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K Number
K062693
Device Name
GLADIATOR BIPOLAR SYSTEM
Manufacturer
WRIGHT MEDICAL TECHNOLOGY, INC.
Date Cleared
2006-09-29

(18 days)

Product Code
KWY
Regulation Number
888.3390
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GLADIATOR™ Bipolar System is indicated for the following conditions: - 1) pathological fractures of the femoral neck - 2) non-union of femoral neck fractures - 3) aseptic necrosis of the femoral head and neck - 4) primary pathology in the young involving the femoral head but with a non-deformed acetabulum.
Device Description
The design features of the GLADIATOR™ Bipolar System are summarized below: - . Shells manufactured from cast CoCr allov - . Shells available in O.D. sizes 36-65mm - . Bearing insert manufactured from cross-linked UHMWPE - Bearing insert available in I.D. (femoral head) sizes 22, 28, 32, 36mm . - Locking and support rings manufactured from UHMWPE . - All components permanently assembled during production .
More Information

Not Found

Not Found

No
The summary describes a mechanical orthopedic implant (bipolar hip system) with no mention of software, algorithms, or any features related to data processing or analysis, which are characteristic of AI/ML devices.

Yes
The device is indicated for treating pathological fractures, non-union of fractures, and aseptic necrosis, all of which are medical conditions, and thus the device is therapeutic.

No

Explanation: The device description and intended use indicate that the GLADIATOR™ Bipolar System is an orthopedic implant for treating specific femoral conditions, not for diagnosing them. It describes components and sizes, not diagnostic functions.

No

The device description clearly outlines physical components made of materials like CoCr alloy and UHMWPE, indicating it is a hardware device, not software-only.

No, the GLADIATOR™ Bipolar System is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside the body.
  • GLADIATOR™ Bipolar System: The description clearly indicates this is a surgical implant used to treat conditions of the femoral head and neck. It is a device that is placed inside the body.

The information provided describes a surgical implant, not a diagnostic test performed on bodily fluids or tissues.

N/A

Intended Use / Indications for Use

The GLADIATOR™ Bipolar System is indicated for the following conditions:

    1. pathological fractures of the femoral neck
    1. non-union of femoral neck fractures
    1. aseptic necrosis of the femoral head and neck
    1. primary pathology in the young involving the femoral head but with a non-deformed acetabulum.

Product codes (comma separated list FDA assigned to the subject device)

KWY

Device Description

The design features of the GLADIATOR™ Bipolar System are summarized below:

  • . Shells manufactured from cast CoCr allov
  • . Shells available in O.D. sizes 36-65mm
  • . Bearing insert manufactured from cross-linked UHMWPE
  • Bearing insert available in I.D. (femoral head) sizes 22, 28, 32, 36mm .
  • Locking and support rings manufactured from UHMWPE .
  • All components permanently assembled during production .

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

femoral neck, femoral head, acetabulum

Indicated Patient Age Range

young (implied by "primary pathology in the young")

Intended User / Care Setting

Not Found

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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.

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K062643

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

SEP 2 9 2006

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In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the use of the GLADIATOR™ Bipolar System.

Submitted By:Wright Medical Technology, Inc.
Date:September 8, 2006
Contact Person:Matt Paul
Regulatory Affairs Specialist
Proprietary Name:GLADIATOR™ Bipolar System
Common Name:Bipolar Hip System
Classification Name and Reference:21 CFR 888.3390 Prosthesis, hip, hemi-, femoral,
metal/polymer, cemented or uncemented - Class II
Device Product Code and Panel Code:Orthopedics/87/KWY

DEVICE INFORMATION

A. Intended Use

The GLADIATOR™ Bipolar System is indicated for the following conditions:

    1. pathological fractures of the femoral neck
    1. non-union of femoral neck fractures
    1. aseptic necrosis of the femoral head and neck
    1. primary pathology in the young involving the femoral head but with a non-deformed acetabulum.

B. Device Description

The design features of the GLADIATOR™ Bipolar System are summarized below:

  • . Shells manufactured from cast CoCr allov
  • . Shells available in O.D. sizes 36-65mm
  • . Bearing insert manufactured from cross-linked UHMWPE
  • Bearing insert available in I.D. (femoral head) sizes 22, 28, 32, 36mm .
  • Locking and support rings manufactured from UHMWPE .
  • All components permanently assembled during production .

C. Substantial Equivalence Information

The indications for use of the GLADIATOR™ Bipolar System are identical to the previously cleared predicate device. The design features and materials of the subject device are substantially equivalent to those of the respective predicate devices. The fundamental scientific technology of the modified device has not changed relative to the predicate devices.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wright Medical Technology, Inc. % Mr. Matt Paul Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

Re: K062693

Trade/Device Name: GLADIAFOR ""Bipolar System Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWY Dated: September 8, 2006 Received: September 11, 2006

Dear Mr. Paul:

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); 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.

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Page 2 - Mr. Matt Paul

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 (240) 276-0120. 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 with ber (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

N. Molkerson

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: GLADIATOR™ Bipolar System

Indications For Use:

The GLADIATOR™ Bipolar System is indicated for the following conditions:

    1. pathological fractures of the femoral neck
    1. non-union of femoral neck fractures
    1. aseptic necrosis of the femoral head and neck
    1. primary pathology in the young involving the femoral head but with a non-deformed acetabulum.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sig. Off

(Division Sign-Division of General, Restorative, and Neurological Devices

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510(k) Number 11062643

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