(90 days)
Synthes® Dynamic Condylar Screw System
Not Found
No
The description focuses on mechanical components for fracture fixation and does not mention any AI/ML capabilities or related concepts like image processing, training/test sets, or performance metrics associated with AI/ML.
No
This device provides mechanical support for healing fractures of the distal femur and is not intended to treat or cure a disease or condition.
No
The device description indicates it is a "distal fracture fixation system" used for "internal fixation" and as an "aid to healing" for fractures, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly states it is comprised of physical components like plates and screws, which are hardware, 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 that the device is a "distal fracture fixation system" used for "internal fixation" of fractures in the distal femur. This describes a surgical implant used to stabilize bone, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description reinforces that it's a system of plates and screws for bone fixation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Osteo Compression Condyle Screw System-is a distal 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 Osteo Compression Condyle Screw System is indicated for the following fractures of the distal femur:
- Intercondylar fractures .
- . Supracondylar fractures
- . Unicondylar fractures
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Osteo Compression Condyle Screw System is a distal 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.
Osteo Compression Condyle Plates:
The Osteo Compression Condyle Plates are part of the Osteo Compression Condyle Screw System. These plates are fabricated from ASTM F-138 Stainless Steel (Grade 2, 316LVM), and are offered both non-sterile. The Osteo Compression Condyle Plates are available in four (4) sizes with varying lengths and number of screw holes (6, 8, 10, and 12) for varied clinical situations. All plates have a 25mm barrel length and autocompression holes for cortical screws with a 4.5mm diameter. The two screw holes closest to the barrel also accommodate cancellous screws with a 6.5mm diameter. The plates feature a 95° barrel angle. The barrel slides over the inserted lag screw; a compression screw may be used for additional compression of the fracture area.
Osteo Lag Screws:
The Osteo Lag Screws which are the included as part of this premarket notification are available in three lengths (50mm, 55mm, and 60mm). Osteo Lag Screws of longer lengths, up to 145mm, have been cleared under a previous premarket notification. The subject Osteo Lag Screws are fabricated from ASTM F-138 Stainless Steel (Grade 2, 316LVM), and are offered both non-sterile and sterile. All lag screws have a 22mm thread length for maximum purchase, a thread diameter of 12.5mm, and a cannulated end for ease of use with guide instrumentation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal 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): 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.
Synthes® Dynamic Condylar Screw System.
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.
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K971321 । of 2
Osteo Compression Condyle Screw System
510(k) Premarket Notification
510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEO COMPRESSION CONDYLE SCREW SYSTEM
JUL - 9 1997
Submission Information
Name and Address of the Sponsor Osteonics Corporation of the 510(k) Submission: 59 Route 17 Allendale, NJ 07401-1677 201-825-4900 Donna S. Wilson Contact Person: Regulatory Affairs Specialist April 9, 1997 Date Summary Prepared: Device Identification Osteo Compression Condyle Screw System Proprietary Name: Compression Condyle Plate and Screw Common Name: Single/Multiple Component Metallic Bone Classification Name and Reference: Fixation Appliances and Accessories 21 CFR §888.3030
Predicate Device Identification
The Osteo Compression Condyle Screw System is substantially equivalent to the Synthes® Dynamic Condylar Screw System.
Device Description
The Osteo Compression Condyle Screw System is a distal 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.
Osteo Compression Condyle Plates:
The Osteo Compression Condyle Plates are part of the Osteo Compression Condyle Screw System. These plates are fabricated from ASTM F-138 Stainless Steel (Grade 2, 316LVM), and are offered both non-sterile. The Osteo Compression Condyle Plates are available in four (4) sizes with varying lengths and number of screw holes (6, 8, 10, and 12) for varied clinical situations. All plates have a 25mm barrel length and autocompression holes for cortical
1
Osteo Compression Condyle Screw System
screws with a 4.5mm diameter. The two screw holes closest to the barrel also accommodate cancellous screws with a 6.5mm diameter. The plates feature a 95° barrel angle. The barrel slides over the inserted lag screw; a compression screw may be used for additional compression of the fracture area.
Osteo Lag Screws:
The Osteo Lag Screws which are the included as part of this premarket notification are available in three lengths (50mm, 55mm, and 60mm). Osteo Lag Screws of longer lengths, up to 145mm, have been cleared under a previous premarket notification. The subject Osteo Lag Screws are fabricated from ASTM F-138 Stainless Steel (Grade 2, 316LVM), and are offered both non-sterile and sterile. All lag screws have a 22mm thread length for maximum purchase, a thread diameter of 12.5mm, and a cannulated end for ease of use with guide instrumentation.
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.
Statement of Technological Comparison
The subject Osteo Compression Condyle Screw System components (compression condyle plates and lag screws) are substantially equivalent in design, materials, and intended use to the predicate devices offered by Synthes in their Dynamic Condylar Screw System.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Donna S. Wilson Regulatory Affairs Specialist Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
JUL - 9 1997
Re : K971321 Osteo Compression Condyle Screw System Regulatory Class: II Product Codes: HRS and HWC Dated: April 9, 1997 Received: April 10, 1997
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlation (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 requlation 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 requlations.
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Page 2 - Ms. Donna S. Wilson
This letter will allow you to begin marketing your device as The FDA described in your 510(k) premarket notification. 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 requlation (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,
la M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K 9 7 i 32 l
Device Name: Osteo Compression Condyle Screw System
Indications For Use:
The Osteo Compression Condyle Screw System-is a distal 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 Osteo Compression Condyle Screw System is indicated for the following fractures of the distal femur:
- Intercondylar fractures .
- . Supracondylar fractures
- . Unicondylar fractures
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division | |
|---|---|
| Division | testorative Devices |
| 510(k) Number | K971321 |
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
(Optional Format 1-2-96)