(77 days)
Not Found
Not Found
No
The summary describes a mechanical device for surgical fixation and does not mention any software, algorithms, or AI/ML capabilities.
No
This device is an orthopedic implant (trochanteric reattachment system) used for fixation during hip surgery, which is a medical device, but not primarily a therapeutic device that delivers therapy in the traditional sense (e.g., radiation, electrical stimulation). Its function is structural support and fixation.
No
Explanation: The device is indicated for fixation of the greater trochanter secondary to osteotomy, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly indicates physical components ("Staple like grip design with proximal and distal hooks") used in conjunction with other physical components ("trochanteric cable and crimp sleeves"). This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "trochanteric reattachment" and "fixation of the greater trochanter secondary to osteotomy in total hip replacement arthroplasty, surface replacement arthroplasty or any hip procedure requiring a trochanteric osteotomy." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description of "Staple like grip design with proximal and distal hooks used in conjunction with trochanteric cable and crimp sleeves" further reinforces that this is a physical implant used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on analysis of biological samples.
Therefore, the Osteonics® FX-Cablelok™ Grip Components are a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Osteonics® FX-Cablelok™ Grip Components are intended for use with the Osteonico® FX-Cablelok" System cable and sleeve components to provide fixation of the greater trochanter secondary to osteotomy in total hip replacement arthroplasty, surface replacement arthroplasty or any hip procedure requiring a trochanteric osteotomy.
The Osteonics® FX-Cablelok™ Grip Components are indicated for trochanteric reattachment and are intended for use with the commercially available Osteonics® FX-Cablelok™ System cable and sleeve components to provide fixation of the greater trochanter secondary to osteotomy in total hip replacement arthroplasty, surface replacement arthroplasty or any hip procedure requiring a trochanteric osteotomy.
Product codes (comma separated list FDA assigned to the subject device)
LYT, JDQ
Device Description
The subject devices are characterized by the following design features: Staple like grip design with proximal and distal hooks used in conjunction with trochanteric cable and crimp sleeves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
greater 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.
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
§ 888.3030 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
5 1898 MAY
Osteonics® FX-Cablelok™ Grip Components
510(k) Premarket Notification
1980594
510(K) SUMMARY
OSTEONICS® FX-CABLELOK™ GRIP COMPONENTS
Submission Information Name and Address of the Sponsor:
Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677
Contact Person:
Donna S. Wilson Regulatory Affairs Specialist
February 16, 1998
Date of Summary Preparation:
Device Identification Proprietary Name:
Common Name:
Bone Fixation Accessory
Osteonics® FX-Cablelok™ Grip
CFR §888.3030
Components
Predicate Device Identification
Classification Name and Reference:
The subject devices are substantially equivalent to the following competitive and/or Osteonics devices, which have previously been determined substantially equivalent by FDA:
- Howmedica Dall Miles Cable Grip System and Mini Cleat
- FX-Cablelok™ System .
Device Description
The subject devices are characterized by the following design features: Staple like grip design with proximal and distal hooks used in conjunction with trochanteric cable and crimp sleeves.
Intended Use
The Osteonics® FX-Cablelok™ Grip Components are intended for use with the Osteonico® FX-Cablelok" System cable and sleeve components to provide fixation of the greater trochanter secondary to osteotomy in total hip replacement arthroplasty, surface replacement arthroplasty or any hip procedure requiring a trochanteric osteotomy.
1
Osteonics® FX-Cablelok™ Grip Components
Indications
- Trochanteric reattachment .
Statement of Technological Comparison:
The substantial equivalence of the subject device is supported by a comparison of the subject device to the above-cited predicate devices. A comparison of the subject and predicate devices in terms of intended use, materials, and design follows:
Intended Use - Trochanteric reattachment
Materials - Cobalt chromium alloy
Design - Staple like grip design used with cable and crimp sleeves.
2
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 5 1898
Ms. Donna S. Wilson Regulatory Affairs Specialist Osteonics Corporation 59 Route 17 07401-1677 Allendale, New Jersey
Re: K980594 Osteonics® FX-Cablelok™ Grip Components Trade Name: Requlatory Class: II Product Codes: LYT and JDQ February 16, 1998 Dated: Received: February 17, 1998
Dear Ms. Wilson:
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 of the Act. The general controls provisions of the Actronian include requirements for annual reqistration, 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. ದಿ 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 action. In addition, FDA may publish further announcements 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.
3
Page 2 - Ms. Donna S. Wilson
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA asboinson in four 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K
Device Name: Osteonics® FX-Cablelok™ Grip Components
Indications For Use:
The Osteonics® FX-Cablelok™ Grip Components are indicated for trochanteric reattachment and are intended for use with the commercially available Osteonics® FX-Cablelok™ System cable and sleeve components to provide fixation of the greater trochanter secondary to osteotomy in total hip replacement arthroplasty, surface replacement arthroplasty or any hip procedure requiring a trochanteric osteotomy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| ------------------ | ---------------------------------------------------- | ---- | ---------------------- | --------------------------------------------------- |
(Per 21 CFR 801.109)
| (Division Sign-Off) | (Optional Format 1-2-96) | |
|---|---|---|
| Division of General Restorative Devices | ||
| 510(k) Number | K980594 |