fatigue test.

Here's an analysis of the provided information based on your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Biomechanical fatigue strength/stability (for worst-case model and smaller components)	The test results of the smaller components were equal or better to the predicate device (FRIEDL Gliding Nail System, K974409) and other commercially available devices.
Sufficient for in vivo loading	The test results were deemed sufficient for in vivo loading.

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

Sample Size: Not explicitly stated. The document mentions "Biomechanical fatigue tests have been performed on the worst-case model." It does not specify the number of components or repetitions used in these tests.
Data Provenance: The study is reported by PLUS ORTHOPEDICS to the FDA, suggesting it was conducted by the manufacturer for regulatory submission. The country of origin for the testing itself is not specified, nor is whether the data is retrospective or prospective, though for a biomechanical test, it's typically a prospective laboratory study.

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

Not Applicable. This is a biomechanical engineering study, not a clinical study involving expert interpretation of medical images or patient outcomes. The "ground truth" is established by the physical testing and engineering principles. The FDA reviewer (Celia M. Witten, Ph.D., M.D.) made the final determination of substantial equivalence, but not of the underlying biomechanical 'ground truth'.

4. Adjudication Method for the Test Set

Not Applicable. As a biomechanical study, there isn't an adjudication method for reconciling different expert opinions on a test set in the way there would be for a diagnostic study. The determination of whether the test results "equal or better" the predicate would be based on quantitative measurements and engineering specifications.

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

No. This document describes a biomechanical engineering study of an orthopedic implant, not a diagnostic device or a study involving human readers or cases. Therefore, an MRMC study is not relevant or included.

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

Not Applicable. This is a physical device, not an algorithm. Therefore, the concept of "standalone performance" for an algorithm is not relevant. The biomechanical testing is inherently "standalone" in that it tests the device properties directly.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the objective physical properties and performance characteristics of the device under stress, as measured through biomechanical fatigue testing. This is compared against established engineering standards and the performance of predicate devices.

8. The Sample Size for the Training Set

Not Applicable. This is a biomechanical engineering study, not a machine learning or AI study. There is no "training set" in this context. The study focuses on evaluating the physical properties of the manufactured device.

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

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

Summary

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SPECIAL 510(K) DEVICE MODIFICATIONSLIM Gliding Nail SystemJanuary 22, 2002		FEB 22 2002	K020240	page 1 of 2
510(k) Summary of Safety and Effectiveness510(k) Summary of Safety and Effectiveness[in accordance with SMDA of 1990, 21 CFR 807.92(c)]
Contact:	PLUS ORTHOPEDICS6055 Lusk Blvd.San Diego, CA 92121Tel: 858-550-3800 x 2506Attn: Mr. Hartmut Loch, RACDirector, Regulatory Affairs
Trade name:	SLIM Gliding Nail System
Common name:	Compression Hip Nail
Classification name:	Appliance, Fixation, Nail/Bl;ade/Plate Combination, Multiple Component§ 888.3030, Class II, Product Code: KTT, 87 Orthopedic Device Panel
Predicate Device:	FRIEDL Gliding Nail System, K974409 – S/E 2/19/1998
DeviceModificationDescription:	We added the following smaller nails to our predicate device (FRIEDLGliding Nail System, K974409):- # 132071 Slim Gliding Nail, 125°, 220 mm, 17 mm / 11 mm Ø- # 132072 Slim Gliding Nail, 135°, 220 mm, 17 mm / 11 mm Ø- # 132073 Slim Gliding Nail, 125°, 180 mm, 17 mm / 11 mm Ø,These 3 nails are narrower than the conventional nails, which 19 mmdiameter proximally and 12 mm distally.- # 132140 Femoral Neck Blade, 75 mm lengthIn addition, this 75 mm long femoral neck blade has been added to theexisting range from 80 mm to 125 mm.
Indications:	The SLIM Gliding Nail System is an all-purpose locking nail system forensuring primary load stability in:- pertrochanteric femoral fractures- subtrochanteric femoral fractures and- lateral femoral neck fractures.Internal fixation with the SLIM Gliding Nail System is indicated in allcombination injuries involving the lateral femoral neck or trochanterregion and femoral shaft fractures. Thanks to its biomechanicalcharacteristics, the SLIM Gliding Nail System is also suitable for medialfemoral neck fractures with retention of the head and simple femoralshaft fractures down to the distal metaphysis. Gliding nail fixation canalso be used to secure pathological fractures or to provide weight-bearing stability after varus and valgus revision osteotomies of theproximal femur

