← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K133662

# SMITH & NEPHEW CANNULATED CAPTURED SCREW (K133662)

_Smith & Nephew, Inc. · HWC · May 15, 2014 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K133662

## Device Facts

- **Applicant:** Smith & Nephew, Inc.
- **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md)
- **Decision Date:** May 15, 2014
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3040
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Indications for Use

The Smith & Nephew Cannulated Captured Screw is intended for use for internal bone fixation including fractures of the tibia, fibula, clavicle, scapula, olecranon, metacarpals, metatarsals, humerus, ulna, middle hand bones, middle foot bones, and calcaneous. Screws are additionally intended for arthrodeses and osteotomies of small bones and small joints including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, clavicle, scapula, olecranon, ulnar styloid, radial head, and radial styloid.

## Device Story

Smith & Nephew Cannulated Captured Screw is a metallic bone fixation device; manufactured from titanium alloy or stainless steel. Used for internal bone fixation of fractures and for arthrodeses and osteotomies of small bones and joints. Provided sterile for single-use. Device functions as a mechanical fastener to stabilize bone segments during healing. Clinical benefit includes stabilization of fractures and support for orthopedic reconstruction. Operated by surgeons in clinical/OR settings.

## Clinical Evidence

Bench testing only. Mechanical performance data provided, including insertion torque, pull-out strength, static torsional strength, and three-point bend fatigue testing.

## Technological Characteristics

Materials: Titanium alloy or stainless steel. Design: Cannulated screw for bone fixation. Single-use, sterile. Mechanical properties validated via torque, pull-out, and fatigue testing.

## Regulatory Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

## Predicate Devices

- Low Profile Screws ([K103705](/device/K103705.md))

## Submission Summary (Full Text)

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# MAY 1 5 2014

K133662

Page 1 of 2

## > We are smith&nephew

| Submitted by:                                | Smith & Nephew, Inc.<br>Advanced Surgical Devices Division<br>150 Minuteman Road<br>Andover, MA 01810 |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Date of Summary:                             | May 12, 2014                                                                                          |
| Contact Person and Address:                  | Katherine Marcaccio<br>Regulatory Affairs Specialist II<br>T (508) 261-3602<br>F (978) 749-1443       |
| Name of Device:                              | Smith & Nephew Cannulated Captured Screw                                                              |
| Common Name:                                 | Screw, Fixation, Bone                                                                                 |
| Device Classification Name and<br>Reference: | 21 CFR 888.3040 Smooth or threaded metallic<br>bone fixation fastener                                 |
| Device Class:                                | Class II                                                                                              |
| Panel Code:                                  | Orthopaedics/87                                                                                       |
| Product Code:                                | HWC                                                                                                   |

#### Device Description

The Smith & Nephew Cannulated Captured Screw is used during the healing period of osteotomies for orthopedic reconstruction and to assist in the management of fracture fixation. The device consists of a titanium alloy or stainless steel fixation device. This device is provided sterile, for single use only.

#### Indications for Use

The Smith & Nephew Cannulated Captured Screw is intended for use for internal bone fixation including fractures of the tibia, fibula, clavicle, scapula, olecranon, metacarpals, metatarsals, humerus, ulna, middle hand bones, middle foot bones, and calcaneous. Screws are additionally intended for arthrodeses and osteotomies of small bones and small joints including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, clavicle, scapula, olecranon, ulnar styloid, radial head, and radial styloid.

#### Technological Characteristics

The Smith & Nephew Cannulated Captured Screw is substantially equivalent in design and fundamental scientific technology to the defined predicate device and does not raise any new issues of safety and efficacy.

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## K133662

#### Performance Data

Mechanical testing, including insertion torque, pull-out strength, static torsional strength, and three-point bend fatigue testing, demonstrates the device has met the performance specifications for the torsional, and compression capabilities of the Smith & Nephew Cannulated Captured Screw; therefore, it is considered substantially equivalent to the currently marketed predicate device.

#### Substantial Equivalence Information

The Smith & Nephew Cannulated Captured Screw is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed predicate device:

#### Table 1: Substantially Equivalent Predicate to the Cannulated Captured Screw

| Manufacturer  | Description        | Submission<br>Number | Clearance Date |
|---------------|--------------------|----------------------|----------------|
| Arthrex, Inc. | Low Profile Screws | K103705              | 3/18/2011      |

#### Conclusion

As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the Smith & Nephew Cannulated Captured Screw. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to above predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 15, 2014

Smith & Nephew, Incorporated Ms. Katherine Marcaccio Regulatory Affairs Specialist II 150 Minuteman Road Andover, Massachusetts 01810

Re: K133662

Trade/Device Name: Smith & Nephew Cannulated Captured Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: April 14, 2014 Received: April 15, 2014

Dear Ms. Marcaccio:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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#### Page 2 - Ms. Katherine Marcaccio

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807,97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Ronald.P. Jean -S for

- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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### Premarket Notification Indications for Use Statement

ﺴﺮﺓ

510(k) Number (if known): K133662

Device Name: Smith & Nephew Cannulated Captured Screw

Indications for Use:

The Smith & Nephew Cannulated Captured Screw is intended for use for internal bone fixation including fractures of the tibia, fibula, clavicle, scapula, olecranon, metacarpals, metatarsals, humerus, ulna, middle hand bones, middle foot bones, and calcaneous. Screws are additionally intended for arthrodeses and osteotomies of small bones and small joints including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, clavicle, scapula, olecranon, ulnar styloid, radial head, and radial styloid.

Prescription Use _ X AND/OR (Part 21 CFR 801 Subpart D)

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of _ 1 -

Elizabeth புதுank -S

Division of Orthopedic Devices

· Exhibit 2-2

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K133662](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K133662)

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