(61 days)
No
The summary describes a mechanical orthopedic implant system for fracture fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is a femoral fracture fixation system used to aid in the healing of fractures, which falls under the definition of a therapeutic device.
No
Explanation: The device is described as a "femoral fracture fixation system" intended for "internal fixation" and "aid to healing" of fractures, indicating it is a therapeutic device for stabilizing bones, not a device for diagnosing medical conditions.
No
The device description explicitly states it is comprised of physical components: compression condyle plates, lag screws, and a compression screw. These are hardware components for fracture fixation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "femoral fracture fixation system" used for "internal fixation" of bone fractures. This is a surgical device used in vivo (within the body) to stabilize bone.
- Device Description: The description reinforces that it's a system of plates and screws for fixing fractures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health.
IVD devices are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device's purpose is mechanical stabilization of bone fractures, not diagnostic testing.
N/A
Intended Use / Indications for Use
The Osteo Compression Condyle Screw System is a femoral fracture fixation system, comprised of compression condyle plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. Osteo cancellous and cortical bone screws (#K913269) 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.
Indications Cleared via 510(k) #K971321 and 510(k) #K920037
- Intercondylar fractures .
- Supracondylar fractures .
- . Unicondylar fractures
Expanded Indications (the subject of this premarket notification)
Fractures of the proximal femur:
- Transverse subtrochanteric fractures .
- . Short oblique subtrochanteric fractures
- . Long oblique subtrochanteric fractures
The Osteo Compression Condyle Screw System is used in the proximal femur in situations which require a more proximal placement of the lag screw in the femoral head, which the 95 degree plate angle accommodates. This allows for the placement of one or more bone screws in the proximal fragment which is intended to result in greater stability in the proximal femur, transmission of load across the fracture site and control of the rotation of the fracture fragment
Product codes
HWC
Device Description
The Osteo Compression Condyle Screw System is a distal and proximal femoral fracture fixation system, comprised of compression condyle plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. Osteo cancellous and 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 #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
distal femur, proximal femur
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)
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
510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEO COMPRESSION CONDYLE SCREW SYSTEM-EXPANDED INDICATIONS
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: | October 6, 1998 |
| Device Identification | |
| Proprietary Name: | Osteo Compression Condyle Screw System |
| Common Name: | Compression Condyle Plate and Screw |
| Classification Name and Reference: | Single/Multiple Component Metallic BoneFixation Appliances and Accessories21 CFR §888.3030 |
Predicate Device Identification
The Osteo Compression Condyle Screw System has previously been determined substantially equivalent via 510(kOs #K971321 and #K920037. The expanded indications are substantially equivalent to those of the Synthes® Dynamic Condylar Screw System.
Device Description
The Osteo Compression Condyle Screw System is a distal and proximal femoral fracture fixation system, comprised of compression condyle plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. Osteo cancellous and 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 #K920037 and remain unchanged from these previous submissions.
1
Intended Use
....
The Osteo Compression Condyle Screw System is indicated for the following fractures of the distal femur: Intercondylar fractures, Supracondylar fractures, and Unicondylar fractures and for the following fractures of the proximal femur: Transverse subtrochanteric fractures, and long and short subtrochanteric fractures.
Statement of Technological Comparison
The subject Osteo Compression Condyle Screw System components (compression condyle plates and lag screws) have been previously determined substantially equivalent in design and materials, and are substantially equivalent with regard to intended use to the predicate devices offered by Synthes in their Dynamic Condylar Screw System.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble a ribbon or banner. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1998 DEC
Ms. Marybeth Naughton Regulatory Affairs Team Member Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
K983508 Re: Osteo Compression Condyle Screw System - Expanded Indications Regulatory Class: II Product Code: HWC Dated: November 11, 1998 Received: November 12, 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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. 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 requlations.
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 (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
K983508
510(k) Number (if known): K#K920037, #K971321-
Device Name: Osteo Compression Condyle Screw System - Expanded Indications
Indications for Use:
The Osteo Compression Condyle Screw System is a femoral fracture fixation system, comprised of compression condyle plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. Osteo cancellous and cortical bone screws (#K913269) 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.
Indications
Cleared via 510(k) #K971321 and 510(k) #K920037
- Intercondylar fractures .
- Supracondylar fractures .
- . Unicondylar fractures
Expanded Indications (the subject of this premarket notification)
Fractures of the proximal femur:
- Transverse subtrochanteric fractures .
- . Short oblique subtrochanteric fractures
- . Long oblique subtrochanteric fractures
The Osteo Compression Condyle Screw System is used in the proximal femur in situations which require a more proximal placement of the lag screw in the femoral head, which the 95 degree plate angle accommodates. This allows for the placement of one or more bone screws in the proximal fragment which is intended to result in greater stability in the proximal femur, transmission of load across the fracture site and control of the rotation of the fracture fragment
(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)
scosella
(Division Sign-Off
Division of General Restorative Devdass K983508
510(k) Number.