K Number
K072083
Device Name
SMALL FRAGMENT LOCKING PLATING SYSTEM
Date Cleared
2007-10-25

(87 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Small Fragment Locking Plating System is intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
Device Description
The technological characteristics of the Small Fragment Locking Plating System are the same as the predicate devices including design and material.
More Information

Not Found

No
The summary explicitly states that the technological characteristics are the same as the predicate devices and there is no mention of AI, ML, or image processing.

No
The device is a plating system intended for fracture fixation, which is a structural support device rather than one that directly treats a disease or condition.

No
The provided text describes a "Small Fragment Locking Plating System" intended for fixation of fractures and non-unions, which is a therapeutic device, not a diagnostic one. It fixes existing conditions rather than identifying them.

No

The device description explicitly states it is a "Small Fragment Locking Plating System," which is a hardware implant used for bone fixation. There is no mention of software as the primary or sole component.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is for the "fixation of fractures, osteotomies and non-unions" of various bones. This is a surgical procedure performed directly on the patient's body.
  • IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
  • Device Description: The description focuses on the physical characteristics of plates and screws used for bone fixation.
  • Lack of IVD-related information: There is no mention of analyzing biological samples, laboratory procedures, or diagnostic information derived from such analysis.

This device is a surgical implant used for orthopedic procedures, not an IVD.

N/A

Intended Use / Indications for Use

The Small Fragment Locking Plating System is intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.

Product codes

HRS

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K000684, K882831, K905048

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

K072083 (pg. 1 of 1)

Section 5 — 510(k) Summary

| Submitted by: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, IN 46581
Phone: (305) 328-3851
Fax: (305) 270-1382 | | | OCT 25 2007 |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------------------------------------------------------------|-------------|
| Contact Person: | Suzana Otaño, Sr. Regulatory Affairs Associate | | | |
| Date Prepared: | July 27, 2007 | | | |
| Proprietary Name: | Small Fragment Locking Plating System | | | |
| Common Name: | Plate, Fixation, Bone | | | |
| Classification
Name: | Single/multiple component metallic bone fixation appliances
and accessories (21 CFR § 888.3030) | | | |
| Predicate Devices: | Synthes | K000684 | Small Fragment Dynamic
Compression Locking (DCL)
System | |
| | DePuy ACE | K882831 | Cancellous Bone Screws | |
| | DePuy ACE | K905048 | 3.5mm Cortical Bone
Screws | |
| Intended Use: | The Small Fragment Locking Plating System is intended for
fixation of fractures, osteotomies and non-unions of the
clavicle, scapula, olecranon, humerus, radius, ulna, pelvis,
distal tibia, fibula, particularly in osteopenic bone. | | | |
| Technological
Characteristics: | The technological characteristics of the Small Fragment
Locking Plating System are the same as the predicate devices
including design and material. | | | |
| Summary of
Substantial
Equivalence: | The Small Fragment Locking Plating System is substantially
equivalent to the currently marketed Synthes and DePuy
devices. No new issues of safety or efficacy have been raised. | | | |

1

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tails, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DuPuv Orthopaedics, Inc. % Ms. Suzana Otaño Sr. Regulatory Affairs Associate 700 Orthopaedic Drive Warsaw, IN 46582

K072083 Trade/Device Name: Small Fragment Locking Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: July 27, 2007 Received: July 30, 2007

Dear Ms. Otaño:

Re:

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.

OCT 2 5 2007

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); labeling (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 (Sections 531-542 of the Act); 21 CFR 1000-1050.

2

Page 2 - Ms. Suzana Otaño

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Rarbara Bucher

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

3

SECTION 4 - INDICATIONS FOR USE STATEMENT

K072083 510(k) Number:

Small Fragment Locking Plating Device Name: System

Indications For Use: The Small Fragment Locking Plating System is intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.

Prescription Use (Per 21 CFR 801 Subpart D) AND/OR

Over-the-Counter (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

vbere melmo

Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number K072083

Small Fragment Locking Plating System Traditional 510(k) DePuy Orthopaedics, Inc.

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