(76 days)
Not Found
No
The device description focuses solely on the physical components and materials of a surgical screw system, with no mention of software, algorithms, or data processing.
Yes
The device is a screw system used to treat various fractures and joint disruptions, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
Explanation: This device is a surgical implant (cannulated screws and washer) used to stabilize fractures and joint disruptions. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly details physical hardware components (screws and a washer) made of Titanium 6Al-4V alloy, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the fixation of bone fractures and joint fusions within the human body. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a system of screws and a washer made of titanium. These are physical implants used to stabilize bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are used in vitro (outside the body) to perform diagnostic tests. This device is used in vivo (inside the body) for surgical treatment.
N/A
Intended Use / Indications for Use
The Osteo Cannulated Screw System is indicated for the following:
- Intracapsular fractures of the femoral neck .
- . Intertrochanteric fractures of the femur
- Tibial plateau fractures .
- Fractures of the dorsal pelvic ring .
- Pelvic sacroiliac joint disruptions .
- Ankle arthrodesis .
Product codes
HWC
Device Description
The Osteo Cannulated Screw System consists of three self-tapping cannulated screws of various lengths, and one washer, which can accommodate any one of the three screws. All devices in the system are provided both sterile. The three screws and washer are manufactured from Titanium 6Al-4V alloy. Two of the three screws have a thread diameter of 6.5mm. One of the two 6.5mm screws has a thread length of 20mm, while the other has a thread length of 40mm. The third screw has an 8.0mm thread diameter and a 25mm thread length. The washer has an outer diameter of 14mm and an inner diameter of 7.5mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral neck, Femur, Tibial plateau, dorsal pelvic ring, Pelvic sacroiliac joint, Ankle
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)
Smith & Nephew 6.5mm Universal Cannulated Screw System, Smith & Nephew 8.0mm Cannulated Screw System, Synthes 7.3mm Cannulated Screw System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
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.(b)
Classification. Class II.
0
JUL 30 par
K471800 1 of 2
Osteo Cannulated Screw System
510(k) Premarket Notification
510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEO CANNULATED SCREW SYSTEM
Submission Information
| Name and Address of the Sponsor of the 510(k) Submission: | Osteonics Corporation
59 Route 17
Allendale, NJ 07401-1677
201-825-4900 |
|-----------------------------------------------------------|----------------------------------------------------------------------------------|
| Contact Person: | Kate Sutton
Regulatory Affairs Specialist |
| Date Summary Prepared: | May 14, 1997 |
Device Identification
| Proprietary Name: | Osteo Cannulated Screw System |
|---|---|
| Common Name: | Cannulated Screws |
| Classification Name and Reference: | Smooth or Threaded Metallic Bone Fixation Fastener |
| 21 CFR §888.3040 |
Predicate Device Identification
The subject components of the Osteo Cannulated Screw System are substantially equivalent to the components of the Smith & Nephew 6.5mm Universal Cannulated Screw System, the Smith & Nephew 8.0mm Cannulated Screw System, and the Synthes 7.3mm Cannulated Screw System.
Device Description
The Osteo Cannulated Screw System consists of three self-tapping cannulated screws of various lengths, and one washer, which can accommodate any one of the three screws. All devices in the system are provided both sterile. The three screws and washer are manufactured from Titanium 6Al-4V alloy. Two of the three screws have a thread diameter of 6.5mm. One of the two 6.5mm screws has a thread length of 20mm, while the other has a thread length of 40mm. The third screw has an 8.0mm thread diameter and a 25mm thread length. The washer has an outer diameter of 14mm and an inner diameter of 7.5mm.
1
Osteo Cannulated Screw System
} Intended Use
The Osteo Cannulated Screw System is indicated for the following:
- Intracapsular fractures of the femoral neck .
- . Intertrochanteric fractures of the femur
- Tibial plateau fractures .
- Fractures of the dorsal pelvic ring .
- Pelvic sacroiliac joint disruptions .
- Ankle arthrodesis .
Statement of Technological Comparison
The subject Osteo Cannulated Screw System components are substantially equivalent in design and intended use to the predicate devices offered by Smith & Nephew Richards and Synthes. Both the subject screws and some predicate Synthes screws are manufactured from Titanium alloys.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. 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 left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kate Sutton Requlatorv Affairs Specialist - Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
Re : K971800 Osteo Cannulated Screw System JUL 30 1997 Regulatory Class: II Product Code: HWC Dated: May 14, 1997 Received: May 15, 1997
Dear Ms. Sutton:
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 Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Note that labeling or otherwise promoting a device for pedicular screw fixation/attachment would cause the device to be adulterated under 501(f)(1) of the Act. This device, if intended for use in pedicular screw fixation/attachment, would be found not substantially equivalent and would be a class III device under Section 513(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:
3
- The package insert must prominently state that the device 1. is intended for the specific use(s) described in the enclosure only; and
- You may not label or in any way promote this device for 2. pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. If this device is a screw with outer diameters of 3 mm - 10 mm and overall lengths of 10 mm - 75 mm inclusively, the package insert must include the following statement, "WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine." Any pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conduct of the investigation.
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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, 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 In addition, FDA may publish further announcements action. 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.
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Page 3 - Ms. Kate Sutton
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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
5
510(k) Number (if known): K971800
Device Name: Osteo Cannulated Screw System
Indications For Use:
ﻟﻤﺴ
ﻤﺴﺎ
ﻟﻤﺴﻴﺴﻴﺔ
The indications for the use of these cannulated screws, in keeping with those of other legally marketed cannulated screws, are as follows.
The Osteo Cannulated Screw System is indicated for the following:
- Intracapsular fractures of the femoral neck .
- Intertrochanteric fractures of the femur .
- Tibial plateau fractures .
- . Fractures of the dorsal pelvic ring
- Pelvic sacroiliac joint disruptions .
- Ankle arthrodesis .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off) of General Restorative Devices Division 510(k) Number 71800