SLIM GLIDING NAIL SYSTEM

K020240 · Plus Orthopedics · KTT · Feb 22, 2002 · Orthopedic

Device Facts

• Record ID: K020240
• Device Name: SLIM GLIDING NAIL SYSTEM
• Applicant: Plus Orthopedics
• Product Code: KTT · Orthopedic
• Decision Date: Feb 22, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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 Story

The SLIM Gliding Nail System is an orthopedic fixation device used by surgeons to stabilize femoral fractures. It consists of metallic nails and femoral neck blades implanted into the femur to provide load-bearing stability. This modification adds smaller diameter nails (17mm proximal/11mm distal) and a 75mm femoral neck blade to the existing product line. The device is used in clinical settings for internal fixation of fractures or post-osteotomy stabilization. Surgeons select the appropriate nail size based on patient anatomy. The device provides mechanical support to the bone, facilitating healing and weight-bearing. Benefits include improved fit for patients requiring narrower implants compared to conventional 19mm/12mm diameter nails.

Clinical Evidence

Bench testing only. Biomechanical fatigue tests were performed on the worst-case model. Results indicated that the smaller components met or exceeded the performance of the predicate and other commercially available devices, confirming suitability for in vivo loading.

Technological Characteristics

Metallic orthopedic fixation system consisting of nails and femoral neck blades. Modifications include reduced diameter nails (17mm proximal/11mm distal) and a 75mm length blade. Designed for internal fixation of femoral fractures. Mechanical fixation principle. No software or electronic components.

Indications for Use

Indicated for patients with pertrochanteric, subtrochanteric, lateral femoral neck, medial femoral neck (with head retention), simple femoral shaft, or pathological fractures, and for stabilization following varus/valgus revision osteotomies of the proximal femur. Contraindicated in patients with acute/chronic local or systemic infections, serious lesions of muscles, nerves, or blood vessels, poor bone quality or bony defects endangering stability, or concurrent diseases interfering with implant function.

Regulatory Classification

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.

Predicate Devices

• FRIEDL Gliding Nail System (K974409)

Submission Summary (Full Text)

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| SPECIAL 510(K) DEVICE MODIFICATION<br>SLIM Gliding Nail System<br>January 22, 2002 | | FEB 22 2002 | K020240 | page 1 of 2 | |
|-------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|---------|-------------|--|
| 510(k) Summary of Safety and Effectiveness<br>510(k) Summary of Safety and Effectiveness<br>[in accordance with SMDA of 1990, 21 CFR 807.92(c)] | | | | | |
| Contact: | PLUS ORTHOPEDICS<br>6055 Lusk Blvd.<br>San Diego, CA 92121<br>Tel: [phone] x 2506<br>Attn: Mr. Hartmut Loch, RAC<br>Director, Regulatory Affairs | | | | |
| Trade name: | SLIM Gliding Nail System | | | | |
| Common name: | Compression Hip Nail | | | | |
| Classification name: | Appliance, Fixation, Nail/Bl;ade/Plate Combination, Multiple Component<br>§ 888.3030, Class II, Product Code: KTT, 87 Orthopedic Device Panel | | | | |
| Predicate Device: | FRIEDL Gliding Nail System, K974409 – S/E 2/19/1998 | | | | |
| Device<br>Modification<br>Description: | We added the following smaller nails to our predicate device (FRIEDL<br>Gliding Nail System, K974409):<br>- # 132071 Slim Gliding Nail, 125°, 220 mm, 17 mm / 11 mm Ø<br>- # 132072 Slim Gliding Nail, 135°, 220 mm, 17 mm / 11 mm Ø<br>- # 132073 Slim Gliding Nail, 125°, 180 mm, 17 mm / 11 mm Ø,<br>These 3 nails are narrower than the conventional nails, which 19 mm<br>diameter proximally and 12 mm distally.<br>- # 132140 Femoral Neck Blade, 75 mm length<br>In addition, this 75 mm long femoral neck blade has been added to the<br>existing range from 80 mm to 125 mm. | | | | |
| Indications: | The SLIM Gliding Nail System is an all-purpose locking nail system for<br>ensuring primary load stability in:<br>- pertrochanteric femoral fractures<br>- subtrochanteric femoral fractures and<br>- lateral femoral neck fractures.<br>Internal fixation with the SLIM Gliding Nail System is indicated in all<br>combination injuries involving the lateral femoral neck or trochanter<br>region and femoral shaft fractures. Thanks to its biomechanical<br>characteristics, the SLIM Gliding Nail System is also suitable for medial<br>femoral neck fractures with retention of the head and simple femoral<br>shaft fractures down to the distal metaphysis. Gliding nail fixation can<br>also be used to secure pathological fractures or to provide weight-<br>bearing stability after varus and valgus revision osteotomies of the<br>proximal 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 [phone] Technological [phone]. 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 [phone] or [phone] 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)