(62 days)
No
The document describes a mechanical orthopedic implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a fracture fixation system designed to aid in the healing of bone fractures, which is a therapeutic purpose.
No
Explanation: The device is described as a "proximal fracture fixation system" used to provide "internal fixation" and aid in "healing" of bone fractures. This indicates a therapeutic or treatment-oriented function rather than a diagnostic one.
No
The device description explicitly states it is comprised of physical components like plates, lag screws, and a compression screw, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Osteo Compression Hip Screw System is a "proximal fracture fixation system" used for "internal fixation" of bone fractures. This is a surgical device used in vivo (within the body) to treat a physical condition.
- Device Description: The description details components like "compression hip screw plates, lag screws, and a compression screw," which are all physical implants used in surgery.
- Anatomical Site: The device is used on the "proximal femur, femoral head, femoral neck," which are parts of the human skeletal system.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose a disease or condition. The device is a treatment, not a diagnostic tool.
Therefore, based on the provided information, the Osteo Compression Hip Screw System is a surgical implant for fracture fixation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Osteo Compression Hip Screw System is cleared for use via 510(k)s #K971654, #K971321 and #K920037 for the following indications: Intertrochanteric femoral fractures and intracapsular femoral neck fractures. The expanded indications for the Osteo Compression Hip Screw System include: extracapsular fractures of the proximal femur (basal neck fractures, trochanteric fractures, and subtrochanteric fractures).
The Osteo Compression Hip Screw System is a proximal fracture fixation system, comprised of compression hip screw plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. It is a system which optimally engages the femoral head and permits impaction of bone fracture fragments. The Osteo I-C Humeral Nail System is intended for single use only.
Indications:
Cleared via 510(k)s #K971654, #K971321, #K920037
- Intracapsular fractures of the femoral neck
- Intertrochanteric fractures
Expanded Indication (the subject of this premarket notification)
- Extracapsular fractures of the proximal femur:
- basal neck fractures
- trochanteric fractures
- subtrochanteric fractures
Product codes
HRS, HWC
Device Description
The Osteo Compression Hip Screw System is a proximal fracture fixation system, comprised of compression hip screw plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. Osteo Cortical Bone Screws may be utilized with this system for additional compression and fixation. This system is utilized as an aid to healing, not as a substitute for normal intact tissues. The design and materials for the Osteo Compression Hip Screw System are determined to be substantially equivalent via 510(k)s #K971654, #K971321 and #K920037, and remain unchanged from these previous submissions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur; femoral neck; femoral head
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)
The expanded indication of the subject components of the Osteo Compression Hip Screw System, which is the subject of this premarket notification, are substantially equivalent to the indications of the components of the Synthes DHS® Dynamic Hip Screw System.
Reference Device(s)
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
SEP 2 2 1998
982553
Osteo Compression Hip Screw System - Expanded Indication
510(k) Premarket Notification
510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEO COMPRESSION HIP SCREW SYSTEM - EXPANDED INDICATION
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: | Marybeth Naughton
Regulatory Affairs Team Member |
| Date Summary Prepared: | July 17, 1998 |
Device Identification
| Proprietary Name: | Osteo Compression Hip Screw System |
|---|---|
| Common Name: | Compression Hip Screw Plate and Screw |
| Classification Name and Reference: | Single/Multiple Component Metallic Bone |
| Fixation Appliances and Accessories | |
| 21 CFR §888.3030 |
Predicate Device Identification
The expanded indication of the subject components of the Osteo Compression Hip Screw System, which is the subject of this premarket notification, are substantially equivalent to the indications of the components of the Synthes DHS® Dynamic Hip Screw System.
Device Description
The Osteo Compression Hip Screw System is a proximal fracture fixation system, comprised of compression hip screw plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. Osteo Cortical Bone Screws may be utilized with this system for additional compression and fixation. This system is utilized as an aid to healing, not as a substitute for normal intact tissues. The design and materials for the Osteo Compression Hip Screw System are determined to be substantially equivalent via 510(k)s #K971654, #K971321 and #K920037, and remain unchanged from these previous submissions.
1
Intended Use
The Osteo Compression Hip Screw System is cleared for use via 510(k)s #K971654, #K971321 and #K920037 for the following indications: Intertrochanteric femoral fractures and intracapsular femoral neck fractures. The expanded indications for the Osteo Compression Hip Screw System include: extracapsular fractures of the proximal femur (basal neck fractures, trochanteric fractures, and subtrochanteric fractures).
Statement of Technological Comparison
The subject Osteo Compression Hip Screw System components are substantially equivalent in intended use to the predicate devices offered by Synthes in their DHS® Dynamic Hip Screw System.
(Divir ' Div ... . . . . 510(k) Number_
2
Image /page/2/Picture/2 description: The image shows a logo for the Department of Health. The logo features a stylized human head in profile, with three wavy lines representing the hair and face. The words "DEPARTMENT OF HEALTH" are written vertically along the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 1998
Ms. Marybeth Naughton Regulatory Affairs Team Member Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
Re : K982553 Trade Name: Osteo Compression Hip Screw System Regulatory Class: II Product Code: HRS, HWC Dated: July 21, 1998 Received: July 22, 1998
Dear Ms. Naughton:
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). F 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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. Marybeth Naughton
This letter will allow you to begin marketing your device as described in your 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 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 at (301) 443-6597, or at its Internet address
"http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia 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): K971654, K971321, K920037
Device Name: Osteo Compression Hip Screw - Expanded Indication
Indications For Use:
The Osteo Compression Hip Screw System is a proximal fracture fixation system, comprised of compression hip screw plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. It is a system which optimally engages the femoral head and permits impaction of bone fracture fragments. The Osteo I-C Humeral Nail System is intended for single use only.
Indications:
Cleared via 510(k)s #K971654, #K971321, #K920037
-
Intracapsular fractures of the femoral neck
- ♪ Intertrochanteric fractures
Expanded Indication (the subject of this premarket notification)
- Extracapsular fractures of the proximal femur:
- ♪ basal neck fractures
- ♪ trochanteric fractures
-
subtrochanteric fractures
(PLEASE DO NOT WRITE BFLOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (per 21 CFR 801.109( | X |
|---|---|
| OR | |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K982553 |
|---|---|
| --------------- | --------- |