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SPECIAL 510(K) DEVICE MODIFICATION SLIM Gliding Nail System January 22, 2002

KAoyo

page 2 of 2

Contraindications include acute or chronic infections (local or systemic), Contraindications: serious lesions of muscles, nerves or blood vessels, which put the affected limb at risk, bony defects or poor bone quality, which might endanger the stability of the prosthesis, and any concurrent disease, which might interfere with the function of the implant.

Biomechanical fatigue tests have been performed on the worst-case Performance model. The test results of the smaller components were equal or better data: to the predicate and other commercially available devices, and they are sufficient for in vivo loading.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem resembling an abstract bird or stylized human figures, composed of three curved lines that suggest movement or flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 2002

Mr. Hartmut Loch, RAC Director, Regulatory Affairs PLUS Orthopedics 6055 Lusk Boulevard San Diego, California 92121-2700

Re: K020240 Trade/Device Name: SLIM Gliding Nail System Regulation Number: 21 CFR 888.3030 Regulation Name: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Regulatory Class: II Product Code: KTT Dated: January 22, 2002 Received: January 23, 2002

Dear Mr. Loch:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreate) to tegans coment date of the Medical Device American processor of to Conninerce prior to May 20, 1978, are exactions of the Federal Food, Drug, de necs mat have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mercere, market of the Act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can may or subject to sach as a same as a legulations, 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 r lease be devilode that I Dr. mination that your device complies with other requirements of the Act that I Dr Has Internand regulations administered by other Federal agencies. You must or any I edetar statutes and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fart 877, accimig (21 CFR Part 820); and if applicable, the electronic form in the quinty by systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Hartmut Loch, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ought mains of substantial equivalence of your device to a legally premarket notification: "The PDF mailing sification 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 11 you desire specific act1809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CHC Far 007.10 Idditionally, for questions on the promotion and advertising of Compliance at (301) 591-1097 Technological (301) 594-4639. Also, please note the your dones, pread "Misbranding by reference to premarket notification" (21CFR Part 807.97). Tegulation citined, "Trisotanaing of responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

A. Mch. N. Mullin.

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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Page 1 of

SPECIAL 510(K) DEVICE MODIFICATION SLIM Gliding Nail System January 22, 2002

510(k) Number: K020240

SLIM Gliding Nail System Device Name(s):

Indications for Use:

The SLIM Gliding Nail System is an all-purpose locking nail system for ensuring primary load stability in:

pertrochanteric femoral fractures -
subtrochanteric femoral fractures and -
lateral femoral neck fractures. -

Internal fixation with the SLIM Gliding Nail System is indicated in all combination injuries internal fixation with the Same of trochanter region and femoral shaft fractures. if worling the lateral londral rearacteristics, the SLIM Gliding Nail System is also r hanks to to blomoonamed. Shartures with retention of the head and simple femoral sunable for modial formeral host mastaphysis. Gliding nail fixation can also be used to shart fractures down to the distal model weight-bearing stability after varus and valgus revision osteotomies of the proximal femur.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

for
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K020240

Prescription Use X OR Over-The-Counter-Use __
(Per 21 CFR 801.109) (Optional format 1-2-96)

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.

132071 Slim Gliding Nail, 125°, 220 mm, 17 mm / 11 mm Ø

132072 Slim Gliding Nail, 135°, 220 mm, 17 mm / 11 mm Ø

132073 Slim Gliding Nail, 125°, 180 mm, 17 mm / 11 mm Ø,

132140 Femoral Neck Blade, 75 mm length

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.