(52 days)
Not Found
No
The device description focuses on mechanical components (hook, cables, clamps) for surgical reattachment and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
Yes
The device is described as a "Cabling System Trochanteric Hook" used for "trochanteric reattachment" in hip arthroplasty procedures. This indicates it is surgically implanted to aid in the healing and reattachment of bone, which constitutes a therapeutic intervention.
No
The device description indicates that the Cabling System Trochanteric Hook is used for reattachment of the trochanter and is designed to prevent proximal migration. This describes a therapeutic or surgical device, not a device used to diagnose a medical condition.
No
The device description clearly describes a physical implantable device made of Ti-6Al-4V, used in conjunction with cables and clamps. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that this device is a "Cabling System Trochanteric Hook" made of Ti-6Al-4V, used in conjunction with cables and clamps. It is designed to physically reattach the trochanter to the femur during surgical procedures.
- Intended Use: The intended use is for "Trochanteric reattachment whenever the trochanter is osteotomized" in specific surgical procedures. This is a surgical implant/device, not a diagnostic test performed on a sample.
The device is a surgical implant used directly on the patient's body during surgery, not a tool for analyzing biological samples.
N/A
Intended Use / Indications for Use
Trochanteric reattachment whenever the trochanter is osteotomized in any of the procedures listed below.
-
- Primary total hip arthroplasty
-
- Revision total hip arthroplasty
-
- Any procedure using anterolateral or lateral approaches
Product codes (comma separated list FDA assigned to the subject device)
JDQ
Device Description
The Cabling System Trochanteric Hook is made of Ti-6Al-4V. The trochanteric hook is used in conjunction with 2.0mm diameter cobalt chrome cables and cobalt chrome clamps from the Smith & Nephew Orthopaedics Cabling System (K031162). The trochanteric hook features one hook to attach to the trochanter and one hole to allow a cable to be routed through the device. The cable is routed through the hole in the device and around the femur. The cable will be tensioned and secured with a clamp. The hook is designed to prevent proximal migration of the trochanter. The device is intended for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trochanter
Indicated Patient Age Range
Not Found
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.
K031162, K984432, K961267, K982545
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
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
0
K043252 (ps 10f2 JAN 1 4 2005 510(K) SUMMARY CABLING SYSTEM TROCHANTERIC HOOK
SUBMITTER'S NAME: SUBMITTER'S ADDRESS: SUBMITTER'S TELEPHONE NUMBER: CONTACT PERSON: DATE SUMMARY PREPARED: TRADE OR PROPRIETARY DEVICE NAME: COMMON OR USUAL NAME: CLASSIFICATION NAME:
Smith & Nephew. Inc.. Orthopaedic Division 1450 Brooks Road, Memphis, TN 38116 901-399-6670 John Reabe November 15, 2004 Cabling System Trochanteric Hook Cabling System Bone fixation cerclage. Single/multiple component metallic bone fixation appliances and accessories. Class II Orthopedic/87
DEVICE CLASS: PANEL CODE:
DEVICE INFORMATION:
INTENDED USE:
Trochanteric reattachment whenever the trochanter is osteotomized in any of the procedures listed below.
-
- Primary total hip arthroplasty
-
- Revision total hip arthroplasty
-
- Any procedure using anterolateral or lateral approaches
DEVICE DESCRIPTION:
The Cabling System Trochanteric Hook is made of Ti-6Al-4V. The trochanteric hook is used in conjunction with 2.0mm diameter cobalt chrome cables and cobalt chrome clamps from the Smith & Nephew Orthopaedics Cabling System (K031162). The trochanteric hook features one hook to attach to the trochanter and one hole to allow a cable to be routed through the device. The cable is routed through the hole in the device and around the femur. The cable will be tensioned and secured with a clamp. The hook is designed to prevent proximal migration of the trochanter. The device is intended for single use.
SUBSTANTIAL EQUIVALENCE INFORMATION:
The Cabling System Trochanteric Hook is similar to the Smith & Nephew Orthopaedic Cabling System Trochanteric Grip (K031162) in that both devices are used with the same cables and clamps for trochanteric reattachment whenever the trochanter is osteotomized. The grips in the predicate system feature two hooks to attach to the trochanter, multiple holes to allow cables to be routed through the grip and clamps to secure the cables. The Cabling System Trochanteric Hook features one hook to attach to the trochanter and one hole to allow a cable to be routed through the device and a clamp to secure the cable.
The Cabling System Trochanteric Hook is similar to the Howmedica Dall-Miles Cable Grip (K984432), Pioneer System Greater Trochanteric Reattachment Device (K961267) and the Biomet BMP Cable System (K982545) in that all devices are used with cables and clamps for trochanteric reattachment whenever the trochanter is osteotomized.
The Cabling System Trochanteric Hook is similar to the Smith & Nephew Hook Piate in that both devices are used for trochanteric reattachment whenever the trochanter is osteotomized. The trochanteric hook is used with cables and clamps to secure the bone. The hook plate is used in conjunction with screws to secure the device to the bone.
1
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The Cabling System Trochantially equivalent to the predicate devices. The differences between the Cabling System Trochanteric Hook and predicate devices. "The safety and effectiveness.
SUMMARY OF TECHNOLOGICAL COMPARISON:
The Ilizarov Pulley System is substantially equivalent to the predicate devices listed in the previous section in terms of indications for use and design.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Public Health Service
JAN 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John Reabe Director Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116
Re: K043252
Trade Name: Cabling System Trochanter Hook Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: II Product Code: JDQ Dated: November 22, 2004 Received: November 23, 2004
Dear Mr. Reabe:
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.
3
Page 2 – Mr. John Reabe
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 toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sincerely yours,
Mark A Mallmann
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
4
510(k) number (if known): _
Device Name: Cabling System Trochanteric Hook
Indications for Use:
Trochanteric reattachment whenever the trochanter is osteotomized in any of the procedures listed below.
-
- Primary total hip arthroplasty
-
- Revision total hip arthroplasty
-
- Any procedure using anterolateral or lateral approaches
Prescription Use_ X (Per 21 CFR 801.109) OR
Over-the-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milherson
(Division Sign-Off) Division of General. Restorative. and Neurological Devices
510(k) Number K043252