TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW

K981529 · Smith & Nephew, Inc. · JDS · Jul 9, 1998 · Orthopedic

Device Facts

• Record ID: K981529
• Device Name: TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW
• Applicant: Smith & Nephew, Inc.
• Product Code: JDS · Orthopedic
• Decision Date: Jul 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures, prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. In addition to the indications for intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (i.e. Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures. In addition to the indications for interlocking intramedullary nails, devices that utilize a retrograde femoral surgical approach (i.e. Retrograde/Tibial and Supracondylar Nails) are indicated for the following: severely comminuted supracondylar fractures with or without difficult intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants. The Titanium Nail System is intended to be removed upon fracture healing.

Device Story

Titanium Nail System consists of femoral and tibial nails and screws; manufactured from titanium alloy. Used for internal fixation of long bone fractures; provides structural stability during healing. Implanted by orthopedic surgeons in clinical/surgical settings. System includes specialized nails for antegrade, retrograde, and reconstruction applications; proximal holes/slots allow screw placement for compression and rotational stability. Intended for removal after fracture healing. Device functions as mechanical support for bone segments; no electronic or software components.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design similarity and historical market use of predicate devices.

Technological Characteristics

Components manufactured from titanium alloy. System includes femoral and tibial nails and screws. Mechanical fixation device; no energy source, connectivity, or software.

Indications for Use

Indicated for patients with simple long bone fractures, comminuted/spiral/oblique/segmental fractures, nonunions, malunions, polytrauma, impending pathologic fractures, or those requiring reconstruction post-tumor resection, bone lengthening, or shortening. Specific indications for femoral/recon nails include subtrochanteric, ipsilateral femoral shaft/neck, and intertrochanteric fractures. Retrograde approaches indicated for supracondylar fractures, intra-articular extension, or fractures above total knee implants.

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

• TriMax Antegrade and Retrograde Nails (Smith & Nephew Orthopaedics)
• Kuntscher Nail (Smith & Nephew Orthopaedics)
• Aim Antegrade Femoral, Retrograde Femoral and Tibial Nails (Ace)
• Unreamed Femoral (URFN) and Tibial Nails (Synthes)
• Retrograde Femoral Nail (Biomet)
• Ace ART Femoral Nail (DePuy Ace)

Submission Summary (Full Text)

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# Summary of Safety and Effectiveness Titanium Nail System

# Substantial Equivalence Information

The Titanium Nail System is similar to the following systems:

- 1. TriMax Antegrade and Retrograde Nails (Smith & Nephew Orthopaedics)
- 2. Kuntscher Nail (Smith & Nephew Orthopaedics)
- Aim Antegrade Femoral, Retrograde Femoral and Tibial Nails (Ace) 3.
- 4. Unreamed Femoral (URFN) and Tibial Nails (Synthes)
- 5. Retrograde Femoral Nail (Biomet)
- 6. Ace ART Femoral Nail (DePuy Ace)

All of the devices listed above are similar in design to the Titanium Nail System. The safety and effectiveness of the Titanium Nail System is based on the long history of use of these devices in the market place.

# Device Description

The Titanium Nail System includes femoral and tibial nails and screws. All components are manufactured from titanium alloy.

### Indications for Use

Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures, prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

In addition to the indications for intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (i.e. Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures.

In addition to the indications for interlocking intramedullary nails, devices that utilize a retrograde femoral surgical approach (i.e. Retrograde/Tibial and Supracondylar Nails) are indicated for the following: severely comminuted supracondylar fractures with or without difficult intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants.

The Titanium Nail System is intended to be removed upon fracture healing.

The Titanium Nail System is substantially equivalent to the predicate devices listed above.

JG10016A/14

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Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the seal, with the caduceus positioned in the center.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. JoAnn Kuhne ·Manager, Regulatory Affairs Smith & Nephew Richards, Inc. 1450 Brooks Road Memphis, Tennessee 38116

Re: K981529 Titanium Intramedullary Nail, Titanium Trade Name: Locking Screw Regulatory Class: II Product Code: JDS Dated: April 28, 1998 Received: April 29, 1998

Dear Ms. Kuhne:

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, 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 regulations 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 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: 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. JoAnn Kuhne

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 requlation (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,

Celia 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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K981529

#### Indications Statement

Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures, nonunions and malunions, polytrauma and multiple fractures, prophylactic nailing of impending pathologic fractures, reconstruction, following tumor resection and grafting, supracondylar fractures, bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (i.e. Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures, and intertrochanteric fractures.

In addition to the indications for interlocking intramedullary nails, devices that utilize a retrograde femoral surgical approach (i.e. Retrograde/Tibial and Supracondylar Nails) are indicated for the following: severely comminuted supracondylar fractures with or without difficult intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants.

**Prescription Use**
(Per 21 CFR 801.109)

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