MODIFICATION TO SLIM GLIDING NAIL SYSTEM

K033763 · Plus Orthopedics · KTT · Dec 18, 2003 · Orthopedic

Device Facts

• Record ID: K033763
• Device Name: MODIFICATION TO SLIM GLIDING NAIL SYSTEM
• Applicant: Plus Orthopedics
• Product Code: KTT · Orthopedic
• Decision Date: Dec 18, 2003
• 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 medical 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

SLIM Gliding Nail System is an orthopedic internal fixation device for femoral fractures. System consists of nail/blade/plate components used to provide primary load stability. Device is implanted by surgeons in clinical settings to stabilize fractures or provide support post-osteotomy. Modification from predicate involves removal of collar from gliding blade. Device is single-use, stainless steel, and constrained. No software or algorithmic components.

Clinical Evidence

No clinical data provided; substantial equivalence based on design characteristics and intended use.

Technological Characteristics

Stainless steel orthopedic fixation system; nail/blade/plate configuration; constrained design; 11 blade sizes; single-use; mechanical fixation principle.

Indications for Use

Indicated for patients with pertrochanteric, subtrochanteric, lateral femoral neck, or medial femoral neck fractures (with head retention), simple femoral shaft fractures, pathological fractures, or those requiring weight-bearing stability following varus/valgus revision osteotomies of the proximal femur.

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

• SI IM Gliding Nail System (K020240)

Submission Summary (Full Text)

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K033763
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#### 510 (k) Summary

Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:

Prepared:

December 1, 2003

Applicant:

PI.US Orthopedics 6055 Lusk Boulevard San Diego, CA 92121-2700

| Telephone: | 888-741-7587 |
|------------|--------------|
| Fax: | 888-741-4002 |

Device Name:

Device Trade Name: Device Classification: Reviewing Panel: Regulation Number Product Code: Original Predicate Device:

Registration Number: Owner Operator Number:

Appliance, Fixation. Nail/Blade/Plate Combination, Multiple Component SLIM Gliding Nail System Class II Orthopedic 21 CFR 888.3030 KTT SI.IM Gliding Nail System, K020240 The indications for use have not changed and are identical to the predicate device. 2086141 9034096

#### Device Description:

The SLIM Gliding Nail Systems designed for internal fixation in all combination injuries involving the lateral femoral neck or trochanter region and femoral shaft fractures. The 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.

### Indications for Use:

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

1

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K033763
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- 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 medical 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.

### Comparison to the Original Predicate Device:

The legally marketed predicate device to which this device is substantially equivalent is the SI IM Gliding Nail System, K020240

II Regulatory Class: Product Code: K.I.I.

original PLUS Orthopedics SLIM Gliding Nail System to the new Comparison of configuration.

| Item | Original PLUS Product | Proposed modified product |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | SLIM Gliding Nail System | SLIM Gliding Nail System |
| Use | Single use | Single use |
| Fixation | Compression Hip Nail | Compression Hip Nail |
| Constraint | Constrained | Constrained |
| Material | Stainless Steel | Stainless Steel |
| Sizes | The blade comes in 11 sizes | The blade comes in 11 sizes |
| Indications for use | The SLIM Gliding Nail System is an all-<br>purpose locking nail system for ensuring<br>primary load stability in: | The SLIM Gliding Nail System is an all-<br>purpose locking nail system for ensuring<br>primary load stability in: |
| | Pertrochanteric femoral fractures | Pertrochanteric femoral fractures |
| | Subtrochanteric femoral fractures | Subtrochanteric femoral-fractures |
| | and | and |
| | Lateral femoral neck fractures | Lateral femoral neck fractures |
| | Internal fixation with the SLIM Gliding<br>Nail System is indicated in all<br>combination injuries involving the lateral<br>femoral neck or trochanter region and | Internal fixation with the SLIM Gliding<br>Nail System is indicated in all<br>combination injuries involving the<br>lateral femoral neck or trochanter region |

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K03.3/% 3
page 3 of 3

femoral shaft fractures. Thanks to its biomechanical characteristics, the SLIM Gliding Nail System is also suitable for medical 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.

and femoral shaft fractures. Thanks to its biomechanical characteristics, the SLIM Gliding Nail System is also suitable for medical 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.

The only design modification to the SLIM Gliding Nail System is the removal of the collar from the gliding blade.

#### Summary:

The device and the predicate device have similar design characteristics and intended use. The modified device is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized graphic of three curved lines, resembling a human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 2003

Mr. Neil Delaney Plus Orthopedics, Inc. 6055 Lusk Boulevard San Diego, California 92121-2700

Re: K033763

Trade/Device Name: SLIM Gliding Nail System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: II Product Codes: KTT Dated: December 1, 2003 Received: December 2, 2003

Dear: Mr. Delaney:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); labcling (21 CFR Part 801); 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 (Scctions 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Neil Delaney

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Sincerely yours,

Mark N. Millam

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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# 510 (k) Number (If Known): Ko 33263

Device Name: SLIM Gliding Nail System

## 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 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 medical 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X
or Over the counter use

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

Number K033763